Does Tourniquet Use in Total Knee Replacement Improve Fixation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- View protocol record
研究概览
简要总结
Although a tourniquet may reduce bleeding during total knee replacement (TKA), and thereby improve fixation, it might also cause complications. Migration as measured by RadioStereometric Analysis (RSA) can predict future loosening. We will investigate if the use of a tourniquet influences fixation measured with RSA.
详细描述
The use of a tourniquet during total knee replacement (TKA) is a generally accepted routine at many departments. It is thought to facilitate dissection and reduce peroperative bleeding, but the main argument for its use is that bleeding bone surfaces might impair the fixation of cemented prostheses, because of less cement penetration.
We investigate in a RCT 50 patient with radiostereometric analysis, where 25 is randomized to a tourniquet during the hole operation and 25 are not.
Primary outcome is MTPM, a meassure of migration(loosening) of the kneeprosthesis.
Secondary outcomes are total bleeeding, pain, range of motion and outcome of a patient self assesed knee score (KOOS) Total follow up time 2 years
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
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary or secondary osteoarthritis without other severe disease (ASA 1-2).
排除标准
- •were inability to give informed consent,
- •rheumatic arthritis,
- •malignancy,
- •coagulation disorder or medical treatment influencing the coagulation,
- •liver disease,
- •severe heart disease or bilateral operation.
结局指标
主要结局
View protocol record
时间窗: 2 years
Measures the migration of the knee prosthesis
次要结局
- View Protocol Record(2 years)
研究者
Per Aspenberg
Professor
University Hospital, Linkoeping