A Study to Determine the Performance of the Press Fit Condylar (P.F.C.) Sigma RP-F Knee System
- Conditions
- Osteoarthritis
- Interventions
- Device: P.F.C. Sigma RP-F Total Knee Replacement
- Registration Number
- NCT00761410
- Lead Sponsor
- DePuy International
- Brief Summary
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
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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 170
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description P.F.C. Sigma RP-F Total Knee Replacement P.F.C. Sigma RP-F Total Knee Replacement An orthopaedic implant for total knee replacement with a mobile-bearing and a high flexion design
- Primary Outcome Measures
Name Time Method Number of patients with a functionally stable knee that can achieve post-operative range of motion of 125° or greater. 1 year 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.
- Secondary Outcome Measures
Name Time Method SF-12 1, 2, 3, 5, 10, 15 and 20 years 1, 2, 3 and 5 years 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 Oxford Knee Score 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 Patellar Score 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
Trial Locations
- Locations (8)
Kobe University Graduate School Of Medicine, 7-5-1 Kusundki- cho
🇯🇵Chuoku, Kobe, Japan
Kyunghee University Hospital, 1 HoegiDong
🇰🇷Dongdaemun Gu, Seoul, Korea, Republic of
The Nook, 51/B SV Road
🇮🇳Mumbai, Maharashtra, India
Wellington School Of Medicine Surgical Research Trust, Main Street
🇳🇿Newtown, Wellington, New Zealand
Tan Tock Seng Hospital, No 11 Jalan
🇸🇬Tan Tock Seng, Singapore
Clifton Park NHS Treatment Centre, Blue Beck Drive, Shipton Road
🇬🇧York, United Kingdom
Nottingham City Hospital, Hucknell Road
🇬🇧Nottingham, United Kingdom
Sirriraj Hospital, Mahidol University
🇹🇭Bangkok, Thailand