Randomized Fixed Bearing vs Mobile Bearing Cruciate Retaining TKA

Not Applicable

Completed

• Conditions: Avascular Necrosis of Bone; Post-traumatic Arthritis; Osteoarthritis; Rheumatoid Arthritis; Juvenile Rheumatoid Arthritis
• Interventions: Device: Total knee replacement

• Registration Number: NCT00289094
• Lead Sponsor: DePuy Orthopaedics

Brief 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.

Study Timeline

• Study Start: 2001-03-01
• Study First Submitted: 2006-02-07
• Study First Submitted QC: 2006-02-07
• Study First Posted: 2006-02-09
• Primary Completion: 2007-12-26
• Study Completion: 2007-12-26
• Results First Submitted: 2010-09-29
• Results First Submitted QC: 2010-11-12
• Results First Posted: 2010-12-10
• Status Verified: 2022-07
• Last Update Submitted: 2022-08-16
• Last Update Posted: 2022-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

• Osteoarthritis
• Rheumatoid Arthritis
• Other inflammatory arthritis
• Avascular necrosis of bone

Exclusion Criteria

• Prior ipsilateral TKA
• Metabolic disorders
• Joint replacement due to autoimmune disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Total knee replacement	P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System
1	Total knee replacement	P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System

Primary Outcome Measures

Name	Time	Method
Knee Society Scores	Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.	The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. For each section, a score of 80-100 = excellent, 70-79 = good; 60-69 = fair; and \< 60 = poor.

Secondary Outcome Measures

Name	Time	Method
Complications/Revisions	On-going to end of study.
SF-12 Patient Outcomes	Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.
Medical Imaging	Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.