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

Phase 4

Completed

• Conditions: Osteoarthritis
• Interventions: Device: Zirconium (Zirconium Genesis II); Device: Cobalt-Chrome (Cobalt Chrome Genesis II)

• Registration Number: NCT01336595
• Lead Sponsor: Ewha Womans University

Brief Summary

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

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.

Study Timeline

• Study Start: 2003-01
• Primary Completion: 2004-03
• Study Completion: 2011-04
• Study First Submitted: 2011-04-14
• Study First Submitted QC: 2011-04-15
• Study First Posted: 2011-04-18
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-04
• Last Update Posted: 2011-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 331

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
Zirconium Femoral Component	Zirconium (Zirconium Genesis II)	Oxidized zirconium femoral component of Genesis II TKR system is used.
Cobalt Chrome	Cobalt-Chrome (Cobalt Chrome Genesis II)	Cobalt-Chromium Femoral component of Genesis II system is used.

Primary Outcome Measures

Name	Time	Method
Improvement in Knee Society Knee Score	Initial(one day before surgery), and at 3 months, 1 year, then annually after surgery	change in knee score will be compared with initial score, until mean follow up of 20 years.

Secondary Outcome Measures

Name	Time	Method
Improvement in the range of motion	Initial(one day before surgery), and at 3 months, 1 year, then annually after surgery	change in the range of motion of knee joint will be compared with the initial value, until mean follow up of 20 years.

Trial Locations

Locations (1)

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