NCT00734110

Long-term Study of The Press Fit Condylar (P.F.C.) Sigma Total Knee Replacement System

Multi-Centre Clinical Study of the P.F.C.® Sigma Total Knee System

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 723 (actual)
• Sponsor: DePuy International · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to record information from clinical and radiographic examinations and patient assessment questionnaires before surgery and at suitable postoperative intervals to assess the functioning and symptomology of each knee following surgery. In addition, any adverse events or complications are to be recorded, and any device failures or early revisions are to be recorded and reported directly to the Sponsor. The data are to be used in an evaluation of the performance of the P.F.C. Sigma knee implants over a minimum of 5 years.

Detailed description

The primary outcome measures are detailed above in the brief summary. Secondary outcomes are any adverse events or complications and any device failures or early revisions to be recorded and reported.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DEVICE	P.F.C. Sigma Total Knee System	An orthopaedic implant for total knee replacement

Timeline

• Start date: 2000-07-01
• Primary completion: 2009-04-01
• Completion: 2010-06-01
• First posted: 2008-08-13
• Last updated: 2025-10-10

Locations

1 site across 1 country: United Kingdom