NCT00208286

P.F.C. Sigma Fixed Versus P.F.C. RP Mobile Bearing Total Knee Systems

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: DePuy International · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This post-market clinical follow-up study was designed to compile long-term knee replacement outcomes of the PFC Sigma fixed and PFC Sigma mobile Rotating Platform (RP) knee systems. The first patient had surgery on November 8, 2001 and the final patient had surgery on July 29, 2005. There were 120 knees consented by a single site, which was the planned sample size in the study protocol, with 117 receiving one of the study devices. The study was terminated as the primary outcome was met and the investigator decided to conduct the study without sponsor support after 2009.

Detailed description

Performance and safety will be assessed using the following surgeon and patient based outcome tools: 1. American Knee Society Knee and Function Scores 2. Knee Society Radiological Analysis 3. Oxford Knee Score 4. SF 12 Score 5. Anterior Knee Pain Score Specific objectives of the evaluation being to assess the following: 1. Improvement in functional recovery 2. Incidence of anterior knee pain 3. Improvement in Quality of life 4. Incidence of tibial loosening 5. Incidence of excessive polyethylene wear

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DEVICE	PFC Sigma Fixed Bearing	PFC Sigma Fixed Bearing system for use in total knee arthroplasty
DEVICE	PFC Sigma Mobile Bearing	PFC Sigma Mobile Bearing system for use in total knee arthroplasty

Timeline

• Start date: 2001-11-01
• Primary completion: 2006-10-01
• Completion: 2015-03-01
• First posted: 2005-09-21
• Last updated: 2016-06-20

Locations

1 site across 1 country: United Kingdom