NCT00208325

PFC Sigma Fixed and Mobile Knee Study

Clinical Evaluation of the P.F.C. Sigma (Fixed Bearing) and P.F.C. Sigma RP (Mobile Bearing) Total Knee Systems

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 754 (actual)
• Sponsor: DePuy International · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this investigation is to evaluate the performance (in terms of post-operative active range of motion at one year) of the P.F.C. Sigma and P.F.C. Sigma Rotating Platform total knee systems in clinical practice.

Detailed description

The secondary objectives of this investigation are:To evaluate the performance of the P.F.C. Sigma and P.F.C. Sigma Rotating Platform total knee systems in clinical practice. To evaluate the impact of patellar resurfacing on the performance of the P.F.C. Sigma and the P.F.C. Sigma Rotating Platform total knee systems. To evaluate the impact of Posterior Cruciate Ligament (PCL) sacrifice or retention on the performance of the P.F.C. Sigma and the P.F.C. Sigma Rotating Platform total knee systems.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DEVICE	P.F.C Sigma Fixed Bearing total knee system	Orthopaedic implant for total knee replacement
DEVICE	P.F.C Sigma RP Mobile Bearing knee system	Orthopaedic implant for total knee replacement

Timeline

• Start date: 2000-05-01
• Primary completion: 2009-01-01
• Completion: 2010-09-01
• First posted: 2005-09-21
• Last updated: 2016-09-13
• Results posted: 2016-07-20

Locations

4 sites across 1 country: United Kingdom