NCT00289107

Randomized Fixed Bearing vs Mobile Bearing Cruciate Substituting TKA

Multi-center, Prospective, Clinical Evaluation of the P.F.C.® Sigma™ Rotating Platform Cruciate Substituting vs P.F.C.® Sigma™ Cruciate Substituting Knee Primary Cases

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 149 (actual)
• Sponsor: DePuy Orthopaedics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study will evaluate the clinical performance of the rotating platform and fixed bearing implants through patient questionnaires, outcomes scoring and radiographic assessment.

Detailed description

The study will evaluate the clinical performance of rotating platform and fixed bearing cruciate ligament substituting implants by obtaining a series of primary TKAS. Patients will receive either the P.F.C.® Sigma™ Rotating Platform Cruciate Substituting Knee System or P.F.C.® Sigma™ Fixed Cruciate Substituting Knee System and assignment is randomized.

Conditions

• Osteoarthritis
• Rheumatoid Arthritis
• Other Inflammatory Arthritis
• Post-Traumatic Arthritis
• Juvenile Rheumatoid Arthritis
• Avascular Necrosis

Interventions

Type	Name	Description
DEVICE	Total Knee Arthroplasty	Rotating Platform (RP) Cruciate Substituting Knee System
DEVICE	Total knee replacement	Fixed Cruciate Substituting Knee System

Timeline

• Start date: 2001-04-01
• Primary completion: 2007-11-01
• Completion: 2007-11-01
• First posted: 2006-02-09
• Last updated: 2023-05-03
• Results posted: 2010-12-10

Locations

3 sites across 1 country: United States