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Sponsored by: |
DePuy International |
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Information provided by: | DePuy International |
ClinicalTrials.gov Identifier: | NCT00761410 |
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.
Condition | Intervention | Phase |
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Osteoarthritis |
Device: P.F.C. Sigma RP-F Total Knee Replacement |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | 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. |
Estimated Enrollment: | 280 |
Study Start Date: | January 2005 |
Estimated Study Completion Date: | January 2025 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
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
Ages Eligible for Study: | 45 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Mick Borroff, BSc, MSc | +44 113 387 7800 ext 7910 | mborroff@its.jnj.com |
India, Maharashtra | |
The Nook, 51/B SV Road | Recruiting |
Mumbai, Maharashtra, India, 400 054 | |
Contact: Rajesh Maniar, FRCS | |
Principal Investigator: Rajesh Maniar, FRCS |
Principal Investigator: | Rajesh Maniar, FRCS | The Nook, 51/B SV Road, Mumbai, Maharashtra, India |
Responsible Party: | DePuy International (see above) ( Mick Borroff ) |
Study ID Numbers: | CT0153 |
Study First Received: | September 26, 2008 |
Last Updated: | September 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00761410 |
Health Authority: | United Kingdom: Research Ethics Committee |
Arthroplasty Knee Replacement High Flexion PFC Sigma RP-F |
Musculoskeletal Diseases Osteoarthritis Joint Diseases Arthritis Rheumatic Diseases |