Techniques of lumbar-sacral spine fusion in spondylosis...
Transcript of Techniques of lumbar-sacral spine fusion in spondylosis...
The Spine Journal 11 (2011) 668–676
Review Article
Techniques of lumbar-sacral spine fusion in spondylosis: systematicliterature review and meta-analysis of randomized clinical trials
Ricardo S.G. Umeta, MDa,*, Osmar Avanzi, MDb
aSpine Surgery Group, Orthopedics Department, Santa Casa School of Medicine and Hospitals, S~ao Paulo, Rua Ces�ario Mota Junior 112 Vila Buarque,
S~ao Paulo 01221-020, BrazilbOrthopedics Department, Santa Casa School of Medicine and Hospitals, S~ao Paulo, Rua Ces�ario Mota Junior 112 Vila Buarque, S~ao Paulo 01221-020, Brazil
Received 19 October 2010; revised 15 February 2011; accepted 28 April 2011
Abstract BACKGROUND CONTEXT: Spine fusions
FDA device/drug
Author disclosure
disclose.
This study receive
Institutional review
tutional Research Eth
* Corresponding
ment, Santa Casa Sc
Ces�ario Mota Junior
Tel./fax: 55 11 3226
E-mail address: r
1529-9430/$ - see fro
doi:10.1016/j.spinee.2
can be performed through different techniques andare used to treat a number of vertebral pathologies. However, there seems to be no consensusregarding which technique of fusion is best suited to treat each distinct spinal disease or groupof diseases.PURPOSE: To study the effectiveness and complications of the different techniques used for spi-nal fusion in patients with lumbar spondylosis.STUDY DESIGN: Systematic literature review and meta-analysis.SAMPLE: Randomized clinical studies comparing the most commonly performed surgical tech-niques for spine fusion in lumbar-sacral spondylosis, as well as those reporting patient outcomewere selected.OUTCOME MEASURES: Identify which technique, if any, presents the best clinical, functional,and radiographic outcome.METHODS: Systematic literature review and meta-analysis based on scientific articles publishedand indexed to the following databases: PubMed (1966–2009), CochraneCollaboration—CENTRAL,EMBASE (1980–2009), and LILACS (1982–2009). The general search strategy focused on the surgi-cal treatment of patients with lumbar-sacral spondylosis.RESULTS: Eight studies met the inclusion criteria and were selected with a total of 1,136 patients.Meta-analysis showed that patients who underwent interbody fusion presented a significantlysmaller blood loss (p5.001) and a greater rate of bone fusion (p5.02). Patients submitted to fusionusing the posterolateral approach had a significantly shorter operative time (p5.007) and less peri-operative complications (p5.03). No statistically significant difference was found for the other stud-ied variables (pain, functional impairment, and return to work).CONCLUSIONS: The most commonly used techniques for lumbar spine fusion in patients withspondylosis were interbody fusion and posterolateral approach. Both techniques were comparablein final outcome, but the former presented better rates of fusion and the latter the less complica-tions. � 2011 Elsevier Inc. All rights reserved.
Keywords: Spondylosis; Lumbar-sacral; Spine fusion; Meta-analysis; Surgery
status: not applicable.
s: RSGU: Nothing to disclose. OA: Nothing to
d no financial support.
board approval was obtained from the local Insti-
ics Committee.
author. Spine Surgery Group, Orthopedics Depart-
hool of Medicine and Hospitals, S~ao Paulo, Rua
112 Vila Buarque, S~ao Paulo 01221-020, Brazil.
-7000 (RAMAL 5669).
[email protected] (R.S.G. Umeta)
nt matter � 2011 Elsevier Inc. All rights reserved.
011.04.026
Introduction
Back pain is a frequent cause of morbidity and incapac-ity and is considered the second most common cause ofpain in humans [1]. It is estimated that approximately85% of adults will experience low back pain at some pointof their lives [2,3]. The term spondylosis is used to refer toany phase of the degenerative diseases affecting the spine.A number of authors used this term to specifically definethe effects of degenerative disc disease on the spine itself
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and the surrounding tissues [4–6]. However, other diseases,such as spondylolisthesis and narrowing of the lumbarspine canal may also contribute to the development of lum-bar spondylosis [4–21].
Spine fusion is defined as the bone fusion of the vertebraeachieved after surgical manipulation [4]. The first author toreport the fusion of the spine for the treatment of Pott’s dis-ease was Albee [22] in 1911. Hibbs [23], in 1924, publishedthe first report on spinal fusion to treat scoliosis. This tech-nique is currently used to treat a great number of spinal dis-eases [12–15].
One of the most common surgical procedures through-out the world to treat degenerative diseases of the spine isspinal fusion. Different methods of fusion, types of instru-mentation, and various bone grafts have been developed inthe past 20 years to improve the rate of success of bonefusion, as well as clinical outcome [24–31]. The classicaltechnique for spinal fusion is the posterolateral fusion withautologous bone graft, which is slowly being replaced byother techniques with fewer limitations. The use of morerigid biomechanical instrumentations has tried to addressthe problems of the classical technique [32–34]. Althoughthere is still controversy regarding the best technique foreach specific spinal disease, there seems to be a trendtoward the use of the interbody technique, which has beenreported to achieve up to 95% to 100% of consolidation.Unfortunately, the clinical outcome of the cases treatedwith this technique of fusion does not seem as promising[19,20]. The interbody lumbar fusions may be achievedby a number of different approaches: anterior lumbar inter-body fusion (ALIF); transforaminal lumbar interbodyfusion; or posterior lumbar interbody fusion (PLIF)[17–21,33–42]. Each of these approaches presents itsown advantages and limitations.
The objective of the current literature review and meta-analysis was to study the effectiveness and complications ofthe different techniques used for lumbar-sacral spine fusionin patients with lumbar spondylosis [4–7].
Methods
Literature search
Systematic literature review andmeta-analysis of random-ized clinical studies comparing the most commonly per-formed surgical techniques for spine fusion in lumbar-sacralspondylosis, as well as those reporting patient outcome wereselected. The following electronic databaseswere used for thesearch: PubMed (1966–2009), Cochrane Collaboration—
CENTRAL, EMBASE (1980–2009), and LILACS (1982–2009). The general search strategy focused on the surgicaltreatment of patients with lumbar-sacral spondylosis.
A manual search was also carried out using the refer-ences from the articles obtained by the method above, aswell as other journals that published on the referred subject.
All the clinical trials identified were reviewed indepen-dently by two experienced spine surgeons (the authors)for selection. In those cases where the original selectionwas discordant, the authors reviewed the article togetheruntil a consensus was reached.
Eligibility criteria
Inclusion criteria
1. Articles published in English language2. Adult patients (aged 18 years or older) of both
genders3. Lumbar pain of more than 6 months duration and
nonresponsive to conservative treatment4. Patients with lumbar spondylosis secondary to degen-
erative disc disease, degenerative spondylolisthesis,and/or narrowing of the spinal canal
5. No prior surgeries to the spine
Exclusion criteria
1. Patients with skeletal immaturity2. Spondylosis secondary to infection3. Prior surgeries to the spine4. Three or more levels of the spine affected5. Involvement of the intervertebral space L3–L4 and
above
Categories of outcomes
The expected outcomes were subdivided into primaryand secondary.
Primary outcomes
1. Improvement in lumbar pain2. Improvement in radicular pain (lower extremities)3. Functional improvement assessed by functional
scales4. Length of surgery5. Intraoperative blood loss6. Fusion rate7. Perioperative complications
Secondary outcomes
1. Improvement in quality of life2. Improvement in neurological status (motor and/or
sensory)3. Return to work4. Length of hospital stay5. Recurrence of symptoms6. Mortality7. Costs
Table 1
Detailed description of the reasons leading to exclusion of the articles
originally selected from the abstracts and titles focused on the surgical
treatment of patients with lumbar spine spondylosis after consensus of the
reviewers
Study Reason for exclusion
Karsten T et al., 1997 No control group (interbody)
Roca J et al., 1999 Retrospective study
M€oller H and Hedlund R, 2000 No control group (interbody)
Fritzell P et al., 2001 Control group: conservative
treatment
Madan S and Boeree N, 2002 Retrospective study
Christensen BF et al., 2002 No control group (interbody)
Sasso RC, Kitchel SH, and
Dawson EG, 2004
No control group (posterolateral)
Pavlov PW et al., 2004 No control group (posterolateral)
Brantingan JW et al., 2000 Incompatible outcomes
Kwon B et al., 2006 Literature review
Fernand�ez-Fairen M et al., 2007 No control group (interbody)
Malmivaara A et al., 2007 No control group (interbody)
Athiviraham A, 2007 Cohort study
Martin CR et al., 2007 Literature review
Weinstein JN, 2007 Cohort study
Freeman BJC et al., 2007 No control group (posterolateral)
Fu YS, Zeng BF, and Xu JG,
2008
No control group (interbody)
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Analysis
The relative risk for the dichotomies was calculated ac-cording to the confidence interval of 95%. These estimateswere based on the analysis of the intent of treatment. Theestimated effects were combined, when possible, usingthe overall random effect model that takes into consider-ation the deviant results based on the heterogeneity of clin-ical nature and the methodology, even when unknown. Theweighed average proportion with a confidence interval of95% was calculated for continuous data expressed as aver-ages and standard deviations [43,44].
When data of more than one study were homogeneousaccording to the method of the present study, the resultswere combined into a meta-analysis using a commerciallyavailable software developed by the Cochrane Collabora-tion (Review Manager 5.0) [45]. The inconsistencies ofthe added studies used for meta-analysis were quantifiedusing the heterogeneity test I25[(Q�df)/Q]�100%, whereQ represents the chi square and df the degree of freedom.Heterogeneity was considered to be present when I2O50%[43,46–48].
The results of each study were summarized to determinethe level of evidence for each of the studied criteria andoutcome. The levels of evidence adopted for the presentstudy followed the recommendations of Grading of Recom-mendations Assessment, Development and Evaluation(GRADE) and the Cochrane Collaboration. According toGRADE factors that might decrease the quality of the evi-dence found should be identified [49–51]. The reliability ofthe study will decrease when there are significant limita-tions that may influence the estimate of the effects of treat-ment, such as flaw in the method of patient allocation, lackof blinding, great number of loss of subjects during thestudy, poor description of results, and others.
Following the GRADE [49–51] recommendations toassess the design and quality of the studies, as well as theconsistency and objectivity of the data reported, the follow-ing levels of evidence may be determined:
� High5further research is very unlikely to change ourconfidence in the estimate of effect;
� Moderate5further research is likely to have an impacton our confidence in the estimate of effect and maychange the estimate;
� Low5further research is very likely to have an impacton our confidence in the estimate of effect and is likelyto change the estimate;
� Very low5we are very uncertain about the estimate.
Results
A total of 415 titles were originally identified from theelectronic databases, manual search, and personal commu-nications. The reviewers independently assessed titles andabstracts and selected 25 full articles. After a consensus
meeting, 17 studies were excluded (Table 1). Thus all re-maining eight articles (1136 patients) were reviewed andextracted for inclusion in the meta-analysis. Table 2 sum-marized the articles and their outcomes.
Intraoperative blood loss
Two studies were selected for meta-analysis for thecriteria intraoperative blood loss. Patients submitted to the in-terbody technique had a significantly smaller intraoperativeblood loss when compared with those who underwent theposterolateral technique of lumbar spine fusion (p5.001)(Table 3).
The significantly smaller intraoperative blood loss foundin patients who underwent the interbody spine fusion tech-nique associated to the moderate level of evidence onGRADE [49–51], despite the limitations offered by thehigh heterogeneity of data, supports the recommendationof the use of this technique for spine fusion in adult patientswith lumbar spondylosis (Table 4).
Fusion rate
Three studies used radiographs to assess the consolida-tion of the fusion. Based on the results of the studies byFritzell et al. in 2002, Kim et al. in 2006, and Chenget al. in 2009, it was observed that patients who were sub-mitted to the interbody technique presented better resultsfor this outcome (Table 5).
Based on the results of the meta-analysis and on theassessment of the GRADE [49–51] level of evidence
Table 2
Detailed description of the articles included for meta-analysis on the surgical treatment of patients with lumbar spine spondylosis
Study and number of patients (n) Interventions Outcomes
Fritzell P et al. 2002, 222 PLF�PLIF or ALIF Pain, disability, fusion rate, blood loss, length of surgery, complications, length of
hospital stay
Videbaek T et al. 2006, 148 PLF�ALIFþPLF (360 �) Pain, disability
Inamdar DN et al. 2006, 20 PLF�PLIF Disability, fusion rate, blood loss, length of surgery, complications
Kim KT et al. 2006, 167 PLF�PLIF Pain, disability, fusion rate, blood loss, length of surgery, complications
Ekman P et al. 2007, 163 PLF�PLIF Pain, disability, complications
Soegaard R et al. 2007, 146 PLF�ALIFþPLF (360 �) Pain, disability, fusion rate, complications, return to work
Dantas FLR et al. 2007, 60 PLF�PLIF Disability, complications
Cheng L et al. 2009, 138 PLF�PLIF Disability, fusion rate, length of surgery, complications
PLF, posterolateral fusion; PLIF, posterior lumbar interbody fusion; ALIF, anterior lumbar interbody fusion.
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(moderate) for the outcome consolidation of spine fusion,the interbody spine fusion technique is also recommended(Table 6).
Length of surgery
For the outcome measure length of surgery, two studieswere selected. Meta-analysis revealed the posterolateralsurgical technique to be superior to the interbody techniquefor this outcome measure (p5.007) (Table 7).
Based on the results of the meta-analysis and on the as-sessment of the GRADE [49–51] quality of evidence (mod-erate) for the outcome measure length of surgery, theposterolateral approach may be recommended (Table 8).
Perioperative complications
Fritzell P et al. in 2002, Kim KT et al. in 2006, DantasFLR et al. in 2007, Ekman P et al. in 2007, and Soegaard Ret al. in 2007 studied the rate of perioperative complica-tions. Meta-analysis of these studies shows the posterolat-eral technique as the technique with the lowest rate ofsuch complications (Table 9).
Despite the favorable meta-analysis result, the lowGRADE [49–51] quality of evidence, as well as the highheterogeneity of the studies (60%), restricts the indicationof the posterolateral technique when the outcome measureperioperative complications is considered as the single vari-able (Table 10).
Table 3
Outcome: intraoperative blood loss in milliliters
Meta-analysis of two studies (Fritzell et al. 2002 and Kim et al. 2006) comp
Lumbar pain
Two studies assessed residual pain using the visual ana-log scale (VAS). Meta-analysis of these studies showed nostatistically significant difference between the two tech-niques (p5.99).
Pain in the lower limbs
Fritzell P et al. in 2002 and Kim KT et al. in 2006assessed residual pain in the lower limbs using the VAS.Meta-analysis of these studies showed no statistically sig-nificant difference between the two techniques (p5.57).
Disability
Two studies addressed the disability using the Oswestryquestionnaire. Meta-analysis of these studies showed nostatistically significant difference between the two tech-niques (p5.96).
Rate of return to work
The studies by Fritzell P et al. in 2002 and Soegaard Ret al. in 2007 evaluated the rate of return to work. Meta-analysis of these studies showed no statistically significantdifference between the two techniques (p5.07), althougha strong trend in favor of the interbody technique wasobserved.
aring the posterolateral and the interbody spine fusion techniques.
Table 4
Outcome: intraoperative blood loss
GRADE quality of evidence: moderate.
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Discussion
The hypothesis of the present study was that by selectingstudies with high methodological quality, one would havea large enough sample to reveal significant differencesbetween the posterolateral and interbody techniques forspine fusion in lumbar spondylosis. In this systematic re-view, we used strict eligibility criteria and chose to includeonly randomized clinical trials, so only eight studies wereselected.
Clinical (ie, lumbar and lower extremity pain usingVAS), functional (Oswestry functional scale and rate of re-turn to work), surgical (length of surgery, volume of bloodloss, and perioperative complications), and radiographic(rate of consolidation) outcomes were assessed.
In the current meta-analysis, there was no significant dif-ference between surgical techniques of fusion for the
Table 5
Outcome: fusion rate
Meta-analysis of three studies (Fritzell et al. 2002, Kim et al. 2006, and Cheng
rates of fusion (p5.02).
outcome measure residual lumbar and lower extremity pain(assessed with the VAS) and for the outcome measuredisability. The same findings were also reported in the liter-ature [9–17,28–30]. An interesting finding was the hetero-geneity of samples (64% for back pain, 55% for pain tothe lower limbs, and 79% for disability). A possible expla-nation is the distinct follow-up period. In the study byFritzell P et al. in 2002, it was 2 years, and in the studyby Kim KT et al. in 2006, it was 3 years. Another signifi-cant bias is that the study by Fritzell P et al. in 2002 wasmulticentric and might have been influenced by the greaternumber of professionals involved in the data sampling andanalysis. In theory, the longer the recovery time greater arethe chances of functional recovery.
The rate of return to work showed a favorable trendtoward patients undergoing the interbody technique, both
et al. 2009). Patients submitted to the interbody technique presented better
Table 6
Outcome: fusion rate
GRADE quality of evidence: moderate.
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in the present study as in literature. However, the differencebetween the interbody and the posterolateral groups wasnot significant. Interestingly, a number of reviewed studieshave addressed functional and psychosocial aspects ofpatients, but only a few consider the rate of return to worka relevant outcome measure. The latter studies reported thisrate to be higher than 60%.
In the current meta-analysis, once again only the studiesby Fritzell P et al. in 2002 and Kim KT et al. in 2006 of-fered reliable data on the volume of intraoperative bloodloss. However, Fritzell reports higher rates of blood lossfor both techniques than those of the present study, mostlikely because of the multicentric nature of the study (19centers were involved). This may also explain the ex-tremely high heterogeneity of the data (96%). Even so,the current meta-analysis found the intraoperative bloodloss of the interbody technique to be significantly smaller.
Table 7
Outcome: length of surgery in minutes
Meta-analysis of two studies (Fritzell et al. 2002 and Kim et al. 2006). The a
lateral technique (p5.007).
Several studies addressed the length of surgery, but onlytwo were selected for meta-analysis because of the greatvariability found for measuring time. None of the studiesmentioned the exact time the surgical procedure beganand ended, and some authors reported their data in hours,whereas others used minutes. The current meta-analysisfound the posterolateral technique to have a significantlyshorter operative length.
As for the fusion rate, in the current meta-analysis, theinterbody technique was superior to the posterolateral tech-nique in this outcome measure. The reviewed articles useda number of different methods to assess this outcome fromplain radiographs to computed tomography. The reasonplain radiographs were selected as the method of choicefor assessment of consolidation of the fusion in the presentstudy was the fact that the results were more uniform allow-ing better comparisons between the studies.
verage length of surgery was shorter in patients submitted to the postero-
Table 8
Outcome: length of surgery
Quality of evidence: Moderate.
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The outcome measure rate of perioperative complica-tions presented a number of peculiarities (early, late,minor, and major). In the present study, they were consid-ered as a whole to avoid bias. The low-GRADE [49–51]quality of evidence found in the present study did notallow recommendation of the apparently favorable pos-terolateral technique for this outcome. These findingsmay have been influenced by the inclusion of the quasi-randomized study by Ekman P et al. 2007 as well as bythe inconsistency of the data in the study by DantasFLR et al. in 2007.
Despite its common use in clinical practice in thecurrent meta-analysis, we did not identify any studywith high methodological quality assessing the TLIFtechnique.
Table 9
Outcome: perioperative complications
Meta-analysis of five studies (Fritzell et al. 2002, Kim et al. 2006, Dantas et a
the posterolateral technique present lower rate of perioperative complications (p
Conclusions
Based on the systematic review of literature and meta-analysis of specific outcome measures of patients submittedto lumbar spine fusion for the treatment of spondylosis, thefollowing conclusions may be drawn:
� Patients submitted to spine fusion using the interbodytechnique trough a posterior (PLIF) or anterior(ALIF) approach presented a smaller blood loss whencompared with those who underwent spine fusionwith the posterolateral technique;
� Patients submitted to spine fusion using the interbodytechnique through a posterior (PLIF) or anterior(ALIF) approach presented a greater fusion rate;
l. 2007, Ekman et al. 2007, and Soegaard et al. 2007). Patients submitted to
5.03).
Table 10
Outcome: perioperative complications
Quality of evidence: low.
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� Patients submitted to spine fusion using the postero-lateral technique presented a shorter operative lengthwhen compared with those submitted to the interbodytechnique (PLIF and ALIF).
� Patients submitted to spine fusion using the posterolat-eral technique presented a smaller rate of perioperativecomplications when compared with those submitted tothe interbody technique (PLIF and ALIF).
� No difference was found between the posterolateraland the interbody techniques regarding the outcomemeasures disability using the Oswestry questionnairereturn to work, residual lumbar, and lower limb pain.
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