NCT01488175撤回4 期
Clinical and Stereoradiological Comparison of the Results After Primary TKA Inserted With or Without the Use of a Tourniquet
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- migration of the prosthesis in millimeters assessed vith RSA.
研究概览
简要总结
The purpose of this study is to investigate if the use of a tourniquet during insertion of a cemented primary total knee arthroplasty will influence clinical and radiological (measured with RSA X-ray technique) outcome.
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis og osteoarthritis of the knee
- •patients must be 18 years or older
- •patients must understand and speak danish
- •must be able to give signed consent
排除标准
- •severe medical illness
- •documented osteoporosis
- •rheumatoid arthritis
- •prior surgery in the knee
- •neuropathy
研究组 & 干预措施
without tourniquet
Placebo Comparator
干预措施: no tourniquet (Procedure)
with tourniquet
Active Comparator
干预措施: tourniquet (Procedure)
结局指标
主要结局
migration of the prosthesis in millimeters assessed vith RSA.
时间窗: 2 years
does the use of a tourniquet around the thigh during insertion of a primary TKA affect postoperative migration of the prosthesis?
次要结局
- postoperative pain.(2 years)
- Patient satisfaction (VAS-scale)(2 years)
- Knee range of motion (degrees)(2 years)
研究者
Morten Grove Thomsen
Principal Investigator
Hvidovre University Hospital
研究点 (1)
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