Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2009-09-30
2011-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Custom Cutting Blocks
Total Knee Arthroplasty with Custom Cutting Blocks
Subjects randomized to this study group will undergo TKA with patient specific custom cutting blocks generated by pre-op MRI and a Biomet Vanguard knee implant
Computer Assisted Surgery
Total Knee Arthroplasty via Computer Assisted Surgery
Subjects randomized to this study group will receive TKA via computer assisted surgery and a Biomet Vanguard knee implant
Interventions
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Total Knee Arthroplasty with Custom Cutting Blocks
Subjects randomized to this study group will undergo TKA with patient specific custom cutting blocks generated by pre-op MRI and a Biomet Vanguard knee implant
Total Knee Arthroplasty via Computer Assisted Surgery
Subjects randomized to this study group will receive TKA via computer assisted surgery and a Biomet Vanguard knee implant
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* must be 18 years of age or older
* must be capable and willing to provide informed consent
* must have flexion contracture less than 15 degrees.
* must have ligament stability no more than 2 degrees instability in varus/valgus extension stress
Exclusion Criteria
* currently participating in or has participated in (within 30 days prior to inclusion in this study) another clinical trial of an investigational drug, biologic, device, or procedure
* known pre-operative systemic infections, uncontrolled diabetes, or diseases or conditions that are known to interfere with the wound healing process
* Knee alignment deformities greater than 7 degrees varus or valgus
* known prior knee revisions or previous surgeries deemed to compromise the TKA incision exposure
* known medical conditions prohibiting the use of MRI or nickel allergy, sensitivity, or hardware in the region of the knee
18 Years
ALL
No
Sponsors
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Foundation for Southwest Orthopedic Research
OTHER
Responsible Party
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Southwest Orthopedic Group, LLP
Locations
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Southwest Orthopedic Group, LLP
Houston, Texas, United States
The Methodist Hospital
Houston, Texas, United States
Countries
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References
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Lionberger DR, Crocker CL, Chen V. Patient specific instrumentation. J Arthroplasty. 2014 Sep;29(9):1699-704. doi: 10.1016/j.arth.2014.03.019. Epub 2014 Mar 28.
Other Identifiers
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0509-0060
Identifier Type: -
Identifier Source: org_study_id
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