Comparison of Total Knee Arthroplasties With Oxidized Zirconium and Cobalt Chromium Femoral Components

Study Overview
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Brief Summary
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The purpose of this study is to determine if there are any clinical or radiographic differences in cemented total knee arthroplasty with an oxidized zirconium and a cobalt-chromium femoral knee component.

Detailed Description
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Although it has been claimed that total knee arthroplasties with an oxidized zirconium femoral knee component had beneficial wear properties in vitro, there are conflicting clinical results. The purpose of the present study was to compare the clinical, subjective, and radiographic results as well as the weight, size and shape of polyethylene wear particles in the patients with an oxidized zirconium and a cobalt-chromium femoral knee component.

Official Title
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Comparison of Total Knee Arthroplasties With Oxidized Zirconium and Cobalt Chromium Femoral Components in the Same Patients: A Prospective, Double Blinded, and Randomized Controlled Study

Conditions
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Osteoarthritis

Intervention / Treatment
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* Device: Zirconium (Zirconium Genesis II)
* Device: Cobalt-Chrome (Cobalt Chrome Genesis II)


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: 30 Years
Maximum Age: 90 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: Zirconium Femoral Component<br>Oxidized zirconium femoral component of Genesis II TKR system is used. | Device: Zirconium (Zirconium Genesis II)<br>* Oxidized Zirconium femoral component of Genesis II TKR system is used.<br>* Other names: Zirconium Genesis II;|
| Active Comparator: Cobalt Chrome<br>Cobalt-Chromium Femoral component of Genesis II system is used. | Device: Cobalt-Chrome (Cobalt Chrome Genesis II)<br>* Cobalt Chrome Femoral Component of Genesis II TKR system is used<br>* Other names: Cobalt Chrome Genesis II;|

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 mean follow up of 20 years. | Initial(one day before surgery), and at 3 months, 1 year, then annually after surgery | 

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 mean follow up of 20 years. | Initial(one day before surgery), and at 3 months, 1 year, then annually after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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total knee arthroplasty, oxidized zirconium, genesis II, femoral component, cobalt chrome