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

Ewha Womans University

Status and phase: Completed; Phase 4

Conditions: Osteoarthritis

Treatments: Device: Cobalt-Chrome (Cobalt Chrome Genesis II); Device: Zirconium (Zirconium Genesis II)

Study type: Interventional

Funder types: Other

Identifiers

NCT01336595

TKRzirconium

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 331 patients

Sex: All

Ages: 30 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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331 participants in 2 patient groups

Zirconium Femoral Component

Experimental group

Description:

Oxidized zirconium femoral component of Genesis II TKR system is used.

Treatment:

Device: Zirconium (Zirconium Genesis II)

Cobalt Chrome

Active Comparator group

Description:

Cobalt-Chromium Femoral component of Genesis II system is used.

Treatment:

Device: Cobalt-Chrome (Cobalt Chrome Genesis II)