Randomized Fixed Bearing vs Mobile Bearing Cruciate Retaining TKA

Multi-center, Prospective, Clinical Evaluation of the PFC Sigma Rotating Platform Cruciate Retaining Versus PFC Sigma Cruciate Retaining Knee Primary Cases

The purpose of this study is to evaluate the clinical performance of the rotating platform and fixed bearing implants in patients undergoing primary total knee replacement. Outcome scoring and radiographic assessment will be the methods used to evaluate performance.

This study will evaluate the clinical performance of rotating platform and fixed bearing knee implants. This will be done by obtaining a series of primary total knee replacements. Patients will receive either the P.F.C.® Sigma™ Rotating Platform Cruciate Retaining Knee System or the P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System and assignment is randomized.

Inclusion Criteria:

• Osteoarthritis
• Rheumatoid Arthritis
• Other inflammatory arthritis
• Avascular necrosis of bone

Exclusion Criteria:

• Prior ipsilateral TKA
• Metabolic disorders
• Joint replacement due to autoimmune disorders