Long-Term Comparison of Fixed- and Mobile-Bearing Total Knee Arthroplasties in Patients With Osteoarthritis Younger Than Fifty Years of Age
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 216
- 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 the prospective study was to evaluate the minimum fifteen year follow-up of prospective total knee arthroplasties performed in patients younger than fifty years of age with osteoarthritis, using fixed- and mobile-bearing knee prostheses in the same patients, to compare
- functional scores
- rates of radiographic failure
- revision rates
- survivorship
详细描述
The randomized prospective comparison of fixed- and mobile-bearing total knee designs in the same patients younger than fifty years of age is limited. The purpose of this study was to compare the long-term clinical and radiographic results of fixed- and mobile-bearing total knee arthroplasties in patients younger than fifty years of age with osteoarthritis.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 29 Years 至 50 Years（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
研究组 & 干预措施
Fixed-bearing group
Fixed-bearing group
干预措施: anatomic modular fixed-bearing (Device)
Mobile-bearing group
Mobile-bearing group
干预措施: low contact stress rotating platform mobile-bearing (Device)
结局指标
主要结局
Improvement in Knee Society Knee Score
时间窗: 18 years
change in knee score will be compared with initial score, until follow up of 18 years
次要结局
- Improvement in the range of motion(18 years)
研究者
Young Hoo Kim
Professor and Director
Ewha Womans University