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The purpose of this study is to evaluate the design and functional performance of the Scorpio Total Knee Cruciate Retaining (CR) System.
The study design is that of a prospective, multi-center clinical trial. The Howmedica Osteonics Scorpio® Cruciate Retaining (CR) Total Knee System is to be implanted for evaluation in this study. This device system is commercially available and is cleared for a cemented intended for use.
The study group will consist of a maximum of 265 cases, requiring primary total knee replacement, and diagnosed with non-inflammatory arthritis. All subjects will be implanted with a femoral component, a tibial insert, a tibial tray and a resurfaced patella. Subjects receiving bilateral total knee replacements will represent two cases. Study participants will be recruited from 5 institutions.
Subjects will be evaluated preoperatively and at follow-up intervals of 7 wks (± 2 wks), 3 months (± 3 weeks), six months (±1 month and an optional visit), 12 months (± 2 months) and annually thereafter (± 2 months). Each subject will be followed for five years post-implantation.
The objectives of this study are to:
1. Evaluate the effect of system component design on functional performance.
2. Evaluate the effect of system component design by comparing postoperative functional and radiographic findings with preoperative.
3. Evaluate complications and the rates in which they occur.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Arthroplasty, Replacement, Knee
Scorpio® Cruciate Retaining (CR) Total Knee System
Foundation for Musculoskeletal Research and Education
Published on BioPortfolio: 2014-08-27T03:19:49-0400
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