NCT01336595

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 331 (actual)
• Sponsor: Ewha Womans University · Academic / Other
• Sex: All
• Age: 30 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DEVICE	Zirconium (Zirconium Genesis II)	Oxidized Zirconium femoral component of Genesis II TKR system is used.
DEVICE	Cobalt-Chrome (Cobalt Chrome Genesis II)	Cobalt Chrome Femoral Component of Genesis II TKR system is used

Timeline

• Start date: 2003-01-01
• Primary completion: 2004-03-01
• Completion: 2011-04-01
• First posted: 2011-04-18
• Last updated: 2011-10-05

Locations

1 site across 1 country: South Korea