MedPath

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

Phase 4
Completed
Conditions
Osteoarthritis
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.

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
Primary Outcome Measures
NameTimeMethod
Knee Society knee scoreat 3 months, 1 year, than annually
Secondary Outcome Measures
NameTimeMethod
Range of motionat 3 months, 1 year, than annually

Trial Locations

Locations (1)

Ewha Womans University Mokdong Hospital

🇰🇷

Seoul, Korea, Republic of

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

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