Long-Term Comparison of Fixed- and Mobile-Bearing Total Knee Arthroplasties (TKAs) in Patients With OA ≤50 Years Old

Phase 4

Completed

• Conditions: Osteoarthritis
• Interventions: Device: anatomic modular fixed-bearing; Device: low contact stress rotating platform mobile-bearing

• Registration Number: NCT01361152
• Lead Sponsor: Ewha Womans University

Brief Summary

The purpose of the prospective study was to evaluate the minimum fifteen year follow-up of prospective total knee arthroplasties performed in patients younger than fifty years of age with osteoarthritis, using fixed- and mobile-bearing knee prostheses in the same patients, to compare

1. functional scores

2. rates of radiographic failure

3. revision rates

4. survivorship

Detailed Description

The randomized prospective comparison of fixed- and mobile-bearing total knee designs in the same patients younger than fifty years of age is limited. The purpose of this study was to compare the long-term clinical and radiographic results of fixed- and mobile-bearing total knee arthroplasties in patients younger than fifty years of age with osteoarthritis.

Study Timeline

• Study Start: 1993-04
• Primary Completion: 1996-03
• Study Completion: 2011-03
• Study First Submitted: 2011-05-17
• Study First Submitted QC: 2011-05-25
• Study First Posted: 2011-05-26
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-04
• Last Update Posted: 2011-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 216

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
Fixed-bearing group	anatomic modular fixed-bearing	Fixed-bearing group
Mobile-bearing group	low contact stress rotating platform mobile-bearing	Mobile-bearing group

Primary Outcome Measures

Name	Time	Method
Improvement in Knee Society Knee Score	18 years	change in knee score will be compared with initial score, until follow up of 18 years

Secondary Outcome Measures

Name	Time	Method
Improvement in the range of motion	18 years	change in the range of motion of knee joint will be compared with the initial value, until follow up of 18 years.

Trial Locations

Locations (1)

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