Randomized Fixed Bearing vs Mobile Bearing Cruciate Retaining TKA

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Osteoarthritis, Rheumatoid Arthritis, Post-traumatic Arthritis, Juvenile Rheumatoid Arthritis, Avascular Necrosis of Bone

Intervention / Treatment
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* Device: Total Knee Replacement
* Device: Total knee replacement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System | Device: Total Knee Replacement<br>* Rotating Platform (RP) Cruciate Retaining Knee System<br>* Other names: P.F.C.® Sigma™ RP Cruciate Retaining Knee System;|
| Active Comparator: 2<br>P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System | Device: Total knee replacement<br>* Fixed Cruciate Retaining Knee System<br>* Other names: P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Society Scores | 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. | Pre-operative, 6 and 12 months and annually thereafter for at least 5 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications/Revisions |  | On-going to end of study. | 
| Medical Imaging |  | Pre-operative, 6 and 12 months and annually thereafter for at least 5 years. | 
| SF-12 Patient Outcomes |  | Pre-operative, 6 and 12 months and annually thereafter for at least 5 years. |