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Sponsors and Collaborators: |
Mayo Clinic DePuy Orthopaedics |
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Information provided by: | Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT00279838 |
The purpose of this study is to determine whether intraoperative computer-assisted navigation improves prosthetic implant positioning as compared to conventional intraoperatve instrumentation in Total Knee Arthroplasty (TKA).
Condition | Intervention | Phase |
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Total Knee Arthroplasty Osteoarthritis |
Procedure: Computer Assisted Navigation Knee Replacement |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study |
Official Title: | Computer Assisted Navigation in Total Knee Arthroplasty |
Estimated Enrollment: | 200 |
Study Start Date: | June 2004 |
Primary data to be obtained is to determine whether mechanical axis of the limb malignment differs between patients whom have computer-assisted TKA and those treated with conventional intraoperative instrumentation.
Three months after surgery follow-up radiographic data will provide evidence on the initial implant position as determined with a series of x-rays including: full length standing, standard AP weight bearing, lateral, patellar, kneelingfilm views and CT evaluation. In addition, a correlation betweeen the CT measures and the kneeling x-ray can be performed at this time. Clinical (Knee Scale Society, WOMAC, and SF-36) data will also be obtained at the three month interval.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Study participants must:
Study ID Numbers: | 957-04 |
Study First Received: | January 18, 2006 |
Last Updated: | June 5, 2007 |
ClinicalTrials.gov Identifier: | NCT00279838 History of Changes |
Health Authority: | United States: Institutional Review Board |
Musculoskeletal Diseases Osteoarthritis Joint Diseases Arthritis Rheumatic Diseases |
Musculoskeletal Diseases Osteoarthritis Joint Diseases Arthritis Rheumatic Diseases |