Primary TKA Cruciate Retaining vs Cruciate Substituting With Rotating Platform Knee Prostheses

Rheumatoid Arthritis Clinical Trial

Official title: Multi-center Prospective Clinical Evaluation of the P.F.C.® Sigma™ Rotating Platform Knee Primary Cases Cruciate Retaining Versus Cruciate Substituting

Status Terminated

Clinical Trial Summary

The purpose of the study is to evaluate the clinical performance of the cruciate ligament retaining or cruciate ligament substituting implants by obtaining a series of primary TKAs. Outcome scoring and radiographic assessment will be the methods used to evaluate performance.

Clinical Trial Description

The study will evaluate the clinical performance of cruciate ligament retaining or cruciate ligament substituting implants through a series of primary TKAs. Patients will receive either the P.F.C.® Sigma™ Rotating Platform Cruciate Retaining Knee implant or the P.F.C.® Sigma™ Rotating Platform Cruciate Substituting Knee implant and assignment will be randomized. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Avascular Necrosis of Bone
• Osteoarthritis
• Osteonecrosis
• Post-traumatic Arthritis
• Rheumatoid Arthritis

• NCT number: NCT00289081
• Study type: Interventional
• Source: DePuy Orthopaedics
• Status: Terminated
• Phase: N/A
• Start date: February 2001
• Completion date: June 2006