References - Künstliche Gelenke | Gelenkersatz | … literature...StageOne Select Hip Cement Spacer...
Transcript of References - Künstliche Gelenke | Gelenkersatz | … literature...StageOne Select Hip Cement Spacer...
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References1. Cui Q, Mihalko WM, Shields JS, Ries M and KJ Saleh. Antibiotic-
Impregnated Cement Spacers for the Treatment of Infection Associated with Total Hip or Knee Arthroplasty. The Journal of Bone & Joint Surgery. 89:871–882. 2007.
2. DataonfileatBiomet.Benchtestresultsnotnecessarilyindica-tive of clinical performance.
3. Report from SP Technical Research Institute of Sweden (2007 08 13). Airborne methyl methacrylate monomer during the use of differ-ent bone cement mixing systems.
4. Schlegel UJ, Sturm M, Eysel P, Breusch SJ. Pre-Packed Vacuum Bone Cement Mixing Systems. A Further Step in Reducing Methlymethacrylate Exposure in Surgery. Ann. Occup. Hyg. 2010 June 30, pp. 1-7.
5. Wang J-S, Franzén H, Jonsson E, Lidgren L. Porosity of bone cement reduced by mixing and collecting under vacuum. Acta Orthop Scand 1993, 64 (2): 143-146.
6. Wang J-S, Kjellson F. Bone Cement Porosity in Vacuum Mixing Systems, Bone Cements and Cementing Technique 2001, Walenkamp, Murray (Eds). Springer Verlag.
7. Malchau H, Herberts P, Garellick G, Söderman P, Eisler T. Prognosis of Total Hip Replacement. Scientific Exhibition pre-sented at the 69 the Annual meeting of the American Academy of Orthopaedic Surgeons. February 13-17, 2002, Dallas.
8. Dunne N-J, Orr J.F. Influence of themixing techniques on thephysical properties of acrylic bone cement. Biomaterials 2001; 22: 1819-1826.
9. Wilkinson J.M., Stockely I, et al. Effect of mixing techniques on the Properties of Acrylic Bone-Cement, The Journal of Arthroplasty, 2000; 15:663-667.
10. Bassam A. Masri, Clive P. Duncan, Christopher P. Beauchamp, Nancy J. Paris, Jennifer Arntorp. Effect of Varying Surface Patterns on Antibiotic Elution from Antibiotic-loaded Bone Cement.The Journal of Arthroplasty Vol. 10, No. 4, 1995, 453-459.
11. Meding, J.B., et al.: “Minimum Ten-Year Follow-Up of a Straight-Stemmed, Plasma-Sprayed, Titanium-Alloy, Uncemented Femoral Component.” Presented at AAOS, San Francisco, CA, February 28 – March 4, 2001.
©2013 Biomet Orthopedics • Form No. BMET0428.0 • REV0413
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www.biomet.co.uk 0086
Over 1 million times per year, Biomet helps one surgeon
provide personalized care to one patient.
The science and art of medical care are to provide the right
solution for each individual patient. This requires clinical
mastery, a human connection between the surgeon and the
patient, and the right tools for each situation.
At Biomet, we strive to view our work through the eyes of
one surgeon and one patient. We treat every solution we
provide as if it’s meant for a family member.
Our approach to innovation creates real solutions that assist
each surgeon in the delivery of durable personalized care
to each patient, whether that solution requires a minimally
invasive surgical technique, advanced biomaterials or a
patient-matched implant.
When one surgeon connects with one patient to provide
personalized care, the promise of medicine is fulfilled.
One Surgeon. One Patient.
StageOne Select Hip Cement Spacer Molds
More options while increasing mobility for the patient
Biomet offers high-quality, customizable
StageOne Select hip cement spacer
molds that optimize patient fit, and
provide the surgeon with more options
while increasing mobility for the patient.
The antibiotic-impregnated PMMA bone cement
spacer is intended for use in patients undergoing
a two-stage revision procedure due to a septic
process. Studies have shown that the use of
articulating spacers in the first stage maintains
better soft tissue tension, allows for a greater
degree of joint motion, facilitates second-stage
reimplantation and results in a better outcome
when compared to the use of static spacers.1
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StageOne Select Hip Cement Spacer Molds
Interchangeable Sizing for a Structured Fit
The StageOne Select Hip Spacer System consists
of independent femoral and acetabular molds
with interchangeable sizing options to create an
articulating hip spacer accommodating various
patient anatomies. Featuring a reinforced stem
for increased spacer strength and modular neck
length options to adjust leg length and retain soft
tissue tension, the StageOne Select Hip Spacer
is an innovative way to care for patients.
Modular Neck Length Adaptor Options
• Designed to adjust leg length, retain soft tissue tension, and provide structural stability
Stem Design
• Based on Echo Bi-Metric broach
• Ensures spacer has maximum possible bone-to-cement interface
Independent Femoral and Acetabular Articulating Spacers
• Permits a greater degree of joint motion and improved function prior to the second-stage reimplantation when compared to non-articulating spacers1
Textured Surface
• Increases surface area to promote higher antibiotic elution2
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StageOne Select Hip Cement Spacer Molds
5 Interchangeable Head Options
• Available in 48 mm, 52 mm, 56 mm, 60 mm and 64 mm sizes
• Complement the most commonly encountered acetabular sizes
3 Modular Neck Length Adaptor Options
• Available in -6 mm, STD and +6 mm
• Stainless steel construct
10 Interchangeable Options
• Standard (125 mm – 165 mm) and revision length spacers (200 mm)
• Revision length stems are tapered proximally and are cylindrical distally to better match patient anatomy
• Available in 9 mm, 11 mm, 13 mm, 15 mm and 17 mm sizes
Modular Neck Length Adaptor Options
• Designed to adjust leg length, retain soft tissue tension, and provide structural stability R
evis
ion S
tand
ard
Head Design
• Based on Endo Bi-Polar primary head
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StageOne Select Hip Cement Spacer Molds
Mold Filling Options
Optivac
• Proven system and on the market since 1993 5,6,7,8,9
• Easy and convenient mixing• Flexible system, many sizes
For the filling of the StageOne Select hip spacer
molds Biomet recommend the use of the bone
cement mixing and delivery system e.g. the proven
and well documented Optivac that can be filled with
antibiotic loaded bone cement.
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StageOne Select Hip Cement Spacer Molds
Threaded Port
Creates a seamless delivery of cement from the Optivac to the mold.
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StageOne Select Hip Cement Spacer Molds
Textured Surface
• Increases the surface area on the temporary hemi-hip prosthesis
• Provides a greater antibiotic elution than that of a matte or shiny surface*,2,10.
StageOne Select Hip Cement Spacer Molds
• Fully customizable to patient needs
• 150 interchangeable sizing options to match patient anatomy and bone defects – bone sparing, allows for a greater degree of joint motion, facilitates second-stage reimplantation and results in a better patient outcome when compared to the use of static spacers1
• Neck length adaptor options maintain soft tissue tension
• Stainless steel reinforcement provides increased strength
• Design based on the Echo Bi-Metric system which has a long clinical history
Hip Cement Spacer Mold Range
Biomet offers three options for surgeons when
treating an infected primary prosthesis. The
StageOne Select Hip Cement Spacer System
provides 150 interchangeable sizing options
for creating a temporary, articulating hip spacer
accommodating various patient anatomies.
StageOne Reinforced Hip Cement Spacer Molds
create 4 different sizes of stainless-steel reinforced,
temporary hip spacers for treating an infected
total joint. StageOne Hip Cement Spacer Molds
also come in 4 sizes. These three options allow
surgeons to choose the optimal solution for each
unique patient situation.
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StageOne Select Hip Cement Spacer Molds
StageOne Reinforced Hip Cement Spacer Molds
• Spacer design based on clinically proven Biomet hip geometry11 • Spacer helps retain the patient’s natural range of motion
• Designed to mold a temporary hip spacer for patients undergoing a two-stage revision due to an infected total joint
• Spacer preserves the soft tissue envelope for second stage re-implantation
• 4 Sizes; 9x125x43 mm, 9x125x51 mm, 13x145x57 mm and 17x165x64 mm
StageOne Hip Cement Spacer Molds
• StageOne hip cement spacer molds possess the same features as the StageOne reinforced hip cement spacer molds without the reinforced core
• 4 Sizes; 9x125x43 mm, 9x125x51 mm, 13x145x57 mm and 17x165x64 mm
*Bench top testing suggests the Day 1 gentamicin elution of a dimpled surface disc sample is more than twice that of a shiny surface and 20% higher than a matte surface. By Day 5 the gentamicin elution for a dimpled surface is 52% higher than a shiny surface and 23% higher than a matte surface 2,10.
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StageOne Select Hip Cement Spacer Molds
Implants
StageOne Select Hip Spacer Mold Stems
ProductPart
NumberDescription Size
Estimated Number of Bone Cement Mixes
(40g)
431190
431191
431192
431193
431194
431195
431196
431197
431198
431199
Reinforced Hip Mold Stem
Reinforced Hip Mold Stem
Reinforced Hip Mold Stem
Reinforced Hip Mold Stem
Reinforced Hip Mold Stem
Reinforced Hip Mold Stem
Reinforced Hip Mold Stem
Reinforced Hip Mold Stem
Reinforced Hip Mold Stem
Reinforced Hip Mold Stem
9 x 125 mm
11 x 135 mm
13 x 145 mm
15 x 155 mm
17 x 165 mm
9 x 200 mm
11 x 200 mm
13 x 200 mm
15 x 200 mm
17 x 200 mm
1
1
1
2
2
1
1
2
2
2
StageOne Select Hip Spacer Mold Heads
ProductPart
NumberDescription Size
Estimated Number of Bone Cement Mixes
(40g)
431181
431182
431183
431184
431185
Head Hip Mold
Head Hip Mold
Head Hip Mold
Head Hip Mold
Head Hip Mold
48 mm
52 mm
56 mm
60 mm
64 mm
2
2
2
3
3
StageOne Select Hip Spacer Mold Neck Length Adaptors
ProductPart
NumberDescription Size
431186
431187
431188
Hip Neck Length Adaptor
Hip Neck Length Adaptor
Hip Neck Length Adaptor
STD
+6 mm
STD -6 mm
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StageOne Select Hip Cement Spacer Molds
Product Range
Cementing Systems
Product Part Number Description
4161Optivac S
For a single mix of 20 gram to 40 gram cement
4160Optivac M
For a double mix of 60 gram to 80 gram cement
4152 Optivac L
For a triple mix of 100 gram to 120 gram cement
4150Optivac Hip Set
For two cement mixings, e.g. 40 gram and 80 gram
4195 Optigun Ratchet
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