NCT01075620已完成4 期
Comparison of Nonposterior- and Posterior-Stabilized Mobile-Bearing Total Knee Arthroplasty A Prospective, Randomized Study
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- 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 non-posterior stabilized rotating mobile bearing design versus a posterior stabilized rotating mobile bearing designs.
详细描述
Out comes measures were to determine
- whether the knee and function scores and the radiographic results of the knees with a PFC Sigma RP knee prosthesis would be better than those with an LCS RP prosthesis.
- whether the patients with a PFC RP knee prosthesis would have a better range of knee motion than those with an LCS RP prosthesis.
- whether patient satisfaction and preference would be better in the patients having a PFC Sigma RP knee prosthesis than those of patients having an LCS RP knee prosthesis
- whether complication rate would be less in the knees with a PFC sigma RP knee prosthesis than in the knees with an LCS RP prosthesis.
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
Knee Society knee score
时间窗: at 3 months, 1 year, than annually
次要结局
- Range of motion(at 3 months, 1 year, than annually)
研究者
研究点 (1)
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