NCT00761410

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

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.

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 170 (actual)
• Sponsor: DePuy International · Industry
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DEVICE	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

Timeline

• Start date: 2004-10-01
• Primary completion: 2010-02-01
• Completion: 2015-05-01
• First posted: 2008-09-29
• Last updated: 2016-06-20

Locations

8 sites across 7 countries: India, Japan, New Zealand, Singapore, South Korea, Thailand, United Kingdom