Comparison of Nonposterior- and Posterior-Stabilized Mobile-Bearing Total Knee Arthroplasty

Phase 4

Completed

• Conditions: Osteoarthritis
• Interventions: Device: PFC-Sigma RP; Device: LPS RP

• Registration Number: NCT01075620
• Lead Sponsor: Ewha Womans University

Brief Summary

The purpose of this study is to determine if there are any clinical or radiographic differences in non-posterior stabilized rotating mobile bearing design versus a posterior stabilized rotating mobile bearing designs.

Detailed Description

Out comes measures were to determine

1. whether the knee and function scores and the radiographic results of the knees with a PFC Sigma RP knee prosthesis would be better than those with an LCS RP prosthesis.

2. whether the patients with a PFC RP knee prosthesis would have a better range of knee motion than those with an LCS RP prosthesis.

3. whether patient satisfaction and preference would be better in the patients having a PFC Sigma RP knee prosthesis than those of patients having an LCS RP knee prosthesis

4. whether complication rate would be less in the knees with a PFC sigma RP knee prosthesis than in the knees with an LCS RP prosthesis.

Study Timeline

• Study Start: 2002-05
• Primary Completion: 2002-12
• Status Verified: 2010-01
• Study Completion: 2010-01
• Study First Submitted: 2010-02-16
• Study First Submitted QC: 2010-02-24
• Last Update Submitted: 2010-02-24
• Study First Posted: 2010-02-25
• Last Update Posted: 2010-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

• End-stage osteoarthritis of the knee joint requiring total knee arthroplasty with bilateral disease

Exclusion Criteria

• Inflammatory disease
• patient with other Lower extremity disease which may affect functional outcome
• Neurologic disease effecting patients lower extremity
• Revision surgery
• Patient not medically cleared for bilateral surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PFC sigma RP	PFC-Sigma RP	Posterior stabilized rotating platform knee (press Fit Condylar Sigma rotating-platform, Depuy, Warsaw, Indiana)
LCS RP	LPS RP	non posterior stabilized Low Contact Stress Rotating-Platform; Depuy, Warsaw, Indiana

Primary Outcome Measures

Name	Time	Method
Knee Society knee score	at 3 months, 1 year, than annually

Secondary Outcome Measures

Name	Time	Method
Range of motion	at 3 months, 1 year, than annually

Trial Locations

Locations (1)

Ewha Womans University Mokdong Hospital; 🇰🇷 Seoul, Korea, Republic of