A Randomized Clinical Trial of Static Versus Articulating Antibiotic Spacer for Treatment of Periprosthetic Joint Infection in Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Number of Subjects With Repeat Infections
研究概览
简要总结
The primary aim of the study is to compare two techniques for treatment of total knee infection: resection total knee arthroplasty with an articulating (motion in the joint) spacer and resection total knee arthroplasty with a static (no motion in the joint) spacer.
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
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of Subjects With Repeat Infections
时间窗: 1 year post-operatively
The rate of repeat infections after re-implantation Total Knee Arthroplasty.
Change in Total Knee Replacement Functional Scores
时间窗: baseline, 1 year post-operatively
Functional scores were measured using the Knee Society Score, a clinical standard for rating the outcome of total knee replacements. Scores range from 0 -100, where a higher score reflects a more positive outcome for the subject.
次要结局
- Pre-operative Range of Motion (ROM)(baseline)
- Post-operative Range of Motion (ROM)(1 year post-operatively)
研究者
Michael J. Taunton, M.D.
Assistant Professor of Orthopedics, College of Medicine
Mayo Clinic