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

Study Overview
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Brief Summary
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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 functional scores rates of radiographic failure revision rates survivorship

Detailed Description
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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.

Official Title
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Long-Term Comparison of Fixed- and Mobile-Bearing Total Knee Arthroplasties in Patients With Osteoarthritis Younger Than Fifty Years of Age

Conditions
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Osteoarthritis

Intervention / Treatment
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* Device: anatomic modular fixed-bearing
* Device: low contact stress rotating platform mobile-bearing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 29 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fixed-bearing group<br>Fixed-bearing group | Device: anatomic modular fixed-bearing<br>* anatomic modular (AMK; DePuy) fixed-bearing prosthesis<br>* Other names: AMK;|
| Experimental: Mobile-bearing group<br>Mobile-bearing group | Device: low contact stress rotating platform mobile-bearing<br>* low contact stress rotating platform (LCS RP; DePuy) mobile-bearing prosthesis<br>* Other names: LCS RP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Knee Society Knee Score | change in knee score will be compared with initial score, until follow up of 18 years | 18 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in the range of motion | change in the range of motion of knee joint will be compared with the initial value, until follow up of 18 years. | 18 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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total knee arthroplasty, fixed-bearing, mobile-bearing, long-term