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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 331
- 试验地点
- 1
- 主要终点
- Improvement in Knee Society Knee Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •End-stage osteoarthritis of the knee joint requiring total knee arthroplasty with bilateral disease
排除标准
- •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
结局指标
主要结局
Improvement in Knee Society Knee Score
时间窗: 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.
次要结局
- Improvement in the range of motion(Initial(one day before surgery), and at 3 months, 1 year, then annually after surgery)
研究者
Young Hoo Kim
Professor and Director
Ewha Womans University