A Study to Determine the Performance of the Press Fit Condylar (P.F.C.) Sigma RP-F Knee System

Study Overview
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Brief Summary
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The purpose of this study is to evaluate if the P.F.C. Sigma RPF knee accommodates functional stability with a post-operative passive range of motion of greater than 125° of flexion and to demonstrate that the range of motion does not compromise the longevity of the implant.

Detailed Description
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Primary endpoint is to demonstrate that 90% of patients have a functionally stable knee that can achieve post operative range of motion of 125 degrees or greater. The secondary endpoint is to investigate the survivorship of the P.F.C. Sigma RP-F knee at 1, 2, 3, 5, 10, 15 and 20 years

Official Title
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A Prospective, Non-Comparative Multi Centre Study to Evaluate the Clinical Performance of the DePuy Press Fit Condylar (P.F.C.) Sigma Rotating Platform High Flexion Knee.

Conditions
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Osteoarthritis

Intervention / Treatment
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* Device: P.F.C. Sigma RP-F Total Knee Replacement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects, aged between 45 and 75 years inclusive. Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained. Subjects who are able to achieve a pre-operative passive range of motion of equal to or greater than 110º. Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups. Subjects who present with idiopathic osteoarthritis that in the opinion of the clinical investigator requires a primary total knee arthroplasty. Subjects who in the opinion of the Clinical Investigator are considered to be suitable for treatment with the P.F.C.® Sigma RPF knee, according to the indications specified in the package insert leaflet. Exclusion Criteria: Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study. Women who are pregnant. Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes. Subjects who have participated in a clinical study with an investigational product in the last month (30 days). Subjects who are currently involved in any personal injury litigation claims. Subjects with a known history of poor compliance to medical treatment. Subjects who have a pre-operative limb deformity of equal to or greater than 10° varus or 15° valgus as defined using the anatomical axis. Subjects who have morbid obesity i.e. BMI ≥40.

Ages Eligible for Study
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Minimum Age: 45 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: P.F.C. Sigma RP-F Total Knee Replacement<br>An orthopaedic implant for total knee replacement with a mobile-bearing and a high flexion design | Device: P.F.C. Sigma RP-F Total Knee Replacement<br>* An orthopaedic implant for total knee replacement with a mobile-bearing and a high flexion design<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with a functionally stable knee that can achieve post-operative range of motion of 125° or greater. | Proportion of cases that have a functionally stable knee (Q10 of Oxford Knee Score is 'rarely/never' or 'sometimes, or just at first'), AND can achieve 1-year post-op passive range of motion of 125 degrees or greater. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survivorship of the P.F.C.® Sigma RPF knee at 1, 2, 3, 5, 10, 15 and 20 years. |  | 1, 2, 3 and 5 years | 
| American Knee Society Change from Baseline Knee and Function Scores at 1, 2, 3, 5, 10, 15 and 20 years |  | 1, 2, 3 and 5 years | 
| Radiographic assessments at 1, 2, 3, 5, 10, 15 and 20 years |  | 1, 2, 3 and 5 years | 
| Oxford Knee Score at 1, 2, 3, 5, 10, 15 and 20 years |  | 1, 2, 3 and 5 years | 
| Patellar Score at 1, 2, 3, 5, 10, 15 and 20 years |  | 1, 2, 3 and 5 years | 
| SF-12 1, 2, 3, 5, 10, 15 and 20 years |  | 1, 2, 3 and 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthroplasty, Knee, Replacement, High Flexion, PFC Sigma RP-F