NCT00289081

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 399 (actual)
• Sponsor: DePuy Orthopaedics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Total Knee Replacement	Rotating Platform (RP) Cruciate Retaining Knee implant
DEVICE	Total knee replacement	Rotating Platform (RP) Cruciate Substituting Knee implant.

Timeline

• Start date: 2001-02-01
• Primary completion: 2006-06-01
• Completion: 2006-06-01
• First posted: 2006-02-09
• Last updated: 2014-05-13

Locations

4 sites across 1 country: United States