Multi-center, Prospective, Clinical Evaluation of the P.F.C.® Sigma™ Rotating Platform Cruciate Substituting vs P.F.C.® Sigma™ Cruciate Substituting Knee Primary Cases
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteoarthritis
- Sponsor
- DePuy Orthopaedics
- Enrollment
- 149
- Primary Endpoint
- Knee Society Score
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The study will evaluate the clinical performance of the rotating platform and fixed bearing implants through patient questionnaires, outcomes scoring and radiographic assessment.
Detailed Description
The study will evaluate the clinical performance of rotating platform and fixed bearing cruciate ligament substituting implants by obtaining a series of primary TKAS. Patients will receive either the P.F.C.® Sigma™ Rotating Platform Cruciate Substituting Knee System or P.F.C.® Sigma™ Fixed Cruciate Substituting Knee System and assignment is randomized.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Osteoarthritis
- •Rheumatoid arthritis
- •Other inflammatory arthritis
- •Avascular necrosis (AVN) of bone
- •Post-Traumatic Arthritis
- •Juvenile Rheumatoid Arthritis
Exclusion Criteria
- •History of recent/active joint sepsis.
- •Charcot neuropathy.
- •Psycho-social disorders that would limit rehabilitation.
- •Greater than 75 years of age at the time of surgery.
- •Prior ipsilateral knee arthroplasty.
- •Metabolic disorders of calcified tissues, such as Paget's disease.
- •Severe diabetes mellitus.
- •Joint replacement due to autoimmune disorders.
- •Skeletal immaturity
Outcomes
Primary Outcomes
Knee Society Score
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(On-going to end of study)
- Medical Imaging(Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.)
- 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.)