NCT00289094

Randomized Fixed Bearing vs Mobile Bearing Cruciate Retaining TKA

Multi-center, Prospective, Clinical Evaluation of the PFC Sigma Rotating Platform Cruciate Retaining Versus PFC Sigma Cruciate Retaining Knee Primary Cases

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: DePuy Orthopaedics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the clinical performance of the rotating platform and fixed bearing implants in patients undergoing primary total knee replacement. Outcome scoring and radiographic assessment will be the methods used to evaluate performance.

Detailed description

This study will evaluate the clinical performance of rotating platform and fixed bearing knee implants. This will be done by obtaining a series of primary total knee replacements. Patients will receive either the P.F.C.® Sigma™ Rotating Platform Cruciate Retaining Knee System or the P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System and assignment is randomized.

Conditions

• Osteoarthritis
• Rheumatoid Arthritis
• Post-traumatic Arthritis
• Juvenile Rheumatoid Arthritis
• Avascular Necrosis of Bone

Interventions

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

Timeline

• Start date: 2001-03-01
• Primary completion: 2007-12-26
• Completion: 2007-12-26
• First posted: 2006-02-09
• Last updated: 2022-09-13
• Results posted: 2010-12-10

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study