NCT00733681

The Press Fit Condylar (P.F.C.) Sigma Rotating Platform (RP) TC3 Revision Knee in Revision Knee Arthroplasty

A Prospective, Non-comparative Study to Evaluate the Performance of the DePuy P.F.C. Sigma Rotating Platform TC3 Knee Prosthesis in Revision Knee Arthroplasty.

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 181 (actual)
• Sponsor: DePuy International · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the long-term clinical and functional performance of the P.F.C. Sigma Rotating Platform TC3 knee system in revision knee surgery and to determine whether the implant design results in a longer-lasting knee replacement.

Detailed description

Primary outcome: Implant survival at 5 years Secondary Outcomes:Evidence of clinical and functional outcome determined by the Knee Society Score, anterior knee pain (Patellar Score). Evidence of health related quality of life determined by WOMAC OA index. Patient satisfaction at 1 and 5 years. Radiographic analysis according to Knee society guidelines. Implant survival annually to 15 years.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DEVICE	PFC Sigma RP TC3 Revision knee system	Orthopaedic implant system for revision total knee replacement

Timeline

• Start date: 2004-03-01
• Primary completion: 2014-02-01
• Completion: 2014-03-01
• First posted: 2008-08-13
• Last updated: 2015-01-22

Locations

9 sites across 4 countries: France, Germany, Switzerland, United Kingdom