Multi-center, Prospective, Clinical Evaluation of the PFC Sigma Rotating Platform Cruciate Retaining Versus PFC Sigma Cruciate Retaining Knee Primary Cases
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteoarthritis
- Sponsor
- DePuy Orthopaedics
- Enrollment
- 99
- Primary Endpoint
- Knee Society Scores
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Knee Society Scores
Time Frame: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.
The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. For each section, a score of 80-100 = excellent, 70-79 = good; 60-69 = fair; and \< 60 = poor.
Secondary Outcomes
- Complications/Revisions(On-going to end of study.)
- SF-12 Patient Outcomes(Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.)
- Medical Imaging(Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.)