Osteoarthritis, Knee Clinical Trial
Official title:
Clinical Evaluation of the P.F.C. Sigma (Fixed Bearing) and P.F.C. Sigma RP (Mobile Bearing) Total Knee Systems
The primary objective of this investigation is to evaluate the performance (in terms of post-operative active range of motion at one year) of the P.F.C. Sigma and P.F.C. Sigma Rotating Platform total knee systems in clinical practice.
The secondary objectives of this investigation are:To evaluate the performance of the P.F.C. Sigma and P.F.C. Sigma Rotating Platform total knee systems in clinical practice. To evaluate the impact of patellar resurfacing on the performance of the P.F.C. Sigma and the P.F.C. Sigma Rotating Platform total knee systems. To evaluate the impact of Posterior Cruciate Ligament (PCL) sacrifice or retention on the performance of the P.F.C. Sigma and the P.F.C. Sigma Rotating Platform total knee systems. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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