Randomized Fixed Bearing vs Mobile Bearing Cruciate Substituting TKA

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Osteoarthritis, Rheumatoid Arthritis, Other Inflammatory Arthritis, Post-Traumatic Arthritis, Juvenile Rheumatoid Arthritis, Avascular Necrosis

Intervention / Treatment
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* Device: Total Knee Arthroplasty
* 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 (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

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 Cruciate Substituting Knee System | Device: Total Knee Arthroplasty<br>* Rotating Platform (RP) Cruciate Substituting Knee System<br>* Other names: P.F.C.® Sigma™ RP Cruciate Substituting Knee System;|
| Active Comparator: 2<br>P.F.C.® Sigma™ Fixed Cruciate Substituting Knee System | Device: Total knee replacement<br>* Fixed Cruciate Substituting Knee System<br>* Other names: P.F.C.® Sigma™ Fixed Cruciate Substituting Knee System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Society Score | 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 |  | On-going to end of study | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Knee Replacement, Knee Prosthesis