Effect of Tourniquet Application on Postoperative Functional Outcome Following Total Knee Arthroplasty; a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 99
- 试验地点
- 2
- 主要终点
- Knee Injury and Osteoarthritis Score (KOOS) questionnaire
研究概览
简要总结
A pneumatic tourniquet is often used during total knee arthroplasty. However, its effect on postoperative outcomes as soft tissue damage resulting in delayed recovery remains unclear. The purpose of the present study was to compare tourniquet use versus non-tourniquet use during total knee arthroplasty for short-term functional recovery.
详细描述
In a prospective cohort design, consecutive series of patients who underwent primary unilateral total knee arthroplasty (TKA) in the Bergman Clinic, the Netherlands were investigated. Patients scheduled for primary TKA due to osteoarthritis, age between 50 and 75 years and with Dutch language proficiency were eligible for inclusion. Exclusion criteria were inflammatory arthritis, severe cardiac complaints, severe pulmonary disorders, Body Mass Index (BMI) >35, severe coagulation disorders or hospitalization in the previous two months before surgery. Each patient included in the study signed informed consent. The research protocol was approved by the Regional Ethics Committee VCMO in Nieuwegein, the Netherlands, registration number W13.022.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled TKA due to osteoarthritis
- •Age between 50 and 75 years
- •Dutch language proficiency
- •Signed informed consent
排除标准
- •Inflammatory arthritis
- •Severe cardiac complaints
- •Severe pulmonary disorders
- •Body Mass Index >35
- •Severe coagulation disorders
- •Hospitalization in the previous two months before surgery
结局指标
主要结局
Knee Injury and Osteoarthritis Score (KOOS) questionnaire
时间窗: 8 weeks
The KOOS questionnaire was used to assess the functional outcome. Changes were evaluated from baseline at 8 weeks.
次要结局
- Range of Motion (ROM)(Baseline, day 1, day 2, day 3 and 8 weeks)
- Isometric bilateral strength(Baseline and 8 weeks)
- VAS questionnaire.(Baseline, day 1, day 2, day 3 and 8 weeks)
- EQ-5D questionnaire(Baseline, day 1, day 2, day 3 and 8 weeks)