Primary TKA Cruciate Retaining vs Cruciate Substituting With Rotating Platform Knee Prostheses

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the clinical performance of the cruciate ligament retaining or cruciate ligament substituting implants by obtaining a series of primary TKAs. Outcome scoring and radiographic assessment will be the methods used to evaluate performance.

Detailed Description
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The study will evaluate the clinical performance of cruciate ligament retaining or cruciate ligament substituting implants through a series of primary TKAs. Patients will receive either the P.F.C.® Sigma™ Rotating Platform Cruciate Retaining Knee implant or the P.F.C.® Sigma™ Rotating Platform Cruciate Substituting Knee implant and assignment will be randomized.

Official Title
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Multi-center Prospective Clinical Evaluation of the P.F.C.® Sigma™ Rotating Platform Knee Primary Cases Cruciate Retaining Versus Cruciate Substituting

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

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 Avascular necrosis (AVN) of bone Other inflammatory arthritis Post-traumatic arthritis Juvenile rheumatoid arthritis Exclusion Criteria: Prior ipsilateral TKA Metabolic disorders Joint replacement due to autoimmune disorders 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 Severe diabetes mellitus 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Society scores |  | 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