THE DIAGNOSIS AND TREATMENT OF ACUTE … DIAGNOSIS AND TREATMENT OF ACUTE ACHILLES TENDON RUPTURE...
Transcript of THE DIAGNOSIS AND TREATMENT OF ACUTE … DIAGNOSIS AND TREATMENT OF ACUTE ACHILLES TENDON RUPTURE...
THE DIAGNOSIS AND TREATMENT OF ACUTE
ACHILLES TENDON RUPTURE
GUIDELINE AND EVIDENCE REPORT
Adopted by the American Academy of Orthopaedic Surgeons Board of Directors December 4, 2009
Disclaimer This Clinical Practice Guideline was developed by an AAOS physician volunteer Work Group based on a systematic review of the current scientific and clinical information and accepted approaches to treatment and/or diagnosis. This Clinical Practice Guideline is not intended to be a fixed protocol, as some patients may require more or less treatment or different means of diagnosis. Clinical patients may not necessarily be the same as those found in a clinical trial. Patient care and treatment should always be based on a clinician’s independent medical judgment, given the individual patient’s clinical circumstances. Disclosure Requirement In accordance with AAOS policy, all individuals whose names appear as authors or contributors to Clinical Practice Guideline filed a disclosure statement as part of the submission process. All panel members provided full disclosure of potential conflicts of interest prior to voting on the recommendations contained within this Clinical Practice Guidelines. Funding Source This Clinical Practice Guideline was funded exclusively by the American Academy of Orthopaedic Surgeons who received no funding from outside commercial sources to support the development of this document. FDA Clearance Some drugs or medical devices referenced or described in this Clinical Practice Guideline may not have been cleared by the Food and Drug Administration (FDA) or may have been cleared for a specific use only. The FDA has stated that it is the responsibility of the physician to determine the FDA clearance status of each drug or device he or she wishes to use in clinical practice. Copyright All rights reserved. No part of this Clinical Practice Guideline may be reproduced, stored in a retrieval system, or transmitted, in any form, or by any means, electronic, mechanical, photocopying, recording, or otherwise, without prior written permission from the AAOS. Published 2009 by the American Academy of Orthopaedic Surgeons 6300 North River Road Rosemont, IL 60018 First Edition Copyright 2007 by the American Academy of Orthopaedic Surgeons
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Summary of Recommendations The following is a summary of the recommendations in the AAOS’ clinical practice guideline, The Diagnosis and Treatment of Acute Achilles Tendon Rupture. The scope of this guideline is specifically limited to acute Achilles tendon rupture. This summary does not contain rationales that explain how and why these recommendations were developed nor does it contain the evidence supporting these recommendations. All readers of this summary are strongly urged to consult the full guideline and evidence report for this information. We are confident that those who read the full guideline and evidence report will also see that the recommendations were developed using systematic evidence-based processes designed to combat bias, enhance transparency, and promote reproducibility. This summary of recommendations is not intended to stand alone. Treatment decisions should be made in light of all circumstances presented by the patient. Treatments and procedures applicable to the individual patient rely on mutual communication between patient, physician and other healthcare practitioners.
1. In the absence of reliable evidence, it is the opinion of this work group that a detailed history and physical exam be performed. The physical examination should include two or more of the following tests to establish the diagnosis of acute Achilles tendon rupture:
o Clinical Thompson test (Simmonds squeeze test) o Decreased ankle plantar flexion strength o Presence of a palpable gap (defect, loss of contour) o Increased passive ankle dorsiflexion with gentle manipulation
Strength of Recommendation – Consensus* Description: The supporting evidence is lacking and requires the work group to make a recommendation based on expert opinion by considering the known potential harm and benefits associated with the treatment. A Consensus recommendation means that expert opinion supports the guideline recommendation even though there is no available empirical evidence that meets the inclusion criteria of the guideline’s systematic review.
Implications: Practitioners should be flexible in deciding whether to follow a
recommendation classified as Consensus, although they may set boundaries on alternatives. Patient preference should have a substantial influencing role.
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2. We are unable to recommend for or against the routine use of magnetic resonance imaging (MRI), ultrasound (ultrasonography), and radiograph (roentgengrams, x-rays) to confirm the diagnosis of acute Achilles tendon rupture.
Strength of Recommendation – Inconclusive Description: Evidence from a single low quality study or conflicting findings that do not allow a recommendation for or against the intervention. An Inconclusive recommendation means that there is a lack of compelling evidence resulting in an unclear balance between benefits and potential harm. Implications: Practitioners should feel little constraint in deciding whether to follow a
recommendation labeled as Inconclusive and should exercise judgment and be alert to future publications that clarify existing evidence for determining balance of benefits versus potential harm. Patient preference should have a substantial influencing role.
3. Non-operative treatment is an option for all patients with acute Achilles tendon rupture.
Strength of Recommendation: Limited Description: Evidence from two or more “Low” strength studies with consistent findings, or evidence from a single “Moderate” quality study recommending for or against the intervention or diagnostic. A Limited recommendation means the quality of the supporting evidence that exists is unconvincing, or that well-conducted studies show little clear advantage to one approach versus another. Implications: Practitioners should be cautious in deciding whether to follow a
recommendation classified as Limited, and should exercise judgment and be alert to emerging publications that report evidence. Patient preference should have a substantial influencing role.
4. For patients treated non-operatively, we are unable to recommend for or against the use of immediate functional bracing for patients with acute Achilles tendon rupture.
Strength of Recommendation: Inconclusive
Description: Evidence from a single low quality study or conflicting findings that do not allow a recommendation for or against the intervention. An Inconclusive recommendation means that there is a lack of compelling evidence resulting in an unclear balance between benefits and potential harm.
Implications: Practitioners should feel little constraint in deciding whether to follow a
recommendation labeled as Inconclusive and should exercise judgment and be alert to future publications that clarify existing evidence for determining balance of benefits versus potential harm. Patient preference should have a substantial influencing role.
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5. Operative treatment is an option in patients with acute Achilles tendon rupture.
Strength of Recommendation: Limited Description: Evidence from two or more “Low” strength studies with consistent findings, or evidence from a single “Moderate” quality study recommending for or against the intervention or diagnostic. A Limited recommendation means the quality of the supporting evidence that exists is unconvincing, or that well-conducted studies show little clear advantage to one approach versus another. Implications: Practitioners should be cautious in deciding whether to follow a
recommendation classified as Limited, and should exercise judgment and be alert to emerging publications that report evidence. Patient preference should have a substantial influencing role.
6. In the absence of reliable evidence, it is the opinion of the work group that
although operative treatment is an option, it should be approached more cautiously in patients with diabetes, neuropathy, immunocompromised states, age above 65, tobacco use, sedentary lifestyle, obesity (BMI >30), peripheral vascular disease or local/systemic dermatologic disorders.
Strength of Recommendation: Consensus Description: The supporting evidence is lacking and requires the work group to make a recommendation based on expert opinion by considering the known potential harm and benefits associated with the treatment. A Consensus recommendation means that expert opinion supports the guideline recommendation even though there is no available empirical evidence that meets the inclusion criteria of the guideline’s systematic review.
Implications: Practitioners should be flexible in deciding whether to follow a
recommendation classified as Consensus, although they may set boundaries on alternatives. Patient preference should have a substantial influencing role.
7. For patients who will be treated operatively for an acute Achilles tendon rupture, we are unable to recommend for or against preoperative immobilization or restricted weight bearing.
Strength of Recommendation: Inconclusive Description: Evidence from a single low quality study or conflicting findings that do not allow a recommendation for or against the intervention. An Inconclusive recommendation means that there is a lack of compelling evidence resulting in an unclear balance between benefits and potential harm. Implications: Practitioners should feel little constraint in deciding whether to follow a
recommendation labeled as Inconclusive and should exercise judgment and be alert to future publications that clarify existing evidence for determining balance of benefits versus potential harm. Patient preference should have a substantial influencing role.
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8. Open, limited open and percutaneous techniques are options for treating patients with acute Achilles tendon rupture.
Strength of Recommendation: Limited Description: Evidence from two or more “Low” strength studies with consistent findings, or evidence from a single “Moderate” quality study recommending for or against the intervention or diagnostic. A Limited recommendation means the quality of the supporting evidence that exists is unconvincing, or that well-conducted studies show little clear advantage to one approach versus another.
Implications: Practitioners should be cautious in deciding whether to follow a
recommendation classified as Limited, and should exercise judgment and be alert to emerging publications that report evidence. Patient preference should have a substantial influencing role.
9. We cannot recommend for or against the use of allograft, autograft, xenograft,
synthetic tissue, or biologic adjuncts in all acute Achilles tendon ruptures that are treated operatively.
Strength of Recommendation: Inconclusive Description: Evidence from a single low quality study or conflicting findings that do not allow a recommendation for or against the intervention. An Inconclusive recommendation means that there is a lack of compelling evidence resulting in an unclear balance between benefits and potential harm.
Implications: Practitioners should feel little constraint in deciding whether to follow a
recommendation labeled as Inconclusive and should exercise judgment and be alert to future publications that clarify existing evidence for determining balance of benefits versus potential harm. Patient preference should have a substantial influencing role.
10. We cannot recommend for or against the use of antithrombotic treatment for
patients with acute Achilles tendon ruptures.
Strength of Recommendation: Inconclusive Description: Evidence from a single low quality study or conflicting findings that do not allow a recommendation for or against the intervention. An Inconclusive recommendation means that there is a lack of compelling evidence resulting in an unclear balance between benefits and potential harm. Implications: Practitioners should feel little constraint in deciding whether to follow a
recommendation labeled as Inconclusive and should exercise judgment and be alert to future publications that clarify existing evidence for determining balance of benefits versus potential harm. Patient preference should have a substantial influencing role.
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11. We suggest early (≤ 2 weeks) post-operative protected weight bearing for patients with acute Achilles tendon rupture who have been treated operatively
Strength of Recommendation: Moderate Description: Evidence from two or more “Moderate” strength studies with consistent findings, or evidence from a single “High” quality study for recommending for or against the intervention. A Moderate recommendation means that the benefits exceed the potential harm (or that the potential harm clearly exceeds the benefits in the case of a negative recommendation), but the strength of the supporting evidence is not as strong. Implications: Practitioners should generally follow a Moderate recommendation but
remain alert to new information and be sensitive to patient preferences.
12. We suggest the use of a protective device that allows mobilization by 2- 4 weeks post operatively.
Strength of Recommendation: Moderate Description: Evidence from two or more “Moderate” strength studies with consistent findings, or evidence from a single “High” quality study for recommending for or against the intervention. A Moderate recommendation means that the benefits exceed the potential harm (or that the potential harm clearly exceeds the benefits in the case of a negative recommendation), but the strength of the supporting evidence is not as strong.
Implications: Practitioners should generally follow a Moderate recommendation but
remain alert to new information and be sensitive to patient preferences.
13. We are unable to recommend for or against post-operative physiotherapy for patients with acute Achilles tendon rupture
Strength of Recommendation: Inconclusive
Description: Evidence from a single low quality study or conflicting findings that do not allow a recommendation for or against the intervention. An Inconclusive recommendation means that there is a lack of compelling evidence resulting in an unclear balance between benefits and potential harm. Implications: Practitioners should feel little constraint in deciding whether to follow a
recommendation labeled as Inconclusive and should exercise judgment and be alert to future publications that clarify existing evidence for determining balance of benefits versus potential harm. Patient preference should have a substantial influencing role.
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14. In all patients with acute Achilles tendon rupture, irrespective of treatment type, we are unable to recommend a specific time at which patients can return to activities of daily living.
Strength of Recommendation: Inconclusive
Description: Evidence from a single low quality study or conflicting findings that do not allow a recommendation for or against the intervention. An Inconclusive recommendation means that there is a lack of compelling evidence resulting in an unclear balance between benefits and potential harm. Implications: Practitioners should feel little constraint in deciding whether to follow a
recommendation labeled as Inconclusive and should exercise judgment and be alert to future publications that clarify existing evidence for determining balance of benefits versus potential harm. Patient preference should have a substantial influencing role.
15. In patients who participate in sports it is an option to return them to sports within
3-6 months after operative treatment for acute Achilles tendon rupture.
Strength of Recommendation: Limited Description: Evidence from two or more “Low” strength studies with consistent findings, or evidence from a single “Moderate” quality study recommending for or against the intervention or diagnostic. A Limited recommendation means the quality of the supporting evidence that exists is unconvincing, or that well-conducted studies show little clear advantage to one approach versus another.
Implications: Practitioners should be cautious in deciding whether to follow a
recommendation classified as Limited, and should exercise judgment and be alert to emerging publications that report evidence. Patient preference should have a substantial influencing role.
16. In patients with acute Achilles tendon rupture treated non-operatively, we are
unable to recommend a specific time at which patients can return to athletic activity.
Strength of Recommendation: Inconclusive Description: Evidence from a single low quality study or conflicting findings that do not allow a recommendation for or against the intervention. An Inconclusive recommendation means that there is a lack of compelling evidence resulting in an unclear balance between benefits and potential harm. Implications: Practitioners should feel little constraint in deciding whether to follow
a recommendation labeled as Inconclusive and should exercise judgment and be alert to future publications that clarify existing evidence for determining balance of benefits versus potential harm. Patient preference should have a substantial influencing role.
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* While we strongly encourage reviewers to read the full guideline, please refer to the sections titled “Judging the Quality of Evidence” and “Defining the Strength of the Recommendations Table 1” for a detailed description of the link between the evidence supporting the Strength of a Recommendation and the language of the guideline.
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Work GroupChristopher P Chiodo MD, Chair Brigham Orthopedic Associates 75 Francis Street Boston MA 02115 Mark Glazebrook MD, Vice-Chair Queen Elizabeth Health Sciences Center Halifax Infirmary Suite 4867 1796 Summer Street Halifax NS B3H 3A7 Canada Eric Michael Bluman MD PhD Madigan Army Medical Center ATTN: MCHJ-SOP (Ortho Clinic) 9040 A Reid Street Tacoma WA 98431-1100 Bruce E Cohen MD 1783 Sterling Road Charlotte NC 28209 John E Femino MD Department of Orthopedics University of Iowa Hospital and Clinics JPP 01022 200 Hawkins Drive Iowa City IA 52242 Eric Giza MD UC Davis Dept of Orthopaedics Ambulatory Care Services Bldg 4860 Y St #3800 Sacramento, CA 95817
Guidelines and Technology Oversight Chair: William C. Watters, III, MD 6624 Fannin #2600 Houston, TX 77030 Guidelines and Technology Oversight Vice-Chair: Michael J. Goldberg, MD Department of Orthopaedics Seattle Children’s Hospital 4800 Sand Point Way NE Seattle, WA 98105 Evidence Based Practice Committee Chair: Michael Keith, MD 2500 Metro Health Drive Cleveland, OH 44109-1900 AAOS Staff: Robert H. Haralson III, MD, MBA AAOS Medical Director 6300 N River Road Rosemont, IL 60018 Charles M. Turkelson, PhD Director of Research and Scientific Affairs Janet L. Wies MPH AAOS Clinical Practice Guideline Mgr AAOS Research Analysts Laura Raymond MA - Lead Analyst Sara Anderson MPH – Lead Analyst Kevin Boyer BS Patrick Sluka MPH
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Peer Review Participation in the AAOS peer review process does not constitute an endorsement of this guideline by the participating organization or the individuals listed below nor does it is any way imply the reviewer supports this document. The following organizations participated in peer review of this clinical practice guideline and gave explicit consent to be listed as a peer review organization of this document: American Academy of Family Practitioners American Academy of Physical Medicine and Rehabilitation American College of Foot and Ankle Surgeons American Orthopaedic Foot and Ankle Society American Orthopaedic Society for Sports Medicine American Physical Therapy Association American Podiatric Medical Association Individuals who participated in the peer review of this document and gave their explicit consent to be listed as reviewers of this document are: Avrill Roy Berkman, MD Christopher R. Carcia, MD Michael Heggeness, MD Harvey Insler, MD John Kirkpatrick, MD Michael S. Lee, DPM, FACFA Angus McBryde Jr., MD Ariz R. Mehta, MD Lawrence Oloff, DPM Steven Raikin, MD Charles Reitman, MD John Richmond, MD Kevin Shea, MD Naomi Sheilds, MD Nelson F. Soohoo, MD Glenn Weinraub, DPM, FACFAS
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Table of Contents
SUMMARY OF RECOMMENDATIONS .............................................................. III
WORK GROUP ................................................................................................... X
PEER REVIEW ................................................................................................... XI
TABLE OF CONTENTS .................................................................................... XII
LIST OF TABLES ............................................................................................. XVI
I. INTRODUCTION ........................................................................................... 1
Overview........................................................................................................................................................ 1
Goals and Rationale ..................................................................................................................................... 1
Intended Users .............................................................................................................................................. 1
Patient Population ........................................................................................................................................ 2
Incidence ....................................................................................................................................................... 2
Burden of Disease ......................................................................................................................................... 2
Etiology .......................................................................................................................................................... 2
Risk Factors .................................................................................................................................................. 2
Emotional and Physical Impact of Achilles Tendon Rupture .................................................................. 2
Potential Benefits, Harms, and Contraindications .................................................................................... 2
II. METHODS ..................................................................................................... 3
Formulating Preliminary Recommendations ............................................................................................. 3
Study Inclusion Criteria ............................................................................................................................... 4
Outcomes Considered .................................................................................................................................. 4
Literature Searches ...................................................................................................................................... 5
Data Extraction ............................................................................................................................................. 6
Judging the Quality of Evidence ................................................................................................................. 6
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Defining the Strength of the Recommendations ........................................................................................ 7
Consensus Development ..............................................................................................................................10
Statistical Methods ......................................................................................................................................10
Peer Review ..................................................................................................................................................11
Public Commentary.....................................................................................................................................11
The AAOS Guideline Approval Process ....................................................................................................12
Revision Plans ..............................................................................................................................................12
Guideline Dissemination Plans ...................................................................................................................12
III. RECOMMENDATIONS AND SUPPORTING EVIDENCE ....................... 13
Recommendation 1 ......................................................................................................................................13 Summary of Evidence ...............................................................................................................................13 Excluded Articles......................................................................................................................................14 Study Quality ............................................................................................................................................15 Study Results ............................................................................................................................................16
Recommendation 2 ......................................................................................................................................17 Summary of Evidence ...............................................................................................................................18 Excluded Articles......................................................................................................................................18 Study Quality ............................................................................................................................................19 Study Results ............................................................................................................................................20
Recommendation 3 ......................................................................................................................................21 Summary of Evidence ...............................................................................................................................22 Excluded Articles......................................................................................................................................26 Study Quality ............................................................................................................................................27 Study Results ............................................................................................................................................28
Recommendation 4 ......................................................................................................................................34 Summary of Evidence ...............................................................................................................................35 Excluded Articles......................................................................................................................................38 Study Quality ............................................................................................................................................39
Recommendation 5 ......................................................................................................................................42 Summary of Evidence ...............................................................................................................................44 Excluded Articles......................................................................................................................................50 Study Quality ............................................................................................................................................55
Recommendation 6 ......................................................................................................................................59
Recommendation 7 ......................................................................................................................................60
Recommendation 8 ......................................................................................................................................61 Percutaneous vs Open Repair ...................................................................................................................62 Summary of Evidence- Percutaneous vs. Open ........................................................................................63 Limited Open vs Open Repair ..................................................................................................................64
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Summary of Evidence- Limited Open vs. Open .......................................................................................65 Excluded Articles......................................................................................................................................67 Study Quality ............................................................................................................................................69 Study Results ............................................................................................................................................73
Recommendation 9 ......................................................................................................................................77 Autograft Tissue vs Open Repair ..............................................................................................................77 Augmentation with Synthetic Tissue vs Open Repair ..............................................................................78 Summary of Evidence ...............................................................................................................................78 Excluded Articles......................................................................................................................................80 Study Quality ............................................................................................................................................82 Study Results ............................................................................................................................................86
Recommendation 10 ....................................................................................................................................90 Excluded Studies ......................................................................................................................................90
Recommendation 11 ....................................................................................................................................91 Summary of Evidence ...............................................................................................................................94 Summary of Complications ......................................................................................................................99 Excluded Articles....................................................................................................................................101 Study Quality ..........................................................................................................................................102 Study Results ..........................................................................................................................................111
Recommendation 12 ..................................................................................................................................116 Summary of Evidence .............................................................................................................................117 Summary of Complications ....................................................................................................................123 Excluded Articles....................................................................................................................................125 Study Quality ..........................................................................................................................................126 Study Results ..........................................................................................................................................131
Recommendation 13 ..................................................................................................................................136 Summary of Evidence .............................................................................................................................136 Excluded articles .....................................................................................................................................137
Recommendation 14 ..................................................................................................................................138 Summary of Evidence .............................................................................................................................138 Excluded Articles....................................................................................................................................145 Study Quality ..........................................................................................................................................147
Recommendation 15 ..................................................................................................................................150 Summary of Evidence .............................................................................................................................151 Excluded Articles....................................................................................................................................153 Study Quality ..........................................................................................................................................155
Recommendation 16 ..................................................................................................................................160 Summary of Evidence .............................................................................................................................160 Excluded Articles....................................................................................................................................163 Study Quality ..........................................................................................................................................163
Future Research ........................................................................................................................................166
Appendix I ..................................................................................................................................................168 Work Group ............................................................................................................................................168
Appendix II ................................................................................................................................................169
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Time from rupture to treatment ..............................................................................................................169
Appendix III ...............................................................................................................................................173 AAOS Bodies That Approved This Clinical Practice Guideline ............................................................173 Documentation of Approval ...................................................................................................................174
Appendix IV ...............................................................................................................................................175 Literature Searches for Primary Studies .................................................................................................175
Appendix V ................................................................................................................................................177 Study Attrition Flowchart .......................................................................................................................177
Appendix VI ...............................................................................................................................................178 Data Extraction Elements .......................................................................................................................178
Appendix VII .............................................................................................................................................179 Judging the Quality of Diagnostic Studies ..............................................................................................179 Judging the Quality of Treatment Studies ..............................................................................................180
Appendix VIII ............................................................................................................................................182 Form for Assigning Strength of Recommendation (Interventions) ........................................................182
Appendix IX ...............................................................................................................................................184 Voting by the Nominal Group Technique ..............................................................................................184
Appendix X ................................................................................................................................................185 Structured Peer Review Form .................................................................................................................185
Appendix XI ...............................................................................................................................................188 Peer Review Panel ..................................................................................................................................188 Public Commentary ................................................................................................................................189
Appendix XII .............................................................................................................................................190 Description of Symbols Used in Tables..................................................................................................190
Appendix XIII ............................................................................................................................................191 Conflict of Interest ..................................................................................................................................191
Appendix XIV ............................................................................................................................................192 References ..............................................................................................................................................192 Excluded articles after full text review ...................................................................................................197
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List of Tables Table 1 Strength of Recommendation Descriptions ........................................................... 9 Table 2 AAOS Guideline Language ................................................................................. 10 Table 3. Excluded Articles ................................................................................................ 14 Table 4. Study Quality ...................................................................................................... 15 Table 5. Sensitivity and specificity of Palpation, Calf Squeeze and Matles tests ............ 16 Table 6. Excluded Articles ................................................................................................ 18 Table 7. Study Quality ...................................................................................................... 19 Table 8. Sensitivity and Specificity .................................................................................. 20 Table 9. Operative vs. Cast – Function ............................................................................. 22 Table 10. Operative vs. Cast – Pain .................................................................................. 22 Table 11. Operative vs. Cast – Return to Work ................................................................ 23 Table 12. Operative vs. Cast - Return to Sport ................................................................ 23 Table 13. Operative vs. Cast - Rerupture .......................................................................... 23 Table 14. Operative vs. Cast - Satisfaction ....................................................................... 24 Table 15. Operative vs. Cast – Complications .................................................................. 24 Table 16. Systematic Review Summary ........................................................................... 25 Table 17. Excluded Articles .............................................................................................. 26 Table 18. Study Quality .................................................................................................... 27 Table 19. Open vs. Cast - Function................................................................................... 28 Table 20. Cast vs. Open Repair - Pain .............................................................................. 29 Table 21. Operative vs. Cast - Return to Work................................................................. 30 Table 22. Operative vs. Cast - Return to Sport ................................................................. 31 Table 23. Operative vs. Cast - Rerupture .......................................................................... 31 Table 24 Cast vs. Open - Complications .......................................................................... 32 Table 25. Cast + Functional Brace vs. Cast - Rerupture ................................................... 35 Table 26. Summary of Results - Case Series .................................................................... 35 Table 27. Summary of Systematic Reviews ..................................................................... 35 Table 28. Functional Bracing – Satisfaction (VAS) ......................................................... 36 Table 29. Functional Bracing - Satisfaction (%) .............................................................. 36 Table 30. Functional Bracing - Pain ................................................................................. 36 Table 31. Functional Bracing - Function .......................................................................... 36 Table 32. Functional Bracing - Strength ........................................................................... 37 Table 33. Functional Bracing - Return to Work and Sports ............................................. 37 Table 34. Functional Bracing - Return to Work and Sports (days) .................................. 37 Table 35. Functional Bracing - Complications ................................................................. 38 Table 36. Functional Bracing - Rerupture ........................................................................ 38 Table 37. Functional Bracing - Excluded Studies ............................................................ 38 Table 38. Study Quality - Randomized Control Trials ..................................................... 39 Table 39. Study Quality - Non-Randomized Comparative Study .................................... 39 Table 40. Study Quality - Case Series .............................................................................. 40 Table 41. Open Repair – All Outcomes ............................................................................ 44 Table 42. Open Repair - Return to work........................................................................... 44 Table 43. Open Repair - Activities of daily living ............................................................ 45 Table 44. Open Repair- Mean time until return to athletic activity .................................. 45 Table 45. Open Repair- Percent of patients able to return to activities of daily living .... 46
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Table 46. Open Repair- Percent of patients able to return to work .................................. 46 Table 47. Open Repair- Percent of patients able to return to sports ................................. 46 Table 48: Open Repair- Percent of patients with pain ..................................................... 47 Table 49. Open Repair- Percent of patients able to complete functional activities .......... 47 Table 50. Open Repair- Percent of patients with excellent satisfaction ........................... 47 Table 51. Minimally Invasive Repair- All outcomes ....................................................... 48 Table 52. Minimally Invasive Repair- Percent of Patients able to return to activity........ 48 Table 53. Minimally Invasive Repair - Percent of patients able to return to sports ......... 49 Table 54. Minimally Invasive Repair - Satisfaction ......................................................... 49 Table 55. Minimally Invasive Repair - Mean time until return to activity ....................... 49 Table 56. Minimally Invasive Repair-Percent of patients able to return to sports ........... 49 Table 57. Minimally Invasive Repair-Percent of patients able to return to work ............. 50 Table 58. Minimally Invasive Repair-Pain ....................................................................... 50 Table 59. Excluded Articles .............................................................................................. 50 Table 60. Study Quality .................................................................................................... 55 Table 61. Percutaneous and Limited Open vs. Open - Global Outcomes ........................ 63 Table 62. Percutaneous vs. Open - Return to Activities and Function ............................. 63 Table 63. Percutaneous vs. Open - Satisfaction ............................................................... 63 Table 64. Percutaneous vs. Open- Complications ........................................................... 63 Table 65. Percutaneous vs. Open- Rerupture................................................................... 64 Table 66. Minimally Invasive vs. Open- Pain ................................................................. 65 Table 67. Minimally Invasive vs. Open- Global Outcomes ............................................ 65 Table 68. Limited Open vs. Open- Return to Activity .................................................... 65 Table 69. Mini-Open vs. Open- Symptoms ..................................................................... 65 Table 70. Limited Open Repair vs. Open - Complications............................................... 66 Table 71. Mini-Open vs. Open – Rerupture ..................................................................... 66 Table 72. Excluded Studies - All Operative Techniques .................................................. 67 Table 73. Study Quality - RCTs ....................................................................................... 69 Table 74. Quality of Studies - Comparative Studies......................................................... 71 Table 75. Limited open vs. Open - Global Outcomes .................................................... 73 Table 76. Percutaneous vs. Open - Return to Activities ................................................... 73 Table 77. Percutaneous vs. Open - Satisfaction ................................................................ 73 Table 78. Percutaneous vs. Open - Complications ........................................................... 73 Table 79. Minimally Invasive vs. Open- Pain ................................................................. 74 Table 80. Minimally Invasive vs. Open- Global Outcomes ............................................ 74 Table 81. Minimally Invasive vs. Open - Function .......................................................... 74 Table 82. Minimally Invasive vs. Open - Complications ................................................. 75 Table 83. Minimally Invasive vs. Open - Symptoms ....................................................... 75 Table 84. Minimally Invasive vs. Open - Return to Sport ................................................ 76 Table 85. Minimally Invasive vs. Open - Complications ................................................. 76 Table 86. Autograft vs. Open - Pain and Stiffness ........................................................... 78 Table 87. Autograft vs. Open - Satisfaction ..................................................................... 78 Table 88. Autograft - Return to Activities and Sports ..................................................... 78 Table 89. Autograft vs. Open - Footwear Restrictions ..................................................... 79 Table 90. Autograft vs. Open - Hospitalization and Immobilization ............................... 79 Table 91. Autograft vs. Open - Complications ................................................................. 79
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Table 92. Excluded Studies - Allograft............................................................................. 80 Table 93. Excluded Studies - Autograft ............................................................................ 80 Table 94. Excluded Studies - Synthetic Tissue ................................................................. 81 Table 95- Biologic Adjuncts ............................................................................................. 81 Table 96. Study Quality – Autograft RCTs ...................................................................... 82 Table 97. Study Quality - Autograft Comparative Studies .............................................. 83 Table 98. Study Quality - Synthetic Tissue Case Series .................................................. 85 Table 99 Autograft vs. Open Pain and Stiffness ............................................................... 86 Table 100. Autograft vs. Open - Satisfaction ................................................................... 86 Table 101. Autograft vs. Open - Return to Sports ............................................................ 87 Table 102. Autograft vs. Open - Return to Activities ....................................................... 87 Table 103. Autograft vs. Open - Footwear Restrictions ................................................... 87 Table 104. Autograft vs. Open - Hospitalization vs. Immobilization ............................... 88 Table 105. Autograft vs. Open - Complications ............................................................... 88 Table 106. Synthetic Tissue - Results ............................................................................... 89 Table 107. Antithrombotic Treatment - Excluded Studies ............................................... 90 Table 108: Description of treatment groups .................................................................... 92 Table 109 Time until return to activity ............................................................................. 94 Table 110 Pain .................................................................................................................. 94 Table 111 Function ........................................................................................................... 96 Table 112 EuroQoL, Rand-36 ........................................................................................... 97 Table 113 Patient Subjective Results ................................................................................ 97 Table 114 Reruptures ........................................................................................................ 98 Table 115 Reported Complications .................................................................................. 99 Table 116 Systematic Reviews ....................................................................................... 100 Table 117 Article Inclusion List- Early weight bearing vs. non-weight bearing ............ 101 Table 118. Quality- Weight bearing vs. non-weight bearing- RCT ............................... 102 Table 119. Quality- Weight bearing vs. non-weight bearing- Comparative.................. 105 Table 120 Study Data: Weight Bearing vs. Non-Weight Bearing .................................. 111 Table 121. Description of Treatment Groups ................................................................. 117 Table 122. Time to Return to Activity ............................................................................ 117 Table 123. Pain .............................................................................................................. 119 Table 124. Function ........................................................................................................ 119 Table 125. EuroQoL, E5D, Ankle Performance Score ................................................... 120 Table 126. Patient opinion of results .............................................................................. 121 Table 127. Footwear restrictions..................................................................................... 122 Table 128. Rerupture ...................................................................................................... 122 Table 129. Early Motion vs. Cast - Complications ......................................................... 123 Table 130. Systematic Reviews ...................................................................................... 124 Table 131. Mobilization vs. Immobilization Included Articles ...................................... 125 Table 132. Mobilization vs. Immobilization Quality...................................................... 126 Table 133. Mobilization vs. Immobilization Study Data ................................................ 131 Table 134. Post Operative Physiotherapy Regiments .................................................... 136 Table 135. Excluded Articles .......................................................................................... 137 Table 136. Non-Operative treatment - Percent of patients able to return to work .......... 138 Table 137. Non-Operative Treatment -Percent of patients able to return to ADL ......... 139
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Table 138. Operative Treatment - Percent of patients returning to ADL ....................... 139 Table 139. Operative Treatment - Percent of patients able to return to work ................ 140 Table 140. Non-Operative Treatment - Mean time until return to work ........................ 142 Table 141. Non-Operative Treatment - Mean time until return to walking .................... 142 Table 142. Operative Treatment - Mean time to return to ADL ..................................... 143 Table 143. Operative Treatment - Mean time until return to work ................................ 144 Table 144. Excluded Articles .......................................................................................... 145 Table 145. Patient return to activities of daily living ...................................................... 147 Table 146. Operative Treatment - Return to Recreational Activity................................ 151 Table 147. Operative Treatment - Return to sports ........................................................ 151 Table 148. Operative Treatment - Mean time to return to athletic activity .................... 153 Table 149. Excluded Articles .......................................................................................... 153 Table 150. Return to sports ............................................................................................. 155 Table 151. Non-Operative Treatment - Percent of patients returning to athletic activity......................................................................................................................................... 160 Table 152. Non-Operative Treatment - Mean time until patients return to athletic activity......................................................................................................................................... 162 Table 153. Excluded studies ........................................................................................... 163 Table 154. Study Quality ................................................................................................ 163 Table 155. Time from injury to treatment ..................................................................... 169
xix
I. INTRODUCTION OVERVIEW This clinical practice guideline is based on a systematic review of published studies on the treatment of acute Achilles tendon rupture in adults. Adults were defined as older than 19 years of age for this guideline. Acute Achilles tendon ruptures were defined for the literature search as those treated within the first six weeks of injury to capture all applicable literature; the patient population of the majority of studies included in this guideline are patients treated within the first two weeks of injury (See Appendix II). In addition to providing practice recommendations, this guideline also highlights gaps in the literature and areas that require future research.
This guideline is intended to be used by all appropriately trained surgeons and all qualified physicians diagnosing and treating Achilles tendon ruptures. It is also intended to serve as an information resource for decision makers and developers of practice guidelines and recommendations.
GOALS AND RATIONALE The purpose of this clinical practice guideline is to help improve treatment based on the current best evidence. Current evidence-based practice (EBP) standards demand that physicians use the best available evidence in their clinical decision making. To assist in this, this clinical practice guideline consists of a systematic review of the available literature regarding the treatment of Achilles tendon ruptures. The systematic review detailed herein was conducted between December 2008 and June 2009 and demonstrates where there is good evidence, where evidence is lacking, and what topics future research must target in order to improve the treatment of patients with acute Achilles tendon ruptures. AAOS staff and the physician work group systematically reviewed the available literature and subsequently wrote the following recommendations based on a rigorous, standardized process.
Musculoskeletal care is provided in many different settings by many different providers. We created this guideline as an educational tool to guide qualified physicians through a series of treatment decisions in an effort to improve the quality and efficiency of care. This guideline should not be construed as including all proper methods of care or excluding methods of care reasonably directed to obtaining the same results. The ultimate judgment regarding any specific procedure or treatment must be made in light of all circumstances presented by the patient and the needs and resources particular to the locality or institution.
INTENDED USERS This guideline is intended to be used by orthopaedic surgeons and all qualified physicians managing patients with acute Achilles tendon rupture. Typically, orthopaedic surgeons will have completed medical training, a qualified residency in orthopaedic surgery, and some may have completed additional sub-specialty training. It is also intended to serve as an information resource for professional healthcare practitioners and developers of practice guidelines and recommendations. Diagnosis and treatment for patients with acute Achilles tendon rupture are based on the assumption that decisions are predicated on
v1.0 12.04.09 1
patient and physician mutual communication including discussion of available treatments and procedures applicable to the individual patient. Once the patient has been informed of available therapies and has discussed these options with his/her physician, an informed decision can be made. Clinician input based on experience with both conservative management and surgical skills increases the probability of identifying patients who will benefit from specific treatment options.
PATIENT POPULATION This document addresses the diagnosis and treatment of acute Achilles tendon rupture in adults (defined as patients 19 years of age and older).
INCIDENCE The incidence of Achilles tendon ruptures has been estimated to range from an annual average of 5.5 ruptures to 9.9 ruptures per 100,000 people in North America (Edmonton, Canada).1 Studies of European communities report comparable values ranging from 6 to 18 ruptures per 100,000 people.1-4
BURDEN OF DISEASE Those afflicted with an acute Achilles tendon rupture face a healing period that requires time away from work and limited athletic activity. Time away from work may impact the patient financially and limiting activity may impact the patient’s health.5
ETIOLOGY Most acute Achilles tendon ruptures are traumatic in origin. Some studies have shown that ruptured Achilles tendons have occult degeneration.3
RISK FACTORS Most ruptures of the Achilles tendons occur during sports activities, are more common in males in the third or fourth decade of life, and occur more frequently on the left side.1
EMOTIONAL AND PHYSICAL IMPACT OF ACHILLES TENDON RUPTURE Acute Achilles tendon rupture often results in sudden pain in the affected leg, the inability to bear weight and noticeable weakness of the affected ankle.3 The injury often results in the patient’s inability to walk or perform their regular activities of daily living. Patients face possible deformity if the tendon does not heal correctly and a substantial recovery period. Possible complications associated with Achilles tendon rupture include rerupture and, in cases of surgical repair, infection. POTENTIAL BENEFITS, HARMS, AND CONTRAINDICATIONS The aim of treatment is pain relief and improvement or maintenance of the patient’s functional status. Long term results were often not available and complications varied by study (frequently they were not reported) in the literature available for this guideline. Most treatments are associated with some known risks, especially invasive and operative treatments. In addition, contraindications vary widely based on the treatment administered. Therefore, discussion of available treatments and procedures applicable to
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the individual patient rely on mutual communication between the patient and physician, weighing the potential risks and benefits for that patient.
II. METHODS Each recommendation in this clinical practice guideline is based on a systematic review of the relevant medical literature. We developed systematic reviews for this guideline because these reviews employ specific processes designed to minimize bias in the selection, summary, and analysis of this literature.6, 7 In referring to bias, we explicitly mean both the biases that can arise from financial conflicts of interest and biases that can arise from intellectual conflicts if interest.
This section of the present document describes how we conducted our systematic reviews and how the guideline was developed. Accordingly, in this section we describe our strategies for finding relevant literature, our criteria for selecting articles to include in this guideline, how we extracted data, how we appraised and graded the evidence, our methods of statistical analysis, and the review and approval steps this guideline went through. Elsewhere in this document, we provide extensive documentation so that interested readers can assure themselves that we attempted to combat bias wherever possible.
This guideline and the underlying systematic reviews were prepared by an AAOS physician work group with the assistance of the AAOS Clinical Practice Guidelines Unit in the Department of Research and Scientific Affairs at the AAOS (Appendix I). The work group met on December 13, 2008 to establish the guideline’s scope. The work group met again on July 31 and August 1, 2009 to write and vote on the final recommendations and rationales for each recommendation. The resulting draft guidelines were then peer-reviewed, subsequently sent for public commentary, and then sequentially approved by the AAOS Evidence Based Practice Committee, AAOS Guidelines and Technology Oversight Committee, AAOS Council on Research, Quality Assessment, and Technology, and the AAOS Board of Directors (see Appendix III for a description of the AAOS bodies involved in the approval process)
FORMULATING PRELIMINARY RECOMMENDATIONS The work group began work on this guideline by constructing a set of preliminary recommendations. These recommendations specify [what] should be done in [whom], [when], [where], and [how often or how long]. They function as questions for the systematic review that underpins each preliminary recommendation, and they do not function as final recommendations or conclusions. Preliminary recommendations do not need to be true.
Once established, these a priori preliminary recommendations cannot be modified until the final work group meeting. The a priori and inviolate nature of the preliminary recommendations combats bias by preventing a “change in course” if a systematic review yields results that are not to someone’s liking. The results of each systematic review are presented and discussed at the final work group meeting. At this time the preliminary recommendations are modified in response to the evidence in the systematic review. All
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of the systematic reviews conducted for a given guideline are presented in it and, in general, all preliminary recommendations are modified.
STUDY INCLUSION CRITERIA We developed a priori article inclusion criteria for our review. These criteria are our “rules of evidence” and articles that do not meet them are, for the purposes of this guideline, not evidence.
To be included in our systematic reviews (and hence, in this guideline) an article had to be a report of a study that:
• Evaluated a treatment for acute Achilles tendon rupture. Acute Achilles tendon ruptures are defined as a rupture treated within zero to six weeks post injury.
• Was a full report of a clinical study and was published in the peer reviewed literature
• Was an English language article published after 1965
• Was not a cadaveric, animal, in vitro, or biomechanical study
• Was not a retrospective case series, medical records review, meeting abstract, unpublished study report, case report, historical article, editorial, letter, or commentary
• Was the most recent report of a study or the report with the largest number of enrolled patients in a study with multiple publications
• Enrolled ≥ 10 patients in each of its study groups
• Enrolled a patient population comprised of at least 80% of patients with acute Achilles tendon rupture
• Reported quantified results
• Must have followed 50% or more of its patients on at least one outcome; if less than 80% follow up the outcome was down graded.
• Study must use validated outcome measures
When considering studies for inclusion, we included only the best available evidence. Accordingly, we first included Level I evidence. In the absence of two or more studies of this Level, we sequentially searched for and included Level II through Level IV evidence, and did not proceed to a lower level if there were two or more studies of a higher level. For example, if there were two Level II studies that addressed a recommendation, we did not include Level III or IV studies.
OUTCOMES CONSIDERED Clinical studies often report many different outcomes. We included only patient-oriented outcomes when they were available. As the term implies, patient-oriented outcomes are
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outcomes that matter to the patient. “They tell clinicians, directly and without the need for extrapolation, that a diagnostic, therapeutic, or preventive procedure helps patients live longer or live better.”8 Examples of patient-oriented outcomes include pain and quality of life.
We included surrogate outcomes only when patient-oriented outcomes were not available. Surrogate outcomes are laboratory or other measurements that are used as substitutes for how a patient feels, functions, or survives.9 Radiographic results are an example of a surrogate outcome.
We only included data for an outcome if ≥ 50% of the patients were followed for that outcome. For example, some studies report short-term outcomes data on nearly all enrolled patients, and report longer-term data on less than half of the enrolled patients. In such cases, we did not include the longer-term data. Additionally, we downgraded the Level of Evidence by one in instances where 50% to ≤80% of patients were followed. For example, if an otherwise perfect randomized controlled trial reported data on all enrolled patients one week after patients received a treatment but reported data on only 60% of patients one year later, we considered data from the later follow-up time as Level II evidence.
We only included data for outcomes reporting the average length of time to return to an activity if >80 % of the patients were included in the calculation. For example, some studies report the mean time for return to work as 6 weeks but are only including data for patients who have actually returned to work and are ignoring patients who are unable to return. An outcome such as this would not be included.
LITERATURE SEARCHES We attempted to make our searches for articles comprehensive. Using comprehensive literature searches ensures that the evidence we considered for this guideline is not biased for (or against) any particular point of view.
We searched for articles published from January 1966 to June 2009. Strategies for searching electronic databases were constructed by a Medical Librarian and reviewed by the work group. The search strategies we used are provided in Appendix IV. We searched six electronic databases; PubMed, EMBASE, CINAHL, The Cochrane Library, The National Guidelines Clearinghouse and TRIP database.
All searches of electronic databases were supplemented with manual screening of bibliographies of all retrieved publications. We also searched the bibliographies of recent systematic reviews and other review articles for potentially relevant citations. Finally, a list of potentially relevant studies not identified by our searches was provided by the work group members. Fifty-six studies met the inclusion criteria and were included.
A study attrition diagram (provided in Appendix V) documents, for each recommendation, the number of articles we identified, where we identified these articles, the number of articles we included, and the number of articles we excluded.
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DATA EXTRACTION Data elements extracted from studies were defined in consultation with the physician work group. Two analysts completed data extraction independently for all studies. The evidence tables were audited by the work group. Disagreements about the accuracy of extracted data were resolved by consensus. The elements extracted are provided in Appendix VI.
The use of extracted data in our systematic reviews is another of our methods to combat bias. It ensures that our results are based on the numerical results reported in published articles and not on the authors’ conclusions in the “Discussion Sections” of their articles. Such author conclusions can be influenced by bias.
JUDGING THE QUALITY OF EVIDENCE Determining the quality of the included evidence is vitally important when preparing any evidence-based work product. Doing so conveys the amount of confidence one can have in any study’s results. One has more confidence in high quality evidence than in low quality evidence.
We assessed the quality of the evidence for each outcome at each time point reported in a study. We did not simply assess the overall quality of a study. Our approach follows the recommendations of the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) working group10 as well as others.11
We evaluated quality on a per outcome basis rather than a per study basis because quality is not necessarily the same for all outcomes and all follow-up times reported in a study. For example, a study might report results immediately after patients received a given treatment and after some period of time has passed. Often, nearly all enrolled patients contribute data at early follow-up times but, at much later follow-up times, only a few patients may contribute data. One has more confidence in the earlier data than in the later data. The fact that we would assign a higher quality score to the earlier results reflects this difference in confidence.
We assessed the quality of treatment studies using a two step process. First, we assigned a Level of Evidence to all results reported in a study based solely on that study’s design. Accordingly, all data presented in randomized controlled trials were initially categorized as Level I evidence, all results presented in non-randomized controlled trials and other prospective comparative studies were initially categorized as Level II, all results presented in retrospective comparative and case-control studies were initially categorized as Level III, and all results presented in case-series reports were initially categorized as Level IV. We next assessed each outcome at each reported time point using a quality questionnaire and, when quality standards were not met, downgraded the Level of evidence (for this outcome at this time point) by one level (Appendix VII).
In studies investigating a diagnostic test, we used the Quality Assessment of Diagnostic Accuracy Studies (QUADAS) instrument to identify potential bias and assess variability and the quality of reporting in studies reporting the effectiveness of diagnostic techniques. We utilized a two step process to assess the quality of diagnostic studies. All
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studies enrolling a prospective cohort of patients are initially categorized as Level I studies. Any study that did not enroll the appropriate spectrum of patients (e.g. case-control studies) was initially categorized as a Level IV study. A study that we determined contained methodological flaws (i.e. QUADAS question answered ‘no’) that introduce bias were downgraded in a cumulative manner for each known bias (Appendix VII). For example, a study that is determined by the QUADAS instrument to have two biases is downgraded to Level III and a study that is determined to have four or more biases is downgraded to a Level V study. Those studies that do not sufficiently report their methods for a potential bias are downgraded to Level II since we are unable to determine if the bias did or did not bias the results of the study.
Assigning a Level of Evidence on the basis of study design plus other quality characteristics ties the Levels of Evidence we report more closely to quality than Levels of Evidence based only on study design. Because we tie quality to Levels of Evidence, we are able to characterize the confidence one can have in their results. Accordingly, we characterize the confidence one can have in Level I evidence as high, the confidence one can have in Level II and III evidence as moderate, and the confidence one can have in Level IV and V evidence as low.
DEFINING THE STRENGTH OF THE RECOMMENDATIONS Judging the quality of evidence is only a stepping stone towards arriving at the strength of the guideline recommendation. Unlike Levels of Evidence (which apply only to a given result at a given follow-up time in a given study) strength of the recommendation takes into account the quality, quantity, and applicability of the available evidence. Strength of the recommendation also takes into account the trade-off between the benefits and harms of a treatment or diagnostic procedure, and the magnitude of a treatment’s effect.
The strength of a recommendation expresses the degree of confidence one can have in a recommendation. As such, the strength expresses how possible it is that a recommendation will be overturned by future evidence. It is very difficult for future evidence to overturn a recommendation that is based on many high quality randomized controlled trials that show a large effect. It is much more likely that future evidence will overturn recommendations derived from a few small case series. Consequently, recommendations based on the former kind of evidence are rated as “strong” and recommendations based on the latter kind of evidence are given strength of recommendation of “limited”.
To develop the strength of a recommendation, AAOS staff first assigned a preliminary strength rating for each recommendation that took only the quality and quantity of the available evidence into account (see Table 1).Work group members then modified the preliminary strength rating using the ‘Form for Assigning Grade of Recommendation (Interventions)’ shown in Appendix VIII. This form is based on recommendations of the GRADE Working group10 and requires the work group to consider the harms, benefits, and critical outcomes associated with a treatment. It also requires the work group to evaluate the applicability of the evidence. The final strength of the recommendation is assigned by the physician work group, which modifies the preliminary strength rating on
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1 The AAOS will issue a consensus-based recommendation only when the service in question has virtually no associated harm and is of low cost (e.g. a history and physical) or when not establishing a recommendation could have catastrophic consequences.
Table 1 Strength of Recommendation Descriptions
Statement Rating
Description of Evidence Strength Implication for Practice
Strong
Evidence is based on two or more “High” strength studies with consistent findings for recommending for or against the intervention. A Strong recommendation means that the benefits of the recommended approach clearly exceed the potential harm (or that the potential harm clearly exceeds the benefits in the case of a strong negative recommendation), and that the strength of the supporting evidence is high.
Practitioners should follow a Strong recommendation unless a clear and compelling rationale for an alternative approach is present.
Moderate
Evidence from two or more “Moderate” strength studies with consistent findings, or evidence from a single “High” quality study for recommending for or against the intervention. A Moderate recommendation means that the benefits exceed the potential harm (or that the potential harm clearly exceeds the benefits in the case of a negative recommendation), but the strength of the supporting evidence is not as strong.
Practitioners should generally follow a Moderate recommendation but remain alert to new information and be sensitive to patient preferences.
Limited
Evidence from two or more “Low” strength studies with consistent findings, or evidence from a single Moderate quality study recommending for or against the intervention or diagnostic. A Limited recommendation means the quality of the supporting evidence that exists is unconvincing, or that well-conducted studies show little clear advantage to one approach versus another.
Practitioners should be cautious in deciding whether to follow a recommendation classified as Limited, and should exercise judgment and be alert to emerging publications that report evidence. Patient preference should have a substantial influencing role.
Inconclusive Evidence from a single low quality study or conflicting findings that do not allow a recommendation for or against the intervention. An Inconclusive recommendation means that there is a lack of compelling evidence resulting in an unclear balance between benefits and potential harm.
Practitioners should feel little constraint in deciding whether to follow a recommendation labeled as Inconclusive and should exercise judgment and be alert to future publications that clarify existing evidence for determining balance of benefits versus potential harm. Patient preference should have a substantial influencing role.
Consensus1
The supporting evidence is lacking and requires the work group to make a recommendation based on expert opinion by considering the known potential harm and benefits associated with the treatment. A Consensus recommendation means that expert opinion supports the guideline recommendation even though there is no available empirical evidence that meets the inclusion criteria.
Practitioners should be flexible in deciding whether to follow a recommendation classified as Consensus, although they may set boundaries on alternatives. Patient preference should have a substantial influencing role.
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Each recommendation was written using language that accounts for the final strength of the recommendation. This language, and the corresponding strength of recommendation, is shown in Table 2.
Table 2 AAOS Guideline Language
Guideline Language Strength of Recommendation
We recommend Strong
We suggest Moderate
Is an option Limited
We are unable to recommend for or against Inconclusive In the absence of reliable evidence, it is the
opinion of this work group Consensus
CONSENSUS DEVELOPMENT The recommendations and their strength were voted on using a structured voting technique known as the nominal group technique.12 We present details of this technique in Appendix . Voting on guideline recommendations was conducted using a secret ballot and work group members were blinded to the responses of other members. If disagreement between work group members was significant, there was further discussion to see whether the disagreement(s) could be resolved. Up to three rounds of voting were held to attempt to resolve disagreements. If disagreements were not resolved following three voting rounds, no recommendation was adopted. Lack of agreement is a reason that the strength for some recommendations is labeled “Inconclusive.”
STATISTICAL METHODS When possible, we report the results of the statistical analyses conducted by the authors of the included studies. In some circumstances, statistical testing was not conducted; however, the authors reported sufficient quantitative data, including measures of dispersion or patient level data for statistical testing. In these circumstances we used the statistical program STATA (StatCorp LP, College Station, Texas) to conduct our own analysis to interpret the results of a study. P-values < 0.05 were considered statistically significant. Any statistical analysis conducted by the AAOS authors is denoted in the tables.
STATA was also used to determine 95% confidence intervals, using the method of Wilson, when authors of the included studies reported counts or proportions. The program was also used to determine the magnitude of the treatment effect. For data reported as means (and associated measures of dispersion) we calculated a standardized mean difference by the method of Hedges and Olkin.13 For proportions, we calculated the odds ratio as a measure of treatment effect. When no events occur (“zero event”) in a proportion, the variance of the arcsine difference was used to determine statistical significance (p < 0.05).14
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We used the program TechDig 2.0 (Ronald B. Jones, Mundelein, Illinois) to estimate means and variances from studies presenting data only in graphical form.
When published studies only reported the median, range, and size of the trial, we estimated their means and variances according to a published method.15
PEER REVIEW The draft of the guideline and evidence report were peer reviewed by outside specialty organizations that were nominated by the physician work group prior to the development of the guideline. Peer review was accomplished using a structured peer review form (Appendix X).
In addition, the physician members of the AAOS Guidelines and Technology Oversight Committee, the Evidence Based Practice Committee and the Chairpersons of the AAOS Occupational Health and Workers’ Compensation Committee and the Medical Liability Committee were given the opportunity to provide peer review of the draft document.
We forwarded the draft guideline to a total of 38 peer reviewers and 17 returned reviews. The disposition of all non-editorial peer review comments was documented and the guideline was modified in response to peer review. The peer reviews and the responses to them accompanied this guideline through the process of public commentary and the subsequent approval process. Peer reviewing organizations and peer reviewing individuals are listed in this document if they explicitly agree to allow us to publish this information (Appendix X).
Peer review of an AAOS guideline does not imply endorsement. This is clearly stated on the structured review form sent to all peer reviewers and is also posted within the guideline. Endorsement cannot be solicited during the peer review process because the documents may still undergo substantial change as a result of both the peer review and public commentary processes. In addition, no guideline can be endorsed by specialty societies outside of the Academy until the AAOS Board of Directors has approved it. Organizations that provide members who participate on the work group or peer review of a draft guideline will be solicited for endorsement once the document has completed the full review and approval processes.
PUBLIC COMMENTARY After modifying the draft in response to peer review, the guideline was submitted for a thirty-day period of “Public Commentary.” Commentators consist of members of the AAOS Board of Directors (BOD), members of the Council on Research, Quality Assessment, and Technology (CORQAT), members of the Board of Councilors (BOC), and members of the Board of Specialty Societies (BOS). Based on these bodies, up to 185 commentators had the opportunity to provide input into the development of this guideline. Of these, 4 returned public comments.
For this guideline, outside specialty societies could post the confidential draft of the guideline to their “member only” website. The responses garnered from these postings were compiled by the specialty society and submitted as one succinct public commentary.
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In addition, members of the AAOS Board of Specialties (BOS) and Board of Councilors (BOC) were encouraged to provide input; including encouragement to seek input from colleagues not necessarily members of the BOS or BOC. As a result, the opportunity to comment on this guideline exceeds the number of public commentators for previously published AAOS guidelines as well as the numbers listed above.
THE AAOS GUIDELINE APPROVAL PROCESS In response to the non-editorial comments submitted during the period of public commentary, the draft was again modified by the AAOS Clinical Practice Guidelines Unit and physician work group members. The AAOS Guidelines and Technology Oversight Committee, the AAOS Evidence-based Practice Committee, the AAOS Council on Research, Quality Assessment, and Technology, and the AAOS Board of Directors approved the final guideline draft. Descriptions of these bodies are provided in Appendix III.
REVISION PLANS This guideline represents a cross-sectional view of current treatment and/or diagnosis and may become outdated as new evidence becomes available. This guideline will be revised in accordance with this new evidence, changing practice, rapidly emerging treatment options, and new technology. This guideline will be updated or withdrawn in five years in accordance with the standards of the National Guideline Clearinghouse.
GUIDELINE DISSEMINATION PLANS The primary purpose of the present document is to provide interested readers with full documentation about not only our recommendations, but also about how we arrived at those recommendations. This document is also posted on the AAOS website at http://www.aaos.org/research/guidelines/guide.asp.
Shorter versions of the guideline are available in other venues. Publication of most guidelines is announced by an Academy press release, articles authored by the work group and published in the Journal of the American Academy of Orthopaedic Surgeons, and articles published in AAOS Now. Most guidelines are also distributed at the AAOS Annual Meeting in various venues such as on Academy Row and at Committee Scientific Exhibits.
Selected guidelines are disseminated by webinar, an Online Module for the Orthopeadic Knowledge Online website, Radio Media Tours, Media Briefings, and by distributing them at relevant Continuing Medical Education (CME) courses and at the AAOS Resource Center.
Other dissemination efforts outside the AAOS include submitting the guideline to the National Guideline Clearinghouse and distributing the guideline at other medical specialty societies’ meetings.
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III. RECOMMENDATIONS AND SUPPORTING EVIDENCE RECOMMENDATION 1 In the absence of the reliable evidence, it is the opinion of this work group that a detailed history and physical exam be performed. The physical examination should include two or more of the following tests to establish the diagnosis of acute Achilles tendon rupture:
o Clinical Thompson test (Simmonds squeeze test) o Decreased ankle plantar flexion strength o Presence of a palpable gap (defect, loss of contour) o Increased passive ankle dorsiflexion with gentle manipulation
AAOS Strength of Recommendation – Consensus Description: The supporting evidence is lacking and requires the work group to make a recommendation based on expert opinion by considering the known potential harm and benefits associated with the treatment. A Consensus recommendation means that expert opinion supports the guideline recommendation even though there is no available empirical evidence that meets the inclusion criteria of the guideline’s systematic review. Implications: Practitioners should be flexible in deciding whether to follow a recommendation classified as Consensus, although they may set boundaries on alternatives. Patient preference should have a substantial influencing role. Rationale: A systematic review of the literature did not identify adequate evidence for or against the use of specific history and physical examination findings to confirm the diagnosis of acute Achilles tendon rupture. There was only one level V study16 identified that did not provide adequate data in support of any individual or combination of the physical tests.
The prompt and accurate diagnosis of acute Achilles tendon rupture is essential to providing patients with timely, effective, and appropriate care. A history and physical examination adds no cost or risk to patients. The work group therefore agreed that an opinion-based recommendation is warranted.
Supporting Evidence:
One Level V prospective study that enrolled patients with unilateral complete Achilles tendon tears was included.16
SUMMARY OF EVIDENCE The study16 used visual inspection at surgery as the gold standard for the diagnosis in patients who had open repair. The study author also used clinical exam, ultrasound and MRI as the reference standard for diagnosis when deciphering if patients had an Achilles tendon tear and to confirm the extent of the tear in patients treated non-operatively. Healthcare providers were not routinely blinded to the results of any given test. All patients received a physical examination; palpation (presence of a gap) and the calf
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squeeze test (Thompson/Simmonds squeeze test) were performed by the author in all patients. The author performed the Matles test (increased passive ankle dorsiflexion) on 107 of 174 patients.
The study author reported sensitivities and specificities for the tests based on the 133 patients treated with open repair and the 28 patients treated who did not have an Achilles tendon rupture. The author reported these test results individually. He did not consider if incremental value exists for any combination of the given physical tests when the tests are all performed during the physical examination.
EXCLUDED ARTICLES Table 3. Excluded Articles
Author Title Exclusion Reason
Copeland SA; Rupture of the Achilles tendon: a new clinical test Not relevant
Matles AL Rupture of the tendo achilles: another diagnostic sign Commentary
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STUDY QUALITY Table 4. Study Quality
● = Yes ○ = No X = Not Reported n/a = not applicable
Spec
trum
bia
s avo
ided
Sele
ctio
n cr
iteria
des
crib
ed
App
ropr
iate
refe
renc
e st
anda
rd
Dis
ease
pro
gres
sion
bia
s avo
ided
Parti
al v
erifi
catio
n bi
as a
void
ed
Diff
eren
tial v
erifi
catio
n bi
as a
void
ed
Inco
rpor
atio
n bi
as a
void
ed
Inde
x te
st e
xecu
tion
desc
ribed
Ref
eren
ce st
anda
rd e
xecu
tion
desc
ribed
Test
revi
ew b
ias a
void
ed
Dia
gnos
tic re
view
bia
s avo
ided
Clin
ical
revi
ew b
ias a
void
ed
Uni
nter
rupt
able
/Inte
rmed
iate
test
re
sult(
s) re
porte
d
With
draw
als e
xpla
ined
Author N Index Test Reference Standard
Maffulli 161 Palpation
Open Repair,Ultrasound
or MRI or Clinical tests
X ○ ● ● ● ○ ● ● ● ● ○ ● ● ●
Maffulli 161
Calf Squeeze Test
(Thompson test/Simmonds squeeze test)
Open Repair, Ultrasound or
MRI or Clinical tests
X ○ ● ● ● ○ ● ● ● ● ○ ● ● ●
Maffulli 105
Matles Test (increased
passive ankle dorsiflexion)
Open Repair, Ultrasound or
MRI or Clinical tests
X ○ ● ● ● ○ ● ● ● ● ○ ● ● ○
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STUDY RESULTS Table 5. Sensitivity and specificity of Palpation, Calf Squeeze and Matles tests
Author N Test Sensitivity‡ (95% CI)
Specificity‡ (95% CI)
Maffulli 161 Palpation (presence of a gap)
0.73 (0.65, 0.80)
0.89 (0.72, 0.98)
Maffulli 161 Calf Squeeze Test (Thompson test /
Simmonds squeeze test)
0.96 (0.91, 0.99)
0.93 (0.76, 0.99)
Maffulli 105 Matles Test (increased passive ankle dorsiflexion)
0.88 (0.79, 0.95)
0.86 (0.67, 0.96)
‡ AAOS Calculation
v1.0 12.04.09 16
RECOMMENDATION 2 We are unable to recommend for or against the routine use of magnetic resonance imaging (MRI), ultrasound (ultrasonography), and radiograph (roentgengrams, x-rays) to confirm the diagnosis of acute Achilles tendon rupture.
AAOS Strength of Recommendation – Inconclusive Description: Evidence from a single low quality study or conflicting findings that do not allow a recommendation for or against the intervention. An Inconclusive recommendation means that there is a lack of compelling evidence resulting in an unclear balance between benefits and potential harm. Implications: Practitioners should feel little constraint in deciding whether to follow a recommendation labeled as Inconclusive and should exercise judgment and be alert to future publications that clarify existing evidence for determining balance of benefits versus potential harm. Patient preference should have a substantial influencing role. Rationale:
A systematic review of the literature failed to identify adequate evidence to make a recommendation for or against the routine use of MRI, ultrasound, or radiographs to confirm the diagnosis of acute Achilles tendon rupture. There were no studies that address MRI or radiographs as confirmatory tests and there were only two level V studies16, 17 that addressed ultrasound. These two studies contain unreliable data and cannot be combined to provide adequate evidence.
Supporting Evidence:
No studies were identified to adequately answer this recommendation. To answer this recommendation the ideal study must investigate the incremental benefit added by one of the specified technologies (MRI, Ultrasound or plain radiograph). We found no studies that addressed MRI or plain radiographs as a confirmatory test. Studies were found that addressed ultrasound but they did not adequately address the recommendation using the necessary study design.
The ideal study design required to address this recommendation compares two groups of patients. Group one patients undergo the Thompson test and then surgery (gold standard). Group two patients undergo the Thompson test and the test of interest (MRI, ultrasound, or plain radiographs) and then surgery. Sensitivity, specificity and likelihood ratios would be calculated and compared between groups to determine the incremental benefit added by the technology. No study included both of the groups.
v1.0 12.04.09 17
SUMMARY OF EVIDENCE Two Level V prospective studies that enrolled patients with complete Achilles tendon tears were found.16, 17 The studies used visual inspection at surgery as the gold standard for the diagnosis. One study had patients that underwent the Thompson test and then surgery. Patients in the second study underwent the Thompson test and Ultrasound and then surgery. The authors of the studies reported sensitivities and specificities or provided enough information for these parameters to be determined.
EXCLUDED ARTICLES Table 6. Excluded Articles
Author Title Exclusion Reason
Fornage, 1986 Achilles tendon: US examination Less than 10 patients per group
Haims, et al. 2000
MR imaging of the Achilles tendon: overlap of findings in symptomatic and asymptomatic
individuals
Does not investigate the diagnostic test
Hartgerink, et al. 2001
Full- versus partial-thickness Achilles tendon tears: sonographic accuracy and characterization in 26
cases with surgical correlation
Retrospective Chart Review
Hollenberg, et al. 2000
Sonographic appearance of nonoperatively treated Achilles tendon ruptures
Does not investigate the diagnostic test
Kabbani, et al. 1993
Magnetic resonance imaging of tendon pathology about the foot and ankle. Part I. Achilles tendon Commentary
Kalebo, et al. 1992
Diagnostic value of ultrasonography in partial ruptures of the Achilles tendon
Chronic/neglected Achilles tendon rupture
Kayser, et al. 2005
Partial rupture of the proximal Achilles tendon: a differential diagnostic problem in ultrasound
imaging Partial Rupture
Kuwada, 2008 Surgical correlation of preoperative MRI findings of
trauma to tendons and ligaments of the foot and ankle
Less than 10 patients per group
Lehtinen, et al. 1994
Sonography of Achilles tendon correlated to operative findings
Chronic/neglected Achilles tendon rupture
Marshall, et al. 2002
Contrast-enhanced magic-angle MR imaging of the Achilles tendon
Less than 10 patients per group
Mathieson, et al. 1988
Sonography of the Achilles tendon and adjacent bursae
Less than 10 patients per group
Paavola, et al. 1998
Ultrasonography in the differential diagnosis of Achilles tendon injuries and related disorders. A
comparison between pre-operative ultrasonography and surgical findings
Retrospective Chart Review
v1.0 12.04.09 18
STUDY QUALITY Table 7. Study Quality
● = Yes ○ = No X = Not Reported n/a = not applicable
Spec
trum
bia
s avo
ided
Sele
ctio
n cr
iteria
des
crib
ed
App
ropr
iate
refe
renc
e st
anda
rd
Dis
ease
pro
gres
sion
bia
s avo
ided
Parti
al v
erifi
catio
n bi
as a
void
ed
Diff
eren
tial v
erifi
catio
n bi
as a
void
ed
Inco
rpor
atio
n bi
as a
void
ed
Inde
x te
st e
xecu
tion
desc
ribed
Ref
eren
ce st
anda
rd e
xecu
tion
desc
ribed
Test
revi
ew b
ias a
void
ed
Dia
gnos
tic re
view
bia
s avo
ided
Clin
ical
revi
ew b
ias
avoi
ded
Uni
nter
rupt
able
/Inte
rmed
iate
test
resu
lt(s)
re
porte
d
With
draw
als
expl
aine
d
Author N Index Test Reference Standard
Maffulli 161
Calf Squeeze Test (Thompson test/Simmonds squeeze test)
Open Repair X ○ ● ● ● ○ ● ● ● ● ○ ● ● ●
Margetic 88
Calf Squeeze Test (Thompson test/Simmonds squeeze test) plus Ultrasound
Surgery X ○ ● ● ● ○ ● ● ● ○ ○ ● ● ○
v1.0 12.04.09 19
STUDY RESULTS Table 8. Sensitivity and Specificity
Author N Test Sensitivity (95% CI)
Specificity (95% CI)
Maffulli 161 Calf Squeeze Test (Thompson test /
Simmonds squeeze test)
0.96 (0.91, 0.99)
0.93 (0.76, 0.99)
Margetic et. al. 88
Calf Squeeze Test (Thompson test /
Simmonds squeeze test) plus ultrasound
0.91 (0.83, 0.96)
1.00 (0.16, 1.00)
v1.0 12.04.09 20
RECOMMENDATION 3 Non-operative treatment is an option for patients with acute Achilles tendon rupture. AAOS Strength of Recommendation: Limited Description: Evidence from two or more “Low” strength studies with consistent findings, or evidence from a single “Moderate” quality study recommending for or against the intervention or diagnostic. A Limited recommendation means the quality of the supporting evidence that exists is unconvincing, or that well-conducted studies show little clear advantage to one approach versus another. Implications: Practitioners should be cautious in deciding whether to follow a recommendation classified as Limited, and should exercise judgment and be alert to emerging publications that report evidence. Patient preference should have a substantial influencing role. Rationale: A systematic review of non-operative treatment compared to operative treatment of acute Achilles tendon ruptures identified four level II studies including all operative techniques.18-21 Three studies included standard open treatment and one included a minimally invasive technique. Increased complications were noted in the open operative group.
When the outcomes of open and minimally invasive techniques were considered separately, the preliminary strength of recommendation was moderate. The group agreed that it was important to evaluate both functional outcomes and complications comparing non-operative and all operative treatment groups. When these heterogeneous groups were separated into non-operative and operative (including minimally invasive) treatments, the strength of recommendation was downgraded to limited.
The functional outcomes were favorable in the operative group in 1 of 2 level II studies and the return to activity and sport in 1 of 3 level II studies. Only 1 of 4 studies demonstrated improvement in the rerupture rate in the operative group. The remainder of the studies demonstrated no difference between the groups.
Higher complication rates, primarily due to impaired wound healing in the operative group, demonstrate the importance of awareness of surgical risk factors in the decision making of operative versus non-operative treatment (see Recommendation 6).
With acceptable functional results and lower complication rates than operative treatment, non-operative treatment of acute Achilles tendon ruptures is an option in all patients, especially those with increased surgical risk factors.
Supporting Evidence:
To address this recommendation, we analyzed studies that made two different comparisons. Three level II studies compared patients treated non-operatively (with
v1.0 12.04.09 21
casting) to patients treated with open repair and one level II study compared casting to minimally invasive open repair.18-21
Two studies examined functional outcomes and both found non-significant results (Table 9). Based on AAOS calculations, one of these studies did have significant results at two, three, and six months measured by the Musculoskeletal Functional Assessment Index (MFAI) in which patients with operative treatment had better functional ability than those treated non-operatively; our results differ from the authors because a higher powered statistical test was used. Two studies reported no significant difference in the number of patients with pain (see Table 10).
Three studies reported patients treated non-operatively did not significantly differ in the amount of time to return to work (see Table 11). Three studies examined return to sports and one reported significant results in favor of patients treated with operative repair (see Table 12). One study reported significantly less reruptures in patients treated operatively (see Table 13).The occurrence of extreme residual tendon lengthening, DVT, and “major” complications were not significantly different between patients treated operatively or non-operatively. Minor complications reported in the included studies were related to the surgical intervention and therefore occurred less in patients treated non-operatively (see Table 15). SUMMARY OF EVIDENCE Table 9. Operative vs. Cast – Function
Author Comparison Outcome LOE N Duration (Months)
2 weeks 2 3 6 12
Twaddle Open vs. Cast MFAI‡ II 42 ○ ●Op ●Op ●Op ○
Cetti Open vs. Cast Function II 111 ○
‡Musculoskeletal Functional Assessment Index ●Op: Statistically Significant in Favor of Operative Repair ●Non-Op: Favors Non-Operative treatment with Cast ○ No statistical significance Table 10. Operative vs. Cast – Pain
Author Comparison Outcome LOE N Duration (Months) 2 3 12
Möller Open vs. Cast % w/ Pain‡ III 85 ○
Metz Minimally Invasive vs. Cast Pain (VAS) II 83 ○ ○ ○
‡Level III evidence due to less than 80% of patients at follow-up ●Op: Statistically Significant in Favor of Operative Repair
v1.0 12.04.09 22
●Non-Op: Favors Non-Operative treatment with Cast ○ No statistical significance Table 11. Operative vs. Cast – Return to Work
Author Comparison Outcome LOE N
Duration (Months)
12 24
Cetti Open vs. Cast Sick Leave II 111 ○
Möller Open vs. Cast Sick Leave II 112 ○
Metz Minimally
Invasive vs. Cast
Return to Work II 78 ○
●Op: Statistically Significant in Favor of Operative Repair ●Non-Op: Favors Non-Operative treatment with Cast ○ No statistical significance Table 12. Operative vs. Cast - Return to Sport
Author Comparison Outcome LOE N Duration (Months)
12 24
Cetti Open vs. Cast Return to Sport II 111 ●Op
Möller Open vs. Cast Return to Sport II 112 ○
Metz Minimally
Invasive vs. Cast
Return to Sport (%) II 69 ○
●Op: Statistically Significant in Favor of Operative Repair ●Non-Op: Favors Non-Operative treatment with Cast ○ No statistical significance Table 13. Operative vs. Cast - Rerupture
Author Outcome LOE N Duration (Months)
12
Twaddle Rerupture II 42 ○
Cetti Rerupture II 111 ○
Möller Rerupture II 112 ●Op
v1.0 12.04.09 23
Metz Rerupture II 83 ○
●Op: Statistically Significant in Favor of Operative Repair ●Non-Op: Favors Non-Operative treatment with Cast ○ No statistical significance
Table 14. Operative vs. Cast - Satisfaction
Author Comparison Outcome LOE N Duration (Months) 2 3 6 12 24
Möller Open Repair vs. Cast Satisfaction‡ (VAS) III 85 ●Op ●Op ●Op ●Op
Metz Minimally Invasive vs. Cast
Satisfaction (VAS) II 83 ○ ○ ○
‡Level III evidence due to less than 80% of patients at follow-up ●Op: Statistically Significant in Favor of Operative Repair ●Non-Op: Favors Non-Operative treatment with Cast ○ No statistical significance
Table 15. Operative vs. Cast – Complications
Author Adverse event/ Complication LOE N
Duration (Months)
12
Cetti Major Complications - (not including rerupture) II 111 ○
Metz Total Complications II 83 ○
Möller Extreme Residual Tendon Lengthening II 112 ○
Möller DVT II 112 ○
Cetti Total - Minor Complications‡ II 111 ●Non-Op
Metz Partial Sensibility II 83 ●Non-Op
Cetti Disturbances of Sensibility II 111 ○
Möller Disturbance of Sensitivity II 112 ○
Metz Scar Adhesions II 83 ●Non-Op
Möller Scar Adhesions II 112 ●Non-Op
v1.0 12.04.09 24
Cetti Suture granuloma II 111 ○
Möller Superficial infection II 112 ○
‡As defined by the author: “Differences between major/minor complications is that major complications give functional discomfort.” Minor Complications include: Scar adhesions, superficial infection, disturbances of sensibility, suture granuloma, delayed wound healing. ●Op: Statistically Significant in Favor of Operative Repair ●Non-Op: Statistically Significant in Favor of Non-Operative treatment with Cast ○ No statistical significance Summary of Systematic Reviews
Table 16. Systematic Review Summary
Author Conclusion Bhandari, M et al. 2002
"Deep venous thrombosis is more common after nonoperative treatment of Achilles tendon ruptures" (p. 195).
Bhandari, M et al. 2002
"…The current group of randomized trials suggests a benefit to surgical repair of acute Achilles tendon ruptures in younger, active patients" (p. 199).
Bhandari, M et al. 2002
"Pooled analysis of studies did not reveal any difference in the risk of minor complaints or return to normal function between surgical repair and conservatively treated groups" (p. 190).
Bhandari, M et al. 2002
"Surgical treatment significantly reduces the risk of Achilles tendon re-ruptures, but increases the risk of infection, when compared with conservative therapy" (p. 190).
Khan, RJK, et al. 2005
"In conclusion, open operative treatment of acute Achilles tendon ruptures significantly reduces the risk of re-rupture compared with nonoperative treatment but has the drawback of a significantly higher risk of other complications, including wound infection" (p.2209).
Lo, IKY, et al. 1997
"Although operative treatment provides a reduced re-rupture rate over nonoperative treatment, the rate of moderate and mild complications in operative treatment is 20 times greater" (p. 211).
Lo, IKY, et al. 1997 "Presently, we favor non-operative treatment in patients with poor healing potential (i.e., smokers, diabetics, and patients with peripheral vascular disease)" (p. 211).
Lo, IKY, et al. 1997 "For healthy active individuals, we offer both forms of treatment, providing the patients with the estimates of treatment success and complication rates" (p. 211).
Lynch, RM 2004 "Surgical treatment is preferable to non-surgical treatment, produces better functional outcomes, and therefore appears to be the treatment of choice" (p. 156).
v1.0 12.04.09 25
Author Conclusion
Lynch, RM 2004 "The incidence of re-rupture following non-surgical treatment is significantly higher than for surgical treatment" (p. 156).
Lynch, RM 2004 "The number of patients that need to be treated surgically to prevent one re-rupture if these patients were treated non-surgically is 5 (3-13, 95% confidence intervals)" (p.156).
Lynch, RM 2004 "The incidence of minor complications following surgical treatment is large, but these do not appear to affect functional outcome" (p. 156).
Lynch, RM 2004 "Non-surgical treatment should be reserved for patients who refuse or who are unfit for operative repair" (p. 156).
EXCLUDED ARTICLES Table 17. Excluded Articles
Author Title Exclusion Reason Doral, et al.
2009 Percutaneous suturing of the ruptured
Achilles tendon with endoscopic control Not best available evidence - not
comparative Neumayer,
et al. 2009
A new conservative-dynamic treatment for the acute ruptured Achilles tendon
Not best available evidence - not comparative
Ebinesan, et al.
2008
Conservative, open or percutaneous repair for acute rupture of the Achilles tendon
Not best available evidence - retrospective comparative
Lorkowski, et al. 2007
Evaluation of long term therapy outcomes for Achilles tendon ruptures
Combines operative and non-operative patients
Kotnis, et al. 2006
Dynamic ultrasound as a selection tool for reducing Achilles tendon re-ruptures Not best available evidence
van, et al. 2004
Results of surgical versus non-surgical treatment of Achilles tendon rupture Not best available evidence
Weber, et al. 2003
Non-operative treatment of acute rupture of the Achilles tendon. results of a new
protocol and comparison with operative treatment
Not best available evidence - retrospective comparative
Follak, et al. 2002
The utility of gait analysis in the rehabilitation of patients after surgical treatment of Achilles tendon rupture
Not best available evidence - not comparative
Moller, et al. 2002
Calf muscle function after Achilles tendon rupture. A prospective, randomised study
comparing surgical and non-surgical treatment
Duplicate - Data reported in prior study
Rumian, et al.
2001
Surgical repair of the Achilles tendon. The lateral approach
Not best available evidence - not comparative
Horstmann, et al.
Isokinetic strength and strength endurance of the lower limb musculature ten years after
Not best available evidence - not comparative
v1.0 12.04.09 26
Author Title Exclusion Reason 2000 Achilles tendon repair
Rowley, et al.
1982
Rupture of the Achilles tendon treated by a simple operative procedure No patient oriented outcome
Inglis, et al. 1976
Ruptures of the tendo achillis. An objective assessment of surgical and non-surgical
treatment Less than 10 patients per group
Nistor, et al. 1981
Surgical and non-surgical treatment of Achilles Tendon rupture. A prospective
randomized study Not best available evidence
Jacobs, et al. 1978
A new conservative-dynamic treatment for the acute ruptured Achilles tendon
Combines acute and neglected/chronic Achilles
tendon tear patients STUDY QUALITY Table 18. Study Quality
● = Yes ○ = No × = Not Reported
Stoc
hast
ic R
ando
miz
atio
n
Allo
catio
n C
once
alm
ent
Patie
nts B
linde
d
Tho
se r
atin
g ou
tcom
e B
linde
d
Follo
w U
p - 8
0% o
r m
ore
All
grou
ps h
ave
sim
ilar
outc
ome
perf
orm
ance
at e
ntry
Author Outcome N Treatment(s) Level of Evidence
Twaddle MFAI 42 Operative vs.
Cast Level II ● ● ○ ● ● ×
Twaddle Re-rupture 42 Operative vs.
Cast Level II ● ● ○ ● ● ×
Moller Re-rupture 112 Operative vs.
Cast Level II ● ● ○ ● ● ●
Moller Return to work 112 Operative vs.
Cast Level II ● ● ○ ● ● ●
Moller Quality of Life
(VAS) 112 Operative vs.
Cast Level II ● ● ○ ● ● ●
Moller Treatment
Results (VAS) 112 Operative vs.
Cast Level II ● ● ○ ● ● ●
Moller Pain 85 Operative vs.
Cast Level III ● ● ○ ● ○ ●
Cetti Return to Work 111 Operative vs.
Cast Level II × × ○ ● ● ●
Cetti Return to Sports 111 Operative vs.
Cast Level II × × ○ ● ● ● Cetti Hospitalization 111 Operative vs. Level II × × ○ ● ● ●
v1.0 12.04.09 27
● = Yes ○ = No × = Not Reported
Stoc
hast
ic R
ando
miz
atio
n
Allo
catio
n C
once
alm
ent
Patie
nts B
linde
d
Tho
se r
atin
g ou
tcom
e B
linde
d
Follo
w U
p - 8
0% o
r m
ore
All
grou
ps h
ave
sim
ilar
outc
ome
perf
orm
ance
at e
ntry
Author Outcome N Treatment(s) Level of Evidence
Cast
Metz Re-rupture 83 Operative vs.
Cast Level II ○ ○ × × ● ×
Metz Return to work 83 Operative vs.
Cast Level II ● ● ○ ● ● ●
Metz Return to sport 83 Operative vs.
Cast Level II ● ● ○ ● ● ●
Metz Pain- VAS 83 Operative vs.
Cast Level II ● ● ○ ● ● ×
Metz Satisfaction -
VAS 83 Operative vs.
Cast Level II ● ● ○ ● ● × STUDY RESULTS Table 19. Open vs. Cast - Function
Author Comparison Outcome LOE N Durati
on
Open Repair Cast
Results mean (SD)
% mean (SD)
%
Twaddle Open vs. Cast MFAI II 42 2 weeks 42.4 (2.7)‡ 43 (2.7)‡ p = 0.48‡
Twaddle Open vs. Cast MFAI II 42 2 months 23.7 (2.6)‡ 27.6 (3.4)‡ p = 0.002‡
Twaddle Open vs. Cast MFAI II 42 3 months 15.2 (2.1)‡ 17 (2.6)‡ p = 0.02‡
Twaddle Open vs. Cast MFAI II 42 6 months 7.8 (2.1)‡ 10.4 (2.2)‡ p = 0.004‡
Twaddle Open vs. Cast MFAI II 42 12 months 3.4 (1.7)‡ 4.2 (1.7)‡ p = 0.14‡
Cetti Open vs. Cast Function - Abnormal
Gait II 111 12
months 5.4% 3.6% NS
Cetti Open vs. Cast Function – Abnormal
Run II 111 12
months 12.5% 18.2% NS
Cetti Open vs. Cast Function - Abnormal Toe Stand
II 111 12 months 8.9% 9.1% NS
v1.0 12.04.09 28
‡ AAOS Calculation NS: No statistical significance; authors do not report p-value. Table 20. Cast vs. Open Repair - Pain
Author Comparison Outcome LOE N Duration
Open Repair
Minimally Invasive Cast
Results mean (SD) %
mean (SD) %
mean (SD) %
Möller Open vs. Cast
Pain - None III 85 12
months 92% n/a 88% p = .69‡
Möller Open vs. Cast
Pain - Moderate III 85 12
months 6% n/a 3% p = .55‡
Möller Open vs. Cast
Pain - During
Walking III 85 12
months 2% n/a 9% p = .129‡
Metz Minimally Invasive vs. Cast
Pain (VAS)‡ II 83 2 months n/a 1.80
(1.40)‡ 1.56
(1.25)‡ p =
0.20‡
Metz Minimally Invasive vs. Cast
Pain (VAS) II 83 3 months n/a 1.53 (1.71)‡
1.80 (1.40)‡ p = 0.78‡
Metz Minimally Invasive vs. Cast
Pain (VAS) II 83 12 months n/a 0.40
(0.93)‡ 0.78(1.40)‡ p = 0.92‡
‡ AAOS Calculation NS: No statistical significance; authors do not report p-value. n/a: not applicable
v1.0 12.04.09 29
Table 21. Operative vs. Cast - Return to Work
Author Comparison Outcome LOE N Duration
Open Repair
Minimally Invasive Cast
Results mean (SD) mean (SD) mean (SD)
Cetti Open vs. Cast Return to Work (days) II 111 12 months
43.4 (15.05) n/a 56 (25.2) NS
Möller Open vs. Cast Sick Leave (days) II 111 24 months 54.9 (47.9) n/a 73.4 (56.5) p =
0.06
Möller Open vs. Cast Return to heavy work (days) II 24 24
months 102.2 (52.7) n/a 108.1(34.7) NS
Möller Open vs. Cast Return to light work (days) II 54 24 months 35.7 (38) n/a 67.2 (65.9) p =
0.03
Möller Open vs. Cast Return to Work – Sedentary (days) II 34 24
months 30.8 (36.5) n/a 33.2 (54.7) NS
Metz Minimally Invasive vs. Cast Return to Work (days) II 78 12
months n/a 59 (82) 108 (115) p < 0.05
‡ AAOS Calculation NS: No statistical significance; authors do not report p-value. n/a: not applicable
v1.0 12.04.09 30
Table 22. Operative vs. Cast - Return to Sport
Author Comparison Outcome LOE N Duration Open
Repair %
Minimally Invasive Cast
% Results %
Cetti Open vs. Cast
Return to Sports- Total
II 111 12 months 79% n/a 64% p =
.21‡
Cetti Open vs. Cast
Return to Sport - Same Level
II 111 12 months 57% n/a 29% p =.005
Möller Open vs. Cast
Return to Sport - Same Level
II 112 12 months 54% n/a 54% NS
Cetti Open vs. Cast
Return to Sport -
Diminished II 111 12
months 21% n/a 35% NS
Cetti Open vs. Cast
Return to Sport -
Stopped II 111 12
months 14% n/a 22% NS
Möller Open vs. Cast
Return to Sport -
Stopped II 112 12
months 16% n/a 14% p = .620‡
Metz Minimally Invasive vs. Cast
Return to Sport II 69 12
months n/a 67% 81% p = 0.16
‡ AAOS Calculation NS: No statistical significance; authors do not report p-value. n/a: not applicable Table 23. Operative vs. Cast - Rerupture
Author Complication LOE N Duration Open
Repair Minimally Invasive Cast Results
% % %
Cetti Rerupture II 111 12 months 5.4% n/a 12.7% p = .167‡
Möller Rerupture II 112 12 months 1.7% n/a 20.8% p = < .001
Twaddle Rerupture II 42 6 months 10.0% n/a 4.5% p = .49‡
Metz Rerupture II 83 12 months n/a 7.1% 12.2% p = 0.44‡
Cetti Second Rerupture II 111 12
months 0.0% n/a 1.8% p = .154‡
‡ AAOS Calculation n/a: not applicable
v1.0 12.04.09 31
Table 24 Cast vs. Open - Complications
Author Complications LOE N Duration
Open Repair
Minimally Invasive Cast
Results % % %
Metz Total Complications II 83 12
months n/a 28.6% 48.8% p = 0.06
Cetti
Major Complications (not including
rerupture)
II 111 12 months 9.0% n/a 16.3% NS
Metz
Total Complications
Other Than Rerupture
II 83 12 months n/a 21.4% 36.6% p = 0.13
Metz Sural Nerve Injury II 83 12 months n/a 7.1% 2.4% p = 0.30‡
Cetti Deep Infection II 111 12 months 3.6% n/a 0% p = 0.05
Metz Deep Wound Infection II 83 12
months n/a 0 0.0% NS
Cetti Delayed Wound Healing II 111 12
months 1.8% n/a 0% p = 0.158‡
Cetti Disturbances of Sensibility II 111 12
months 12.5% n/a 1.8% p = 0.017‡
Möller Disturbance of Sensitivity II 112 24
months 1.7% n/a 0% p = 0.16‡
Metz Partial Sensibility II 83 12 months n/a 9.5% 0.0% p = 0.01‡
Metz DVT - lower leg II 83 12 months n/a 0.0% 2.4% p = 0.15‡
Möller DVT II 112 24 months 0.0% n/a 1.9% p = 0.14‡
Cetti Necrosis of the Skin II 112 12
months 0.0% n/a 0% NS
Cetti Extreme Residual
Tendon Lengthening
II 111 12 months 0.0% n/a 1.8% p = 0.15‡
Möller Extreme Residual
Tendon Lengthening
II 112 24 months 0.0% n/a 1.9% p = 0.14‡
Cetti Total - Minor Complications II 111 12
months 26.8% n/a 5.4% p = 0.004
Metz Skin Related Complications II 83 12
months n/a 4.8% 31.7% p = .001‡
Cetti Scar Adhesions II 111 12 months 10.7% n/a 3.6% p = 0.136‡
Metz Scar Adhesions II 83 12 months n/a 7.1% 0.0% p = 0.01‡
v1.0 12.04.09 32
Author Complications LOE N Duration
Open Repair
Minimally Invasive Cast
Results % % %
Möller Scar Adhesions II 112 24 months 13.6% n/a 0% p = <.001‡
Cetti Suture Granuloma II 111 12 months 1.8% n/a 0% p = 0.158‡
Möller Superficial Infection II 112 24
months 1.7% n/a 0% p = 0.16‡
‡ AAOS Calculation NS: No statistical significance; authors do not report p-value. n/a: not applicable
v1.0 12.04.09 33
RECOMMENDATION 4 For patients treated non-operatively, we are unable to recommend for or against the use of immediate functional bracing for patients with acute Achilles tendon rupture.
AAOS Strength of Recommendation: Inconclusive
Description: Evidence from a single low quality study or conflicting findings that do not allow a recommendation for or against the intervention. An Inconclusive recommendation means that there is a lack of compelling evidence resulting in an unclear balance between benefits and potential harm. Implications: Practitioners should feel little constraint in deciding whether to follow a recommendation labeled as Inconclusive and should exercise judgment and be alert to future publications that clarify existing evidence for determining balance of benefits versus potential harm. Patient preference should have a substantial influencing role. Rationale: Non-operative treatment for Achilles tendon ruptures was evaluated by comparing the use of immediate functional bracing or a combination of casting with functional bracing (for a period of 0-12 weeks) to casting alone. One level II and one level IV comparative study were analyzed. The only outcome that could be adequately determined in these studies was rerupture rate which was not significantly different. 22, 22
Functional outcomes of the functional bracing group were analyzed with three studies (level IV and V) and no case series of cast treatment alone was identified. 23-25
With the lack of functional data demonstrating improved outcomes with functional bracing and the lack of demonstrable difference in rerupture rates, we are unable to recommend for or against the use of immediate functional bracing for patients treated non-operatively for acute Achilles tendon rupture.
Supporting Evidence:
We analyzed one level II and one level IV study that compared patients treated with cast plus a functional brace vs. patients treated with a cast only. 26 22 We reported the rerupture rates of both comparative studies but other outcomes were considered due to the reliability of the evidence reported in both studies (See Methods Section – Outcomes considered). We then examined three studies (Level IV and V) that reported results for patients treated with functional bracing. 23-25
In both comparative studies, rerupture rates did not significantly differ between patients treated with cast plus orthosis vs. cast (see Table 25). See Table 36 for case series re-rupture rates.
Seventy-eight percent of patients treated with a functional brace had no pain, 55% reported no stiffness, 56% had no weakness, 98% of patients returned to full level of employment and 37% returned to the same level of sports at 2.9 years. The average time to return to work was 7 days (range 21 – 52) (see Table 26).
v1.0 12.04.09 34
One study reported 2% of patients had a pulmonary embolism and another study reported 1% of patients with a DVT and “temporary drop foot” (see Table 35). SUMMARY OF EVIDENCE Table 25. Cast + Functional Brace vs. Cast - Rerupture
Author Outcome LOE N Duration Cast
Cast + orthosis
(%) Results (%)
Saleh, et al. 1992 Rerupture II 31
12 months 6% 7% p=.96‡
Ingvar, et al. 2005 Rerupture IV 194 4 years 7% 10% p=.51‡
‡ AAOS calculation
Table 26. Summary of Results - Case Series
Author Outcome LOE N Duration Results
(%) Wallace Pain - none IV 140 2.9 years 78%
Wallace Stiffness –
none IV 140 2.9 years 55%
Wallace Weakness –
none IV 140 2.9 years 56%
Wallace
Return to Full Preinjury Level of Employment IV 122 2.9 years 98%
Wallace, et al. 2004
Return to Sports - same or better level IV 101 2.9 years 37%
Table 27. Summary of Systematic Reviews
Author Conclusion
Lynch, RM 2004 "Early functional mobilisation is more acceptable to patients than plaster cast immobilisation and results in improved functional outcomes" (p. 156).
v1.0 12.04.09 35
Table 28. Functional Bracing – Satisfaction (VAS)
Author Outcome LOE N Duration Results (mean ± SD)
Neumayer, et al. 2009
Satisfaction (VAS) IV 46 5 years 8.1 ± 2
Table 29. Functional Bracing - Satisfaction (%)
Author Outcome LOE N Duration Results (%)
Wallace, et al. 2004
Satisfaction – very satisfied IV 140 2.9 years 83%
Wallace, et al. 2004
Satisfaction –satisfied with
minor reservations IV 140 2.9 years 15%
Wallace, et al. 2004
Satisfaction –satisfied with
major reservations IV 140 2.9 years 1%
Wallace, et al. 2004
Satisfaction –dissatisfied IV 140 2.9 years 1%
Table 30. Functional Bracing - Pain
Author Outcome LOE N Duration Results (%)
Wallace, et al. 2004 Pain - none IV 140 2.9 years 78%
Wallace, et al. 2004 Pain - mild IV 140 2.9 years 13%
Wallace, et al. 2004 Pain - moderate IV 140 2.9 years 8%
Wallace, et al. 2004 Pain – severe IV 140 2.9 years 1%
Table 31. Functional Bracing - Function
Author Outcome LOE N Duration Results (%)
Wallace, et al. 2004 Stiffness – none IV 140 2.9 years 55%
v1.0 12.04.09 36
Wallace, et al. 2004 Stiffness – mild IV 140 2.9 years 41%
Wallace, et al. 2004
Stiffness – moderate IV 140 2.9 years 3%
Wallace, et al. 2004 Stiffness – severe IV 140 2.9 years 1%
Table 32. Functional Bracing - Strength
Author Outcome LOE N Duration Results (%)
Wallace, et al. 2004 Weakness – none IV 140 2.9 years 56%
Wallace, et al. 2004 Weakness - mild IV 140 2.9 years 33%
Wallace, et al. 2004
Weakness - moderate IV 140 2.9 years 10%
Wallace, et al. 2004 Weakness -severe IV 140 2.9 years 1%
Table 33. Functional Bracing - Return to Work and Sports
Author Outcome LOE N Duration Results (%)
Wallace, et al. 2004
Return to Full Preinjury Level of
Employment IV 122 2.9 years 98%
Wallace, et al. 2004
Return to Sports - same or better
level IV 101 2.9 years 37%
Wallace, et al. 2004
Return to Sports - diminished or
none IV 101 2.9 years 63%
McComis, et al. 1997
Return to Sports - same level V 15 26 weeks 67%
McComis, et al. 1997
Return to Sports - diminished V 15 26 weeks 33%
Table 34. Functional Bracing - Return to Work and Sports (days)
Author Outcome LOE N Results (mean)
v1.0 12.04.09 37
Wallace, et al. 2004
Time to Return to Work IV 122 7 days
(max: 52 days) McComis, et al. 1997
Time to Return to Work V 15 4 days
(max: 3 weeks)
Wallace, et al. 2004
Time to Return to Sports IV 101
8 weeks (range 2 weeks
- 6 months) Table 35. Functional Bracing - Complications
Author Outcome LOE N Duration
Cast Cast + orthosis
(%)
Results (%)
Neumayer, et al. 2009
Pulmonary embolism IV 57
12 months n/a 2% n/a
Wallace, et al. 2004 DVT IV 140
2.9 years (0.4-8.2) n/a 1% n/a
Wallace, et al. 2004
Temporary Drop foot IV 140
2.9 years (0.4-8.2) n/a 1% n/a
n/a: not applicable Table 36. Functional Bracing - Rerupture
Author Outcome LOE N Duration Cast (%)
Cast + orthosis
(%) Results
Neumayer, et al. 2009
Complete rerupture IV 57 12 months n/a 9% n/a
Wallace, et al. 2004
Complete rerupture IV 140 2.9 years
(0.4-8.2) n/a 2% n/a
Neumayer, et al. 2009 Partial rerupture IV 57 12 months n/a 4% n/a
Wallace, et al. 2004 Partial rerupture IV 140 2.9 years
(0.4-8.2) n/a 4% n/a
n/a: not applicable EXCLUDED ARTICLES Table 37. Functional Bracing - Excluded Studies
Author Title Exclusion Reason Edna TH; Non-operative treatment of Achilles tendon ruptures case series cast only
Fruensgaard S, et al.
Conservative treatment for acute rupture of the Achilles tendon casting only
v1.0 12.04.09 38
Author Title Exclusion Reason
Hufner TM, et al. Long-term results after functional non-operative treatment of Achilles tendon rupture cast only case series
Inglis AE, et al. Ruptures of the tendo achillis. An objective assessment of surgical and non-surgical treatment Less than 10 patients per arm
Josey RA, et al. Immediate, full weight bearing cast treatment of acute Achilles tendon ruptures: a long-term follow-up study cast only case series
Keller J, et al Closed treatment of Achilles tendon rupture case series cast only Lea RB; Smith L; Non-surgical treatment of tendo achillis rupture casting only
Lildholdt T, et al Conservative treatment to Achilles tendon rupture. A follow-up study of 14 cases cast only case series
Nistor L; Conservative treatment of fresh subcutaneous rupture of the Achilles tendon casting only case series
Pendleton H, et al. Residual functional problems after non-operative treatment of Achilles tendon rupture cast only case series
Persson A, et al. The treatment of total ruptures of the Achilles tendon by plaster immobilisation cast only case series
Roberts CP, et al Dynamised cast management of Achilles tendon ruptures retrospective case series
STUDY QUALITY Table 38. Study Quality - Randomized Control Trials
● = Yes ○ = No × = Not Reported
Stoc
hast
ic R
ando
miz
atio
n
Allo
catio
n C
once
alm
ent
Patie
nts B
linde
d
Thos
e ra
ting
outc
ome
Blin
ded
Follo
w U
p - 8
0% o
r mor
e
All
grou
ps h
ave
sim
ilar
outc
ome
perf
orm
ance
at e
ntry
Author Outcome N Treatment(s) Level of
Evidence
Saleh, et al. 1992 Rerupture 31 Cast vs. Cast +
Orthosis Level II × × ○ ○ ● ●
Table 39. Study Quality - Non-Randomized Comparative Study
● = Yes ○ = No × = Not Reported
th
an 2
0%
diff
eren
ce
All
grou
ps
conc
urre
ntly
treat
ed
All
grou
ps
rece
ive
sam
e tre
atm
ent
eval
uate
d us
ing
sam
e ou
tcom
e
have
ap
prox
imat
ely
equa
l fol
low
Follo
w U
p -
80%
or m
ore
for
expe
rimen
tal
and
cont
rol
perf
orm
ance
on
out
com
e at
char
acte
ristic
s co
mpa
rabl
e at
v1.0 12.04.09 39
Author Outcome N Treatment(s) Level of Evidence
Ingvar, et al. 2005 Re-rupture 194
Cast vs. Cast + Orthosis Level IV × ○ ● ● × ● ● ● ×
Table 40. Study Quality - Case Series
● = Yes ○ = No × = Not Reported
Con
secu
tive
enro
llmen
t
of p
atie
nts
Follo
w U
p - 8
0% o
r mor
e
All
patie
nts e
valu
ated
usi
ng
sam
e ou
tcom
e m
easu
res
All
patie
nts r
ecei
ve sa
me
treat
men
t
All
patie
nts h
ave
appr
oxim
atel
y eq
ual
follo
w-u
p tim
es
Author Outcome N Treatment(s) Level of Evidence
Neumayer, et al. 2009 Satisfaction (VAS) 46 Cast + Orthosis Level IV ● ● ● ● ●
Wallace, et al. 2004 Satisfaction 140 Cast + Orthosis Level IV ● ● ● ● ●
Wallace, et al. 2004 Pain 140 Cast + Orthosis Level IV ● ● ● ● ●
Wallace, et al. 2004 Stiffness 140 Cast + Orthosis Level IV ● ● ● ● ●
Wallace, et al. 2004 Weakness 140 Cast + Orthosis Level IV ● ● ● ● ●
Wallace, et al. 2004
Return to Full Preinjury Level of
Employment 122 Cast + Orthosis Level IV ● ● ● ● ●
Wallace, et al. 2004
Return to Sports - same or better level 101 Cast + Orthosis Level IV ● ● ● ● ●
Wallace, et al. 2004
Return to Sports - diminished or none 101 Cast + Orthosis Level IV ● ● ● ● ●
McComis, et al. 1997
Return to Sports - same level 15 Cast + Orthosis Level V ● ○ ● ● ●
McComis, et al. 1997
Return to Sports - diminished 15 Cast + Orthosis Level V ● ○ ● ● ●
v1.0 12.04.09 40
● = Yes ○ = No × = Not Reported
Con
secu
tive
enro
llmen
t
of p
atie
nts
Follo
w U
p - 8
0% o
r mor
e
All
patie
nts e
valu
ated
usi
ng
sam
e ou
tcom
e m
easu
res
All
patie
nts r
ecei
ve sa
me
treat
men
t
All
patie
nts h
ave
appr
oxim
atel
y eq
ual
follo
w-u
p tim
es
Author Outcome N Treatment(s) Level of Evidence
Wallace, et al. 2004
Time to Return to Work 122 Cast + Orthosis Level IV ● ● ● ● ●
McComis, et al. 1997
Time to Return to Work 15 Cast + Orthosis Level V ● ○ ● ● ●
Wallace, et al. 2004
Time to Return to Sports 140 Cast + Orthosis Level IV ● ● ● ● ●
Neumayer, et al. 2009
Complete re-rupture 57 Cast + Orthosis Level IV ● ● ● ● ●
Wallace, et al. 2004
Complete re-rupture 140 Cast + Orthosis Level IV ● ● ● ● ●
Neumayer, et al. 2009 Partial rerupture 57 Cast + Orthosis Level IV ● ● ● ● ●
Wallace, et al. 2004 Partial rerupture 140 Cast + Orthosis Level IV ● ● ● ● ●
Neumayer, et al. 2009
Pulmonary embolism 57 Cast + Orthosis Level IV ● ● ● ● ●
Wallace, et al. 2004 DVT 140 Cast + Orthosis Level IV ● ● ● ● ●
Wallace, et al. 2004
Temporary Drop foot 140 Cast + Orthosis Level IV ● ● ● ● ●
v1.0 12.04.09 41
RECOMMENDATION 5 Operative treatment is an option in patients with acute Achilles tendon rupture. AAOS Strength of Recommendation: Limited Description: Evidence from two or more “Low” strength studies with consistent findings, or evidence from a single “Moderate” quality study recommending for or against the intervention or diagnostic. A Limited recommendation means the quality of the supporting evidence that exists is unconvincing, or that well-conducted studies show little clear advantage to one approach versus another. Implications: Practitioners should be cautious in deciding whether to follow a recommendation classified as Limited, and should exercise judgment and be alert to emerging publications that report evidence. Patient preference should have a substantial influencing role. Rationale: To answer this recommendation, we reviewed studies addressing the efficacy of operative treatment. A systematic review of the literature included eight studies20, 19, 27, 28, 29, 30,31,
32that addressed the efficacy of open repair and six studies33, 29, 34, 21, 27, 31, addressing the efficacy of minimally invasive techniques. This systematic review addressed only the efficacy of operative treatment and therefore did not consider the comparisons made in the studies. Please refer to Recommendation 3 and its rationale for a comparison of non-operative and operative treatment of acute Achilles tendon ruptures. In addition, relevant comparative information about operative techniques can be found in Recommendation 8 and its rationale.
A systematic review of the literature included eight studies20, 19, 27, 28, 29, 30,31, 32 that addressed the efficacy of open repair and six studies33, 29, 34, 21, 27, 31 addressing the efficacy of minimally invasive techniques. By six months the return to activity ranged from 73% to 100% after operative treatment (see Table 42 through Table 58). After twelve months, 92% of patients reported they had no pain (see Table 48).
All studies relevant to this Recommendation were Level IV (see Table 60) because this is non comparative data.
Supporting Evidence:
To determine the efficacy of open repair and/or minimally invasive repair we need a study with preoperative and postoperative data. However, the data we identified only provides postoperative measures and is therefore unreliable. We have tabled the postoperative data from eight studies20, 19, 27, 28, 29, 30,31,32 that address efficacy of open repair and six studies 33, 29, 34, 21, 27, 31 that address minimally invasive techniques. Table 42 through Table 58 demonstrate the wide variety of patient-oriented outcome measures and duration to follow-up used to evaluate patients receiving operative treatment for Achilles tendon rupture. The inconsistency of these outcome measures makes comparisons between studies difficult. Because the body of evidence is limited, it does not allow for additional statistical analysis.
v1.0 12.04.09 42
SUMMARY OF EVIDENCE Table 41. Open Repair – All Outcomes
Outcome Result
(Efficacy) Time until Return to Work ?
Time until Return to Stair Climbing ?
Time until Return to Walking ?
Time until Return to Sports ?
Return to work (%) ?
Return to ADL (%) ?
Return to Final Functional Activities (%) ?
Pain (%) ?
Function- Abnormal ankle movement (%) ?
Abnormal Run (%) ?
Abnormal toe stand (%) ?
Satisfaction (%) ?
Table 42. Open Repair - Return to work
Author LOE N Outcome Mean time Mean (SD)
Moller, et al. 2001 IV 59 Return to work (days) 54.9 (nr)
Cetti, et al. 1993 IV 56 Return to work (weeks) 6.2 (SD 2.15)
Moller, et al. 2001 IV 59 Return to heavy work (days) 102.2 (nr)
Moller, et al. 2001 IV 59 Return to sedentary work (days) 30.8 (nr)
Moller, et al. 2001 IV 59 Return to light, mobile work (days) 35.7 (nr)
nr: not reported
v1.0 12.04.09 44
Table 43. Open Repair - Activities of daily living
Author LOE N Outcome
Mean time Mean
(SD)/(range) Bhattacharyya, et al.
2009 IV 53 Return to Normal Stair Climbing (weeks) 19 (3.5)‡
Bhattacharyya, et al. 2009 IV 53 Return to Normal Walking
(weeks) 17 (3)‡
Uchiyama, et al. 2007 IV 84 Return to same level of sports (months) (high level athletes) 5 (17-26 weeks)
Uchiyama, et al. 2007 IV 84 Return to jogging (weeks) 12.3 (range 8-21)
‡AAOS Calculation
Table 44. Open Repair- Mean time until return to athletic activity
Author LOE N Outcome Mean time
Mean (range)
Uchiyama, et al. 2007 IV 84 Return to same level of sports (months) (high level athletes) 5 (17-26 weeks)
Uchiyama, et al. 2007 IV 84 Return to jogging (weeks) 12.3 (8-21)
v1.0 12.04.09 45
Table 45. Open Repair- Percent of patients able to return to activities of daily living
Author LOE N Outcome Follow-up
% of Patients
Lim, et al. 2001 IV 33 Return to ADL 2 months 6%
Lim, et al. 2001 IV 33 Return to ADL 3 months 85%
Lim, et al. 2001 IV 33 Return to ADL 6 months 100%
Lim, et al. 2001 IV 33 Return to final functional activity‡
3 months 36%
Lim, et al. 2001 IV 33 Return to final functional activity‡
6 months 64%
‡ Final functional activity defined as “patient is unhindered in all his or her activities apart from active sports”
Table 46. Open Repair- Percent of patients able to return to work
Author LOE N Outcome Follow-up
% of Patients
Moller, et al. 2001 IV 59 Return to work (days) nr 100%
Moller, et al. 2001 IV 59 Return to sedentary work (days) nr 22%
Moller, et al. 2001 IV 59 Return to light, mobile work (days) nr 54%
Moller, et al. 2001 IV 59 Return to heavy work (days) nr 24%
Nr: not reported
Table 47. Open Repair- Percent of patients able to return to sports
Author LOE N Outcome Follow-up
% of Patients
Coutts, et al 2002 IV 22 Return to pre-injury sporting level nr 91%
Moller, et al. 2001 IV 47 Return to sports - same level 12 months 54%
Cetti, et al. 1993 IV 52 Return to sports - same level 12 months 62%
Lim, et al. 2001 IV 33 Return to active sporting/outdoor activities
3 months 9%
Lim, et al. 2001 IV 33 Return to active sporting/outdoor activities
6 months 48%
Moller, et al. 2001 IV 47 Return to sports - stopped 12 months 16%
v1.0 12.04.09 46
Author LOE N Outcome Follow-up
% of Patients
Cetti, et al. 1993 IV 52 Return to sports - stopped 12 months 15%
Cetti, et al. 1993 IV 52 Return to sports - diminished level
12 months 23%
Table 48: Open Repair- Percent of patients with pain
Author LOE N Outcome Follow-up % of Patients Aktas, et al. 2007 IV 30 Pain - Mild w/ maximal exertion 6 months 14%
Aktas, et al. 2007 IV 30 Pain - Absent 6 months 86%
Moller, et al. 2001 IV 52 Pain-during walking 12 months 2%
Moller, et al. 2001 IV 52 Pain-moderate 12 months 6%
Moller, et al. 2001 IV 52 Pain-none 12 months 92%
Aktas, et al. 2009 IV 23 Pain- mild during exertion 22 months 13%
Table 49. Open Repair- Percent of patients able to complete functional activities
Author LOE N Outcome Follow-up % of Patients
Cetti, et al. 1993 IV 56 Function-Abnormal ankle movement 4 months 52%
Cetti, et al. 1993 IV 56 Function-Abnormal ankle movement 12 months 18%
Cetti, et al. 1993 IV 56 Function-Abnormal gait 4 months 27%
Cetti, et al. 1993 IV 56 Function-Abnormal gait 12 months 5%
Cetti, et al. 1993 IV 56 Function-Abnormal run 4 months 52%
Cetti, et al. 1993 IV 56 Function-Abnormal run 12 months 13%
Cetti, et al. 1993 IV 56 Function-Abnormal toe stand 4 months 21%
Cetti, et al. 1993 IV 56 Function-Abnormal toe stand 12 months 9%
Table 50. Open Repair- Percent of patients with excellent satisfaction
Author LOE N Outcome Follow-up % of Patients Lim, et al. 2001 IV 33 Satisfaction - Excellent 6 months 42%
v1.0 12.04.09 47
Table 51. Minimally Invasive Repair- All outcomes
Outcome Result
(Efficacy)
Return to Work (%) ?
Return to Stair Climbing (%) ?
Return to Walking (%) ?
Return to Sports (%) ?
Return to work (%) ?
Return to ADL (%) ?
Return to Final Functional Activities (%) ?
Satisfaction (%) ?
Function- Abnormal ankle movement (%) ?
Return to same level of activity (%) ?
Able to walk without limitations (%) ?
Return to sports (%) ?
Pain (%) ? Table 52. Minimally Invasive Repair- Percent of Patients able to return to activity
Author LOE N Treatment Outcome Follow-up % of Patients
ES Ng, et al. 2007 IV 25 percutaneous Return to activity -
same level 65.5
months 96%
Lim, et al. 2001 IV 33 percutaneous Return to ADL 2 months 6%
Lim, et al. 2001 IV 33 percutaneous Return to ADL 3 months 76%
Lim, et al. 2001 IV 33 percutaneous Return to ADL 6 months 100%
Lim, et al. 2001 IV 33 percutaneous Return to final
functional activity 3 months 27%
Lim, et al. 2001 IV 33 percutaneous Return to final
functional activity 6 months 73%
Chillemi, et al. 2002 IV 38 percutaneous Able to walk
without limitation 6 months 100%
v1.0 12.04.09 48
Table 53. Minimally Invasive Repair - Percent of patients able to return to sports
Author LOE N Treatment Outcome Follow-up % of Patients
Lim, et al. 2001 IV 33 percutaneous
Return to active sporting/outdoor
activities 3 months 0%
Lim, et al. 2001 IV 33 percutaneous
Return to active sporting/outdoor
activities 6 months 67%
Chillemi, et al. 2002 IV 14 percutaneous
Return to sports activity (frequent
participant 2-3 times per week)
nr 57%
nr: not reported
Table 54. Minimally Invasive Repair - Satisfaction
Author LOE Treatment N Outcome Follow-up %
Lim, et al. 2001
IV percutaneous 33 Satisfaction - Excellent 6 months 52%
Table 55. Minimally Invasive Repair - Mean time until return to activity
Author LOE Treatment N Outcome Mean Time (Days) Mean (SD)
Metz, et al. 2008 IV minimally-invasive 40 Return to work 59 (82)
Bhattacharyya, et al. 2009 IV minimally-invasive 53 Return to Normal
Walking (weeks) 12.5 (3)‡
Bhattacharyya, et al. 2009 IV minimally-invasive 53
Return to Normal Stair Climbing
(weeks) 14 (3)‡
‡= AAOS Calculation
Table 56. Minimally Invasive Repair-Percent of patients able to return to sports
Author LOE Treatment N Outcome Follow-up % of
Patients Metz, et al.
2008 IV minimally-invasive 36 Return to sports 12 months 67%
Metz, et al. 2008
IV minimally-invasive 36 Change sports 12 months 11%
Metz, et al. 2008
IV minimally-invasive 36 Stop sports 12 months 22%
Metz, et al. 2008
IV minimally-invasive 40 Return to work nr 98%
nr: not reported
v1.0 12.04.09 49
Table 57. Minimally Invasive Repair-Percent of patients able to return to work
Author LOE Treatment N Outcome Follow-up % of
Patients Metz, et al.
2008 IV minimally-invasive 40 Return to work nr 98%
nr: not reported
Table 58. Minimally Invasive Repair-Pain
Author LOE Treatment N Outcome Follow-up % of
Patients
Aktas, et al.2009
IV minimally-invasive 23
Percent of patient with mild pain during exertion
22 months 4.5%
EXCLUDED ARTICLES Table 59. Excluded Articles
Author Title Exclusion Reason
Leppilahti J;Forsman K;Puranen J;Orava S;
Outcome and prognostic factors of Achilles rupture repair using a new scoring method
Not best available evidence
Chiodo CP;Wilson MG;
Current concepts review: acute ruptures of the Achilles tendon
Not best available evidence
Weber M;Niemann M;Lanz R;Muller T;
Nonoperative treatment of acute rupture of the Achilles tendon: results of a new protocol and
comparison with operative treatment Retrospective
Maffulli N;Tallon C;Wong J;Lim
KP;Bleakney R;
Early weightbearing and ankle mobilization after open repair of acute midsubstance tears of the Achilles
tendon Not Relevant
Halasi T;Tallay A;Berkes I;
Percutaneous Achilles tendon repair with and without endoscopic control Retrospective
Costa ML;Shepstone L;Darrah C;Marshall
T;Donell ST;
Immediate full-weight bearing mobilisation for repaired Achilles tendon ruptures: a pilot study
Not best available evidence
Maffulli N;Tallon C;Wong J;Peng LK;Bleakney R;
No adverse effect of early weight bearing following open repair of acute tears of the Achilles tendon
Not relevant- looks at effect
of weight bearing
following surgery
van der Linden-van der Zwaag HM;Nelissen
RG;Sintenie JB;
Results of surgical versus non-surgical treatment of Achilles tendon rupture
Not best available evidence
v1.0 12.04.09 50
Author Title Exclusion Reason
Steele GJ;Harter RA;Ting AJ;
Comparison of functional ability following percutaneous and open surgical repairs of acutely
ruptured Achilles tendons
No patient- oriented outcome
Cretnik A;Kosanovic M;Smrkolj V;
Percutaneous versus open repair of the ruptured Achilles tendon: a comparative study
Not best available evidence
Goren D;Ayalon M;Nyska M;
Isokinetic strength and endurance after percutaneous and open surgical repair of Achilles tendon ruptures
No patient -oriented outcome
Wagnon R;Akayi M; The Webb-Bannister percutaneous technique for acute
Achilles' tendon ruptures: a functional and MRI assessment
Not best available evidence
Mortensen HM;Skov O;Jensen PE;
Early motion of the ankle after operative treatment of a rupture of the Achilles tendon. A prospective,
randomized clinical and radiographic study
Not best available evidence
Hufner TM;Brandes DB;Thermann
H;Richter M;Knobloch K;Krettek C;
Long-term results after functional nonoperative treatment of Achilles tendon rupture
Not best available evidence
Kauranen K;Kangas J;Leppilahti J;
Recovering motor performance of the foot after Achilles rupture repair: a randomized clinical study
about early functional treatment vs. early immobilization of Achilles tendon in tension
No patient oriented outcome
Majewski M;Rohrbach M;Czaja S;Ochsner P;
Avoiding sural nerve injuries during percutaneous Achilles tendon repair
Not best available evidence
Attinger CE;Ducic I;Hess CL;Basil A;Abbruzzesse M;Cooper P;
Outcome of skin graft versus flap surgery in the salvage of the exposed Achilles tendon in diabetics
versus nondiabetics Not relevant
Kotnis R;David S;Handley R;Willett
K;Ostlere S;
Dynamic ultrasound as a selection tool for reducing Achilles tendon re-ruptures
Combines open and
percutaneous repair
Schonberger TJ;Janzing HM;Morrenhof JW;de Visser AC;Muitjens P;
Operative treatment of acute Achilles tendon rupture: Open end-to-end-reconstruction versus reconstruction
with Mitek-anchors
Retrospective case series
Metz R;Verleisdonk EJ;van der Heijden
GJ;Clevers GJ;Hammacher
ER;Verhofstad MH;van der WC;
Acute Achilles tendon rupture: minimally invasive surgery versus nonoperative treatment with immediate
full weightbearing--a randomized controlled trial Not Relevant
Suchak AA;Bostick GP;Beaupre
LA;Durand DC;Jomha NM;
The influence of early weight bearing compared with non-weight bearing after surgical repair of the Achilles
tendon
All patients do not receive same
treatment
v1.0 12.04.09 51
Author Title Exclusion Reason
Blankstein A;Israeli A;Dudkiewicz
I;Chechik A;Ganel A;
Percutaneous Achilles tendon repair combined with real-time sonography
No patient oriented outcome
Maffulli N;Longo UG;Ronga M;Khanna
A;Denaro V;
Favorable Outcome of Percutaneous Repair of Achilles Tendon Ruptures in the Elderly
Not best available evidence
Twaddle BC;Poon P; Early motion for Achilles tendon ruptures: is surgery important? A randomized, prospective study
No relevant outcomes
Fujikawa A;Kyoto Y;Kawaguchi M;Naoi
Y;Ukegawa Y;
Achilles tendon after percutaneous surgical repair: serial MRI observation of uncomplicated healing
No patient oriented outcome
Costa ML;MacMillan K;Halliday D;Chester
R;Shepstone L;Robinson AH;Donell
ST;
Randomised controlled trials of immediate weight bearing mobilisation for rupture of the tendo Achillis Not Relevant
Carter TR;Fowler PJ;Blokker C;
Functional postoperative treatment of Achilles tendon repair Retrospective
Perez TA; Traumatic rupture of the Achilles Tendon.
Reconstruction by transplant and graft using the lateral peroneus brevis
Insufficient Quantitative
Data
Martinelli B; Percutaneous repair of the Achilles tendon in athletes Not best available evidence
Gorschewsky O;Pitzl M;Putz A;Klakow A;Neumann W;
Percutaneous repair of acute Achilles tendon rupture Insufficient Quantitative
Data Mullaney MJ;McHugh MP;Tyler TF;Nicholas
SJ;Lee SJ;
Weakness in end-range plantar flexion after Achilles tendon repair
No patient oriented outcome
Rumian AP;Molloy S;Solan M;Newman
KJ;Elliott D;
Surgical repair of the Achilles tendon: The lateral approach
Not best available evidence
Ebinesan AD;Sarai BS;Walley GD;Maffulli
N;
Conservative, open or percutaneous repair for acute rupture of the Achilles tendon
Retrospective comparative
Chan SK;Chung SC;Ho YF; Minimally invasive repair of ruptured Achilles tendon Retrospective
Lildholdt T;Munch-Jorgensen T;
Conservative treatment to Achilles tendon rupture. A follow-up study of 14 cases
No description of surgery
v1.0 12.04.09 52
Author Title Exclusion Reason
Nistor L; Surgical and non-surgical treatment of Achilles Tendon rupture. A prospective randomized study
Not best available evidence
Haggmark T;Liedberg H;Eriksson
E;Wredmark T;
Calf muscle atrophy and muscle function after non-operative vs operative treatment of Achilles tendon
ruptures
No patient oriented outcome
Kangas J;Pajala A;Siira P;Hamalainen
M;Leppilahti J;
Early functional treatment versus early immobilization in tension of the musculotendinous unit after Achilles
rupture repair: a prospective, randomized, clinical study
Not Relevant
Synder M;Zwierzchowski H;
Post-operative results in fresh injuries the Achilles tendon
Insufficient Quantitative
Data Therbo M;Petersen
MM;Nielsen PK;Lund B;
Loss of bone mineral of the hip and proximal tibia following rupture of the Achilles tendon
No patient oriented outcome
Solveborn SA;Moberg A;
Immediate free ankle motion after surgical repair of acute Achilles tendon ruptures
Surgeons did not follow same
technique
Kakiuchi M; A combined open and percutaneous technique for repair of tendo Achillis. Comparison with open repair
Not best available evidence
Buchgraber A;Passler HH;
Percutaneous repair of Achilles tendon rupture. Immobilization versus functional postoperative
treatment No baseline data
Speck M;Klaue K; Early full weightbearing and functional treatment after surgical repair of acute Achilles tendon rupture No baseline data
Aoki M;Ogiwara N;Ohta T;Nabeta Y;
Early active motion and weightbearing after cross-stitch Achilles tendon repair
Insufficient Data
Dargel J;Ninck J;Koebke J;Appell
HJ;Pennig D;Hillekamp J;
Influence of knee flexion on plantarflexion moments after open or percutaneous Achilles tendon repair
Retrospective comparative
Follak N;Ganzer D;Merk H;
The utility of gait analysis in the rehabilitation of patients after surgical treatment of Achilles tendon
rupture
No relevant patient oriented
outcomes Horstmann T;Lukas C;Mayer F;Winter
E;Ambacher T;Heitkamp
H;Dickhuth H;
Isokinetic strength and strength endurance of the lower limb musculature ten years after Achilles tendon repair
All patients did not receive
exact surgery
Kerkhoffs GM;Struijs PA;Raaymakers EL;Marti RK;
Functional treatment after surgical repair of acute Achilles tendon rupture: wrap vs walking cast Not Relevant
v1.0 12.04.09 53
Author Title Exclusion Reason
Soldatis JJ;Goodfellow DB;Wilber JH; End-to-end operative repair of Achilles tendon rupture Retrospective
Cetti R; Ruptured Achilles tendon--preliminary results of a new treatment No baseline data
Cetti R;Henriksen LO;Jacobsen KS;
A new treatment of ruptured Achilles tendons. A prospective randomized study Not Relevant
v1.0 12.04.09 54
STUDY QUALITY Table 60. Study Quality
● = Yes ○ = No × = Not Reported
Con
secu
tive
Enr
ollm
ent
Follo
w u
p <8
0%
Sam
e O
utco
mes
Sam
e T
reat
men
ts
Equ
al F
ollo
w u
p T
ime
Author Outcome Measure N Treatment LoE
Aktas, et al. 2007 Pain - Mild w/ maximal exertion‡
30 Open Repair IV ● ● ● ● ●
Aktas, et al. 2007 Pain - Absent‡ 30 Open Repair IV ● ● ● ● ●
Bhattacharyya, et al. 2009
Return to Normal Walking (weeks) 53 Open Repair IV ● ● ● ● ●
Bhattacharyya, et al. 2009
Return to Normal Stair Climbing (weeks)
53 Open Repair IV ● ● ● ● ●
Bhattacharyya, et al. 2009
Return to Normal Walking (weeks) 53 Minimally
Invasive Repair IV ● ● ● ● ●
Bhattacharyya, et al. 2009
Return to Normal Stair Climbing (weeks)
53 Minimally Invasive Repair IV ● ● ● ● ●
Cetti, et al. 1993 Return to work (weeks) 56 Open Repair IV ● ● ● ● ●
Cetti, et al. 1993 Return to sports - diminished level 56 Open Repair IV ● ● ● ● ●
Cetti, et al. 1993 Return to sports - same level 56 Open Repair IV ● ● ● ● ●
Cetti, et al. 1993 Return to sports - stopped 56 Open Repair IV ● ● ● ● ●
Cetti, et al. 1993 Function-Abnormal ankle movement
56 Open Repair IV ● ● ● ● ●
Cetti, et al. 1993 Function-Abnormal ankle movement
56 Open Repair IV ● ● ● ● ●
Cetti, et al. 1993 Function-Abnormal gait 56 Open Repair IV ● ● ● ● ●
Cetti, et al. 1993 Function-Abnormal gait 56 Open Repair IV ● ● ● ● ●
Cetti, et al. 1993 Function-Abnormal run 56 Open Repair IV ● ● ● ● ●
v1.0 12.04.09 55
● = Yes ○ = No × = Not Reported
Con
secu
tive
Enr
ollm
ent
Follo
w u
p <8
0%
Sam
e O
utco
mes
Sam
e T
reat
men
ts
Equ
al F
ollo
w u
p T
ime
Author Outcome Measure N Treatment LoE
Cetti, et al. 1993 Function-Abnormal run 56 Open Repair IV ● ● ● ● ●
Cetti, et al. 1993 Function-Abnormal toe stand
56 Open Repair IV ● ● ● ● ●
Cetti, et al. 1993 Function-Abnormal toe stand
56 Open Repair IV ● ● ● ● ●
Chillemi, et al. 2002
Able to walk without limitation 38 Percutaneous
Repair IV ● ● ● ● ●
Chillemi, et al. 2002
Return to sports activity (frequent participant 2-3 times per week)
14 Percutaneous Repair IV ● ● ● ● ●
Coutts, et al 2002 Return to pre-injury sporting level
22 Open Repair IV ○ ● ● ● ●
ES Ng, et al. 2007 Return to activity - same level 25 Percutaneous
Repair IV ● ● ● ● ●
Gigante, et al. 2008
SF-12 - Physical Component Score 19 Percutaneous
Repair IV ● ● ● ● ●
Gigante, et al. 2008
SF-12 - Mental Component Score 19 Percutaneous
Repair IV ● ● ● ● ●
Lim, et al. 2001 Return to active sporting/outdoor activities
33 Open Repair IV ● ● ● ● ●
Lim, et al. 2001 Return to active sporting/outdoor activities
33 Percutaneous Repair IV ● ● ● ● ●
Lim, et al. 2001 Return to ADL 33 Open Repair
IV ● ● ● ● ●
Lim, et al. 2001 Return to final functional activity
33 Open Repair
IV ● ● ● ● ●
Lim, et al. 2001 Satisfaction - Excellent 33
Open Repair IV ● ● ● ● ●
Lim, et al. 2001 Return to final functional activity
33 Percutaneous Repair IV ● ● ● ● ●
v1.0 12.04.09 56
● = Yes ○ = No × = Not Reported
Con
secu
tive
Enr
ollm
ent
Follo
w u
p <8
0%
Sam
e O
utco
mes
Sam
e T
reat
men
ts
Equ
al F
ollo
w u
p T
ime
Author Outcome Measure N Treatment LoE
Lim, et al. 2001 Return to active sporting/outdoor activities
33 Percutaneous Repair IV ● ● ● ● ●
Lim, et al. 2001 Return to active sporting/outdoor activities
33 Percutaneous Repair IV ● ● ● ● ●
Lim, et al. 2001 Satisfaction - Excellent 33 Percutaneous
Repair IV ● ● ● ● ●
Metz, et al. 2008 Return to work 40 Minimally Invasive Repair IV ● ● ● ● ●
Metz, et al. 2008 Return to sports 40 Minimally Invasive Repair IV ● ● ● ● ●
Metz, et al. 2008 Change sports 40 Minimally Invasive Repair IV ● ● ● ● ●
Metz, et al. 2008 Stop sports 40 Minimally Invasive Repair IV ● ● ● ● ●
Moller, et al. 2001 Return to sedentary work (days)
59 Open Repair IV ● ● ● ● ●
Moller, et al. 2001 Return to light, mobile work (days)
59 Open Repair IV ● ● ● ● ●
Moller, et al. 2001 Return to work (days) 59 Open Repair IV ● ● ● ● ●
Moller, et al. 2001 Return to heavy work (days) 59 Open Repair IV ● ● ● ● ●
Moller, et al. 2001 Return to sports - same level 59 Open Repair IV ● ● ● ● ●
Moller, et al. 2001 Return to sports - stopped 59 Open Repair IV ● ● ● ● ●
Moller, et al. 2001 Return to sedentary work (days)
59 Open Repair IV ● ● ● ● ●
Moller, et al. 2001 Return to light, mobile work (days)
59 Open Repair IV ● ● ● ● ●
Moller, et al. 2001 Return to work (days) 59 Open Repair IV ● ● ● ● ●
Moller, et al. 2001 Return to heavy work (days) 59 Open Repair IV ● ● ● ● ●
v1.0 12.04.09 57
● = Yes ○ = No × = Not Reported
Con
secu
tive
Enr
ollm
ent
Follo
w u
p <8
0%
Sam
e O
utco
mes
Sam
e T
reat
men
ts
Equ
al F
ollo
w u
p T
ime
Author Outcome Measure N Treatment LoE
Moller, et al. 2001 Pain-during walking 59 Open Repair IV ● ● ● ● ●
Moller, et al. 2001 Pain-moderate 59 Open Repair IV ● ● ● ● ● Moller, et al. 2001 Pain-none 59 Open Repair IV ● ● ● ● ● Uchiyama, et al. 2007
Return to jogging (weeks) 84 Open Repair IV ○ ● ● ● ●
Uchiyama, et al. 2007
Return to same level of sports (months) (high level athletes)
84 Open Repair IV ○ ● ● ● ●
Aktas, et al.Aktas, et al.2009 Pain 46 Minimally
Invasive Repair IV ● ● ● ● ●
Aktas, et al.Aktas, et al.2009 Pain 46 Open Repair IV ● ● ● ● ●
v1.0 12.04.09 58
RECOMMENDATION 6 In the absence of reliable evidence, it is the opinion of the work group that although operative treatment is an option , it should be approached more cautiously in patients with diabetes, neuropathy, immunocompromised states, age above 65, tobacco use, sedentary lifestyle, obesity (BMI >30), peripheral vascular disease or local/systemic dermatologic disorders.
AAOS Strength of Recommendation: Consensus Description: The supporting evidence is lacking and requires the work group to make a recommendation based on expert opinion by considering the known potential harm and benefits associated with the treatment. A Consensus recommendation means that expert opinion supports the guideline recommendation even though there is no available empirical evidence that meets the inclusion criteria of the guideline’s systematic review. Implications: Practitioners should be flexible in deciding whether to follow a recommendation classified as Consensus, although they may set boundaries on alternatives. Patient preference should have a substantial influencing role. Rationale:
Rupture of the Achilles tendon occurs not only in healthy active individuals, but also in those with substantial medical histories. We were unable to find any published studies that addressed the effects of co-morbid conditions on the success of operative repair. Therefore, this recommendation is based on expert opinion, and is consistent with current clinical practice.
The consensus of the work group is that consideration of non-operative treatment should occur before performing operative repair of Achilles tendon ruptures in those individuals with conditions that may impair wound healing. These individuals may be at increased risk for wound problems and infection with subsequent detrimental effect on outcome.
Supporting Evidence:
We did not identify any studies to address this recommendation.
v1.0 12.04.09 59
RECOMMENDATION 7 For patients who will be treated operatively for an acute Achilles tendon rupture, we are unable to recommend for or against preoperative immobilization or restricted weight bearing.
AAOS Strength of Recommendation: Inconclusive
Description: Evidence from a single low quality study or conflicting findings that do not allow a recommendation for or against the intervention. An Inconclusive recommendation means that there is a lack of compelling evidence resulting in an unclear balance between benefits and potential harm. Implications: Practitioners should feel little constraint in deciding whether to follow a recommendation labeled as Inconclusive and should exercise judgment and be alert to future publications that clarify existing evidence for determining balance of benefits versus potential harm. Patient preference should have a substantial influencing role. Rationale: We were unable to find any published studies that addressed the effects of preoperative immobilization or restricted weight bearing on the success of operative repair of acute rupture of this tendon. Supporting Evidence:
We did not identify any studies to address this recommendation.
v1.0 12.04.09 60
RECOMMENDATION 8 Open, limited open and percutaneous techniques are options for treating patients with acute Achilles tendon rupture. AAOS Strength of Recommendation: Limited Description: Evidence from two or more “Low” strength studies with consistent findings, or evidence from a single “Moderate” quality study recommending for or against the intervention or diagnostic. A Limited recommendation means the quality of the supporting evidence that exists is unconvincing, or that well-conducted studies show little clear advantage to one approach versus another. Implications: Practitioners should be cautious in deciding whether to follow a recommendation classified as Limited, and should exercise judgment and be alert to emerging publications that report evidence. Patient preference should have a substantial influencing role. Rationale:
We defined the following operative repairs:
Open – procedure utilizing an extended incision for exposure allowing visualization of the rupture and tendon to allow direct placement of sutures for the repair. Limited-Open – procedure utilizing a small incision for exposure allowing direct visualization of the ruptured ends. Percutaneous – procedure without direct exposure of the tendon rupture site.
A systematic review identified three level II comparative trials29, 33, 35 investigating percutaneous repair and one level II and two level III comparative trials studying limited-open repairs.27, 36, 31 In both these comparisons, there was no significant difference in reruptures between open and minimally invasive techniques.
Two studies 29, 33 that compared percutaneous to open repairs found no statistically significant difference in return to activity. Two studies27, 36 comparing limited open to open repair found that patients treated with a limited open technique returned to activity sooner than those treated with an open repair. There is no statistically significant difference in satisfaction in patients treated with percutaneous or open repairs.29 Patients treated with limited open repair techniques have statistically significantly fewer symptoms than those treated with open technique but no statistically significant differences in pain. One study33 showed a statistically significant difference in the short term in favor of the percutaneous group for wound breakdown/delayed healing. Two studies29, 33 showed statistically significantly less scar adhesion in the percutaneous repair group compared with the open repair. Similarly, patients treated with limited open groups had statistically
v1.0 12.04.09 61
significantly fewer minor surgical site infections leading to delayed wound healing and in one study fewer severe wound infections.27 Beyond short term wound complications, there is no identified added benefit when comparing long term adverse events between open repair and minimally invasive repair. While in some studies33, 31 there were an increased number of superficial infections in the open repair group, there was no statistically significant difference between groups for deep infections31. One study29 reported a statistically significant difference in superficial infections between the open group and percutaneous groups, however, the authors29 did not administer IV antibiotics to the open control group. Based on these considerations, we downgraded this body of evidence to limited. The literature reviewed refers primarily to non insertional ruptures in which there is sufficient distal tendon for repair. It is acknowledged that a small subset of ACTR consist of purely insertional injuries, often with a segment of bone attached. The latter group is beyond the scope of this GL. However, the reader should be aware of the fact that the repair techniques reviewed may not be compatible with these distal ruptures.
Consideration should also be given to the location of the tear when performing a repair in a percutaneous or limited-open fashion. Tears located at the proximal or distal ends of the tendon may compromise the ability to successfully complete a limited open repair. The orthopaedic surgeon performing the repair may need to extend the incision, converting it to an open technique if unable to obtain good suture fixation with a limited-open or percutaneous technique.
Supporting Evidence:
We examined studies that made two different comparisons. Two level II studies compared percutaneous repair to open repair.29, 35 Two level II studies and two level III studies compared limited open to open repair.31,33 27, 36
PERCUTANEOUS VS OPEN REPAIR Patients treated with percutaneous repair scored significantly higher on the SF-12 physical and mental component scores (see Table 61). There was no significant difference in the amount of patients who returned to functional activities, activities of daily living, (see Table 62) or patient satisfaction (see Table 63). The amount of reruptures did not significantly differ between treatment groups (see Table 65)
Studies29, 33 reported no significant difference in the number of sural nerve injuries, superficial infection with staphalococcus, hypertonic scars, or keloid formation (Table 64). Patients treated with percutaneous repair had significantly less wound breakdown/delay of healing as well as less scar adhesions (see Table 64). No significant difference in the amount of deep infections was reported. One study29 reported a statistically significant difference in superficial infection, while another study33 did not report a difference(see Table 64). However, the study which did report more superficial infections in the open repair group, did not administer IV antibiotics. Wound puckering occurred significantly more in patients treated with percutaneous repair (see Table 64).
v1.0 12.04.09 62
SUMMARY OF EVIDENCE- PERCUTANEOUS VS. OPEN Table 61. Percutaneous and Limited Open vs. Open - Global Outcomes
Author Outcome LOE N Duration
24 months
Gigante SF-12 - Physical Component Score II 39 ● P
Gigante SF-12 - Mental Component Score II 39 ● P
● P: Statistically Significant in Favor of Percutaneous Repair ● Op: Statistically Significant in Favor of Open Repair ○ No statistical significance
Table 62. Percutaneous vs. Open - Return to Activities and Function
Author Outcome
LOE N Duration (months)
% 6 65.5
ES Ng Return to Activity II 68 ○
Lim Return to Activities of Daily Living II 66 ○
Lim Returned to Final Functional Activity‡ II 66 ○
● P: Statistically Significant in Favor of Percutaneous Repair ● L: Statistically Significant in Favor of Limited Open Repair ● Op: Statistically Significant in Favor of Open Repair ○ No statistical significance ‡ Final Functional Activity: “When patient was unhindered in all his or her activities apart from sports.” Table 63. Percutaneous vs. Open - Satisfaction
Author Outcome
LOE N Duration
% 6 months Lim Satisfaction II 66 ○
● P: Statistically Significant in Favor of Percutaneous Repair ● Op: Statistically Significant in Favor of Open Repair ○ No statistical significance Table 64. Percutaneous vs. Open- Complications
Author Adverse Event LOE N Duration (months) 6 65.5
v1.0 12.04.09 63
Author Adverse Event LOE N Duration (months) 6 65.5
Ng Wound breakdown/ delay healing II 68 ●P
Ng Sural Nerve Injury II 68 ○ Lim Sural Nerve Problems II 66 ○
Lim Deep Infection with staphalococcus II 66 ○
Lim Adhesions II 66 ●P Ng Scar Adhesion II 68 ●P Ng Superficial Infection II 68 ○ Lim Superficial Infection II 66 ●P
Lim Superficial Infection with staphalococcus ○
Ng Hypertrophic Scar II 68 ○ Lim Keloid Formation II 66 ○ Lim Wound Puckering II 66 ● Op
● P: Statistically Significant in Favor of Percutaneous Repair ● Op: Statistically Significant in Favor of Open Repair ○ No statistical significance Table 65. Percutaneous vs. Open- Rerupture
Author Adverse Event LOE N Duration (months) 6 65.5
Lim et al 2001 Rerupture II 66 ○
Ng, et al 2006 Rerupture II 68 ○ ● P: Statistically Significant in Favor of Percutaneous Repair ● L: Statistically Significant in Favor of Limited Open Repair ● Op: Statistically Significant in Favor of Open Repair ○ No statistical significance
LIMITED OPEN VS OPEN REPAIR Patients treated with limited open repair did not have less pain or score higher on the AOFAS scale than patients treated with open repair (see Table 66 and Table 67). Patients treated with limited open repair returned to normal walking, stair climbing, and sports in significantly less time than patients treated with standard open repair (seeTable 68). A significantly larger percentage of patients treated with limited open repair had fewer symptoms compared to patients treated with open repair (seeTable 69). There was no significant difference in the number of reruptures between treatment groups (see Table 71). There was no statistically significant difference in DVT, large hematoma,
v1.0 12.04.09 64
stiffness of ankle, insertional tendinopathy, or deep infection between the open and limited repair groups (see Table 70). However, patients treated with limited open repair had significantly fewer severe wound infections, superficial infections, and minor surgical site infections than patients treated with open repair (see Table 70). SUMMARY OF EVIDENCE- LIMITED OPEN VS. OPEN Table 66. Minimally Invasive vs. Open- Pain
Author Outcome
LOE N Duration
% 6 months Aktas Pain II 46 ○
● P: Statistically Significant in Favor of Percutaneous Repair ● Op: Statistically Significant in Favor of Open Repair ○ No statistical significance Table 67. Minimally Invasive vs. Open- Global Outcomes
Author Outcome LOE N Duration
24 months
Aktas AOFAS II 40 ○
● P: Statistically Significant in Favor of Percutaneous Repair ● Op: Statistically Significant in Favor of Open Repair ○ No statistical significance Table 68. Limited Open vs. Open- Return to Activity
Author Outcome
LOE N Duration
(weeks) 12 months
63.5 months
Bhattacharyya Return to Normal Walking III 53 ●Mini
Bhattacharyya Return to Normal Stair Climbing III 53 ●Mini
Kakiuchi Return to Sports III 22 ● Mini
● Mini: Statistically Significant in Favor of Minimally Invasive (mini-open) Repair ● Op: Statistically Significant in Favor of Open Repair ○ No statistical significance Table 69. Mini-Open vs. Open- Symptoms
Author Outcome
LOE N Duration
(%) 63.5 months
Kakiuchi Symptoms III 22 ● Mini
● Mini: Statistically Significant in Favor of Minimally Invasive Repair
v1.0 12.04.09 65
● Op: Statistically Significant in Favor of Open Repair ○ No statistical significance Table 70. Limited Open Repair vs. Open - Complications
Author Complication LOE N Duration
6 Months
12 months
Bhattacharyya
Minor Surgical Site Infection with
Delayed Wound Healing
III 53 ● Mini
Bhattacharyya Severe Wound Infection and Dehiscence
III 53 ● Mini
Aktas, 2009 Deep Infection II 40 ○
Aktas, 2009 Superficial Infection II 40 ● Mini
Aktas, 2009 Insertional Tendinopathy II 40 ○
Aktas, 2009 Stiffness of the ankle II 40 ○
Aktas, 2009 Large Hematoma II 40 ○
Aktas, 2009 DVT II 40 ○
● P: Statistically Significant in Favor of Percutaneous Repair ● L: Statistically Significant in Favor of Limited Open Repair ● Op: Statistically Significant in Favor of Open Repair ○ No statistical significance Table 71. Mini-Open vs. Open – Rerupture
Author Adverse Events LOE N Duration
63.5 months Kakiuchi Rerupture III 22 ○
● P: Statistically Significant in Favor of Percutaneous Repair ● L: Statistically Significant in Favor of Limited Open Repair ● Op: Statistically Significant in Favor of Open Repair ○ No statistical significance
v1.0 12.04.09 66
EXCLUDED ARTICLES Table 72. Excluded Studies - All Operative Techniques
Author Title Exclusion Reason
Cretnik A, et al Percutaneous versus open repair of the ruptured Achilles tendon. a comparative study
Not best available evidence
Wagnon R, et al The Webb-Bannister percutaneous technique for acute
Achilles' tendon ruptures. a functional and MRI assessment
Not best available evidence
Assal M, et al Limited open repair of Achilles tendon ruptures. a technique with a new instrument and findings of a
prospective multicenter study
Not best available evidence - not comparative
Halasi T, et al Percutaneous Achilles tendon repair with and without endoscopic control
Not best available evidence - not comparative
Cretnik A, et al Percutaneous suturing of the ruptured Achilles tendon under local anesthesia
Not best available evidence - not comparative
Coutts A, et al Clinical and functional results of open operative repair for Achilles tendon rupture in a non-specialist surgical unit
Not best available evidence - not comparative
Calder JD, et al Independent evaluation of a recently described Achilles tendon repair technique
Not best available evidence - not comparative
Uchiyama E, et al A modified operation for Achilles tendon ruptures Not best available
evidence - not comparative
Maes R, et al; Is percutaneous repair of the Achilles tendon a safe technique? A study of 124 cases
Not best available evidence - not comparative
Amlang MH, et al The percutaneous suture of the Achilles tendon with the Dresden instrument
Not best available evidence - not comparative
Tang KL, et al Arthroscopically assisted percutaneous repair of fresh closed Achilles tendon rupture by Kessler's suture
Not best available evidence - not comparative
Fortis AP, et al Repair of Achilles tendon rupture under endoscopic control
Not best available evidence - not comparative
Schonberger TJ, et al
Operative treatment of acute Achilles tendon rupture. Open end-to-end-reconstruction versus reconstruction with
Mitek-anchors Retrospective case series
Hohendorff B, et al Long-term results after operatively treated Achilles tendon rupture. fibrin glue versus suture suture technique
Kuwada GT; Critical analysis of tendo Achillis repair using Achilles tendon rupture classification system and repair
Not best available evidence - not comparative
v1.0 12.04.09 67
Author Title Exclusion Reason
Lansdaal JR, et al The results of 163 Achilles tendon ruptures treated by a
minimally invasive surgical technique and functional after treatment
Not best available evidence - not comparative
Blankstein A, et al Percutaneous Achilles tendon repair combined with real-time sonography
Not best available evidence - not comparative
Majewski M, et al Avoiding sural nerve injuries during percutaneous Achilles tendon repair
Not best available evidence - not comparative
Jung HG, et al Outcome of Achilles tendon ruptures treated by a limited open technique
Not best available evidence - not comparative
Scarfi G, et al Percutaneous repair of Achilles tendon Not best available
evidence - not comparative
Crnica S, et al Follow-up results of Achilles tendon rupture treatment by the method of modified percutaneous suture
Not best available evidence - not comparative
Perez TA; Traumatic rupture of the Achilles Tendon. Reconstruction by transplant and graft using the lateral peroneus brevis
Not best available evidence - not comparative
Ma GW;Griffith TG;
Percutaneous repair of acute closed ruptured Achilles tendon. a new technique
Not best available evidence - not comparative
Boyden EM, et al; Late versus early repair of Achilles tendon rupture. Clinical and biomechanical evaluation
Not best available evidence - not comparative
Soldatis JJ, et al End-to-end operative repair of Achilles tendon rupture Not best available
evidence - not comparative
Martinelli B; Percutaneous repair of the Achilles tendon in athletes Not best available
evidence - not comparative
Mellor SJ;Patterson MH; Tendo Achillis rupture; surgical repair is a safe option
Not best available evidence - not comparative
Bruggeman NB, et al
Wound complications after open Achilles tendon repair. an analysis of risk factors
Not best available evidence - not comparative
Webb JM;Bannister GC; Percutaneous repair of the ruptured tendo Achillis
Not best available evidence - not comparative
Gillespie HS;George EA;
Results of surgical repair of spontaneous rupture of the Achilles tendon
Not best available evidence - not comparative
Jessing P;Hansen E; Surgical treatment of 102 tendo achillis ruptures-- suture or tenontoplasty?
Not best available evidence - not comparative
v1.0 12.04.09 68
Author Title Exclusion Reason
Kiviluoto O, et al Surgical repair of subcutaneous rupture of the Achilles tendon
Not best available evidence - not comparative
Haggmark T, et al Calf muscle atrophy and muscle function after non-operative vs. operative treatment of Achilles tendon
ruptures
Not best available evidence - not comparative
Bomler J;Sturup J; Achilles tendon rupture. An 8-year follow up Not best available
evidence - not comparative
Hogsaa B, et al Surgical treatment of Achilles tendon ruptures Not best available
evidence - not comparative
FitzGibbons RE, et al Percutaneous Achilles tendon repair
Not best available evidence - not comparative
Chillemi C, et al Percutaneous repair of Achilles tendon rupture. Ultrasonographical and isokinetic evaluation
Not best available evidence - not comparative
Gorschewsky O, et al Percutaneous repair of acute Achilles tendon rupture
Not best available evidence - not comparative
STUDY QUALITY Table 73. Study Quality - RCTs
● = Yes ○ = No × = Not Reported
Stoc
hast
ic
Ran
dom
izat
ion
Allo
catio
n C
once
alm
ent
Patie
nts B
linde
d
Tho
se r
atin
g ou
tcom
e B
linde
d
Follo
w U
p - 8
0% o
r m
ore
All
grou
ps h
ave
sim
ilar
outc
ome
perf
orm
ance
at
entr
y
Author Outcome N Treatment(s) Level of Evidence
Gigante, et al. 2008
SF-12. Physical
Component 39
Open Repair vs.
Percutaneous Repair
Level II ● × × ● ● ×
Gigante, et al. 2008
SF-12. Mental Component 39
Open Repair vs.
Percutaneous Repair
Level II ● × × ● ● ×
Lim, et al.
2001 Complications 66
Open Repair vs.
Percutaneous Repair
Level II ○ ● ● × ● ×
Lim, et al.
Duration of Immobilization 66 Open Repair
vs. Level II ○ ● ● × ● ×
v1.0 12.04.09 69
● = Yes ○ = No × = Not Reported
Stoc
hast
ic
Ran
dom
izat
ion
Allo
catio
n C
once
alm
ent
Patie
nts B
linde
d
Tho
se r
atin
g ou
tcom
e B
linde
d
Follo
w U
p - 8
0% o
r m
ore
All
grou
ps h
ave
sim
ilar
outc
ome
perf
orm
ance
at
entr
y
Author Outcome N Treatment(s) Level of Evidence
2001 Percutaneous Repair
Lim, et al.
2001
Return to activities of daily living
66
Open Repair vs.
Percutaneous Repair
Level II ○ ● ● × ● ×
Lim, et al.
2001
Return to functional
activity 66
Open Repair vs.
Percutaneous Repair
Level II ○ ● ● × ● ×
Aktas, et al. 2009
AOFAS 40 Minimally
Invasive vs. Open
Level II × × × ○ ● ●
v1.0 12.04.09 70
Table 74. Quality of Studies - Comparative Studies
● = Yes ○ = No × = Not Reported
All
grou
ps h
ave
sim
ilar
char
acte
ristic
s at e
ntry
All
grou
ps h
ave
sim
ilar
outc
ome
perf
orm
ance
at
entry
All
grou
ps c
oncu
rren
tly
tre
ated
Follo
w U
p - 8
0% o
r mor
e
Sam
e ce
nter
for
expe
rimen
tal a
nd c
ontro
l gr
oup
data
Author Outcome N Treatment(s) Level of Evidence
Kakiuchi, et al. 1995
Return to Sports 22
Percutaneous and Minimally
Invasive vs. Open Repair
Level III × × ● ○ ●
Kakiuchi, et al. 1995
Symptoms - None 22
Percutaneous and Minimally
Invasive vs. Open Repair
Level III × × ● ○ ●
Kakiuchi, et al. 1995
Symptoms - Stiffness 22
Percutaneous and Minimally
Invasive vs. Open Repair
Level III × × ● ○ ●
Kakiuchi, et al. 1995
Symptoms - Discomfort 22
Percutaneous and Minimally
Invasive vs. Open Repair
Level III × × ● ○ ●
Kakiuchi, et al. 1995
Symptoms - Pain 22
Percutaneous and Minimally
Invasive vs. Open Repair
Level III × × ● ○ ●
Kakiuchi, et al. 1995 Re-rupture 22
Percutaneous and Minimally
Invasive vs. Open Repair
Level III × × ● ○ ●
Ng, et al. 2006 Return to Activity -
Same Level 68
Percutaneous vs. Open Repair
Level II ● × ● ● ●
Ng, et al. 2006 Complications 68 Percutaneous
vs. Open Repair
Level II ● × ● ● ●
Bhattacharyya, et al. 2009
Return to Normal Walking
53 Minimally
Invasive vs. Open Repair
Level III ○ × ● ● ●
Bhattacharyya, et al. 2009
Return to Normal Stair
Climbing 53
Minimally Invasive vs. Open Repair
Level III ○ × ● ● ●
Bhattacharyya, et al. 2009
Severe Wound
Infection and 53
Minimally Invasive vs. Open Repair
Level III ○ × ● ● ●
v1.0 12.04.09 71
● = Yes ○ = No × = Not Reported
All
grou
ps h
ave
sim
ilar
char
acte
ristic
s at e
ntry
All
grou
ps h
ave
sim
ilar
outc
ome
perf
orm
ance
at
entry
All
grou
ps c
oncu
rren
tly
tre
ated
Follo
w U
p - 8
0% o
r mor
e
Sam
e ce
nter
for
expe
rimen
tal a
nd c
ontro
l gr
oup
data
Author Outcome N Treatment(s) Level of Evidence
Dehiscence
Bhattacharyya, et al. 2009
Minor Surgical Site
Infection 53
Minimally Invasive vs. Open Repair
Level III ○ × ● ● ●
Bhattacharyya, et al. 2009
Delayed Wound Healing
53 Minimally
Invasive vs. Open Repair
Level III ○ × ● ● ●
v1.0 12.04.09 72
STUDY RESULTS Table 75. Limited open vs. Open - Global Outcomes
Author Outcome LOE N Duration Minimally Invasive Open
Results mean (SD) mean (SD)
Gigante, et al. 2008
SF-12 - Physical Component Score II 39 24 months 52.6 (2.31) 50.7 (2.57) p = 0.02‡
SF-12- Mental Component Score II 39 24 months 52.2 (1.91) 50.4 (2.75) p = 0.02‡
‡ AAOS calculation Table 76. Percutaneous vs. Open - Return to Activities
Author Outcome LOE N Duration Percutaneous (%)
Open (%) Results
Lim, et al. 2001 Return to
Activities of Daily Living
II 66 6 months 100% 100% NS
Lim, et al. 2001 Returned to Final
Functional Activity
II 66 6 months 100% 100% NS
NS: not significant; authors do not report p-value
Table 77. Percutaneous vs. Open - Satisfaction
Author Outcome LOE N Duration Percutaneous (%)
Open (%) Results
Lim, et al. 2001 Satisfaction - Excellent II 66 6 months 52% 42% NS
NS: not significant; authors do not report p-value Table 78. Percutaneous vs. Open - Complications
Author Complications LOE N Duration Percutaneous (%)
Open (%) Results
Lim, et al 2001 Re-rupture II 66 6 months 3% 6% p = .55‡
Lim, et al. 2001
Sural Nerve Problems II 66 6 months 3% 0% p = .15‡
Lim, et al. 2001
Deep infection with wound
breakdown and staphalococcus
infection
II 66 6 months 0% 3% p = 0.155‡
Lim, et al. 2001
Superficial Infection with staphalococcus
infection
II 66 6 months 0% 3% p = 0.155‡
v1.0 12.04.09 73
Author Complications LOE N Duration Percutaneous (%)
Open (%) Results
Lim, et al. 2001
Superficial Infection II 66 6 months 0% 15% p=0.001‡
Lim, et al. 2001
Keloid Formation II 66 6 months 0% 3% p = .15‡
Lim, et al. 2001 Adhesions II 66 6 months 0% 6% p = .043
Lim, et al. 2001
Wound Puckering II 66 6 months 9% 0% p = .013‡
Aktas, et al. 2009 Deep Infection II 40 Post
operative 0% 5% p=0.15‡
Aktas, et al. 2009
Superficial Infection II 40 Post
operative 0% 15% p=0.011‡
Aktas, et al. 2009
Insertional Tendinopathy II 40 Post
operative 5% 0 p=0.15‡ Aktas, et al.
2009 Stiffness of the
ankle II 40 Post operative 0% 5% p=0.15‡
Aktas, et al. 2009
Large Hematoma II 40 Post
operative 0% 5% p=0.15‡ Aktas, et al.
2009 DVT II 40 Post operative 0% 5% p=0.15‡
‡ AAOS calculation
Table 79. Minimally Invasive vs. Open- Pain
Author Outcome LOE N Duration Percutaneous (%)
Open (%) Results
Aktas, et al. 2009 Pain II 46 22 months 4.5% 13% P=0.3
Table 80. Minimally Invasive vs. Open- Global Outcomes
Author Outcome LOE N Duration Percutaneous (%)
Open (%) Results
Aktas, et al. 2009 Pain II 46 22 months 4.5% 13% P=0.3
Table 81. Minimally Invasive vs. Open - Function
Author Outcome LOE N Duration Minimally
Invasive mean (SD)
Open Repair
mean (SD) Results
Bhattacharyya, et al. 2009
Return to Normal Walking (weeks) III 53 12 months 12.5 (3)‡ 17 (3)‡ p ≤ .001‡
Return to Normal Stair Climbing
(weeks) III 53 12 months 14 (3)‡ 19 (3.5)‡ p ≤ .001‡
v1.0 12.04.09 74
Author Outcome LOE N Duration Minimally
Invasive mean (SD)
Open Repair
mean (SD) Results
Ng, et al 2006 Return to
Activity - Same Level
II 68 65.5 months 96% 88% p = 0.244
‡ AAOS calculation
Table 82. Minimally Invasive vs. Open - Complications
Author Complications LOE N Duration
Minimally Invasive Open
Repair (%)
Open (%) Results
Bhattacharyya, et al. 2009
Minor Surgical Site Infection with Delayed
Wound Healing
III 53 12 months 0% 17% p <.001‡
Bhattacharyya, et al. 2009
Severe Wound Infection and Dehiscence
III 53 12 months 0% 7% p =.034‡
Ng, et al. 2006 Re-rupture II 68 65.5
months 0% 2% p = .223‡
Ng, et al. 2006
Sural Nerve Injury II 68 65.5
months 0% 2% p = .22‡
Ng, et al. 2006
Superficial Infection II 68 65.5
months 8% 5% p = .58‡
Ng, et al. 2006
Hypertrophic Scar II 68 65.5
months 4% 19% p = .052‡
Ng, et al. 2006 Scar Adhesion II 68 65.5
months 0% 9% p = .014‡
Ng, et al. 2006
Wound Breakdown/delay II 68 65.5
months 0% 12% p = .005‡
‡ AAOS calculation
Table 83. Minimally Invasive vs. Open - Symptoms
Author Outcome LOE N Duration Minimally Invasive (%)
Open (%) Results
Kakiuchi, et al. 1995 Symptoms - Pain III 22 63.5
months 0% 20% p = .05‡
Kakiuchi, et al. 1995 Symptoms- None III 22 63.5
months 83% 40% p <.001‡
Kakiuchi, et al. 1995
Symptoms - Stiffness III 22 63.5
months 17% 30% p =.78‡
Kakiuchi, et al. 1995
Symptoms - Discomfort III 22 63.5
months 0% 10% p = .17‡
‡ AAOS calculation
v1.0 12.04.09 75
Table 84. Minimally Invasive vs. Open - Return to Sport
Author Outcome LOE N Duration
Minimally Invasive (%)
Open (%) Results
Kakiuchi, et al. 1995
Return to Sport - Same or
increased level III 22 63.5
months 75% 10% p < .001‡
Return to Sport - Decreased III 22 63.5
months 8% 40% p = .17‡
Return to Sport - No participation for other reasons
III 22 63.5 months 17% 50% p = .27‡
‡ AAOS calculation
Table 85. Minimally Invasive vs. Open - Complications
Author Complications LOE N Duration Minimally
Invasive (%) Open Results
% % Kakiuchi, et al.
1995 Rerupture III 22 63.5 months 0% 0% NS
NS: not significant; authors do not report p-value
v1.0 12.04.09 76
RECOMMENDATION 9 We cannot recommend for or against the use of allograft, autograft, xenograft, synthetic tissue, or biologic adjuncts in acute Achilles tendon ruptures that are treated operatively.
AAOS Strength of Recommendation: Inconclusive
Description: Evidence from a single low quality study or conflicting findings that do not allow a recommendation for or against the intervention. An Inconclusive recommendation means that there is a lack of compelling evidence resulting in an unclear balance between benefits and potential harm. Implications: Practitioners should feel little constraint in deciding whether to follow a recommendation labeled as Inconclusive and should exercise judgment and be alert to future publications that clarify existing evidence for determining balance of benefits versus potential harm. Patient preference should have a substantial influencing role.
Rationale
A systematic review failed to identify adequate evidence to make a recommendation for or against the use of allograft, autograft, xenograft, synthetic tissue, or biologic adjuncts in acute Achilles tendon ruptures that are treated operatively.
No studies addressed adjunctive augmentation with allograft, xenograft, or biologic adjuncts.
Three level II studies32, 37, 38 compared open repair alone and autograft augmentation. One level IV study39 compared patients treated with synthetic tissue augmentation to open repair alone. All four of these studies failed to demonstrate significant improvement in outcomes or complications.
Supporting Evidence: No studies were identified that address adjunctive augmentation with allograft (see Table 92), xenograft, or biologic adjuncts (see Table 95). We examined three level II studies that compared patients given adjunctive augmentation with autograft tissue vs. open repair.32, 37, 38 One Level IV study that compared patients given adjunctive augmentation with synthetic tissue vs. open repair.39 AUTOGRAFT TISSUE VS OPEN REPAIR Three studies reported that patients given adjunctive augmentation did not significantly differ in pain, stiffness, satisfaction, return to daily activities, return to sport, or footwear restrictions (see Table 86 - Table 89).
One study reported one patient given adjunct augmentation had a pulmonary embolism; no significant difference was found between treatment groups (see Table 91). In two studies, DVT rates did not significantly differ in patients given augmentation with autograft tissue vs. open repair. Two studies reported patients with deep infection. One study found patients treated with open repair had significantly less deep infections and
v1.0 12.04.09 77
the other study reported no significant difference. No significant differences were found in patients given augmentation with superficial infections, dysesthesia, Keloid, and dehiscence (see Table 91).
AUGMENTATION WITH SYNTHETIC TISSUE VS OPEN REPAIR We analyzed one non-comparative study that analyzed patients treated with synthetic tissue (polypropylene braid). All patients reported excellent results and all patients returned to previous activity (see Table 106). There were no reruptures and no healing impairment (see Table 106). One patient underwent a PB removal procedure 1 year after surgery because of the distal heat-sealed end of the PB device stuck out of the tendon, causing an impingement on the shoe (see Table 106).
SUMMARY OF EVIDENCE Table 86. Autograft vs. Open - Pain and Stiffness
Author LOE N Outcome Duration (months) 6 12 42
Pajala II 59 Pain ○
Aktas II 30 Pain ○
Taglialavoro II 46 Pain ○
Pajala II 59 Stiffness ○
●Op: Statistically Significant in Favor of Open Operative Repair ●A: Statistically Significant in Favor of Open Repair with Adjunctive Augmentation ○ No statistical significance Table 87. Autograft vs. Open - Satisfaction
Author LOE N Outcome Duration (months) 12 42
Taglialavoro II 46 Satisfaction ○
Pajala II 59 Satisfaction ○
●Op: Statistically Significant in Favor of Open Operative Repair ●A: Statistically Significant in Favor of Open Repair with Adjunctive Augmentation ○ No statistical significance Table 88. Autograft - Return to Activities and Sports
Author LOE N Outcome Duration (months) 6 42
Taglialavoro II 46 Recovery of Daily Activities (days) ○
v1.0 12.04.09 78
Author LOE N Outcome Duration (months) 6 42
Taglialavoro II 46
Return to Sports – Complaints during normal
activity ○
Aktas, et al II 30 Return to Sports – Same
Level / Pre-injury ○
Taglialavoro II 46 Return to Sports ○ ●Op: Statistically Significant in Favor of Open Operative Repair ●A: Statistically Significant in Favor of Open Repair with Adjunctive Augmentation ○ No statistical significance Table 89. Autograft vs. Open - Footwear Restrictions
Author LOE N Outcome Duration (months)
12 42
Pajala II 59 Footwear Restrictions ○
Taglialavoro II 46 Conflict with shoes ○
●Op: Statistically Significant in Favor of Open Operative Repair ●A: Statistically Significant in Favor of Open Repair with Adjunctive Augmentation ○ No statistical significance Table 90. Autograft vs. Open - Hospitalization and Immobilization
Author Outcome (Days) LOE N Duration
42 months
Taglialavoro Hospitalization II 46 ●Op
Taglialavoro Immobilization II 46 ●Op
●Op: Statistically Significant in Favor of Open Operative Repair ●A: Statistically Significant in Favor of Open Repair with Adjunctive Augmentation ○ No statistical significance Table 91. Autograft vs. Open - Complications
Author LOE N Outcome Duration (months) 6 12 42
Taglialavoro II 46 PE ○ Taglialavoro II 46 DVT ○
Pajala II 60 DVT ○ Aktas II 30 Deep Infection ○ Pajala II 60 Deep Infection ●Op Pajala II 60 Superficial ○
v1.0 12.04.09 79
Author LOE N Outcome Duration (months) 6 12 42
Infection
Pajala II 60 Re-rupture ○
Aktas II 30 Re-rupture ○ Taglialavoro II 46 Dysesthesia ○ Taglialavoro II 46 Keloid ○ Taglialavoro II 46 Dehiscence ○
●Op: Statistically Significant in Favor of Open Operative Repair ●A: Statistically Significant in Favor of Open Repair with Adjunctive Augmentation ○ No statistical significance EXCLUDED ARTICLES Table 92. Excluded Studies - Allograft
Author Title Exclusion Reason
Bleakney, et al. 2005 Imaging of the Achilles tendon Commentary
Lee, et al. 2007
Achilles tendon repair with acellular tissue graft augmentation in neglected ruptures
Neglected/chronic Achilles tear patients
Table 93. Excluded Studies - Autograft
Author Title Exclusion Reason
Bradley, et al. 1990
Percutaneous and open surgical repairs of Achilles tendon ruptures. A comparative study
Not best available evidence
Coull, et al. 2003
Flexor hallucis longus tendon transfer: evaluation of postoperative morbidity
Not best available evidence
Cretnik, et al. 2004 Incidence and outcome of rupture of the Achilles tendon Not best available
evidence Dekker, et al.
1977 Results of surgical treatment of rupture of the Achilles
tendon with use of the plantaris tendon Not best available
evidence
Elias, et al. 2007
Reconstruction for missed or neglected Achilles tendon rupture with V-Y lengthening and flexor hallucis longus
tendon transfer through one incision
Neglected/chronic Achilles tear patients
Garabito, et al. 2005
Augmented repair of acute Achilles tendon ruptures using gastrocnemius-soleus fascia
Not best available evidence
Hahn, et al. 2008
Treatment of chronic Achilles tendinopathy and ruptures with flexor hallucis tendon transfer: clinical outcome and
MRI findings
Less than 10 patients per group
Jessing, et al. 1975
Surgical treatment of 102 tendo achillis ruptures-- suture or tenontoplasty?
Not best available evidence
v1.0 12.04.09 80
Author Title Exclusion Reason
Kiviluoto, et al. 1985
Surgical repair of subcutaneous rupture of the Achilles tendon cast only
Leppilahti, et al. 1998
Outcome and prognostic factors of Achilles rupture repair using a new scoring method
Not best available evidence
Lynn, et al. 1966
Repair of the torn Achilles tendon, using the plantaris tendon as a reinforcing membrane
Less than 50% follow-up
Maffulli, et al. 2005
Free gracilis tendon graft in neglected tears of the Achilles tendon
Neglected/chronic Achilles tear patients
Roberts, et al. 1989
Team physician #6. Surgical treatment of Achilles tendon rupture
Not best available evidence
Schedl, et al. 1979
Achilles tendon repair with the plantaris tendon compared with repair using polyglycol threads
Not best available evidence
Stein, et al. 2005 Duthie's biological repair of ruptured Achilles tendons Insufficient
Quantitative Data Winter, et al.
1998 Surgical repair of Achilles tendon rupture. Comparison of
surgical with conservative treatment Retrospective case
series Wong, et al.
2005 Modified flexor hallucis longus transfer for Achilles
insertional rupture in elderly patients Less than 10 patients
per group Table 94. Excluded Studies - Synthetic Tissue
Author Title Exclusion Reason Fernandez-Fairen, et
al. 1997
Augmented repair of Achilles tendon ruptures Retrospective case series
Hohendorff, et al. 2008
Long-term results after operatively treated Achilles tendon rupture: fibrin glue versus suture Suture Technique
Parsons, et al. 1984
Achilles tendon repair with an absorbable polymer-carbon fiber composite
Combines acute and neglected/chronic
Achilles tendon tear patients
Parsons, et al. 1989
Long-term follow-up of Achilles tendon repair with an absorbable polymer carbon fiber composite
Patients had prior surgical or
conservative treatment Table 95- Biologic Adjuncts
Author Title Exclusion Reason
Aspenberg, et al. 2007
Stimulation of tendon repair: mechanical loading, GDFs and platelets. A mini-review Review
Sanchez, et al. 2007
Comparison of surgically repaired Achilles tendon tears using platelet-rich fibrin matrices
Less than 10 patients per group
v1.0 12.04.09 81
STUDY QUALITY Table 96. Study Quality – Autograft RCTs
● = Yes ○ = No × = Not Reported
Stoc
hast
ic R
ando
miz
atio
n
Allo
catio
n C
once
alm
ent
Patie
nts B
linde
d
Tho
se r
atin
g ou
tcom
e B
linde
d
Follo
w U
p - 8
0% o
r m
ore
All
grou
ps h
ave
sim
ilar
outc
ome
perf
orm
ance
at e
ntry
Author Outcome N Treatment(s) Level of Evidence
Pajala, et al.
2009 Stiffness 60 Open vs. Autograft
Augmentation Level II ● ● ● ○ ● ×
Pajala, et al.
2009
Footwear Restrictions 60 Open vs. Autograft
Augmentation Level II ● ● ● ○ ● ×
Pajala, et al.
2009 Pain 60 Open vs. Autograft
Augmentation Level II ● ● ● ○ ● ×
Pajala, et al.
2009 Satisfaction 60 Open vs. Autograft
Augmentation Level II ● ● ● ○ ● ×
Pajala, et al.
2009 Re-rupture 60 Open vs. Autograft
Augmentation Level II ● ● ● ○ ● ×
Pajala, et al.
2009 Deep Infection 60 Open vs. Autograft
Augmentation Level II ● ● ● ○ ● ×
Pajala, et al.
2009 DVT 60 Open vs. Autograft
Augmentation Level II ● ● ● ○ ● ×
Pajala, et al.
2009
Superficial Infection 60 Open vs. Autograft
Augmentation Level II ● ● ● ○ ● ×
Aktas, et al.
2007 Return to sport 30 Open vs. Autograft
Augmentation Level II × × ● ○ ● ×
Aktas, et al.
2007 Pain 30 Open vs. Autograft
Augmentation Level II ○ ● ● ○ ● ×
v1.0 12.04.09 82
● = Yes ○ = No × = Not Reported
Stoc
hast
ic R
ando
miz
atio
n
Allo
catio
n C
once
alm
ent
Patie
nts B
linde
d
Tho
se r
atin
g ou
tcom
e B
linde
d
Follo
w U
p - 8
0% o
r m
ore
All
grou
ps h
ave
sim
ilar
outc
ome
perf
orm
ance
at e
ntry
Author Outcome N Treatment(s) Level of Evidence
Aktas, et al.
2007 Deep Infection 30 Open vs. Autograft
Augmentation Level II ○ ● ● ○ ● ×
Aktas, et al.
2007 Re-rupture 30 Open vs. Autograft
Augmentation Level II ○ ● ● ○ ● ×
Table 97. Study Quality - Autograft Comparative Studies
● = Yes ○ = No × = Not Reported
All
grou
ps h
ave
sim
ilar c
hara
cter
istic
s at
ent
ry
All
grou
ps h
ave
sim
ilar o
utco
me
perf
orm
ance
at e
ntry
A
ll gr
oups
con
curr
ently
treat
ed
Follo
w U
p - 8
0% o
r mor
e
Sam
e ce
nter
for e
xper
imen
tal a
nd
cont
rol g
roup
dat
a
Author Outcome N Treatment(s) Level of Evidence
Taglialavoro, et al 2004 Pain 46 Open vs. Autograft
Augmentation Level II ● ● ● ● ●
Taglialavoro, et al 2004
Recovery of Daily Activities 46 Open vs. Autograft
Augmentation Level II ● ● ● ● ●
Taglialavoro, et al 2004 Return to Sports 46 Open vs. Autograft
Augmentation Level II ● ● ● ● ●
Taglialavoro, et al 2004 Satisfaction 46 Open vs. Autograft
Augmentation Level II ● ● ● ● ●
Taglialavoro, et al 2004 Hospitalization 46 Open vs. Autograft
Augmentation Level II ● ● ● ● ●
v1.0 12.04.09 83
● = Yes ○ = No × = Not Reported
All
grou
ps h
ave
sim
ilar c
hara
cter
istic
s at
ent
ry
All
grou
ps h
ave
sim
ilar o
utco
me
perf
orm
ance
at e
ntry
A
ll gr
oups
con
curr
ently
treat
ed
Follo
w U
p - 8
0% o
r mor
e
Sam
e ce
nter
for e
xper
imen
tal a
nd
cont
rol g
roup
dat
a
Author Outcome N Treatment(s) Level of Evidence
Taglialavoro, et al 2004 Immobilization 46 Open vs. Autograft
Augmentation Level II ● ● ● ● ●
Taglialavoro, et al 2004 DVT 46 Open vs. Autograft
Augmentation Level II ● ● ● ● ●
Taglialavoro, et al 2004 PE 46 Open vs. Autograft
Augmentation Level II ● ● ● ● ●
Taglialavoro, et al 2004 Dysesthesia 46 Open vs. Autograft
Augmentation Level II ● ● ● ● ●
Taglialavoro, et al 2004 Shoe conflict 46 Open vs. Autograft
Augmentation Level II ● ● ● ● ●
Taglialavoro, et al 2004 Keloid 46 Open vs. Autograft
Augmentation Level II ● ● ● ● ●
Taglialavoro, et al 2004 Dehiscence 46 Open vs. Autograft
Augmentation Level II ● ● ● ● ●
v1.0 12.04.09 84
Table 98. Study Quality - Synthetic Tissue Case Series
● = Yes ○ = No × = Not Reported
Con
secu
tive
enro
llmen
t
of p
atie
nts
Follo
w U
p - 8
0% o
r mor
e
All
patie
nts e
valu
ated
usi
ng
sam
e ou
tcom
e m
easu
res
All
patie
nts r
ecei
ve sa
me
treat
men
t
All
patie
nts h
ave
appr
oxim
atel
y eq
ual f
ollo
w-u
p tim
es
Author Outcome N Treatment(s) Level of Evidence
Giannini et al, 1994 Return to Sports 15 Synthetic Adjunctive
Augmentation Level IV ● ● ● ● ●
Giannini et al, 1994
Return to Previous Activity
15 Synthetic Adjunctive Augmentation Level IV ● ● ● ● ●
Giannini et al, 1994
Subjective Results-
Excellent 15 Synthetic Adjunctive
Augmentation Level IV ● ● ● ● ●
Giannini et al, 1994
Full weight bearing (weeks) 15 Synthetic Adjunctive
Augmentation Level IV ● ● ● ● ●
Giannini et al, 1994 Rerupture 15 Synthetic Adjunctive
Augmentation Level IV ● ● ● ● ●
Giannini et al, 1994
Healing Impairment 15 Synthetic Adjunctive
Augmentation Level IV ● ● ● ● ●
Giannini et al, 1994
Return to Swimming 15 Synthetic Adjunctive
Augmentation Level IV ● ● ● ● ●
v1.0 12.04.09 85
STUDY RESULTS Table 99 Autograft vs. Open Pain and Stiffness
Author Outcome LOE N Duration Adjunctive
Augmentation Open Results % %
Pajala, et al. 2009 No Pain vs. Pain II 59 12
months 79% (4%) 90% (0%) p = 0.35
Aktas, et al. 2007 Pain - Absent‡ II 30 6 months 94% 86% NS
Aktas, et al. 2007
Pain - Mild w/ maximal exertion‡ II 30 6 months 6% 14% NS
Taglialavoro, et al 2004 Pain - Absentª II 46 42
months 83% 73% NS
Taglialavoro, et al 2004
Pain - During Intense Trainingª II 46 42
months 17% 18% NS
Taglialavoro, et al 2004
Pain - During Moderate Trainingª II 46 42
months 0% 5% NS
Taglialavoro, et al 2004 Pain - Continuousª II 46 42
months 0% 5% NS
Pajala, et al. 2009 No stiffness vs. stiffness II 59 12
months 46% (36% 72% (16%) p = .10
‡American Orthopaedic Foot and Ankle Score NS: not significant; authors do not report p-value
Table 100. Autograft vs. Open - Satisfaction
Author Outcome LOE N Duration Adjunctive
Augmentation (%)
Open (%) Results
Pajala, et al. 2009
Very satisfied vs. all other satisfaction levels II 59 12
months 71% (11%) 71% (19%) p = 0.55
Taglialavoro, et al 2004 Satisfaction - Very Goodª II 46 42
months 46% 46% p = .98‡
Taglialavoro, et al 2004 Satisfaction - Goodª II 46 42
months 42% 46% p = .8‡
Taglialavoro, et al 2004 Satisfaction - Fairª II 46 42
months 13% 0% p = .01‡
Taglialavoro, et al 2004 Satisfaction - Poorª II 46 42
months 0% 9% p = .04‡
ª Modified McComis Score ‡ AAOS Calculation
v1.0 12.04.09 86
Table 101. Autograft vs. Open - Return to Sports
Author Outcome LOE N Duration Adjunctive
Augmentation (%)
Open (%) Results
Aktas, et al. 2007
Return to Sports - Same Level / Pre-injury II 30 6 months 85% 89% p = .620‡
Taglialavoro, et al 2004
Return to Sports - Complete II 46 42
months 38% 32% NS
Taglialavoro, et al 2004
Return to Sports - Low Loss II 46 42
months 50% 55% NS
Taglialavoro, et al 2004
Return to Sports - Decreased II 46 42
months 8% 9% NS
Taglialavoro, et al 2004
Return to Sports - Not Recovered II 46 42
months 4% 0% NS
Taglialavoro, et al 2004
Return to Sports - Complaints during
normal activity II 46 42
months 0% 5% NS
‡ AAOS Calculation NS: not significant; authors do not report p-value Table 102. Autograft vs. Open - Return to Activities
Author Outcome LOE N Duration
Adjunctive Augmentation
mean (SD)
Open mean(SD) Results
Taglialavoro, et al 2004
Recovery of Daily Activities(days) II 46 42
months 128 (39) 106 (66) p = .17‡
‡ AAOS Calculation Table 103. Autograft vs. Open - Footwear Restrictions
Author Outcome LOE N Duration Adjunctive
Augmentation (%)
Open (%) Results
Pajala, et al. 2009
No footwear restrictions vs. footwear restrictions II 60 12
months 79% (4%) 90% (0%) p = 0.35
Taglialavoro, et al 2004 Shoe conflict II 46 42
months 38% 23% NS
‡ AAOS Calculation NS: not significant; authors do not report p-value
v1.0 12.04.09 87
Table 104. Autograft vs. Open - Hospitalization vs. Immobilization
Author Outcome LOE N Duration Adjunctive
Augmentation mean (SD)
Open mean(SD) Results
Taglialavoro, et al 2004 Hospitalization (days) II 46 42
months 8.2 (2.3) 5.0 (1.9) p <.001‡
Taglialavoro, et al 2004 Immobilization (days) II 46 42
months 63.9 (15.8) 49.5 (10.6) p <.001‡
‡ AAOS Calculation Table 105. Autograft vs. Open - Complications
Author Complication LOE N Duration Adjunctive
Augmentation Open
Repair
% % Results Taglialavoro,
et al 2004 PE II 46 42 months 4% 0% NS
Taglialavoro, et al 2004 DVT II 46 42 months 4% 14% NS
Pajala, et al. 2009 DVT II 60 3 weeks 4% 0% NS
Pajala, et al. 2009 Deep Infection II 60 12 months 7% 0% p = .04‡
Aktas et al. 2007 Deep Infection II 30 6 months 6% 0% NS
Pajala, et al. 2009
Superficial Infection II 60 12 months 4% 13% NS
Pajala, et al. 2009 Re-rupture‡ II 60 12 months 11% 9% NS
Aktas et al. 2007 Re-rupture II 30 6 months 0% 0% NS
Taglialavoro, et al 2004 Dysesthesia II 46 42 months 13% 14% NS
Taglialavoro, et al 2004 Keloid II 46 42 months 8% 5% NS
Taglialavoro, et al 2004 Dehiscence II 46 42 months 13% 9% NS
‡ Three of the patients with reruptures had obvious new injury during recovery period. One re-rupture occurred at ten weeks when patient was cycling up a steep hill. Two re-ruptures occurred at twelve weeks with minimum trauma; these patients were in the Open repair group and recalled having sustained a slight injury during the first three weeks. ‡ AAOS calculation NS: Non-Significant; Authors did not report p-value
v1.0 12.04.09 88
Table 106. Synthetic Tissue - Results
Author Outcome LOE N Duration Adjunctive
Augmentation mean (SD) %
Giannini et al, 1994 Subjective Results- Excellent IV 15 18
months 100%
Giannini et al, 1994 Return to Previous Activity IV 15 18
months 100%
Giannini et al, 1994 Rerupture IV 15 18
months 0%
Giannini et al, 1994 Healing Impairment IV 15 18
months 0%
v1.0 12.04.09 89
RECOMMENDATION 10 We cannot recommend for or against the use of antithrombotic treatment for patients with acute Achilles tendon ruptures.
AAOS Strength of Recommendation: Inconclusive
Description: Evidence from a single low quality study or conflicting findings that do not allow a recommendation for or against the intervention. An Inconclusive recommendation means that there is a lack of compelling evidence resulting in an unclear balance between benefits and potential harm. Implications: Practitioners should feel little constraint in deciding whether to follow a recommendation labeled as Inconclusive and should exercise judgment and be alert to future publications that clarify existing evidence for determining balance of benefits versus potential harm. Patient preference should have a substantial influencing role.
Rationale: A systematic review was conducted to determine if prophylaxis for thromboembolic events is warranted for patients with acute Achilles tendon rupture. No studies were identified that address this issue.
EXCLUDED STUDIES Table 107. Antithrombotic Treatment - Excluded Studies
Author Title Exclusion Reason
Nilsson-Helander, et al. 2009
High Incidence of deep venous thrombosis after Achilles tendon rupture: a prospective study
Not Relevant; Does not answer the
recommendation. Lapidus, et al.
2007 Prolonged thromboprophylaxis with dalteparin after surgical treatment
of Achilles tendon rupture: a randomized, placebo-controlled study Less than 50%
follow up
Lassen, et al. 2002
Use of the low-molecular-weight heparin reviparin to prevent deep-vein thrombosis after leg injury requiring immobilization
Less than 80% Achilles tendon tear
patients
v1.0 12.04.09 90
RECOMMENDATION 11 We suggest early (≤ 2 weeks) post-operative protected weight bearing (including limiting dorsiflexion) for patients with acute Achilles tendon rupture who have been treated operatively.
AAOS Strength of Recommendation: Moderate
Description: Evidence from two or more “Moderate” strength studies with consistent findings, or evidence from a single “High” quality study for recommending for or against the intervention. A Moderate recommendation means that the benefits exceed the potential harm (or that the potential harm clearly exceeds the benefits in the case of a negative recommendation), but the strength of the supporting evidence is not as strong. Implications: Practitioners should generally follow a Moderate recommendation but remain alert to new information and be sensitive to patient preferences. Rationale: A systematic review identified four Level II studies40, 5, 41,42 that compared early postoperative weight bearing to non-weight bearing following surgical repair of the Achilles tendon. All studies compared patients with either six weeks of non-weight bearing in a cast to early weight bearing. Two studies40, 42 permitted immediate weight bearing starting the day of surgery in a cast, defined as toe-touch weight bearing in one study.40 The second study5 allowed the weight bearing group to begin immediate rehabilitation on the first post-operative day in a modified splint. The patients in the third study41 began weight bearing two weeks after surgery. By two weeks, three investigators40, 5, 41 used a splint device that limited dorsiflexion to prevent compromise of the repair. After four weeks, Maffulli et al.40, 42 allowed the non-weight bearing group to begin full weight bearing in a cast, while the other two studies5, 41 kept the non-weight bearing group on crutches for six weeks. One study,5 found a significantly higher re-rupture rate in the early postoperative weight bearing group (2 of 23 patients) compared to non-weight bearing group (0 of 25 patients). Both patients had documented non-compliance with the use of their postoperative splint and fell during the first four weeks after surgery. Three studies40, 5, 42 found that the weight bearing group had statistical improvement in the time to return to activities including work, sports, and normal walking. Suchak et al.41 found significantly better scores in physical functioning and reported fewer limitations of daily living six weeks after the operation. By 12 months, all four studies found that there was no significant difference between the two groups in outcomes such as pain and function. Although the ultimate level of function achieved after operative repair of an Achilles rupture is similar regardless of the post-operative weight bearing protocol, early post-operative weight bearing allows the patient to achieve a quicker return to activities during the first six months than those patients treated with traditional postoperative casting. Treatment decisions should be made in light of all circumstances presented by the patient.
v1.0 12.04.09 91
Mutual communication between patient and physician should include a discussion of the importance of patient compliance when a program is prescribed for the use of early weight bearing. Patient compliance to protocol is important to prevent re-rupture.
Supporting Evidence:
Four Level II studies 40, 5, 41, 42 compare early postoperative weight bearing to non-weight bearing following surgical repair of the Achilles tendon. The post-operative regimes in the three studies are detailed in Table 108. For results of early weight bearing versus non-weight bearing see Table 109 through Table 115.
Of forty-nine outcome measures comparing early weight bearing to non-weight bearing, seventeen were statistically significant in favor of early weight bearing, while one was in favor of non-weight bearing. Eleven of the seventeen results in favor of early weight bearing measured time until returning to activity (return to sports, return to normal walking, return to stair climbing, return to work, return to full weight bearing, number of physical therapy visits, and time until release from physical therapy) (see Table 109). A third study5 that measured time until return to work did not find a statistically significant difference between groups. At one and a half months, the early weight bearing group had no limitation and scored statistically significantly higher on the physical function, social function, vitality, and emotion components of the Rand-36 scale. One study reported that statistically significantly more patients returned to sports at 12 months (see Table 109).. However, two other studies reported no statistically significant difference in return to sports at six or twelve months. There was no statistically significant difference in pain, satisfaction, return to work, or footwear restrictions at twelve months (see Table 110 through Table 113).
One study5, reported significantly more reruptures in the early weight bearing group. Of the two patients with re-ruptures, one patient did not follow the written rehabilitation protocol and the second patient suffered a fall on ice and forcibly dorsiflexed his ankle.
There were no statistically significant differences between groups in complications.
Table 108: Description of treatment groups Author Post operative Instructions
Maffulli, et al.(a)
Early weight bearing group: Bear weight on the tiptoes of the operated leg as tolerated but keep leg elevated for the first two weeks. Begin weight bearing as tolerated. Non-weight bearing group: No weight bearing and keep leg elevated for first two weeks. Increase weight bearing at 4 weeks.
Maffulli, et al (b)
Early weight bearing group: Bear weight on the operated leg as tolerated but keep leg elevated for the first two weeks. Begin weight bearing as tolerated. Non-weight bearing group: No weight bearing and keep leg elevated for first two weeks. Increase weight bearing at 4 weeks.
Costa, et al. Early weight bearing group: Immediate weight bearing and
v1.0 12.04.09 92
mobilization using carbon fibre orthosis with 1.5 cm heal raises. Non-weight bearing group: Traditional plaster cast.
Suchak, et al.
Early weight bearing group: Two weeks of non-weight bearing followed by weight bearing. Non-weight bearing group: 6 weeks of non-weight bearing using auxiliary crutches.
v1.0 12.04.09 93
SUMMARY OF EVIDENCE Table 109 Time until return to activity
Author Outcome LoE N Time to
Return to Activity
Maffulli, et al 2003 (a) Return to Sports (months) II 53 ●wb
Maffulli, et al 2003 (b) Return to Sports (months) II 56‡ ●wb
Costa, et al 2006 Return to Normal Walking (weeks) II 48‡‡ ●wb
Costa, et al 2006 Return to Normal Stair Climbing (weeks) II 48‡‡ ●wb
Costa, et al 2006 Return to Work (weeks) II 48‡‡ ○
Maffulli, et al 2003 (a) Return to Work (weeks) II 53 ●wb
Maffulli, et al 2003 (a) Full weight bearing (wks) II 53 ●wb
Maffulli, et al 2003 (b) Full weight bearing (wks) II 56‡ ●wb
Maffulli, et al 2003 (a) Physiotherapy sessions (visits) II 53 ●wb
Maffulli, et al 2003 (b) Physiotherapy sessions (visits) II 56‡ ●wb
Maffulli, et al 2003 (a) Discharged from Physiotherapy (months) II 53 ●wb
Maffulli, et al 2003 (b) Discharged from Physiotherapy (months) II 56‡ ●wb
Wb= weight bearing ○= no statistically significant difference ●= statistically significant difference ‡ AAOS calculations ‡‡= Number of patients is unclear. The authors state both 56 and 53 as the number of patients enrolled Table 110 Pain
Result (months)
Author Outcome LoE N 1.5 2 3 6 12
Maffulli, et al 2003 (a) Pain- None II 53 ○‡
Maffulli, et al 2003 (a) Pain- Mild, Occasional II 53 ○‡
Maffulli, et al 2003 (a) Pain- Moderate II 53 ○‡
Maffulli, et al 2003 (b) Pain- None II 53 ○‡
v1.0 12.04.09 94
Result (months)
Author Outcome LoE N 1.5 2 3 6 12
Maffulli, et al 2003 (b) Pain- Mild, Occasional II 53 ○‡
Maffulli, et al 2003 (b) Pain- Moderate II 53 ○‡
Wb= weight bearing ○= no statistically significant difference ●= statistically significant difference ‡ AAOS calculations ‡‡= Open cast group converted to orthosis at 3 weeks
v1.0 12.04.09 95
Table 111 Function
Author Outcome Result (months)
LoE N 1.5 6 12
Suchak, et al 2008
No Limitations or Limitations only in recreation II 110 ●wb
Maffulli, et al 2003 (a) No Limitations II 53 ○‡
Maffulli, et al 2003 (b) No Limitations II 53 ○
Maffulli, et al 2003 (a)
Activity Limitation - Limited Recreational but not Daily Activities II 53 ○‡
Maffulli, et al 2003 (b)
Activity Limitation - Limited Recreational but not Daily Activities II 53 ○‡
Suchak, et al 2008 (a) Return to at least partial sports II 38 ○‡
Maffulli, et al 2003 (a) Return to Sports II 48 ○‡
Maffulli, et al 2003 (b) Return to Sports II 53 ○‡
Costa, et al 2006 Return to Sports II 48‡‡ ●wb
Maffulli, et al 2003 (a) Return to Work II 49 ○‡
Maffulli, et al 2003 (b) Return to Work II 53 ○‡
Maffulli, et al 2003 (a) Changed Jobs II 49 ○‡
Maffulli, et al 2003 (b) Changed Jobs ○‡
Maffulli, et al 2003 (a)
Experience Problems at work due to injury II 49 ○‡
Maffulli, et al 2003 (b)
Experience Problems at work due to injury II 53 ○‡
Maffulli, et al 2003 (a)
Footwear restrictions- None, mild (most shoes tolerated) II 53 ○‡
Maffulli, et al 2003 (b)
Footwear restrictions- None, mild (most shoes tolerated) II 53 ○‡
Maffulli, et al 2003 (a)
Footwear restrictions- Moderate (unable to tolerate fashionable shoes,
with or without insert) II
53 ○‡
Maffulli, et al 2003 (b)
Footwear restrictions- Moderate (unable to tolerate fashionable shoes,
with or without insert) II 53 ○‡
Wb= weight bearing ○= no statistically significant difference ●= statistically significant difference
v1.0 12.04.09 96
‡ AAOS calculations ‡‡= Open cast group converted to orthosis at 3 weeks Table 112 EuroQoL, Rand-36
Author Outcome LoE N Results (Months)
1.5 2 6 12 Costa, et al
2006 EuroQoL - Health
Score II 48‡‡ ○ ○ ○
Costa, et al 2006 EuroQoL - E5D II 48‡‡ ○ ○ ○
Suchak, et al 2008
Rand-36 Physical Functioning II 110 ●wb
Suchak, et al 2008
Rand-36 Social Functioning II 110 ●wb
Suchak, et al 2008 Rand-36 Vitality II 110 ●wb
Suchak, et al 2008
Rand-36 Role-Emotional II 110 ●wb
Wb= weight bearing ○= no statistically significant difference ●= statistically significant difference ‡ AAOS calculations ‡‡= Open cast group converted to orthosis at 3 weeks Table 113 Patient Subjective Results
Results (Months)
Author Outcome LoE N 12 months
Maffulli, et al 2003 (a)
Patient opinion of results- Excellent
II 53 ○‡
Maffulli, et al 2003 (a)
Percent satisfied with results of
surgery II 53 ○‡
Maffulli, et al 2003 (a)
Patient opinion of results- Excellent
II 53 ○‡
Maffulli, et al 2003 (a)
Percent satisfied with results of
surgery II 53 ○‡
Wb= weight bearing ○= no statistically significant difference ●= statistically significant difference ‡ AAOS calculations ‡‡= Open cast group converted to orthosis at 3 weeks
v1.0 12.04.09 97
Table 114 Reruptures
Author LoE Duration N Weight Bearing
Non-Weight Bearing
Statistically Significant Difference
Costa, et al 2006
II 1 year 48‡‡ 8.69% 0% ●‡ nwb
‡‡= Open cast group converted to orthosis at 3 weeks; ●‡ nwb= statistically significant difference in favor of non-weight bearing
v1.0 12.04.09 98
SUMMARY OF COMPLICATIONS Table 115 Reported Complications
Author Complication LoE Duration N Weight Bearing
Non-Weight Bearing
Statistically Significant Difference
Suchak, et al 2008
DVT II 6 months 110 0% 2% ○‡
Suchak, et al 2008
Necrosis of the skin II 6 months 110 0% 2% ○‡
Suchak, et al 2008
Sural nerve dysesthesias, superficial infections,
delayed wound healing, scar adhesions.
II 6 months 110 15% 16% ○‡
Maffulli, et al
2003 (a)
Superficial Infection II 12 months 53 7.69% 7.40% ○‡
Maffulli, et al
2003 (a)
Hypersensitivity of surgical
wounds II 10-12 wks 53 15.38% 18.51% ○‡
Maffulli, et al
2003 (a)
Hypertrophic Scar II 10-12 weeks 53 3.84% 0% ○‡
Costa, et al 2006
Minor wound complications II Nr 48‡‡ 26% 21% ○‡
Costa, et al 2006
Persistent paraethesiae II Nr 48‡‡ 0% 4.3% ○‡
Maffulli, et al
2003 (b)
Hypersensitivity of surgical
wounds II 10-12 wks 53‡‡‡ 12% 4% ○‡
Maffulli, et al
2003 (b)
Hypertrophic Scar II 10-12 weeks 53‡‡‡ 4% 4% ○‡
Wb= weight bearing Nwb= non-weight bearing ○= no statistically significant difference ●= statistically significant difference ‡ AAOS calculations ‡‡= Open cast group converted to orthosis at 3 weeks ‡‡‡= Number of patients is unclear. The authors state both 56 and 53 as the number of patients enrolled
v1.0 12.04.09 99
Table 116 Systematic Reviews Author Conclusion
Khan, RJK, et al. 2005 "Postoperative splinting in a cast followed by a functional brace rather than a cast alone reduces the overall complication rate" (p. 2209).
Lynch, RM 2004 "Early functional mobilisation is more acceptable to patients than plaster cast immobilisation and results in improved functional outcomes" (p. 156).
Suchak, AA et al. 2006 "An early functional rehabilitation protocol for Achilles tendon ruptures improves patient satisfaction with reduction in minor complications and no increase in rerupture rate or infection rate" (p. 220).
v1.0 12.04.09 100
EXCLUDED ARTICLES Table 117 Article Inclusion List- Early weight bearing vs. non-weight bearing
Author Title Exclusion Reason Costa, et al.
2003 Immediate full-weight bearing mobilisation for repaired Achilles tendon ruptures: a pilot study
Less than 10 patients per group
Wagnon, et al.
2005
The Webb-Bannister percutaneous technique for acute Achilles' tendon ruptures: a functional and MRI
assessment
No patient-oriented outcome
Aoki, et al. 1998
Early active motion and weight bearing after cross-stitch Achilles tendon repair
Not best available evidence - not comparative
Speck, et al. 1998
Early full weight bearing and functional treatment after surgical repair of acute Achilles tendon rupture
Not best available evidence - not comparative
Solveborn, et al. 1994
Immediate free ankle motion after surgical repair of acute Achilles tendon ruptures
Not best available evidence - not comparative
v1.0 12.04.09 101
STUDY QUALITY Table 118. Quality- Weight bearing vs. non-weight bearing- RCT
● = Yes ○ = No × = Not Reported n/a = not applicable
Stoc
hast
ic R
ando
miz
atio
n
Allo
catio
n C
once
alm
ent
Patie
nts B
linde
d
Tho
se r
atin
g ou
tcom
e B
linde
d
Follo
w U
p - 8
0% o
r m
ore
All
grou
ps h
ave
sim
ilar
outc
ome
perf
orm
ance
at
bas
elin
e
Author Outcome N Treatment(s) LoE
Costa, et al.
2006 Return to Sports 43
Weight bearing vs. Non-weight
bearing II ● ● × × ● ●
Costa, et al.
2006
Return to Sport (weeks) ‡‡ 43
Weight bearing vs. Non-weight
bearing II ● ● × × ● ●
Costa, et al.
2006
Return to Normal Walking (weeks) 43
Weight bearing vs. Non-weight
bearing II ● ● × × ● ●
Costa, et al.
2006
Return to Normal Stair Climbing
(weeks) 43
Weight bearing vs. Non-weight
bearing II ● ● × × ● ●
Costa, et al.
2006
Return to Work (weeks) 43
Weight bearing vs. Non-weight
bearing II ● ● × × ● ●
Costa, et al.
2006
EuroQoL - Health Score‡‡ 43
Weight bearing vs. Non-weight
bearing II ● ● × × ● ×
Costa, et al.
2006 EuroQoL - E5D‡ 43
Weight bearing vs. Non-weight
bearing II ● ● × × ● ×
v1.0 12.04.09 102
● = Yes ○ = No × = Not Reported n/a = not applicable
Stoc
hast
ic R
ando
miz
atio
n
Allo
catio
n C
once
alm
ent
Patie
nts B
linde
d
Tho
se r
atin
g ou
tcom
e B
linde
d
Follo
w U
p - 8
0% o
r m
ore
All
grou
ps h
ave
sim
ilar
outc
ome
perf
orm
ance
at
bas
elin
e
Author Outcome N Treatment(s) LoE
Suchak, et al.
2008
RAND-36: Physical Function 109
Weight bearing vs. Non-weight
bearing II ● ● × × ● ×
Suchak, et al.
2008
RAND-36: Mental health 109
Weight bearing vs. Non-weight
bearing II ● ● × × ● ×
Suchak, et al.
2008 Complications 110
Weight bearing vs. Non-weight
bearing II ● ● × × ● ×
Suchak, et al.
2008
RAND-36: Social Functioning 109
Weight bearing vs. Non-weight
bearing II ● ● × × ● ×
Suchak, et al.
2008
RAND-36: Role-physical 109
Weight bearing vs. Non-weight
bearing II ● ● × × ● ×
Suchak, et al.
2008
RAND-36: Bodily pain 109
Weight bearing vs. Non-weight
bearing II ● ● × × ● ×
Suchak, et al.
2008
RAND-36: General health 109
Weight bearing vs. Non-weight
bearing II ● ● × × ● ×
Suchak, et al.
2008
RAND-36: Vitality 109
Weight bearing vs. Non-weight
bearing II ● ● × × ● ×
v1.0 12.04.09 103
● = Yes ○ = No × = Not Reported n/a = not applicable
Stoc
hast
ic R
ando
miz
atio
n
Allo
catio
n C
once
alm
ent
Patie
nts B
linde
d
Tho
se r
atin
g ou
tcom
e B
linde
d
Follo
w U
p - 8
0% o
r m
ore
All
grou
ps h
ave
sim
ilar
outc
ome
perf
orm
ance
at
bas
elin
e
Author Outcome N Treatment(s) LoE
Suchak, et al.
2008
RAND-36: Role-emotional 109
Weight bearing vs. Non-weight
bearing II ● ● × × ● ×
v1.0 12.04.09 104
Table 119. Quality- Weight bearing vs. non-weight bearing- Comparative
● = Yes ○ = No × = Not Reported n/a = not applicable
All
grou
ps h
ave
sim
ilar c
hara
cter
istic
s at e
ntry
All
grou
ps h
ave
sim
ilar o
utco
me
perf
orm
ance
at e
ntry
All
grou
ps c
oncu
rren
tly
treat
ed
Follo
w U
p - 8
0% o
r mor
e
Sam
e ce
nter
for e
xper
imen
tal a
nd c
ontro
l gro
up d
ata
Author Outcome N Treatment(s) LoE
Maffulli, et al.
2003 (a) Pain- None 53
Weight Bearing vs. Non-Weight
Bearing
II ● ● x ● ●
Maffulli, et al.
2003 (a)
Pain- Mild, Occasional 53
Weight Bearing vs. Non-Weight
Bearing
II ● ● x ● ●
Maffulli, et al.
2003 (a) Pain- Moderate 53
Weight Bearing vs. Non-weight bearing
II ● ● x ● ●
Maffulli, et al.
2003 (a) Return to Sports 53
Weight Bearing vs. Non-weight
bearing
II ● ● x ● ●
Maffulli, et al.
2003 (a)
Return to Sports (months) 53
Weight Bearing vs. Non-weight
bearing
II ● ● x ● ●
Maffulli, et al.
2003 (a)
Return to Work (weeks) 53
Weight Bearing vs. Non-weight bearing
II ● ● x ● ●
v1.0 12.04.09 105
● = Yes ○ = No × = Not Reported n/a = not applicable
All
grou
ps h
ave
sim
ilar c
hara
cter
istic
s at e
ntry
All
grou
ps h
ave
sim
ilar o
utco
me
perf
orm
ance
at e
ntry
All
grou
ps c
oncu
rren
tly
treat
ed
Follo
w U
p - 8
0% o
r mor
e
Sam
e ce
nter
for e
xper
imen
tal a
nd c
ontro
l gro
up d
ata
Author Outcome N Treatment(s) LoE
Maffulli, et al.
2003 (a) Return to Work 53
Weight Bearing vs. Non-weight bearing
II ● ● x ● ●
Maffulli, et al.
2003(a) Changed Jobs 53
Weight Bearing vs. Non-weight bearing
II ● ● x ● ●
Maffulli, et al.
2003 (a)
Experience Problems at work
due to injury 53
Weight Bearing vs. Non-weight
bearing
II ● ● x ● ●
Maffulli, et al.
2003 (a)
Full weight bearing (wks) 53
Weight Bearing vs. Non-weight
bearing
II ● ● x ● ●
Maffulli, et al.
2003 (a)
Activity Limitation - None 53
Weight Bearing vs. Non-weight
bearing
II ● ● x ● ●
Maffulli, et al.
2003(a)
Activity Limitation - Limited
Recreational but not Daily Activities
53 Weight
Bearing vs. Non Weight
II ● ● x ● ●
Maffulli, et al.
2003 (a)
Discharged from Physiotherapy
(months) 53
Weight Bearing vs. Non-weight
bearing
II ● ● x ● ●
v1.0 12.04.09 106
● = Yes ○ = No × = Not Reported n/a = not applicable
All
grou
ps h
ave
sim
ilar c
hara
cter
istic
s at e
ntry
All
grou
ps h
ave
sim
ilar o
utco
me
perf
orm
ance
at e
ntry
All
grou
ps c
oncu
rren
tly
treat
ed
Follo
w U
p - 8
0% o
r mor
e
Sam
e ce
nter
for e
xper
imen
tal a
nd c
ontro
l gro
up d
ata
Author Outcome N Treatment(s) LoE
Maffulli, et al.
2003 (a)
Physiotherapy sessions (visits) 53
Weight Bearing vs. Non-weight
bearing
II ● ● x ● ●
Maffulli, et al.
2003 (a)
Footwear restrictions- None, mild (most shoes
tolerated)
53
Weight Bearing vs. Non Weight
Bearing
II ● ● x ● ●
Maffulli, et al.
2003 (a)
Footwear restrictions-
Moderate (unable to tolerate
fashionable shoes, with or without
insert)
53
Weight Bearing vs. Non-weight
bearing
II ● ● x ● ●
Maffulli, et al.
2003 (a)
Percent satisfied with results of
surgery 53
Weight Bearing vs. Non-weight
bearing
II ● ● x ● ●
Maffulli, et al.
2003 (a)
Patient opinion of results- Excellent 53
Weight Bearing vs. Non-weight
bearing
II ● ● x ● ●
Maffulli, et al.
2003 (b) Pain- None 53
Weight Bearing vs. Non-Weight
Bearing
II ● ● x ● ●
v1.0 12.04.09 107
● = Yes ○ = No × = Not Reported n/a = not applicable
All
grou
ps h
ave
sim
ilar c
hara
cter
istic
s at e
ntry
All
grou
ps h
ave
sim
ilar o
utco
me
perf
orm
ance
at e
ntry
All
grou
ps c
oncu
rren
tly
treat
ed
Follo
w U
p - 8
0% o
r mor
e
Sam
e ce
nter
for e
xper
imen
tal a
nd c
ontro
l gro
up d
ata
Author Outcome N Treatment(s) LoE
Maffulli, et al.
2003 (b)
Pain- Mild, Occasional 53
Weight Bearing vs. Non-Weight
Bearing
II ● ● x ● ●
Maffulli, et al.
2003 (b) Pain- Moderate 53
Weight Bearing vs. Non-weight
bearing
II ● ● x ● ●
Maffulli, et al.
2003 (b) Return to Sports 53
Weight Bearing vs. Non-weight
bearing
II ● ● x ● ●
Maffulli, et al.
2003 (b)
Return to Sports (months) 53
Weight Bearing vs. Non-weight
bearing
II ● ● x ● ●
Maffulli, et al.
2003 (b)
Return to Work (weeks) 51
Weight Bearing vs. Non-weight
bearing
II ● ● x ● ●
Maffulli, et al.
2003 (b) Return to Work 51
Weight Bearing vs. Non-weight
bearing
II ● ● x ● ●
Maffulli, et al.
2003(b) Changed Jobs 51
Weight Bearing vs. Non-weight
bearing
II ● ● x ● ●
v1.0 12.04.09 108
● = Yes ○ = No × = Not Reported n/a = not applicable
All
grou
ps h
ave
sim
ilar c
hara
cter
istic
s at e
ntry
All
grou
ps h
ave
sim
ilar o
utco
me
perf
orm
ance
at e
ntry
All
grou
ps c
oncu
rren
tly
treat
ed
Follo
w U
p - 8
0% o
r mor
e
Sam
e ce
nter
for e
xper
imen
tal a
nd c
ontro
l gro
up d
ata
Author Outcome N Treatment(s) LoE
Maffulli, et al.
2003 (b)
Experience Problems at work
due to injury 51
Weight Bearing vs. Non-weight
bearing
II ● ● x ● ●
Maffulli, et al.
2003 (b)
Full weight bearing (wks) 56‡‡
Weight Bearing vs. Non-weight
bearing
II ● ● x ● ●
Maffulli, et al.
2003 (b)
Activity Limitation - None 53
Weight Bearing vs. Non-weight
bearing
II ● ● x ● ●
Maffulli, et al.
2003(b)
Activity Limitation - Limited
Recreational but not Daily Activities
53 Weight
Bearing vs. Non Weight
II ● ● x ● ●
Maffulli, et al.
2003 (b)
Discharged from Physiotherapy
(months) 56‡‡
Weight Bearing vs. Non-weight
bearing
II ● ● x ● ●
Maffulli, et al.
2003 (b)
Physiotherapy sessions (visits) 56‡‡
Weight Bearing vs. Non-weight
bearing
II ● ● x ● ●
Maffulli, et al.
2003 (b)
Footwear restrictions- None, mild (most shoes
tolerated)
53
Weight Bearing vs. Non Weight
Bearing
II ● ● x ● ●
v1.0 12.04.09 109
● = Yes ○ = No × = Not Reported n/a = not applicable
All
grou
ps h
ave
sim
ilar c
hara
cter
istic
s at e
ntry
All
grou
ps h
ave
sim
ilar o
utco
me
perf
orm
ance
at e
ntry
All
grou
ps c
oncu
rren
tly
treat
ed
Follo
w U
p - 8
0% o
r mor
e
Sam
e ce
nter
for e
xper
imen
tal a
nd c
ontro
l gro
up d
ata
Author Outcome N Treatment(s) LoE
Maffulli, et al.
2003 (b)
Footwear restrictions-
Moderate (unable to tolerate
fashionable shoes, with or without
insert)
53
Weight Bearing vs. Non-weight
bearing
II ● ● x ● ●
Maffulli, et al.
2003 (b)
Percent satisfied with results of
surgery 53
Weight Bearing vs. Non-weight
bearing
II ● ● x ● ●
Maffulli, et al.
2003 (b)
Patient opinion of results- Excellent 53
Weight Bearing vs. Non-weight
bearing
II ● ● x ● ●
v1.0 12.04.09 110
STUDY RESULTS Table 120 Study Data: Weight Bearing vs. Non-Weight Bearing
Author Outcome LoE Duration N Weight Bearing
Non-Weight Bearing Result
Suchak, et al 2008
Rand-36 Physical Functioning II 6 week 110 61.4 (SD
29.4) 47.6 (SD
34.4) p = 0.03
Suchak, et al 2008
Rand-36 Social Functioning II 6 week 110 72.7 (SD
28.5) 60.7 (SD
26.8) p = 0.03
Suchak, et al 2008 Rand-36 Vitality II 6 week 110 69.4 (SD
23.7) 60.6 (SD
21.1) p = 0.04
Suchak, et al 2008
Rand-36 Role-Emotional II 6 week 110 84.6 (SD
32.0) 67.3 (SD
43.1) p = 0.02
Suchak, et al 2008
No Limitations or Limitations only in
recreation II 6 week 110 43% 9% p = <.001
Suchak, et al 2008
Return to at least partial sports II 6 months 110 67% 63% p=0.68
Maffulli, et al 2003(a)
Full weight bearing (wks) II 12
months 53 2.5 (SD 0.4) 5.5 (SD 2.2) p = 0.021
Maffulli, et al 2003(a)
Physiotherapy sessions (visits) II 12
months 53 6.1 (SD 3.1) 13.6 (SD 4.8) p = 0.03
Maffulli, et al 2003(a)
Discharged from Physiotherapy
(months) II 12
months 53 2.1 (SD 1.1) 4.6 (SD 2) p = <.0001
Maffulli, et al 2003(a) Pain- None II 12
months 53 88% 89% p= 0.96 ‡
Maffulli, et al 2003(a)
Pain- Mild, Occasional II 12
months 53 8% 7% p=0.97‡
Maffulli, et al 2003(a) Pain- Moderate II 12
months 53 4% 4% p=0.98 ‡
Maffulli, et al 2003(a)
Activity Limitation - None II 12
months 53 92% 93% p=0.97‡
Maffulli, et al 2003(a)
Activity Limitation - Limited Recreational
but not Daily Activities
II 12 months 53 8% 7% p=0.97
v1.0 12.04.09 111
Author Outcome LoE Duration N Weight Bearing
Non-Weight Bearing Result
Maffulli, et al 2003(a) Return to Sports II 12
months 38 89% 89% p=0.99 ‡
Maffulli, et al 2003(a)
Return to Sports (months) II 12
months 53 5.1 (SD 2.8) 6 (SD 3) p= 0.04
Maffulli, et al 2003(a)
Footwear restrictions-None, mild (most shoes tolerated)
II 12 months 53 96% 93% p=0.57‡
Maffulli, et al 2003(a)
Footwear restrictions-Moderate (unable to tolerate fashionable
shoes, with or without insert)
II 12 months 53 4% 7% p=0.57‡
Maffulli, et al 2003(a)
Percent satisfied with results of surgery II 12
months 53 88% 85% p=0.51‡
Maffulli, et al 2003(a) Excellent II 12
months 53 88% 81% p=0.47‡
Maffulli, et al 2003(a)
Return to Work (weeks) II 12
months 53 9.2 (SD 2.5) 13.2 (SD 3) p= 0.05
Maffulli, et al 2003(a) Return to Work II 12
months 49 100% 100% 1
Maffulli, et al 2003(a) Changed Jobs II 12
months 49 1 2 p=0.51‡
Maffulli, et al 2003(a)
Experience Problems at work due to injury II 12
months 49 2 4 .p=0.41‡
Maffulli, et al 2003 (b)
Full weight bearing (wks) II 6 weeks 53‡‡
‡ 2.5 (SD
0.4) 5.7 (SD 2.2) P=0.013
Maffulli, et al 2003 (b)
Physiotherapy sessions (visits) II 12
months 53‡‡
‡ 8.3 (SD
4.1) 14.6 (SD 5.3) p = 0.008
Maffulli, et al 2003(b)
Discharged from Physiotherapy
(months) II 12
months 53‡ 2.7 (SD 1.1) 4.7 (SD 2) <.08
Maffulli, et al 2003(b) Pain- None II 12
months 53 92% 86% P=0.46‡
Costa, et al 2006 Return to Sports II 1 year 48‡‡ 83% 68% p= 0.04
v1.0 12.04.09 112
Author Outcome LoE Duration N Weight Bearing
Non-Weight Bearing Result
Costa, et al 2006
Return to Normal Walking (weeks) II 1 year 48‡‡ 12.5 (CI
10-18) 18 (CI 18-22) p= 0.03
Costa, et al 2006
Return to Normal Stair Climbing
(weeks) II 1 year 48‡‡ 13 (CI 10-
18) 22 (CI 18-22) p= 0.02
Costa, et al 2006
Return to Work (weeks) II 1 year 48‡‡ 8 (CI 2-13) 4(CI 1-13) p= 0.59
Costa, et al 2006
EuroQoL - Health Score II 2 months 48‡‡ 75 (IQR
70-85) 75 (IQR 65-
80) p= 0.85
Costa, et al 2006
EuroQoL - Health Score II 6 months 48‡‡ 85 (IQR
80-90) 81 (IQR 75-
95) p= 0.96
Costa, et al 2006
EuroQoL - Health Score‡‡ II 1 year 48‡‡ 84 (IQR
75-95) 90 (IQR 85-
95) p= 0.14
Costa, et al 2006 EuroQoL - E5D II 2 months 48‡‡ 0.69 (IQR
0.6-0.9) 0.69 (IQR 0.6-0.7) p= 0.45
Costa, et al 2006 EuroQoL - E5D II 6 months 48‡‡ 0.8 (IQR
0.7-1.0) 0.8 (IQR 0.8-
1.0) p= 0.96
Costa, et al 2006 EuroQoL - E5D II 1 year 48‡‡ 1 (IQR
0.9-1.0) 1(IQR 0.8-
1.0) p= 0.15
Costa, et al 2006 Re-rupture II 1 year 48‡‡ 8.69% 0 p= 0.03‡
Suchak, et al 2008 DVT II 6 months 110 0 2% p= 0.14‡
Suchak, et al 2008 Necrosis of the skin II 6 months 110 0 2% p= 0.14‡
Suchak, et al 2008
Sural nerve dysesthesias,
superficial infections, delayed wound
healing, scar adhesions.
II 6 months 110 15% 16% p= 0.89‡
Maffulli, et al 2003(a) Superficial Infection II 12
months 53 7.69% 7.40% p= 0.97‡
Costa, et al 2006 Minor wound
complications II Nr 48‡‡ 26% 21% p=0.17‡
v1.0 12.04.09 113
Author Outcome LoE Duration N Weight Bearing
Non-Weight Bearing Result
Costa, et al 2006
Persistent paraethesiae II Nr 48‡‡ 0% 4.3% p= 0.60‡
Maffulli, et al 2003(a)
Hypersensitivity of surgical wounds II 10-12
wks 53 15.38% 18.51% p= 0.76‡
Maffulli, et al 2003(a) Hypertrophic Scar II 10-12
weeks 53 3.84% 0% p= 0.15‡
Maffulli, et al 2003 (b)
Pain- Mild, Occasional II 12
months 53 8% 8% p=0.93
Maffulli, et al 2003 (b) Pain- Moderate II 12
months 53 0% 7% p=0.95
Maffulli, et al 2003 (b)
Activity Limitation - None II 12
months 53 0.96 89% p=0.37
Maffulli, et al 2003 (b)
Activity Limitation - Limited Recreational
but not Daily Activities
II 12 months 53 4% 11% p=0.91
Maffulli, et al 2003 (b) Return to Sports II 12
months 53‡ 89% 89% p=0.93
Maffulli, et al 2003 (b)
Time until Return to Sports (months) II 12
months 53‡‡
‡ 5.2 (SD 3) 6.1 (SD 2.8) p=0.45
Maffulli, et al 2003 (b)
Footwear restrictions-None, mild (most shoes tolerated)
II 12 months 53 96% 96% p=0.33
Maffulli, et al 2003 (b)
Footwear restrictions-Moderate (unable to tolerate fashionable
shoes, with or without insert)
II 12 months 53 4% 4% p=0.97
Maffulli, et al 2003 (b)
Percent satisfied with results of surgery II 12
months 53 84% 89% p=0.37
Maffulli, et al 2003 (b) Excellent II 12
months 53 84% 89% p=0.37
Maffulli, et al 2003 (b) Return to Work II 12
months 51 100% 100% 1
Maffulli, et al 2003 (b) Changed Jobs II 12
months 49 1 2 p=0.61
v1.0 12.04.09 114
Author Outcome LoE Duration N Weight Bearing
Non-Weight Bearing Result
Maffulli, et al 2003 (b)
Experience Problems at work due to injury II 12
months 49 20% 11% p=0.91
Maffulli, et al 2003 (b)
Hypersensitivity of the surgical wound II 6 weeks 53 12% 4% p=0.97
Maffulli, et al 2003 (b) Hypertrophic scar II 6 weeks 53 4% 4% p=0.97
‡= AAOS calculations
v1.0 12.04.09 115
RECOMMENDATION 12 We suggest the use of a protective device that allows mobilization by 2- 4 weeks post operatively. AAOS Strength of Recommendation: Moderate
Description: Evidence from two or more “Moderate” strength studies with consistent findings, or evidence from a single “High” quality study for recommending for or against the intervention. A Moderate recommendation means that the benefits exceed the potential harm (or that the potential harm clearly exceeds the benefits in the case of a negative recommendation), but the strength of the supporting evidence is not as strong. Implications: Practitioners should generally follow a Moderate recommendation but remain alert to new information and be sensitive to patient preferences. Rationale: A systematic review identified five Level II 40, 43-45 studies comparing postoperative immobilization to postoperative mobilization following surgical repair of the Achilles tendon. All five studies randomized the patients into two groups with either six weeks in a cast or early motion with a modified splint device. For all studies, patients in the mobilization group had a splint or modified cast device that limited dorsiflexion to protect the repair. All five studies40, 5, 43-45 found that the weight bearing group had statistical improvement in the mean time to return to activities such as work and normal walking. One44 of three studies found a significantly higher rate in return to sport activities at twelve months, while two40, 39 found no difference. One study 5 found a significantly higher re-rupture rate in the postoperative mobilization group (2 of 23 patients) compared to the immobilization group (0 of 25 patients). Both patients had documented non-compliance with the use of their postoperative splint and fell during the first 4 weeks after surgery. By 12 to 18 months, all five studies40, 5, 43-45 found that there was no significant difference between the two groups in outcomes such as pain and function. Although the ultimate level of function achieved after operative repair of an Achilles rupture is similar regardless of the postoperative immobilization protocol, early postoperative mobilization allows the patient to achieve a quicker return to activities during the first six months than those patients treated with immobilization. However, treatment decisions should be made in light of all circumstances presented by the patient. Mutual communication between patient and physician should include a discussion of the importance of patient compliance when a program is prescribed for early mobilization. Patient compliance to protocol is important to aid in protection of the incision during the early post-operative period and is also important to prevent wound healing complications.
Supporting Evidence
Five Level II studies40, 5, 43-45 compare postoperative immobilization to postoperative mobilization. The post operative mobilization and immobilization regimes are detailed in
v1.0 12.04.09 116
Table 121. Please see Table 122 through Table 129 for results of mobilization versus immobilization.
Of the forty outcomes reported, seventeen were statistically significant in favor of early motion. Nine of the seventeen statistically significant results measured time until return to activity, sports, walking, stair climbing, work, weight bearing, discharge from physiotherapy, number of physiotherapy sessions, and sick leave (see Table 122). However, another study that reported time until return to sport and work did statistically significantly differ between groups (see Table 122). Patients in the early motion group reported statistically significantly less pain at one month but no statistically significant difference in pain at three, six, or twelve months (see Table 123). One of seven outcome measures found a statistically significant difference in the percent of patients able to return to sports in favor of the motion group. Statistically significantly more patients were able to stand on their toes and walk as far as they could before surgery in the early motion group at three and six months. Patients in the early motion group were more satisfied with their cast at one year. There was no statistically significant difference between groups in regard to: patient opinion of results, footwear restrictions, EuroQoL, E5D, or Ankle Performance Score (see Table 124).
Costa, et al5, reported significantly more re-ruptures in the early weight bearing group. Of the two patients with re-ruptures, one patient did not follow the written rehabilitation protocol and the second patients suffered a fall on ice and forcibly dorsiflexed his ankle.
Abnormal sensibility was significantly more prevalent in the immobilized group than in the motion group. There were no other statistically significant differences between groups in complications.
Table 121. Description of Treatment Groups Author Post operative Instructions
Costa, et al. Mobilization group: Immediate weight bearing and mobilization using carbon fibre orthosis with 1.5 cm heal raises. Immobilization group: Traditional plaster cast.
Mortensen, et al. Mobilization group: Below the knee dorsal plaster splint followed by walker brace. Immobilization group: Below the knee plaster cast
Cetti, et al. Mobilization group. Mobile cast Immobilization group. Rigid below the knee cast
Kangas, et al Mobilization group. Below the knee dorsal cast for 6 weeks, this allowed for free plantar flexion. Immobilization group. Below the knee plaster cast
Maffulli, et al. (a) Mobilization group: Removable splint and mobilization at 2 weeks. Immobilization group: Below the knee plaster cast.
SUMMARY OF EVIDENCE Table 122. Time to Return to Activity
v1.0 12.04.09 117
Author Outcome LoE Comparison N Time to return
Maffulli, et al
2003(a)
Return to Sports
(months) II
Early Motion vs.
Immobilization 53 ●em
Costa, et al 2005
Time in weeks taken to return to
sport
II Early Motion
vs. Cast
48‡‡ ○
Cetti, et al. 1994
Return to same level of
sports activities
II Early Motion
vs. Cast
60 ●em
Costa, et al 2005
Time in weeks until
return to stair climbing
II Early Motion
vs. Cast
48‡‡ ●em
Costa, et al 2005
Time in weeks taken to return to
walking
II Early Motion
vs. Cast
48‡‡ ●em
Costa, et al 2005
Time in weeks taken to return to
work.
II Early Motion
vs. Cast
48‡‡ ○
Cetti, et al. 1994
Mean Sick leave (days) II
Early Motion vs.
Cast 60 ●em
Maffulli, et al
2003(a)
Return to Work (weeks) II
Early Motion Vs.
Immobilization 53 ●em
Maffulli, et al
2003(a)
Full weight bearing (wks) II
Early Motion Vs.
Immobilization 53 ●em
Maffulli, et al 2003
Physiotherapy sessions (visits)
II Early Motion
Vs. Immobilization
53 ●em
Maffulli, et al 2003
Discharged from
Physiotherapy (months)
II Early Motion
Vs. Immobilization
53 ●em
em= early motion ○= no statistically significant difference ●= statistically significant difference ‡ AAOS calculations ‡‡= Open cast group converted to orthosis at 3 weeks
v1.0 12.04.09 118
Table 123. Pain
Author Outcome LoE Comparison N Duration (Months)
1 3 6 12
Kangas, et al 2002 Vas Pain II
Early Motion vs.
Cast 50 ●em ○ ○
Maffulli, et al 2003 Pain- None II
Early Motion vs.
Immobilization 53
○
Maffulli, et al 2003
Pain- Mild, Occasional II
Early Motion Vs.
Immobilization 53
○
Maffulli, et al 2003 Pain- Moderate II
Early Motion Vs.
Immobilization 53
○
em= early motion ○= no statistically significant difference ●= statistically significant difference ‡ AAOS calculations ‡‡= Open cast group converted to orthosis at 3 weeks
Table 124. Function
Author Outcome LoE Comparison N Duration (Months)
3 6 12 18
Costa, et al 2005
Return to sports II
Early Motion vs.
Cast
48‡‡ ○
Mortensen, et al 1999
Return to sports II
Early Motion vs.
Cast 61 ○
Maffulli, et al 2003
Return to Sports II Early Motion vs.
Immobilization 38 ○
Cetti, et al. 1994
Return sports
activities II
Early Motion vs.
Cast 60 ●e
m
Mortensen, et al 1999
Reached pre-injury
level II
Early Motion vs.
Cast 61 ○
Cetti, et al. 1994
Return to lesser level
of sports activities
II Early Motion
vs. Cast
60 ○
Cetti, et al. 1994
Stopped sports
activities II
Early Motion vs.
Cast 60 ○
v1.0 12.04.09 119
Author Outcome LoE Comparison N Duration (Months)
3 6 12 18
Maffulli, et al 2003
No Limitations II
Early Motion Vs.
Immobilization 53 ○
Maffulli, et al 2003
Activity Limitation - Limited
Recreational but not
Daily Activities
II Early Motion
Vs. Immobilization
53 ○
Mortensen, et al 1999
Able to walk as far
before surgery
II Early Motion
vs. Cast
71 ●em
Cetti, et al. 1994
Able to stand on
toes II
Early Motion vs.
Cast 60 ●em ●em ○
Mortensen, et al 1999
Sick Leave (days) II
Early Motion vs.
Cast ●em
Maffulli, et al 2003
Return to Work II 49 ○
Maffulli, et al 2003
Changed Jobs II 49 ○
em= early motion ○= no statistically significant difference ●= statistically significant difference ‡ AAOS calculations ‡‡= Open cast group converted to orthosis at 3 weeks Table 125. EuroQoL, E5D, Ankle Performance Score
Duration (Months)
Author Outcome LoE Comparison N 3.5 4 12 15
Costa, et al 2006
EuroQoL - Health
Score‡‡ II
Early Motion
vs. Cast
48‡‡ ○ ○ ○
Costa, et al 2006
E5D (Dimension of Health
II Early
Motion vs.
48‡‡ ○ ○ ○
v1.0 12.04.09 120
Score) Cast
Kangas, et al 2002
Ankle Performance
Score - Excellent
II
Early Motion
vs. Cast
50 ○
em= early motion ○= no statistically significant difference ●= statistically significant difference ‡ AAOS calculations ‡‡= Open cast group converted to orthosis at 3 weeks
Table 126. Patient opinion of results
Author Outcome LoE 3 m 6 m 12m 16m
Cetti, et al. 1994
Patient opinion of cast-
excellent II
●em
Mortensen, et al. 1999
Subjective Result-
Excellent II ●em
Cetti, et al. 1994 Complaints II ●em ○ ●em
Maffulli, et al 2003
Patient opinion of results- Excellent
II ○
Maffulli, et al 2003
Percent satisfied with results of
surgery II ○
em= early motion ○= no statistically significant difference ●= statistically significant difference ‡ AAOS calculations ‡‡= Open cast group converted to orthosis at 3 weeks
v1.0 12.04.09 121
Table 127. Footwear restrictions
Duration (Months)
Author Outcome LoE Comparison N 12 16 Kangas,
et al 2002
Footwear Restrictions II
Early Motion vs.
Cast 50 ○
Maffulli, et al 2003
Footwear restrictions- None, mild (most shoes tolerated)
II Early Motion
vs. Cast
53 ○
Maffulli, et al 2003
Footwear restrictions- Moderate (unable to
tolerate fashionable
shoes, with or without insert)
II Early Motion
vs. Cast
53 ○
em= early motion ○= no statistically significant difference ●= statistically significant difference ‡ AAOS calculations ‡‡= Open cast group converted to orthosis at 3 weeks Table 128. Rerupture
Author LoE Duration N Early Motion
Immobilization
Statistically Significant Difference
Cetti, et al. 1994
Re-rupture II 3% 7% ○
Costa, et al 2006 II 1 year 48
‡‡ 8.69% 0% ●‡ nwb
em= early motion ○= no statistically significant difference ●= statistically significant difference ‡ AAOS calculations ‡‡= Open cast group converted to orthosis at 3 weeks
v1.0 12.04.09 122
SUMMARY OF COMPLICATIONS Table 129. Early Motion vs. Cast - Complications
Author Complication LoE N Early Motion
Rigid Cast Group
Statistically Significant Difference
Cetti, et al. 1994 Infection II 60 0% 3% ○
Cetti, et al. 1994 Scar Adhesion II 60 3% 13% ○
Cetti, et al. 1994 Suture Granuloma II 60 3% 0% ○
Cetti, et al. 1994
Abnormal Sensibility II 60 3% 17% ●em
Cetti, et al. 1994 Keloid Scar II 60 10% 23% ○
Cetti, et al. 1994 Re-rupture II 60 3% 7% ○
Mortensen Deep Infection II 61 3% 0% ○
Mortensen Failed Repair II 61 3% 7% ○
Costa, et al 2006
Minor Wound Complications II 60 23% 20% ○
Maffulli, et al 2003
Superficial Infection II 53 7.69% 7.40% ○
Maffulli, et al 2003
Hypersensitivity of surgical wounds II 53 15.38% 18.51% ○
Maffulli, et al 2003 Hypertrophic Scar II 53 3.84% 0% ○
em= early motion nem= not early motion ○= no statistically significant difference ●= statistically significant difference ‡ AAOS calculated
v1.0 12.04.09 123
Table 130. Systematic Reviews
Author Conclusion
Khan, RJK, et al. 2005
"Postoperative splinting in a cast followed by a functional brace rather than a cast alone reduces the overall complication rate" (p. 2209).
Lynch, RM 2004 "Early functional mobilisation is more acceptable to patients than plaster cast immobilisation and results in improved functional outcomes" (p. 156).
Suchak, AA et al. 2006
"An early functional rehabilitation protocol for Achilles tendon ruptures improves patient satisfaction with reduction in minor complications and no increase in rerupture rate or infection rate" (p. 220).
v1.0 12.04.09 124
EXCLUDED ARTICLES Table 131. Mobilization vs. Immobilization Included Articles
Author Title Exclusion Reason
Sorrenti SJ; Achilles tendon rupture: effect of early mobilization in rehabilitation after surgical repair Not relevant
Buchgraber A;Passler HH;
Percutaneous repair of Achilles tendon rupture. Immobilization versus functional postoperative
treatment
Not best available evidence
Kerkhoffs GM;Struijs PA;Raaymakers EL;Marti RK;
Functional treatment after surgical repair of acute Achilles tendon rupture: wrap vs. walking
cast Not relevant
Kauranen K;Kangas J;Leppilahti J;
Recovering motor performance of the foot after Achilles rupture repair: a randomized clinical
study about early functional treatment vs. early immobilization of Achilles tendon in tension
No patient oriented outcome
Maffulli N;Tallon C;Wong J;Lim
KP;Bleakney R;
Early weight bearing and ankle mobilization after open repair of acute midsubstance tears of
the Achilles tendon Not relevant
Kangas J;Pajala A;Ohtonen
P;Leppilahti J;
Achilles tendon elongation after rupture repair: a randomized comparison of 2 postoperative
regimens
Duplicate - Data reported in prior
study Majewski M;Schaeren S;Kohlhaas U;Ochsner
PE;
Postoperative rehabilitation after percutaneous Achilles tendon repair: Early functional therapy
versus cast immobilization
Not best available evidence
Solveborn SA;Moberg A;
Immediate free ankle motion after surgical repair of acute Achilles tendon ruptures
Not best available evidence - not comparative
v1.0 12.04.09 125
STUDY QUALITY Table 132. Mobilization vs. Immobilization Quality
● = Yes ○ = No × = Not Reported n/a = not applicable
Stoc
hast
ic R
ando
miz
atio
n
Allo
catio
n C
once
alm
ent
Patie
nts B
linde
d
Tho
se r
atin
g ou
tcom
e B
linde
d
Follo
w U
p - 8
0% o
r m
ore
All
grou
ps h
ave
sim
ilar
outc
ome
perf
orm
ance
at
entr
y
Author Outcome N Treatment(s) LoE
Costa, et al.
2006 Sport 43
Mobilization vs.
Immobilization II ● ● × × ● ×
Costa, et al.
2006 Walking 43
Mobilization vs.
Immobilization II ● ● × × ● ×
Costa, et al.
2006
Stair Climbing 43
Mobilization vs.
Immobilization II ● ● × × ● ×
Costa, et al.
2006 Work 43
Mobilization vs.
Immobilization II ● ● × × ● ×
Kangas, et al.
2003
VAS Pain 50
Mobilization vs.
Immobilization II × ● ○ ○ ● ●
Kangas, et al.
2003
VAS Pain 50
Mobilization vs.
Immobilization II × ● ○ ○ ● ●
Kangas, et al.
2003
VAS Pain 50
Mobilization vs.
Immobilization II × ● ○ ○ ● ●
Kangas, et al.
2003
VAS Pain 50
Mobilization vs.
Immobilization II × ● ○ ○ ● ●
Kangas, et al.
2003
VAS Pain 50
Mobilization vs.
Immobilization II × ● ○ ○ ● ●
v1.0 12.04.09 126
● = Yes ○ = No × = Not Reported n/a = not applicable
Stoc
hast
ic R
ando
miz
atio
n
Allo
catio
n C
once
alm
ent
Patie
nts B
linde
d
Tho
se r
atin
g ou
tcom
e B
linde
d
Follo
w U
p - 8
0% o
r m
ore
All
grou
ps h
ave
sim
ilar
outc
ome
perf
orm
ance
at
entr
y
Author Outcome N Treatment(s) LoE
Kangas, et al.
2003 Stiffness 50
Mobilization vs.
Immobilization II × ● ○ ○ ● ●
Kangas, et al.
2003
subjective calf muscle weakness
50 Mobilization
vs. Immobilization
II × ● ○ ○ ● ●
Kangas, et al.
2003
footwear restrictions 50
Mobilization vs.
Immobilization II × ● ○ ○ ● ●
Kangas, et al.
2003
Ankle performance
score 50
Mobilization vs.
Immobilization II × ● ○ ○ ● ●
Mortensen, et al. 1999
Sick Leave 61 Mobilization
vs. Immobilization
II ● ○ ○ ○ ○ ●
Mortensen, et al. 1999
Subjective assessment 61
Mobilization vs.
Immobilization II ● ○ ○ ○ ○ ●
Mortensen, et al. 1999
Sports Activity 61
Mobilization vs.
Immobilization II ● ○ ○ ○ ○ ●
Mortensen, et al. 1999
Pain 61 Mobilization
vs. Immobilization
II ● ○ ○ ○ ○ ●
v1.0 12.04.09 127
● = Yes ○ = No × = Not Reported n/a = not applicable
Stoc
hast
ic R
ando
miz
atio
n
Allo
catio
n C
once
alm
ent
Patie
nts B
linde
d
Tho
se r
atin
g ou
tcom
e B
linde
d
Follo
w U
p - 8
0% o
r m
ore
All
grou
ps h
ave
sim
ilar
outc
ome
perf
orm
ance
at
entr
y
Author Outcome N Treatment(s) LoE
Mortensen, et al. 1999
Stiffness 61
Mobilization vs.
Immobilization
II ● ○ ○ ○ ○ ●
Mortensen, et al. 1999
Able to walk as far as pre surgery
61
Mobilization vs.
Immobilization
II ● ○ ○ ○ ○ ●
Cetti, et al.
1994
Resumption of sports activity 111
Mobilization vs.
Immobilization
II × × × × × ○
Cetti, et al.
1993 Return to sport 111
Mobilization vs.
Immobilization
II × × ○ ● ● ●
Cetti, et al.
1993 Return to work 111
Mobilization vs.
Immobilization
II × × ○ ● ● ●
Cetti, et al.
1993 Re-rupture 111
Mobilization vs.
Immobilization
II × × ○ ● ● ●
Maffulli, et al. 2003
Pain- None 53
Mobilization vs.
Immobilization
II ○ ○ ○ ● ● ×
Maffulli, et al. 2003
Pain- Mild, Occasional 53
Mobilization vs.
Immobilization II ○ ○ ○ ● ● ×
Maffulli, et al. 2003
Pain- Moderate 53 Mobilization
vs. Immobilization
II ○ ○ × × ● ×
Maffulli, et al. 2003
Return to Sports 53
Mobilization vs.
Immobilization II ○ ○ × × ● ×
v1.0 12.04.09 128
● = Yes ○ = No × = Not Reported n/a = not applicable
Stoc
hast
ic R
ando
miz
atio
n
Allo
catio
n C
once
alm
ent
Patie
nts B
linde
d
Tho
se r
atin
g ou
tcom
e B
linde
d
Follo
w U
p - 8
0% o
r m
ore
All
grou
ps h
ave
sim
ilar
outc
ome
perf
orm
ance
at
entr
y
Author Outcome N Treatment(s) LoE
Maffulli, et al. 2003
Return to Sports (months) 53
Mobilization vs.
Immobilization II ○ ○ × × ● ●
Maffulli, et al. 2003
Return to Work (weeks) 53
Mobilization vs.
Immobilization
II ○ ○ × × ● ●
Maffulli, et al. 2003
Return to Work 53 Mobilization
vs. Immobilization
II ○ ○ × × ● ●
Maffulli, et al. 2003
Changed Jobs 53 Mobilization
vs. Immobilization
II ○ ○ × × ● ●
Maffulli, et al. 2003
Experience Problems at work due to
injury
53 Mobilization
vs. Immobilization
II ○ ○ × × ● ●
Maffulli, et al. 2003
Full weight bearing (wks) 53
Mobilization vs.
Immobilization II ○ ○ × × ● ●
Maffulli, et al. 2003
Activity Limitation -
None 53
Mobilization vs.
Immobilization II ○ ○ × × ● ●
Maffulli, et al. 2003
Activity Limitation -
Limited Recreational but not Daily
Activities
53 Mobilization
vs. Immobilization
II ○ ○ × × ● ●
Maffulli, et al. 2003
Discharged from
Physiotherapy (months)
53 Mobilization
vs. Immobilization
II ○ ○ × × ● ●
Maffulli, et al. 2003
Physiotherapy sessions (visits) 53
Mobilization vs.
Immobilization II ○ ○ × × ● ●
Maffulli, et al. 2003
Footwear restrictions- None, mild
53 Mobilization
vs. Immobilization
II ○ ○ × × ● ●
v1.0 12.04.09 129
● = Yes ○ = No × = Not Reported n/a = not applicable
Stoc
hast
ic R
ando
miz
atio
n
Allo
catio
n C
once
alm
ent
Patie
nts B
linde
d
Tho
se r
atin
g ou
tcom
e B
linde
d
Follo
w U
p - 8
0% o
r m
ore
All
grou
ps h
ave
sim
ilar
outc
ome
perf
orm
ance
at
entr
y
Author Outcome N Treatment(s) LoE
Maffulli, et al. 2003
Footwear restrictions- Moderate (unable to
tolerate fashionable
shoes)
53 Mobilization
vs. Immobilization
II ○ ○ × × ● ●
Maffulli, et al. 2003
Percent satisfied with
results of surgery
53
Weight Bearing vs. Non-weight
bearing
II ○ ○ × × ● ●
Maffulli, et al. 2003
Patient opinion of results- Excellent
53
Weight Bearing vs. Non-weight
bearing
II ○ ○ × × ● ●
v1.0 12.04.09 130
STUDY RESULTS Table 133. Mobilization vs. Immobilization Study Data
Author
Outcome
LoE
Duration
N
Results Early Motion Cast Results
Cetti, et al. 1994
Return to same level of sports
activities II 1 year 60 80% 50% p=
0.0292
Cetti, et al. 1994
Return to lesser level of sports
activities II 1 year 60 7% 13% p= 0.616
Cetti, et al. 1994
Stopped sports activities II 1 year 60 3% 13% p= 0.141
Cetti, et al. 1994
Patient opinion of cast- excellent II 1 year 60 77% 20% p=
0.0005
Cetti, et al. 1994
Mean Sick leave (days) II NA 60 20.2
(Range 3-75)
53.4 (Range 1-182)
p= 0.0009
Cetti, et al. 1994
Able to stand on toes II 3 months 60 83% 53% p= 0.025
Cetti, et al. 1994
Able to stand on toes II 6 months 60 100% 77% p= 0.011
Cetti, et al. 1994
Able to stand on toes II 12
months 60 100% 97% p= 0.15‡
Cetti, et al. 1994 Re-rupture II NA 60 3% 7% p= 0.55‡
Cetti, et al. 1994 Complaints II 3 months 60 17.0 25.00 p= 0.047
Cetti, et al. 1994 Complaints II 6 months 60 10.00 14.00 p=
0.290‡ Cetti, et al.
1994 Complaints II 12 months 60 3.00 11.00 p= 0.03
Mortensen, et al 1999
Able to walk as far as they could before surgery
II 12 weeks 61 19% 40% p= 0.06
Mortensen, et al 1999
Subjective Result - excellent II 16
months 61 84% 63% p=0.06‡
Mortensen, et al 1999
Returned to sports II 16 months 61 73% 76% OR =1
‡= AAOS calculations ‡‡= Open cast group converted to orthosis at 3 weeks
v1.0 12.04.09 131
Results Author Outcome LoE Duration N Early Motion Cast Results Mortensen,
et al 1999
Reached pre-injury level II 16 months 61 57% 55% 1
Mortensen, et al 1999
Time until pre-injury level
reached (months)
II NA 61 6 (2.5-13)
9 (6-14) P <0.01
Kangas, et al
2002 Vas Pain II 1 week 50 2.17± 2.7 2.02 ±
1.7 p= 0.08
Kangas, et al
2003 Vas Pain II 3 weeks 50 .83 ± 1.2 .82 ±
1.3 p= 0.797
Kangas, et al
2003 Vas Pain II 6 weeks 50 .65 ± 1.4 .60 ±
.09 p= 0.9
Kangas, et al
2003 No Stiffness II 60 weeks 50 44% 68% p>0.08
Kangas, et al
2003 Mild Stiffness II 60 weeks 50 56% 32% p>0.08
Kangas, et al
2003
No footwear restrictions II 60 weeks 50 68% 92% p>0.08
Kangas, et al
2003
Ankle Performance
Score - Excellent II 60 weeks 50 88% 92% p>0.08
Kangas, et al
2003 Re-rupture II 5 months 50 4% 8% 1.000
Costa, et al 2006
Return to Normal
Walking‡‡ II Time
measurement 48 18 (95% CI 12-22)
18 (95% CI 18-
22)
p= 0.027
Costa, et al 2006
Return to Normal Stair Climbing‡‡
II Time measurement 48 17 (95% CI 11-
18)
18 (95% CI 14-
22)
p= 0.023
Cetti, et al. 1994 Infection II Not Reported 60 0 3.3 p= 0.155‡
Cetti, et al. 1994 Scar Adhesion II Not Reported 60 3.3 13.3 0.141‡
v1.0 12.04.09 132
Results Author Outcome LoE Duration N Early Motion Cast Results Cetti, et al.
1994 Suture
Granuloma II Not Reported 60 3.3 0 0.155‡
Maffulli, et al 2003
Full weight bearing (wks) II 12 months 53 2.5 (SD 0.4) 5.5 (SD
2.2) p= 0.021
Maffulli, et al 2003
Physiotherapy sessions (visits) II 12 months 53 6.1 (SD 3.1)
13.6 (SD 4.8)
p= 0.03
Maffulli, et al 2003
Discharged from Physiotherapy
(months) II 12 months 53 2.1 (SD 1.1) 4.6 (SD
2) p<.0001
Maffulli, et al 2003 Pain- None II 12 months 53 88% 89% p= 0.96 ‡
Maffulli, et al 2003
Pain- Mild, Occasional II 12 months 53 8% 7% p=0.97‡
Maffulli, et al 2003 Pain- Moderate II 12 months 53 4% 4% p=0.98 ‡
Maffulli, et al 2003
Activity Limitation -
None II 12 months 53 92% 93% p=0.97‡
Maffulli, et al 2003
Activity Limitation -
Limited Recreational but
not Daily Activities
II 12 months 53 8% 7% p=0.97
Maffulli, et al 2003 Return to Sports II 12 months 38 89% 89% p=0.99 ‡
Maffulli, et al 2003
Return to Sports (months) II 12 months 53 5.1 (SD 2.8) 6 (SD
3) 0.04
Maffulli, et al 2003
Footwear restrictions-None, mild
II 12 months 53 96% 93% p=0.57‡
Maffulli, et al 2003
Footwear restrictions-Moderate (unable to
tolerate fashionable
shoes, with or without insert)
II 12 months 53 4% 7% p=0.57‡
v1.0 12.04.09 133
Results Author Outcome LoE Duration N Early Motion Cast Results Maffulli, et
al 2003
Percent satisfied with results of
surgery II 12 months 53 88% 85% p=0.51‡
Maffulli, et al 2003 Excellent II 12 months 53 88% 81% p=0.47‡
Maffulli, et al 2003
Return to Work (weeks) II 12 months 53 9.2 (SD 2.5) 13.2
(SD 3) p= 0.05
Maffulli, et al 2003 Return to Work II 12 months 49 100% 100% 1
Maffulli, et al 2003 Changed Jobs II 12 months 49 1 2 p=0.51‡
Maffulli, et al 2003
Hypersensitivity of surgical
wounds II 10-12 wks 53 15.38% 18.51% p= 0.76‡
Maffulli, et al 2003
Hypertrophic Scar II 10-12 weeks 53 3.84% 0% p= 0.15‡
‡= AAOS calculations ‡‡= Open cast group converted to orthosis at 3 weeks
v1.0 12.04.09 134
Results
Author Outcome LoE Duration N Early Motion Cast Results Cetti, et
al. 1994
Abnormal Sensibility II Not
Reported 60 3.3 16.7 p= 0.066‡
Cetti, et al.
1994 Keloid Scar II Not
Reported 60 10 23.3 p = 0.157‡
Mortensen Deep Infection II 6 weeks 3% 0% p =
0.154‡
Mortensen Failed Repair II 6 weeks 3% 7% p = 0.52‡
Costa Minor Wound Complications II Varying Tie 23% 20% p =
0.79‡ Kangas, et
al 2002
Re-rupture II 5 months 4% 8% p = 0.545‡
Costa, et al
2005
Time in weeks taken to return to
work.
II Time measurement 48 22 26 p =
0.593‡
Costa, et al 2006
EuroQoL - Health
Score‡‡ II 10 weeks 48 75 (IQR 70-85) 75 (IQR 65-80) p =
0.854
Costa, et al 2006
EuroQoL - Health
Score‡‡ II 6months 48 85 (IQR 80-90) 81 (IQR 75-95) p =
0.956
Costa, et al 2006
EuroQoL - Health
Score‡‡ II 12 months 48 84 (IQR 75-95) 90 (IQR 85-95) p =
.138
Costa, et al 2006
E5D (Dimension of Health Score)
II 10 weeks 48 0.69 (IQR 0.6-0.9) 0.69 (IQR 0.6-0.7) p = 0.450
Costa, et al 2006
E5D (Dimension of Health Score)
II 6months 48 0.8 (IQR 0.7-1.0) 0.8 (IQR 0.8-1.0) p = 0.956
Costa, et al 2006
E5D (Dimension of Health Score)
II 12 months 48 1 (IQR 0.9-1.0) 1(IQR 0.8-1.0) p = 0.146
‡= AAOS calculations ‡‡= Open cast group converted to orthosis at 3 weeks
v1.0 12.04.09 135
RECOMMENDATION 13 We are unable to recommend for or against post-operative physiotherapy for patients with acute Achilles tendon rupture. AAOS Strength of Recommendation: Inconclusive
Description: Evidence from a single low quality study or conflicting findings that do not allow a recommendation for or against the intervention. An Inconclusive recommendation means that there is a lack of compelling evidence resulting in an unclear balance between benefits and potential harm. Implications: Practitioners should feel little constraint in deciding whether to follow a recommendation labeled as Inconclusive and should exercise judgment and be alert to future publications that clarify existing evidence for determining balance of benefits versus potential harm. Patient preference should have a substantial influencing role.
Rationale:
A systematic review did not identify any studies that met the inclusion criteria. Supporting Evidence:
We searched for any studies addressing post operative physical therapy including supervised and unsupervised physical therapy. The only studies that we identified did not specifically study whether physical therapy was effective. Therefore, it is not possible to draw evidence-based conclusions for this recommendation. SUMMARY OF EVIDENCE Table 134. Post Operative Physiotherapy Regiments
Author LOE Treatment N Post Treatment PT Regimen
Majewski III Percutaneous Repair
15 Cast followed
by walking cast Both groups received same PT at 8
weeks 88 Combination
splint and shoe
Calder IV Mini-Open Repair 46 Functional
Brace "Active physiotherapy programme"
at 2 weeks
Troop IV Open Repair 13 Cast (5) Splint (8)
All had supervised PT. Authors do not report details of PT regimen.
Saw IV Open Repair 19 Cast followed
by walking boot
All patients began supervised active ankle dorsiflexion at 1 week. Neutral
position of the ankle at 2 weeks. Active non-weight bearing exercises at 6 weeks. Normal walking allowed
at 8 weeks.
v1.0 12.04.09 136
Author LOE Treatment N Post Treatment PT Regimen
Moberg IV Operative Repair 17 Mobile plaster
cast
Immediate free ankle joint movement. Free weightbearing and
mobilization at 6 weeks.
Kangas
II Open Repair 25 Dorsal rigid splint at 6
weeks
Both groups performed "standard rehabilitation program;" Authors do not specify details of PT program
II Open Repair 25 Plaster splint Both groups performed "standard
rehabilitation program;" Authors do not specify details of PT program
EXCLUDED ARTICLES Table 135. Excluded Articles
Author Title Exclusion Reason
Majewski M, et al
Postoperative rehabilitation after percutaneous Achilles tendon repair: Early functional therapy versus cast
immobilization
Does not answer the recommendation
Calder JD, et al.
Early, active rehabilitation following mini-open repair of Achilles tendon rupture: a prospective study
Does not answer the recommendation
Troop RL, et al. Early motion after repair of Achilles tendon ruptures Does not answer the
recommendation Saw Y, et
al. Early mobilization after operative repair of ruptured
Achilles tendon Does not answer the
recommendation
Moberg A, et al.
Surgically repaired Achilles tendon ruptures with postoperative mobile ankle cast: A 12-month follow-up study with an isokinetic and a dynamic muscle function
test
Does not answer the recommendation
Kangas J, et al.
Achilles tendon elongation after rupture repair: a randomized comparison of 2 postoperative regimens
Does not answer the recommendation
v1.0 12.04.09 137
RECOMMENDATION 14 In patients with acute Achilles tendon rupture, irrespective of treatment type, we are unable to recommend a specific time at which patients can return to activities of daily living. AAOS Strength of Recommendation: Inconclusive
Description: Evidence from a single low quality study or conflicting findings that do not allow a recommendation for or against the intervention. An Inconclusive recommendation means that there is a lack of compelling evidence resulting in an unclear balance between benefits and potential harm. Implications: Practitioners should feel little constraint in deciding whether to follow a recommendation labeled as Inconclusive and should exercise judgment and be alert to future publications that clarify existing evidence for determining balance of benefits versus potential harm. Patient preference should have a substantial influencing role. Rationale: A systematic review identified 18 studies that reported on return to low impact activities. Our meta-analysis suggested the results of these studies were very different from each other and this is confirmed by examining their individual results (See supporting evidence below). Supporting Evidence: Eighteen studies5, 46, 47, 48, 49, 50, 20,41, 51, 30,21,52,53, 25,48, 19, 40 are included that report data on return to low impact activity. We have tabled the mean length of time to return to activity and the percent of patients able to return after either non-operative or operative treatments (see Table 136 through Table 143). We attempted meta-analysis for the following patient groups and outcomes: mean time for non-operative patients to return to work (I^2 95%), mean time for operative patients to return to work (I^2 >90%), and the percent of operative patients able to return to work at three months (I^2 at 3 months >75%). The results of these studies are so different from each other, as demonstrated by the high heterogeneity, that it is difficult to draw any conclusions about the time to return to recreational or athletic activity. There were too few studies included for each outcome to investigate the reasons for heterogeneity. SUMMARY OF EVIDENCE Table 136. Non-Operative treatment - Percent of patients able to return to work
Author LOE Treatment N Outcome Duration (months)
% of Patients
Costa, et al. 2006 IV
immediate weight bearing
mobilization 22 Return to work 12 59%
Costa, et al. 2006 IV plaster cast
immobilization 26 Return to work 12 65%
Hufner, et al. IV cast and boot 125 Return to work 0.6 45%
v1.0 12.04.09 138
2006
Table 137. Non-Operative Treatment -Percent of patients able to return to ADL
Author LOE Treatment N Outcome Duration (months)
% of Patients
Costa, et al. 2006 IV
immediate weight bearing
mobilization 22 Return to normal
walking 12 73%
Costa, et al. 2006 IV plaster cast
immobilization 26 Return to normal walking 12 85%
Table 138. Operative Treatment - Percent of patients returning to ADL
Author LOE Treatment N Outcome Duration (months) %
Scarfi, et al. 2002 IV percutaneous repair 20 Return to ADL 2 100%
Tang, et al. 2007 IV arthroscopically assisted
percutaneous 20 Resume walking 3 100%
Costa, et al. 2006 IV
open end-to-end (immediate weight
bearing mobilisation) 23 Return to normal
walking 12 96%
Costa, et al. 2006 IV open end-to-end (plaster
cast immobilisation) 25 Return to normal walking 12 100%
Costa, et al. 2006 IV
open end-to-end (immediate weight
bearing mobilisation) 23 Return to stair
climbing 12 96%
Costa, et al. 2006 IV open end-to-end (plaster
cast immobilisation) 25 Return to stair climbing (months) 12 96%
v1.0 12.04.09 139
Table 139. Operative Treatment - Percent of patients able to return to work
Author LOE Treatment N Outcome Duration (months) %
Kiviluoto, et al. 1985
IV open repair 70 Return to work 1-3 70%
Hogsaa, et al. 1990
IV open repair 68 Return to work -
same employment (weeks)
1.5-3 35%
Moller, et al. 2001 IV end-to-end suture w/o
augmentation 32 Return to light, mobile work 1 100%
Moller, et al. 2001 IV end-to-end suture w/o
augmentation 13 Return to sedentary work 1 100%
Hogsaa, et al. 1990
IV open repair 68 Return to work -
same employment (weeks)
< 1 29%
Suchak, et al. 2008
IV open repair 103 Return to work 1.7 65%
Jung, et al. 2008 IV limited open 27 Return to work 2 100%
Hogsaa, et al. 1990
IV open repair 68 Return to work -
same employment (weeks)
> 3 15%
Suchak, et al. 2011
IV open repair 103 Return to work 3 82%
Moller, et al. 2001 IV end-to-end suture w/o
augmentation 14 Return to heavy work 3.5 100%
Kuskucu, et al. 2005
IV fibrin sealant 32 Return to daily work 6 97%
Hogsaa, et al. 1990
IV open repair 68 Return to work -
same employment (weeks)
< 6 18%
Suchak, et al. 2008
IV open repair 103 Return to work 6 97%
Lansdaal, et al. 2007
IV minimally-invasive 150 Return to work - same work 12 98%
v1.0 12.04.09 140
Author LOE Treatment N Outcome Duration (months) %
Costa, et al. 2006 IV
open end-to-end (immediate weight
bearing mobilisation) 23 Return to work 12 87%
Costa, et al. 2006 IV open end-to-end (plaster
cast immobilisation) 25 Return to work 12 100%
Maffulli, et al. 2003
IV open repair (non-weight bearing) 26 Return to work -
same job 12 92%
Maffulli, et al. 2003
IV open repair (non-weight bearing) 26 Return to work 12 100%
Maffulli, et al. 2003
IV open repair (weight bearing) 23 Return to work -
same job 12 96%
Maffulli, et al. 2003
IV open repair (weight bearing) 23 Return to work 12 100%
v1.0 12.04.09 141
Table 140. Non-Operative Treatment - Mean time until return to work Author LOE Treatment N Outcome Duration (weeks)
Metz, et al. 2008 IV functional brace 33 Return to work 15.4 (SD 16.42)
Costa, et al. 2006 IV immediate weight
bearing mobilisation 22 Return to work 1 (95% CI 1-13) ‡
Costa, et al. 2006 IV immediate weight
bearing mobilisation 22 Return to normal walking 18 (95% CI 12-22) ‡
Moller, et al. 2001 IV Below the knee plaster
cast 53 Return to work 10.48 (SD 8.07)
Wallace, et al. 2004 IV cast 122 Return to work 2.36 (SD 1.19)
Cetti, et al. 1993 IV below-knee plaster cast 55 Return to work 8 (SD 3.6)
Costa, et al. 2006 IV plaster cast
immobilisation 26 Return to work 10 (95% CI 2-22) ‡
Moller, et al. 2001 IV Below the knee plaster
cast 22 Return to light, mobile work 9.6 (SD 9.4)
Moller, et al. 2001 IV Below the knee plaster
cast 22 Return to sedentary work 4.7 (SD7.8)
Costa, et al. 2006 IV plaster cast
immobilisation 26 Return to normal walking 18 (95% CI 18-22) ‡
‡ AAOS Calculation
Table 141. Non-Operative Treatment - Mean time until return to walking Author LOE Treatment N Outcome Duration (weeks)
Costa, et al. 2006 IV immediate weight
bearing mobilisation 22 Return to normal walking 18 (95% CI 12-22) ‡
Costa, et al. 2006 IV plaster cast
immobilisation 26 Return to normal walking 18 (95% CI 18-22) ‡
v1.0 12.04.09 142
Table 142. Operative Treatment - Mean time to return to ADL Author LOE Treatment N Outcome Duration (Weeks)
Costa, et al. 2006 IV
open end-to-end (immediate weight
bearing mobilisation) 23 Return to normal
walking 12.5 (95% CI 10-
18) ‡
Costa, et al. 2006 IV open end-to-end (plaster
cast immobilisation) 25 Return to normal walking
18 (95% CI 18-22) ‡
Maffulli, et al. 2003 IV open repair (non-weight
bearing) 27 Walk w/o crutches 5.5 (SD 2.2; range 4.6-8.1)
Maffulli, et al. 2003 IV open repair (weight
bearing) 26 Walk w/o crutches 2.5 (SD 0.4; range 1.2-3.1)
Costa, et al. 2006 IV
open end-to-end (immediate weight
bearing mobilisation) 23 Return to stair
climbing 13 (95% CI 10-18)
‡
Costa, et al. 2006 IV open end-to-end (plaster
cast immobilisation) 25 Return to stair climbing
22 (95% CI 18-22) ‡
Calder, et al. 2006 IV percutaneous repair 25 Return to driving 4.14 (range .7-9)
‡ AAOS Calculation
v1.0 12.04.09 143
Table 143. Operative Treatment - Mean time until return to work Author LOE Treatment N Outcome Duration (Weeks)
Moller, et al. 2001 IV end-to-end suture w/o
augmentation 14 Return to heavy work 14.6 (SD 7.5)
Coutts, et al. 2002 IV open repair 15 Return to work -
manual 11.1 (range 8-24)
Moller, et al. 2001 IV end-to-end suture w/o
augmentation 32 Return to light, mobile work 5.1 (SD 5.4)
Moller, et al. 2001 IV end-to-end suture w/o
augmentation 13 Return to sedentary work 4.4(SD 5.2)
Moller, et al. 2001 IV end-to-end suture w/o
augmentation 59 Return to work 7.8(SD 68.4)
Cetti, et al. 1993 IV end-to-end suture 56 Return to work 6.2 (SD 2.15)
Metz, et al. 2008 IV minimally-invasive 40 Return to work 8.4 (SD 11.71)
Lansdaal, et al. 2007 IV minimally-invasive 15
0 Return to work 4 (range .14-52.57) ‡
Calder, et al. 2005 IV
mini-open repair w/ early active
rehabilitation 46 Return to work 3.12 (range .57-11)
Costa, et al. 2006 IV
open end-to-end (immediate weight
bearing mobilisation) 23 Return to work 8 (95% CI 2-13) ‡
Costa, et al. 2006 IV
open end-to-end (plaster cast
immobilisation) 25 Return to work 4 (95% CI 1-13) ‡
Calder, et al. 2006 IV percutaneous repair 25 Return to work 2.7 (range .85-11)
Majewski, et al. 2008 IV percutaneous w/ shoe 14 Return to work 5.2 (range .7-18.85)
Wagnon, et al. 2005 IV percutaneous repair
(Webb-Bannister) 22 Return to work (months) 1.07
Doral, et al. 2009 IV endoscopy assisted
percutaneous 62 Return to work 11.7 (range 10-13)
‡ AAOS Calculation
v1.0 12.04.09 144
EXCLUDED ARTICLES Table 144. Excluded Articles
Author Title Reason for Exclusion Costa ML;Shepstone L;Darrah C;Marshall
T;Donell ST;
Immediate full-weight bearing mobilisation for repaired Achilles
tendon ruptures: a pilot study
Less than 80% follow up
Goren D;Ayalon M;Nyska M;
Isokinetic strength and endurance after percutaneous and open surgical
repair of Achilles tendon ruptures
No patient oriented outcome
van der Linden-van der Zwaag HM;Nelissen
RG;Sintenie JB;
Results of surgical versus non-surgical treatment of Achilles tendon
rupture Not 80% follow
Kakiuchi M; A combined open and percutaneous
technique for repair of tendo Achilles. Comparison with open repair
Not 80% time follow up
Hufner TM;Brandes DB;Thermann H;Richter M;Knobloch K;Krettek
C;
Long-term results after functional nonoperative treatment of Achilles
tendon rupture
Not best available evidence
Roberts C;Rosenblum S;Uhl R;Fetto J;
Team physician #6. Surgical treatment of Achilles tendon rupture
Not best available evidence
Mortensen HM;Skov O;Jensen PE;
Early motion of the ankle after operative treatment of a rupture of the
Achilles tendon. A prospective, randomized clinical and radiographic
study
Not best available evidence
Maes R;Copin G;Averous C;
Is percutaneous repair of the Achilles tendon a safe technique? A study of
124 cases
Not best available evidence
Cretnik A;Kosanovic M;Smrkolj V;
Percutaneous versus open repair of the ruptured Achilles tendon: a
comparative study
Not best available evidence
Chiodo CP;Wilson MG; Current concepts review: acute ruptures of the Achilles tendon
Not best available evidence
Fernandez-Fairen M;Gimeno C;
Augmented repair of Achilles tendon ruptures
Not best available evidence
Wagnon R;Akayi M;
The Webb-Bannister percutaneous technique for acute Achilles' tendon
ruptures: a functional and MRI assessment
Not best available evidence
Martinelli B; Percutaneous repair of the Achilles tendon in athletes
Not best available evidence
Park HG;Moon DH;Yoon JM;
Limited open repair of ruptured Achilles tendons with Bunnel-type
sutures
Not best available evidence
Edna TH; Non-operative treatment of Achilles tendon ruptures
Not best available evidence
v1.0 12.04.09 145
Author Title Reason for Exclusion
Jessing P;Hansen E; Surgical treatment of 102 tendo
achillis ruptures-- suture or tenontoplasty?
Not best available evidence
Keller J;Rasmussen TB; Closed treatment of Achilles tendon rupture
Not best available evidence
Majewski M;Rohrbach M;Czaja S;Ochsner P;
Avoiding sural nerve injuries during percutaneous Achilles tendon repair
Not best available evidence
Jennings AG;Sefton GK;Newman RJ;
Repair of acute rupture of the Achilles tendon: a new technique
using polyester tape without external splintage
Not best available evidence
Suchak AA;Bostick GP;Beaupre LA;Durand
DC;Jomha NM;
The influence of early weight bearing compared with non-weight bearing after surgical repair of the Achilles
tendon
Does not report relevant outcomes
Pendleton H;Resch S;Stenstrom A;Astrom I;
Residual functional problems after non-operative treatment of Achilles
tendon rupture Retrospective
Weber M;Niemann M;Lanz R;Muller T;
Nonoperative treatment of acute rupture of the Achilles tendon: results
of a new protocol and comparison with operative treatment
Retrospective
v1.0 12.04.09 146
STUDY QUALITY Table 145. Patient return to activities of daily living
●= yes ○= no x= not reported
Con
secu
tive
Follo
w u
p 80
Sam
e O
utco
mes
Sam
e T
reat
men
t E
qual
Fol
low
up
Tim
e
Author Outcome Measure N LoE
Calder, et al. 2005 Return to previous sporting activities 46 IV ● ● ● ● x
Calder, et al. 2006 Return to previous sporting activities 25 IV ● ● ● ● x
Cetti, et al. 1993 Return to sports - same level 47 IV ● ● ● ● ●
Cetti, et al. 1993 Return to sports - same level 52 IV ● ● ● ● ●
Chillemi, et al. 2002
Return to sports - frequent‡‡ (months) 14 IV ● ● ● ● ●
Costa, et al. 2006 Return to sports 23 IV x ● ● ● ● Costa, et al. 2006 Return to sports 25 IV x ● ● ● ●
Costa, et al. 2006 Return to stair climbing (weeks) 26 IV x ● ● ● ●
Costa, et al. 2006 Return to stair climbing (weeks) 22 IV x ● ● ● ●
Costa, et al. 2006 Return to sports (weeks) 23 IV x ● ● ● ●
Coutts, et al. 2002 Return to pre-injury level of sporting participation 22 IV x ● ● ● ●
Coutts, et al. 2002 Return to sports 20 IV x ● ● ● ●
Doral, et al. 2009 Return to previous sporting activities 62 IV ● ● ● ● ●
Doral, et al. 2009 Rehabilitation training 62 IV ● ● ● ● ●
Fortis, et al. 2008 Return to previous activity levels 20 IV x ● ● ● ●
Garabito, et al. 2004
Return to sports - pre-injury level 54 IV ● ● ● ● ●
Giannini, et al. 1994
Return to pre-injury level of activity 15 IV ● ● ● ● ●
Hogsaa, et al. 1990 Resumption of recreational activities 63 IV ● ● ● ● ●
Hogsaa, et al. 1990 Resumption of recreational activities 63 IV ● ● ● ● x
Hogsaa, et al. 1990 Resumption of recreational activities 63 IV ● ● ● ● ●
v1.0 12.04.09 147
●= yes ○= no x= not reported
Con
secu
tive
Follo
w u
p 80
Sam
e O
utco
mes
Sam
e T
reat
men
t E
qual
Fol
low
up
Tim
e
Author Outcome Measure N LoE
Jung, et al. 2008 Resume light exercise 27 IV x ● ● ● ●
Jung, et al. 2008 Return to previous sporting activities 27 IV x ● ● ● ●
Kuskucu, et al. 2005
Return to amateur sports activity 32 IV x ● ● ● ●
Lansdaal, et al. 2007 Return to sports - same level 152 IV x ● ● ● ●
Lansdaal, et al. 2007 Return to sports 152 IV x ● ● ● ●
Maffulli, et al. 2003 Activity limitations - none 27 IV ● ● ● ● ●
Maffulli, et al. 2003 Activity limitations - none 26 IV ● ● ● ● ●
Maffulli, et al. 2003 Return to sports 19 IV ● ● ● ● ●
Maffulli, et al. 2003 Return to sports 19 IV ● ● ● ● ●
Maffulli, et al. 2003 Return to sports 19 IV ● ● ● ● ●
Maffulli, et al. 2003 Return to sports 19 IV ● ● ● ● ●
Maffulli, et al. 2009 Return to sports 24 IV ● ● ● ● ●
Metz, et al. 2008 Return to sports 33 IV ● ● ● ● ● Metz, et al. 2008 Return to sports 36 IV ● ● ● ● ●
Moller, et al. 2001 Return to sports - same level 47 IV ● ● ● ● ●
Scarfi, et al. 2002 Return to sports activities 20 IV x ● ● ● ●
Solveborn, et al. 1994
Return to previous sports activity w/o any difficulty 16 IV ● ● ● ● ●
Solveborn, et al. 1994 Return to sports 16 IV ● ● ● ● ●
Taglialavoro, et al. 2004 Return to sports - complete 24 IV ● ● ● ● ●
Taglialavoro, et al. 2004 Return to sports - complete 22 IV ● ● ● ● ●
Tang, et al. 2007 Return to sports level 6 IV x ● ● ● ● Troop, et al. 1995 Resume jogging/running 13 IV ● ● ● ● ● Troop, et al. 1995 Resume jogging/running 13 IV ● ● ● ● ●
v1.0 12.04.09 148
●= yes ○= no x= not reported
Con
secu
tive
Follo
w u
p 80
Sam
e O
utco
mes
Sam
e T
reat
men
t E
qual
Fol
low
up
Tim
e
Author Outcome Measure N LoE
Uchiyama, et al. 2007 Resume jogging (weeks) 84 IV x ● ● ● ●
Uchiyama, et al. 2007
Return to sports for high-level athletes - original game level 21 IV x ● ● ● ●
Wallace, et al. 2004 Return to sports (weeks) 101 IV ● ● ● ● x
v1.0 12.04.09 149
RECOMMENDATION 15 In patients who participate in sports it is an option to return them to sports within 3-6 months after operative treatment for acute Achilles tendon rupture. AAOS Strength of Recommendation: Limited
Description: Evidence from two or more “Low” strength studies with consistent findings, or evidence from a single “Moderate” quality study recommending for or against the intervention or diagnostic. A Limited recommendation means the quality of the supporting evidence that exists is unconvincing, or that well-conducted studies show little clear advantage to one approach versus another. Implications: Practitioners should be cautious in deciding whether to follow a recommendation classified as Limited, and should exercise judgment and be alert to emerging publications that report evidence. Patient preference should have a substantial influencing role.
Rationale:
A systematic review identified 23 level IV studies providing data on return to sports after operative treatment. Two studies54, 51 reported return to jogging at three months. One study 47 reported return to sport at four months. Five studies55, 32,54, 51,56 reported that 83%-100% of patient returned to sports at six months. Ten studies19,57, 58, 53, 56, 54 , 40, 5, 21,
20 reported that 32-100% of patients returned to sports at 12 months or more.
Supporting Evidence:
Twenty-three21,5,20, 19, 50,39, 59,54,51,47,32,57, 58,38,25, 60,53,28,30,34, 55, 40studies are included that report data on return to athletic activity. We have tabled the percent of patients able to return to recreational and sports activities after operative treatments and the mean length of time to return to athletic activity (see Table 146 through Table 148 ). We attempted meta-analysis for the following patient groups and outcomes: percent operative patients able to return to activity at ≥ 12 months (I2>80%) (see Table 146 ) percent of operative patients able to return to sports at 6 and at 12 months (I2>90%) (see Table 147), and mean time for operative patients to return to sports (I2>95%) (see Table 148). The results of these studies are so different from each other, as demonstrated by the high heterogeneity, that it is difficult to draw any conclusions about the time to return to recreational or athletic activity. There were too few studies included for each outcome to investigate the reasons for heterogeneity. The remainder of outcomes and patient groups do not include enough studies to attempt meta-analysis.
v1.0 12.04.09 150
SUMMARY OF EVIDENCE Table 146. Operative Treatment - Return to Recreational Activity
Author LOE Treatment N Outcome Duration (months) % Hogsaa, et al.
1990 IV open repair 63 Resumption of recreational activities 6-12 30%
Hogsaa, et al. 1990 IV open repair 63 Resumption of recreational
activities 3-6 33%
Hogsaa, et al. 1990 IV open repair 63 Resumption of recreational
activities < 3 10%
Maffulli, et al. 2003 IV open repair (non-
weight bearing) 27 Activity limitations - none 12 93%
Maffulli, et al. 2003 IV open repair
(weight bearing) 26 Activity limitations - none 12 92%
Hogsaa, et al. 1990 IV open repair 63 Resumption of recreational
activities > 12 51%
Giannini, et al. 1994 IV
adjunctive augmentation
(synthetic graft) 15 Return to pre-injury level
of activity 18 100%
Fortis, et al. 2008 IV
endoscopically assisted
percutaneous 20 Return to previous activity
levels 30 100%
Table 147. Operative Treatment - Return to sports
Author LOE Treatment N Outcome Duration (months) %
Troop, et al. 1995 IV end-to-end w/
early motion 13 Resume jogging/running 3 92%
Jung, et al. 2008 IV limited open 27 Resume light exercise 3 100%
Troop, et al. 1995 IV end-to-end w/
early motion 13 Resume jogging/running 3 92%
Scarfi, et al. 2002 IV percutaneous
repair 20 Return to sports activities 4 100%
Kuskucu, et al. 2005 IV fibrin sealant 32 Return to amateur sports
activity 6 97%
Aktas, et al. 2007 IV
adjunctive augmentation
(autograft) 16 Return to sports - pre-injury
level of activity 6 85%
Tang, et al. 2007 IV
arthroscopically assisted
percutaneous 6 Return to sports level 6 83%
Jung, et al. 2008 IV limited open 27 Return to previous sporting
activities 6 100%
v1.0 12.04.09 151
Author LOE Treatment N Outcome Duration (months) %
Calder, et al. 2005 IV
mini-open repair w/ early active rehabilitation
46 Return to previous sporting activities 6 100%
Aktas, et al. 2008 IV open repair 14 Return to sports - pre-injury
level of activity 6 89%
Calder, et al. 2006 IV percutaneous
repair 25 Return to previous sporting activities 6 100%
Cetti, et al. 1993 IV end-to-end suture 52 Return to sports - same level 12 62%
Solveborn, et al. 1994 IV
end-to-end suture w/ below-knee transport splint
cast
16 Return to previous sports activity w/o any difficulty 12 81%
Solveborn, et al. 1994 IV
end-to-end suture w/ below-knee transport splint
cast
16 Return to sports 12 100%
Moller, et al. 2001 IV end-to-end suture
w/o augmentation 47 Return to sports - same level 12 54%
Metz, et al. 2008 IV minimally-
invasive 36 Return to sports 12 67%
Lansdaal, et al. 2007 IV minimally-
invasive 152 Return to sports - same level 12 64%
Costa, et al. 2006 IV
open end-to-end (immediate
weight bearing mobilisation)
23 Return to sports 12 83%
Costa, et al. 2006 IV
open end-to-end (plaster cast
immobilisation) 25 Return to sports 12 68%
Maffulli, et al. 2003 IV open repair (non-
weight bearing) 19 Return to sports 12 89%
Maffulli, et al. 2003 IV open repair
(weight bearing) 19 Return to sports 12 89%
Taglialavoro, et al. 2004 IV
adjunctive augmentation
(autograft) 24 Return to sports - complete 42 38%
Taglialavoro, et al. 2004 IV open repair 22 Return to sports - complete 42 32%
Doral, et al. 2009 IV
endoscopy assisted
percutaneous 62 Return to previous sporting
activities 46 95%
Garabito, et al. 2004 IV
adjunctive augmentation
(autograft) 54 Return to sports - pre-injury
level 96 43%
v1.0 12.04.09 152
Table 148. Operative Treatment - Mean time to return to athletic activity
Author LOE Treatment N Outcome Duration (months)
Doral, et al. 2009 IV endoscopy assisted
percutaneous 62 Rehabilitation training 11.7 (SD 0.75)
Troop, et al. 1995 IV end-to-end w/ early
motion 13 Resume jogging/running 3 (SD 0.75)
Lansdaal, et al. 2007 IV minimally-invasive 152 Return to sports 7.1 (SD 3.8)
Costa, et al. 2006 IV
open end-to-end (immediate weight
bearing mobilisation)
23 Return to sports (weeks)
11.14 (95% CI 5-17) ‡
Uchiyama, et al. 2007 IV open repair 84 Resume jogging
(weeks) 3.5(SD .9)
Coutts, et al. 2002 IV open repair 22
Return to pre-injury level of sporting
participation 40.8 (SD 25.2)
Coutts, et al. 2002 IV open repair 20 Return to sports 4.5 (SD 2.14)
Uchiyama, et al. 2007 IV open repair 21
Return to sports for high-level athletes - original game level
5 (SD .35)
Maffulli, et al. 2003 IV open repair (non-
weight bearing) 19 Return to sports 6 (SD 3)
Maffulli, et al. 2003 IV open repair (weight
bearing) 19 Return to sports 5.1 (SD 2.8)
Gorschewsky, et al. 2004 IV percutaneous repair 66 Return to original
sport 5.46 (SD 1.5)
Maffulli, et al. 2009 IV percutaneous repair 24 Return to sports 88 (SD 14.5)
Chillemi, et al. 2002 IV percutaneous repair 14 Return to sports -
frequent‡ (months) 8 (SD 1.5)
EXCLUDED ARTICLES Table 149. Excluded Articles
Author Title Reason for Exclusion
Suchak AA;Bostick GP;Beaupre LA;Durand
DC;Jomha NM;
The influence of early weight bearing compared with non-weight bearing after surgical repair of the
Achilles tendon
No relevant outcomes
Majewski M;Rohrbach M;Czaja S;Ochsner P;
Avoiding sural nerve injuries during percutaneous Achilles tendon repair
Not best available evidence
v1.0 12.04.09 153
Author Title Reason for Exclusion
Wagnon R;Akayi M; The Webb-Bannister percutaneous technique for acute Achilles' tendon ruptures: a functional and
MRI assessment
Time of return to sports not reported
Goren D;Ayalon M;Nyska M;
Isokinetic strength and endurance after percutaneous and open surgical repair of Achilles
tendon ruptures
No patient-oriented outcome
Chiodo CP;Wilson MG; Current concepts review: acute ruptures of the Achilles tendon
Not best available evidence
Cretnik A;Kosanovic M;Smrkolj V;
Percutaneous versus open repair of the ruptured Achilles tendon: a comparative study
Not best available evidence
Jennings AG;Sefton GK;Newman RJ;
Repair of acute rupture of the Achilles tendon: a new technique using polyester tape without external
splintage
Not best available evidence
van der Linden-van der Zwaag HM;Nelissen
RG;Sintenie JB;
Results of surgical versus non-surgical treatment of Achilles tendon rupture
Less than 80% follow up
Costa ML;Shepstone L;Darrah C;Marshall
T;Donell ST;
Immediate full-weight bearing mobilisation for repaired Achilles tendon ruptures: a pilot study
Less than 80% follow up
Mortensen HM;Skov O;Jensen PE;
Early motion of the ankle after operative treatment of a rupture of the Achilles tendon. A prospective,
randomized clinical and radiographic study
Not best available evidence
Kakiuchi M; A combined open and percutaneous technique for repair of tendo Achillis. Comparison with open
repair
Less than 80% follow up
Roberts C;Rosenblum S;Uhl R;Fetto J;
Team physician #6. Surgical treatment of Achilles tendon rupture
Not best available evidence
Keller J;Rasmussen TB; Closed treatment of Achilles tendon rupture Not best available evidence
Martinelli B; Percutaneous repair of the Achilles tendon in athletes
Not best available evidence
Fernandez-Fairen M;Gimeno C; Augmented repair of Achilles tendon ruptures Not best available
evidence Park HG;Moon DH;Yoon
JM; Limited open repair of ruptured Achilles tendons
with Bunnel-type sutures Not best available
evidence
v1.0 12.04.09 154
STUDY QUALITY Table 150. Return to sports
●= yes ○= no x= not reported
Con
secu
tive
Follo
w u
p 80
Sam
e O
utco
mes
Sam
e T
reat
men
t
Equ
al F
ollo
w u
p T
ime
Author Outcome Measure N LoE
Aktas, et al. 2007 Return to sports - pre-injury level of activity 16 IV ● ● ● ● ●
Aktas, et al. 2008 Return to sports - pre-injury level of activity 14 IV ● ● ● ● ●
Calder, et al. 2005 Return to previous sporting activities 46 IV ● ● ● ● x
Calder, et al. 2006 Return to previous sporting activities 25 IV ● ● ● ● x
Cetti, et al. 1993 Return to sports - same level 47 IV ● ● ● ● ●
Cetti, et al. 1993 Return to sports - same level 52 IV ● ● ● ● ●
Chillemi, et al. 2002
Return to sports - frequent‡ (months) 14 IV ● ● ● ● ●
Costa, et al. 2006 Return to sports 23 IV x ● ● ● ●
Costa, et al. 2006 Return to sports 25 IV x ● ● ● ●
Costa, et al. 2006 Return to stair climbing (weeks) 26 IV x ● ● ● ●
Costa, et al. 2006 Return to stair climbing (weeks) 22 IV x ● ● ● ●
Costa, et al. 2006 Return to sports (weeks) 23 IV x ● ● ● ●
Coutts, et al. 2002 Return to pre-injury level of sporting participation 22 IV x ● ● ● ●
Coutts, et al. 2002 Return to sports 20 IV x ● ● ● ●
Doral, et al. 2009 Return to previous sporting activities 62 IV ● ● ● ● ●
Doral, et al. 2009 Rehabilitation training 62 IV ● ● ● ● ●
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●= yes ○= no x= not reported
Con
secu
tive
Follo
w u
p 80
Sam
e O
utco
mes
Sam
e T
reat
men
t
Equ
al F
ollo
w u
p T
ime
Author Outcome Measure N LoE
Fortis, et al. 2008 Return to previous activity levels 20 IV x ● ● ● ●
Garabito, et al. 2004
Return to sports - pre-injury level 54 IV ● ● ● ● ●
Giannini, et al. 1994
Return to pre-injury level of activity 15 IV ● ● ● ● ●
Hogsaa, et al. 1990 Resumption of recreational activities 63 IV ● ● ● ● ●
Hogsaa, et al. 1990 Resumption of recreational activities 63 IV ● ● ● ● ●
Hogsaa, et al. 1990 Resumption of recreational activities 63 IV ● ● ● ● ●
Hogsaa, et al. 1990 Resumption of recreational activities 63 IV ● ● ● ● ●
Jung, et al. 2008 Resume light exercise 27 IV x ● ● ● ●
Jung, et al. 2008 Return to previous sporting activities 27 IV x ● ● ● ●
Kuskucu, et al. 2005
Return to amateur sports activity 32 IV ● ● ● ● ●
Lansdaal, et al. 2007 Return to sports - same level 152 IV x ● ● ● ●
Lansdaal, et al. 2007 Return to sports 152 IV x ● ● ● ●
Metz, et al. 2008 Re-rupture 33 IV ● ● ● ● ●
Metz, et al. 2008 Absence from work 33 IV ● ● ● ● ●
Metz, et al. 2008 Return to sport 33 IV ● ● ● ● ●
Metz, et al. 2008 Pain - VAS 33 IV ● ● ● ● ●
Metz, et al. 2008 Pain - VAS 33 IV ● ● ● ● ●
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●= yes ○= no x= not reported
Con
secu
tive
Follo
w u
p 80
Sam
e O
utco
mes
Sam
e T
reat
men
t
Equ
al F
ollo
w u
p T
ime
Author Outcome Measure N LoE
Metz, et al. 2008 Pain - VAS 33 IV ● ● ● ● ●
Metz, et al. 2008 Satisfaction - VAS 33 IV ● ● ● ● ●
Metz, et al. 2008 Satisfaction - VAS 33 IV ● ● ● ● ●
Metz, et al. 2008 Satisfaction - VAS 33 IV ● ● ● ● ●
Metz, et al. 2008 Return to sedentary work
(days) 59 IV ● ● ● ● ●
Moller, et al. 2001 Return to light, mobile work (days) 59 IV ● ● ● ● ●
Moller, et al. 2001 Return to work (days) 59 IV ● ● ● ● ●
Moller, et al. 2001 Return to heavy work (days) 59 IV ● ● ● ● ●
Moller, et al. 2001 Return to sports - same level 59 IV ● ● ● ● ●
Moller, et al. 2001 Return to sports - stopped 59 IV ● ● ● ● ●
Moller, et al. 2001 Return to sedentary work (days) 59 IV ● ● ● ● ●
Moller, et al. 2001 Return to light, mobile work (days) 59 IV ● ● ● ● ●
Scarfi, et al. 2002 Return to sports activities 20 IV x ● ● ● ●
Solveborn, et al. 1994
Return to previous sports activity w/o any difficulty 16 IV ● ● ● ● ●
Solveborn, et al. 1994 Return to sports 16 IV ● ● ● ● ●
Taglialavoro, et al. 2004 Return to sports - complete 24 IV ● ● ● ● ●
Taglialavoro, et al. 2004 Return to sports - complete 22 IV ● ● ● ● ●
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●= yes ○= no x= not reported
Con
secu
tive
Follo
w u
p 80
Sam
e O
utco
mes
Sam
e T
reat
men
t
Equ
al F
ollo
w u
p T
ime
Author Outcome Measure N LoE
Uchiyama, et al. 2007
Return to sports for high-level athletes - original game level 21 IV ● ● ● ● ●
Cetti, et al. 1993 Return to work (weeks) 56 IV ● ● ● ● ●
Cetti, et al. 1993 Return to sports - diminished level 56 IV ● ● ● ● ●
Cetti, et al. 1993 Return to sports - same level 56 IV ● ● ● ● ●
Cetti, et al. 1993 Return to sports - stopped 56 IV ● ● ● ● ●
Cetti, et al. 1993 Function-Abnormal ankle movement 56 IV ● ● ● ● ●
Cetti, et al. 1993 Function-Abnormal ankle movement 56 IV ● ● ● ● ●
Cetti, et al. 1993 Function-Abnormal gait 56 IV ● ● ● ● ●
Cetti, et al. 1993 Function-Abnormal gait 56 IV ● ● ● ● ●
Cetti, et al. 1993 Function-Abnormal run 56 IV ● ● ● ● ●
Cetti, et al. 1993 Function-Abnormal run 56 IV ● ● ● ● ●
Cetti, et al. 1993 Function-Abnormal toe stand 56 IV ● ● ● ● ●
Cetti, et al. 1993 Function-Abnormal toe stand 56 IV ● ● ● ● ●
Chillemi, et al. 2002
Able to walk without limitation 38 IV ● ● ● ● ●
Chillemi, et al. 2002
Return to sports activity (frequent participant 2-3 times
per week) 14 IV ● ● ● ● ●
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●= yes ○= no x= not reported
Con
secu
tive
Follo
w u
p 80
Sam
e O
utco
mes
Sam
e T
reat
men
t
Equ
al F
ollo
w u
p T
ime
Author Outcome Measure N LoE
Coutts, et al 2002 Return to pre-injury sporting level 22 IV x ● ● ● ●
Maffulli, et al. 2003 Activity limitations - none 27 IV ● ● ● ● ●
Maffulli, et al. 2003 Activity limitations - none 26 IV ● ● ● ● ●
Maffulli, et al. 2003 Return to sports 19 IV ● ● ● ● ●
Maffulli, et al. 2003 Return to sports 19 IV ● ● ● ● ●
Maffulli, et al. 2003 Return to sports 19 IV ● ● ● ● ●
Maffulli, et al. 2003 Return to sports 19 IV ● ● ● ● ●
Maffulli, et al. 2009 Return to sports 24 IV ● ● ● ● ●
Troop, et al. 1995 Resume jogging/running 13 IV ● ● ● ● ●
Troop, et al. 1995 Resume jogging/running 13 IV ● ● ● ● ●
Tang, et al. 2007 Return to sports level 6 IV x ● ● ● ●
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RECOMMENDATION 16 In patients with acute Achilles tendon rupture treated non-operatively, we are unable to recommend a specific time at which patients can return to athletic activity. AAOS Strength of Recommendation: Inconclusive
Description: Evidence from a single low quality study or conflicting findings that do not allow a recommendation for or against the intervention. An Inconclusive recommendation means that there is a lack of compelling evidence resulting in an unclear balance between benefits and potential harm. Implications: Practitioners should feel little constraint in deciding whether to follow a recommendation labeled as Inconclusive and should exercise judgment and be alert to future publications that clarify existing evidence for determining balance of benefits versus potential harm. Patient preference should have a substantial influencing role.
Rationale:
A systematic review identified 5 level IV studies21,5,20, 19,25 providing data on return to sports after non-operative treatment. These studies did not provide adequate evidence to make a recommendation for the specific time patients can return to athletic activity following non-operative treatment for Achilles tendon rupture. Supporting Evidence:
Five Level IV studies21,5,20, 19,25 that provided data on return to sports after non-operative treatment were identified. We have tabled the percent of patients and the mean length of time to return to athletic activity reported by the authors of these studies (see Table 151 and Table 152). The lack of studies, variation in treatments and variation in reported outcomes makes it difficult to draw any conclusions about the time to return to athletic activity following non-operative treatment.
SUMMARY OF EVIDENCE Table 151. Non-Operative Treatment - Percent of patients returning to athletic activity
Author LOE Treatment N Outcome Duration (months) %
Metz, et al. 2008 IV functional brace 33 Return to sports 12 82%
Costa, et al. 2006 IV immediate weight
bearing mobilisation 18 Return to sports (months) 12 56%
Costa, et al. 2006 IV plaster cast
immobilisation 21 Return to sports (months) 12 52%
Moller, et al. 2001 IV below the knee
plaster cast 38 Return to sports - same level (months) 12 54%
Cetti, et al. 1993 IV below-knee plaster
cast 47 Return to sports-same level 12 34 %
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Table 152. Non-Operative Treatment - Mean time until patients return to athletic activity
Author LOE Treatment N Outcome Duration (weeks)
Wallace, et al. 2004 IV cast 101 Return to sports (weeks) 10 (SD 4.9)
Costa, et al. 2006 IV plaster cast immobilisation 26 Return to stair climbing
(weeks) 18 (95% CI
14-22) ‡
Costa, et al. 2006 IV immediate weight
bearing mobilisation
22 Return to stair climbing (weeks)
17 (95% CI 11-18) ‡
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EXCLUDED ARTICLES Table 153. Excluded studies
Author Title Reason for Exclusion
Chiodo CP;Wilson MG; Current concepts review: acute ruptures of the Achilles tendon
Not best available evidence
van der Linden-van der Zwaag HM;Nelissen
RG;Sintenie JB;
Results of surgical versus non-surgical treatment of Achilles tendon rupture
Less than 80% follow up
Costa ML;Shepstone L;Darrah C;Marshall
T;Donell ST;
Immediate full-weight bearing mobilisation for repaired Achilles tendon ruptures: a pilot study
Less than 80% follow up
Weber M;Niemann M;Lanz R;Muller T;
Nonoperative treatment of acute rupture of the Achilles tendon: results of a new protocol and
comparison with operative treatment Retrospective
Pendleton H;Resch S;Stenstrom A;Astrom I;
Residual functional problems after non-operative treatment of Achilles tendon rupture Retrospective
STUDY QUALITY Table 154. Study Quality
●= yes ○= no x= not reported
Con
secu
tive
Follo
w u
p 80
Sam
e O
utco
mes
Sam
e Tr
eatm
ent
Equa
l Fol
low
up
Tim
e
Author Outcome Measure N LoE
Cetti, et al. 1993 Return to sports - same level 47 IV ● ● ● ● ●
Cetti, et al. 1993 Return to sports - same level 52 IV ● ● ● ● ●
Costa, et al. 2006 Return to sports 23 IV x ● ● ● ●
Costa, et al. 2006 Return to sports 25 IV x ● ● ● ●
Costa, et al. 2006 Return to stair climbing (weeks) 26 IV x ● ● ● ●
Costa, et al. 2006 Return to stair climbing (weeks) 22 IV x ● ● ● ●
Metz, et al. 2008 Re-rupture 33 IV ● ● ● ● ●
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●= yes ○= no x= not reported
Con
secu
tive
Follo
w u
p 80
Sam
e O
utco
mes
Sam
e Tr
eatm
ent
Equa
l Fol
low
up
Tim
e
Author Outcome Measure N LoE
Metz, et al. 2008 Absence from work 33 IV ● ● ● ● ●
Metz, et al. 2008 Return to sport 33 IV ● ● ● ● ●
Metz, et al. 2008 Pain - VAS 33 IV ● ● ● ● ●
Metz, et al. 2008 Pain - VAS 33 IV ● ● ● ● ●
Metz, et al. 2008 Pain - VAS 33 IV ● ● ● ● ●
Metz, et al. 2008 Satisfaction - VAS 33 IV ● ● ● ● ●
Metz, et al. 2008 Satisfaction - VAS 33 IV ● ● ● ● ●
Metz, et al. 2008 Satisfaction - VAS 33 IV ● ● ● ● ●
Metz, et al. 2008 Return to sedentary work
(days) 59 IV ● ● ● ● ●
Moller, et al. 2001 Return to light, mobile work (days) 59 IV ● ● ● ● ●
Moller, et al. 2001 Return to work (days) 59 IV ● ● ● ● ●
Moller, et al. 2001 Return to heavy work (days) 59 IV ● ● ● ● ●
Moller, et al. 2001 Return to sports - same level 59 IV ● ● ● ● ●
Moller, et al. 2001 Return to sports - stopped 59 IV ● ● ● ● ●
Moller, et al. 2001 Return to sedentary work (days) 59 IV ● ● ● ● ●
Moller, et al. 2001 Return to light, mobile work (days) 59 IV ● ● ● ● ●
Wallace, et al. 2004 Return to sports (weeks) 101 IV x ● ● ● ●
v1.0 12.04.09 164
●= yes ○= no x= not reported
Con
secu
tive
Follo
w u
p 80
Sam
e O
utco
mes
Sam
e Tr
eatm
ent
Equa
l Fol
low
up
Tim
e
Author Outcome Measure N LoE
Cetti, et al. 1993 Return to sports - same level 56 IV ● ● ● ● ●
Cetti, et al. 1993 Return to sports - stopped 56 IV ● ● ● ● ●
Cetti, et al. 1993 Function-Abnormal ankle movement 56 IV ● ● ● ● ●
Cetti, et al. 1993 Function-Abnormal ankle movement 56 IV ● ● ● ● ●
Cetti, et al. 1993 Function-Abnormal gait 56 IV ● ● ● ● ●
Cetti, et al. 1993 Function-Abnormal gait 56 IV ● ● ● ● ●
Cetti, et al. 1993 Function-Abnormal run 56 IV ● ● ● ● ●
Cetti, et al. 1993 Function-Abnormal run 56 IV ● ● ● ● ●
Cetti, et al. 1993 Function-Abnormal toe stand 56 IV ● ● ● ● ●
Cetti, et al. 1993 Function-Abnormal toe stand 56 IV ● ● ● ● ●
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FUTURE RESEARCH While the current guideline is instructive in many ways, it also demonstrates a substantial need for future research. Wherever the strength of a specific Recommendation is limited or inconclusive, there exists a need for well-designed studies and high-level evidence. As such, the most obvious need is for further, high-level investigations into the fundamental question of whether or not surgical management is superior to non-operative management of acute Achilles ruptures. There are hundreds of studies that are centered on this question, but too few are high-level randomized control trials. Beyond this, there are several other areas of needed research. Does the clinician routinely need MRI or an ultrasound for the diagnosis of an Achilles rupture? Probably not. However, there are no high-level studies to help answer this question. For non-operative treatment, low-level evidence supports the use of immediate functional bracing, but again more randomized trials are necessary. Post-operatively, is DVT prophylaxis necessary? Does the patient really need physical therapy? These are very important questions that so far remain unanswered.
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APPENDIX I WORK GROUP Christopher P Chiodo MD, Chair Brigham Orthopedic Associates 75 Francis Street Boston MA 02115 Mark Glazebrook MD, Vice-Chair Queen Elizabeth Health Sciences Center Halifax Infirmary Suite 4867 1796 Summer Street Halifax NS B3H 3A7 Canada Eric Michael Bluman MD PhD Madigan Army Medical Center ATTN: MCHJ-SOP (Ortho Clinic) 9040 A Reid Street Tacoma WA 98431-1100 Bruce E Cohen MD 1783 Sterling Road Charlotte NC 28209 John E Femino MD Department of Orthopedics University of Iowa Hospital and Clinics JPP 01022 200 Hawkins Drive Iowa City IA 52242 Eric Giza MD UC Davis Dept of Orthopaedics Ambulatory Care Services Bldg 4860 Y St #3800 Sacramento, CA 95817
Guidelines and Technology Oversight Chair: William C. Watters, III, MD 6624 Fannin #2600 Houston, TX 77030 Guidelines and Technology Oversight Vice-Chair: Michael J. Goldberg, MD Department of Orthopaedics Seattle Children’s Hospital 4800 Sand Point Way NE Seattle, WA 98105 Evidence Based Practice Committee Chair: Michael Keith, MD 2500 Metro Health Drive Cleveland, OH 44109-1900 AAOS Staff: Robert H. Haralson III, MD, MBA AAOS Medical Director 6300 N River Road Rosemont, IL 60018 Charles M. Turkelson, PhD Director of Research and Scientific Affairs Janet L. Wies MPH AAOS Clinical Practice Guideline Mgr AAOS Research Analysts Laura Raymond MA - Lead Analyst Sara Anderson MPH Kevin Boyer BS Patrick Sluka MPH
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APPENDIX II TIME FROM RUPTURE TO TREATMENT Table 155. Time from injury to treatment Author Time from Injury to treatment
Maffulli, et al. 1998
0-3 days, 45 patients 4-7 days, 14 patients 8-14 days, 7 patients 14-28 days, 10 patients
Moller, et al 2001
Attended hospital within 3 days Non-op group treated immediately Surgery performed within 2 days in 95% of cases
Metz, et al. 2008 Within 3 days of rupture
Cetti, et al 1993 Mean 0.6 days (range 0-7 days)
Twaddle, et al 2007
Presented within 10 days of injury Operated within 48 hours
Ingvar, et al. 2005
1 day after injury, 25 patients 2-7 days after injury, 10 patients 8-31 days after injury, 11 patients
Saleh, et al. 1992 Presented within 48 hours of injury
Neumayer, et al. 2009 Less than ten days
Wallace, et al. 2004 Mean 22 hours (range 1 hour, 17.5 days)
Bhattacharyya, et al 2008
7 days
Uchiyama, et al. 2007 Acute not defined
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Author Time from Injury to treatment
Lim, et al. 2001 Presented less than 7 days
Coutts, et al. 2002
Time to presentation: 24 hours, 13 patients 1-14 days, 7 patients 4-18 weeks, 5 patients Operated on within an average of 3 days (range 24 hours -10 days) from presentation
Aktas, et al 2007 1.5 days (range 2-56 hours)
Aktas, et al 2009 1.5 days (range 2-56 hours)
Ng et al. 2006 within 7 days (85% treated within one day)
Chellemi, et al. 2002 Within 4 days
Gigante, et al. 2007 Acute not defined
Kakiuchi, et al 1995 Range 1-9 days
Giannini, et al 1994 6 days
Taglialavoro, et al 2004 Not Reported
Suchak, et al. 2008 Within 2 weeks of injury
Maffulli, et al. 2003 (a) 0-7 days
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Author Time from Injury to treatment
Maffulli, et al. 2003 (b) 0-7 days
Costa, et al. 2005 0-7 days
Mortensen, et al. 1999 0-48 hours to presentation
Cetti, et al 1993 7-112 hours
Kangas, et al 2002 0-7 days
Scarfi, et al 2002 2 days (range 1-5 days)
Hogsaa, et al 1990
Less than 3 days, 96% of patients More than 3 days, 4% of patients
Doral, et al 2009 0-10 days
Troop, et al 1995 0-2 weeks
Kuskucu, et al 2005 Average 4 days (range, 3-8 days)
Solveborn, et al. 1994 Average 1.8 days (range, 0-5 days)
Lansdaal, et al. 2007 0-2 weeks
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Author Time from Injury to treatment
Garbito, et al. 2004 Within 24 hours of injury
Gorschewsky, et al 2004
Average within 24 hours
Hufner, et al. 2006 Within one week
Tang, et al 2007 6 hours- 18 days
Jung, et al 2008
Mean 5.4 days ( range 1-23 days) 87% of patients were operated in less than 2 weeks
Wagnon, et al 2005 Less than 2 weeks to presentation
Aktas, et al 2009 1.5 days (range 2-56 hours)
Margetic, et al 2007 Not Reported
McComis, et al. 1997 Not Reported
Fortis, et al. 2008 Not Reported
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APPENDIX III AAOS BODIES THAT APPROVED THIS CLINICAL PRACTICE GUIDELINE Guidelines and Technology Oversight Committee The AAOS Guidelines and Technology Oversight Committee (GTOC) consist of sixteen AAOS members. The overall purpose of this Committee is to oversee the development of the clinical practice guidelines, performance measures, health technology assessments and utilization guidelines.
Evidence Based Practice Committee The AAOS Evidence Based Practice Committee (EBPC) consists of ten AAOS members. This Committee provides review, planning and oversight for all activities related to quality improvement in orthopaedic practice, including, but not limited to evidence-based guidelines, performance measures, and outcomes.
Council on Research, Quality Assessment, and Technology To enhance the mission of the AAOS, the Council on Research, Quality Assessment, and Technology promotes the most ethically and scientifically sound basic, clinical, and translational research possible to ensure the future care for patients with musculoskeletal disorders. The Council also serves as the primary resource to educate its members, the public, and public policy makers regarding evidenced-based medical practice, orthopaedic devices and biologics, regulatory pathways and standards development, patient safety, occupational health, technology assessment, and other related areas of importance.
The Council is comprised of the chairs of the AAOS Biological Implants, Biomedical Engineering, Evidence Based Practice, Guidelines and Technology Oversight, Occupational Health and Workers’ Compensation, Patient Safety, Research Development, and US Bone and Joint Decade committees. Also on the Council are the AAOS second vice-president, representatives of the Diversity Advisory Board, the Women's Health Issues Advisory Board, the Board of Specialty Societies (BOS), the Board of Councilors (BOC), the Communications Cabinet, the Orthopaedic Research Society (ORS), the Orthopedic Research and Education Foundation (OREF), and three members at large.
Board of Directors The 17 member AAOS Board of Directors manages the affairs of the AAOS, sets policy, and determines and continually reassesses the Strategic Plan.
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DOCUMENTATION OF APPROVAL
AAOS Work Group Draft Completed August 18, 2009
Peer Review Completed September 18, 2009
Public Commentary Completed November 12, 2009
AAOS Guidelines and Technology Oversight Committee December 2, 2009
AAOS Evidence Based Practice Committee December 2, 2009
AAOS Council on Research, Quality Assessment, December 2, 2009 and Technology
AAOS Board of Directors December 4, 2009
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APPENDIX IV LITERATURE SEARCHES FOR PRIMARY STUDIES The literature searches were performed using the following databases. The full search strategies are listed below:
• PubMed • EMBASE • CINAHL • The Cochrane Library • The National Guidelines Clearinghouse • TRIP Database - Guidelines
All literature searches were supplemented with manual screening of bibliographies in publications accepted for inclusion into the evidence base. In addition, the bibliographies of recent review articles were searched for potentially relevant citations.
PubMed was searched using the following strategy:
(("Achilles Tendon"[mh] OR Achilles[tw]) AND ((("Tendon Injuries"[mh] OR injuries[sh] OR injur*[tiab] OR ruptur*[tiab] OR re-ruptur*[tiab] OR tears[tiab] OR torn[tiab] OR tear[tiab]) AND (diagnosis[sh] OR diagnos*[tw] OR "Magnetic Resonance Imaging"[mh] OR MRI[tiab] OR Ultrasonography[mh] OR sonograph*[tiab] OR ultrasound[tiab] OR radiograph*[tiab] OR Radiography[mh] OR x-ray[tiab] OR imaging[tiab] OR gap[tiab] OR "Thompson test"[tw] OR therapy[sh] OR treated[tiab] OR treatment*[tiab] OR brace[tiab] OR bracing[tiab] OR cast[tiab] OR casting[tiab] OR casts[tw] OR "Casts, Surgical"[mh] OR immobiliz*[tiab] OR surgery[tiab] OR surgical*[tiab] OR operati*[tiab] OR repair*[tiab] OR reconstruct*[tiab] OR non-operativ*[tiab] OR nonoperativ*[tiab] OR "weight bearing"[tiab] OR "Recovery of Function"[mh] OR "Physical Therapy Modalities"[mh] OR physiotherapy[tiab] OR Anticoagulants[pa])) OR ((repair*[tiab] OR surgery[tiab] OR surgery[sh] OR surgical*[tiab] OR operati*[tiab] OR repair*[tiab] OR reconstruct*[tiab] OR post-operative*[tiab] OR postoperative*[tiab]) AND ("Physical Therapy Modalities"[mh] OR physiotherapy[tiab] OR brace[tiab] OR bracing[tiab] OR cast[tiab] OR casting[tiab] OR casts[tw] OR "Casts, Surgical"[mh] OR immobiliz*[tiab] OR low-impact[tiab] OR activity[tiab] OR activities[tiab] OR "weight bearing"[tiab] OR weight bearing[tiab] OR "Recovery of Function"[mh])))) AND "1966"[PDat]:"2008"[PDat] AND “1”[EDat]:”2008/12/21”[EDAT] AND English[lang] AND (human[mh] OR in process[sb] OR publisher[sb]) NOT (comment[pt] OR editorial[pt] OR letter[pt] OR addresses[pt] OR news[pt] OR "newspaper article"[pt] OR “historical article”[pt] OR "case reports"[pt] OR "retrospective case study"[tw])
EMBASE was searched using the following strategy:
('Achilles tendon rupture'/de OR (('Achilles tendon'/de OR Achilles) AND ('tendon reconstruction'/de OR ((('tendon injury'/de OR injur* OR ruptur* OR reruptur* OR tears OR torn OR tear) AND (diagnos* OR 'nuclear magnetic resonance imaging'/exp OR mri OR 'ultrasound'/de OR ultrasound OR sonograph* OR radiograph* OR 'radiography'/de
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OR imaging OR gap OR 'thompson test' OR treated OR treatment* OR brace OR bracing OR cast OR casts OR 'plaster cast'/de OR 'walking aid'/de OR immobiliz* OR surgery OR surgical* OR operati* OR repair* OR reconstruct* OR nonoperativ* OR 'weight bearing'/de OR 'weight bearing' OR 'convalescence'/de OR 'physiotherapy'/exp OR physiotherapy OR 'anticoagulant agent'/exp)) OR ((repair* OR surgery OR surgical* OR operti* OR reconstruct* OR postoperative*) AND ('physiotherapy'/de OR physiotherapy OR brace OR bracing OR case OR casting OR casts OR 'plaster cast'/de OR 'walking aid'/de OR immobiliz* OR 'low impact' OR activity OR activities OR 'weight bearing'/de OR 'weight bearing' OR convalescence/de)))))) AND ([article]/lim OR [conference paper]/lim OR [review]/lim) AND [english]/lim AND [humans]/lim AND [embase]/lim NOT [22-12-2008]/sd
CINAHL was searched using the following strategy:
MM "Achilles Tendon" or Achilles and MM "tendon injuries" or ruptur* and ( PT “research” and LA English and PY 1966-2008 ) not (PT “editorial” or PT “letter” or PT “case study” or MM “case studies”)
The Cochrane Library was searched using the following strategy:
Achilles AND (injur* OR ruptur* OR re-ruptur* OR tears OR torn OR tear)
The National Guidelines Clearinghouse was searched using the following strategy:
Achilles tendon rupture
The TRIP Database - Guidelines was searched using the following strategy:
Achilles tendon rupture
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APPENDIX V STUDY ATTRITION FLOWCHART
4247 citations identified by literature search
2481 abstracts screened for inclusion
1766 citations excluded
281 articles recalled for full text review
2200 abstracts excluded
235 articles excluded
46 articles included
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APPENDIX VI DATA EXTRACTION ELEMENTS The data elements below were extracted into electronic forms in Microsoft® Access and Microsoft® Excel. The extracted information includes: Study Characteristics (for all relevant outcomes in a study)
• methods of randomization and allocation • use of blinding (patient, caregiver, evaluator) • funding source/conflict of interest • duration of the study • number of subjects and follow-up percentage • experimental and control groups
Patient Characteristics (for all treatment groups in a study)
• patient inclusion/exclusion criteria • co-interventions (if used) and co-morbidities (if present) • measures of disease severity • Complications
Results (for all relevant outcomes in a study)
• outcome measure • is the outcome measure patient-oriented? validated? objective/subjective? • duration at which outcome measure was evaluated • statistic reported (for dichotomous results) • mean value and measure and value of dispersion (continuous results) • statistical test used, value of test statistic, and p-value • verification of calculations
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APPENDIX VII JUDGING THE QUALITY OF DIAGNOSTIC STUDIES The QUADAS tool is used to identify sources of bias, variability, and the quality of reporting in studies of diagnostic accuracy. Fourteen questions answered “yes”, “no”, or “unclear” contribute to the QUADAS tool. There is no score derived from the use of the QUADAS tool.
Was the spectrum of patient’s representative of the patients who will receive the test in practice?
Were selection criteria clearly described?
Is the reference standard likely to correctly classify the target condition?
Is the time period between ref. standard and index test short enough to be reasonably sure that the target condition did not change between the two tests?
Did the whole sample or a random selection of the sample, receive verification using a reference standard of diagnosis?
Did patients receive the same reference standard regardless of the index test result?
Was the reference standard independent of the index test (i.e. the index test did not form part of the reference standard)?
Was the execution of the index test described in sufficient detail to permit replication of the test?
Was the execution of the reference standard described in sufficient detail to permit its replication?
Were the index test results interpreted without knowledge of the results of the reference standard?
Were the reference standard results interpreted without knowledge of the results of the index test?
Were the same clinical data available when test results were interpreted as would be available when the test is used in practice?
Were uninterpretable/intermediate test results reported?
Were withdrawals from the study explained?
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JUDGING THE QUALITY OF TREATMENT STUDIES RANDOMIZED CONTROLLED TRIALS
Did the study employ stochastic randomization?
Was there concealment of allocation?
Were subjects blinded to the treatment they received?
Were those who assessed/rated the patient’s outcomes blinded to the group to which the patients were assigned?
Was there more than 80% follow-up for all patients in the control group and the experimental group on the outcome of interest?
Did patients in the different study groups have similar levels of performance on ALL of the outcome variables at the time they were assigned to groups?
For randomized crossover studies, was there evidence that the results obtained in the study’s two experimental groups (in period 1 and 2) did not differ?
For randomized crossover studies, was there evidence that the results of the two control groups (in period 1 and 2) did not differ?
PROSPECTIVE NON- RANDOMIZED CONTROLLED STUDIES
Were the characteristics of patients in the different study groups comparable at the beginning of the study?
Did patients in the different study groups have similar levels of performance on ALL of the outcome variables at baseline?
Were all of the study’s groups concurrently treated?
Was there more than 80% follow-up for all patients in the control group and the experimental group on the outcome of interest?
Did the study avoid collecting control group data from one center and experimental group data from another?
For crossover studies, was there evidence that the results obtained in the study’s two experimental groups (in period 1 and 2) did not differ?
For crossover studies, was there evidence that the results of the two control groups (in period 1 and 2) did not differ?
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RETROSPECTIVE COMPARATIVE STUDIES
Was there less than 20% difference in completion rates in the study’s groups?
Were all of the study’s groups concurrently treated?
Was the same treatment given to all patients enrolled in the experimental and
Were the same laboratory tests, clinical findings, psychological instruments, etc. used to measure the outcomes in all of the study’s groups?
Were the follow-up times in all of the study’s relevant groups approximately equal?
Was there more than 80% follow-up for all patients in the control group and the experimental group on the outcome of interest?
Did the study avoid collecting control group data from one center and experimental group data from another?
Did patients in the different study groups have similar levels of performance on ALL of the outcome variables at the time they were assigned to groups?
Were the characteristics of patients in the different study groups comparable at the beginning of the study?
CASE SERIES
Was enrollment in the study consecutive?
Was there more than 80% follow-up for all patients on the outcome of interest?
Were the same laboratory tests, clinical findings, psychological instruments, etc. used to measure the outcomes in all patients?
Were the patients instructed/not given concomitant or adjuvant treatments?
Were the follow-up times for all patients approximately equal?
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APPENDIX VIII FORM FOR ASSIGNING STRENGTH OF RECOMMENDATION (INTERVENTIONS) GUIDELINE RECOMMENDATION___________________________________
PRELIMINARY STRENGTH OF RECOMMENDATION:________________________________________
STEP 1: LIST BENEFITS AND HARMS
Please list the benefits (as demonstrated by the systematic review) of the intervention
Please list the harms (as demonstrated by the systematic review) of the intervention
Please list the benefits for which the systematic review is not definitive
Please list the harms for which the systematic review is not definitive
STEP 2: IDENTIFY CRITICAL OUTCOMES
Please circle the above outcomes that are critical for determining whether the intervention is beneficial and whether it is harmful
Are data about critical outcomes lacking to such a degree that you would lower the preliminary strength of the recommendation?
What is the resulting strength of recommendation?
STEP 3: EVALUATE APPLICABILITY OF THE EVIDENCE
Is the applicability of the evidence for any of the critical outcomes so low that substantially worse results are likely to be obtained in actual clinical practice?
Please list the critical outcomes backed by evidence of doubtful applicability:
Should the strength of recommendation be lowered because of low applicability?
What is the resulting strength of recommendation?
STEP 4: BALANCE BENEFITS AND HARMS
Are there trade-offs between benefits and harms that alter the strength of recommendation obtained in STEP 3?
What is the resulting strength of recommendation?
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STEP 5 CONSIDER STRENGTH OF EVIDENCE
Does the strength of the existing evidence alter the strength of recommendation obtained in STEP 4?
What is the resulting strength of recommendation?
NOTE: Because we are not performing a formal cost analyses, you should only consider costs if their impact is substantial.
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APPENDIX IX VOTING BY THE NOMINAL GROUP TECHNIQUE Voting on guideline recommendations will be conducted using a modification of the nominal group technique (NGT), a method previously used in guideline development.12 Briefly each member of the guideline work group ranks his or her agreement with a guideline recommendation on a scale ranging from 1 to 9 (where 1 is “extremely inappropriate” and 9 is “extremely appropriate”). Consensus is obtained if the number of individuals who do not rate a measure as 7, 8, or 9 is statistically non-significant (as determined using the binomial distribution). Because the number of work group members who are allowed to dissent with the recommendation depends on statistical significance, the number of permissible dissenters varies with the size of the work group. The number of permissible dissenters for several work group sizes is given in the table below:
Work group Size Number of Permissible
Dissenters
≤ 3 Not allowed, statistical significance cannot be
obtained
4-5 0
6-8 1
9 1 or 2
The NGT is conducted by first having members vote on a given recommendation without discussion. If the number of dissenters is “permissible”, the recommendation is adopted without further discussion. If the number of dissenters is not permissible, there is further discussion to see whether the disagreement(s) can be resolved. Three rounds of voting are held to attempt to resolve disagreements. If disagreements are not resolved after three voting rounds, no recommendation is adopted.
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APPENDIX X STRUCTURED PEER REVIEW FORM Review of any AAOS confidential draft allows us to improve the overall guideline but does not imply endorsement by any given individual or any specialty society who participates in our review processes. The AAOS review process may result in changes to the documents; therefore, endorsement cannot be solicited until the AAOS Board of Directors officially approves the final guideline. Reviewer Information: Name of Reviewer_________________________________________ Address_________________________________________________ City___________________ State_________________ Zip Code___________ Phone _____________________Fax ________________________ E-mail_______________________ Specialty Area/Discipline: _______________________________________ Work setting: _________________________________________________ Credentials: _________________________________________________ May we list you as a Peer Reviewer in the final Guidelines? Yes No Are you reviewing this guideline as Yes No a representative of a professional society? If yes, may we list your society as a reviewer Yes No of this guideline? Reviewer Instructions Please read and review this Draft Clinical Practice Guideline and its associated Technical Report with particular focus on your area of expertise. Your responses are confidential and will be used only to assess the validity, clarity, and accuracy of the interpretation of the evidence. If applicable, please specify the draft page and line numbers in your comments. Please feel free to also comment on the overall structure and content of the guideline and Technical Report. If you need more space than is provided, please attach additional pages. Please complete and return this form electronically to [email protected] or fax the form back to Jan Weis at (847) 823-9769. Thank you in advance for your time in completing this form and giving us your feedback. We value your input and greatly appreciate your efforts. Please send the completed form and comments by Month, Day, Year
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COMMENTS Please provide a brief explanation of both your positive and negative answers in the preceding section. If applicable, please specify the draft page and line numbers in your comments. Please feel free to also comment on the overall structure and content of the guideline and Technical Report
OVERALL ASSESSMENT Would you recommend these guidelines for use in practice? (check one) Strongly recommend _______ Recommend (with provisions or alterations) _______ Would not recommend _______ Unsure _______ COMMENTS: Please provide the reason(s) for your recommendation.
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APPENDIX XI PEER REVIEW PANEL Participation in the AAOS peer review process does not constitute an endorsement of this guideline by the participating organization. Peer review of the draft guideline is completed by an outside Peer Review Panel. Outside peer reviewers are solicited for each AAOS guideline and consist of experts in the guideline’s topic area. These experts represent professional societies other than AAOS and are nominated by the guideline Work group prior to beginning work on the guideline. For this guideline, eleven outside peer review organizations were invited to review the draft guideline and all supporting documentation. Seven societies participated in the review of this guideline draft and explicitly consented to be listed as a peer review organization in this appendix. The organizations that reviewed the document and gave written consent to publication are listed below:
American Academy of Family Practitioners American Academy of Physical Medicine and Rehabilitation American College of Foot and Ankle Surgeons American Orthopaedic Foot and Ankle Society American Orthopaedic Society for Sports Medicine American Physical Therapy Association American Podiatric Medical Association Individuals who participated in the peer review of this document and gave their explicit written consent to be listed as reviewers of this document are: Avrill Roy Berkman, MD Christopher R. Carcia, MD Michael Heggeness, MD Harvey Insler, MD John Kirkpatrick, MD Michael S. Lee, DPM, FACFA Angus McBryde Jr., MD Ariz R. Mehta, MD Lawrence Oloff, DPM Steven Raikin, MD Charles Reitman, MD John Richmond, MD Kevin Shea, MD Naomi Sheilds, MD Nelson F. Soohoo, MD Glenn Weinraub, DPM, FACFAS
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Again, participation in the AAOS guideline peer review process does not constitute an endorsement of the guideline by the participating organizations or the individuals listed above. PUBLIC COMMENTARY A period of public commentary follows the peer review of the draft guideline. If significant non-editorial changes are made to the document as a result of public commentary, these changes are also documented and forwarded to the AAOS bodies that approve the final guideline. The organizations that reviewed the document and consented to publication are listed below:
German Society for Foot and Ankle Surgery (GFFC) Public commentators who gave explicit written consent to be listed in this document include the following: Laura Gehrig, MD Kurt F. Konkel, MD John McGraw COL, USAR, MC David Thordarson, MD Mathew Walther, MD Kristy Weber, MD For this guideline, outside specialty societies could post the confidential draft of the guideline to their “member only” website. The only society that submitted a compiled response as a result of this posting was the American Orthopaedic Foot and Ankle Society. Responses garnered from this posting were compiled by the specialty society and submitted as one succinct public commentary by a member of the AOFAS evidence-based medicine committee. Please contact the AOFAS for these member names since we do not have explicit written consent to publish the names of these members.
Participation in the AAOS guideline public commentary review process does not constitute an endorsement of the guideline by the participating organizations or the individual listed nor does it is any way imply the reviewer supports this document.
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APPENDIX XII DESCRIPTION OF SYMBOLS USED IN TABLES Symbol Description
OR Odds Ratio = The odds in Group B divided by the odds in Group A, where the odds is the probability of the outcome occurring divided by the probability of the outcome not occurring.
95% CI 95% Confidence Interval = A measure of uncertainty of the point estimate: if the trial were repeated an infinite number of times, then the 95% CI calculated for each trial would contain the true effect 95% of the time.
○ An open circle in a Summary of Evidence Table indicates that the result is not statistically significant.
● op A filled-in circle in a Summary of Evidence Table indicates that the result is statistically significant in favor of the listed treatment (in this example, in favor of op = operative treatment)
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APPENDIX XIII CONFLICT OF INTEREST
Eric Michael Bluman, MD (Tacoma, WA): 4 (DePuy, A Johnson & Johnson Company). Submitted on: 08/23/2008 and last confirmed as accurate on 10/09/2008.
Christopher P Chiodo, MD (Boston, MA): 1 (American Orthopaedic Foot and Ankle Society; Mass Ortho Association); 2 (Foot and Ankle International); 3 (Aircast(DJ); Arthrex, Inc); 4 (DePuy, A Johnson & Johnson Company); 5A (Smith & Nephew; Zimmer); 7 (DJ Orthopaedics; EBI; Carticept); 8 (Johnson & Johnson; Zimmer). Submitted on: 10/24/2008.
Bruce E Cohen, MD (Charlotte, NC): 2 (Foot and Ankle International; Techniques in Foot and Ankle Surgery); 3 (DJ Orthopaedics; Wright Medical Technology, Inc); 4 (Arthrex, Inc); 5A (Wright Medical Technology, Inc.; Smith & Nephew); 7 (DJ Orthopaedics; Wright Medical Technology, Inc.); 9 (Lippincott). Submitted on: 05/18/2008.
John E Femino, MD (Iowa City, IA): (n). Submitted on: 10/30/2008.
Eric Giza, MD (Sacramento, CA): 5A (Arthrex, Inc). Submitted on: 02/13/2008.
Mark Glazebrook, MD (Halifax,NS Canada): 2 (Foot and Ankle International); 5A (DePuy, A Johnson & Johnson Company; Linvatec); 7 (Arthrex, Inc; Biomimetic; DePuy, A Johnson & Johnson Company); 8 (Smith & Nephew; Stryker; Wright Medical Technology, Inc.). Submitted on: 11/04/2008.
William Charles Watters III, MD: 1 (North American Spine Society; Work Loss Data Institute); 2 (The Spine Journal); 5A (Stryker; Intrinsic Therapeutics; MeKessen Health Care Solutions). Submitted on: 10/09/2007 at 08:09 PM and last confirmed as accurate on 04/23/2008.
Disclosure Items: (n) = Respondent answered 'No' to all items indicating no conflicts. 1=Board member/owner/officer/committee appointments; 2= Medical/Orthopaedic Publications; 3= Royalties; 4= Speakers bureau/paid presentations;5A= Paid consultant; 5B= Unpaid consultant; 6= Research or institutional support from a publisher; 7= Research or institutional support from a company or supplier; 8= Stock or Stock Options; 9= Other financial/material support from a publisher; 10= Other financial/material support from a company or supplier.
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APPENDIX XIV REFERENCES
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