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
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Ewha Womans University
- Enrollment
- 331
- Locations
- 1
- Primary Endpoint
- Improvement in Knee Society Knee Score
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Zirconium Femoral Component
Oxidized zirconium femoral component of Genesis II TKR system is used.
Intervention: Zirconium (Zirconium Genesis II) (Device)
Cobalt Chrome
Cobalt-Chromium Femoral component of Genesis II system is used.
Intervention: Cobalt-Chrome (Cobalt Chrome Genesis II) (Device)
Outcomes
Primary Outcomes
Improvement in Knee Society Knee Score
Time Frame: 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 Outcomes
- Improvement in the range of motion(Initial(one day before surgery), and at 3 months, 1 year, then annually after surgery)
Investigators
Young Hoo Kim
Professor and Director
Ewha Womans University