The Effects of Tourniquet Use in Total Knee Arthroplasty: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Intraoperative blood loss
研究概览
简要总结
Tourniquets are still widely used in total knee arthroplasty, but are associated with several adverse effects. Most of previous studies did not randomize the participants so the baseline difference of the patients might have influenced the outcome. Therefore, investigators conducted a randomized controlled trial, in which all the patients received staged bilateral TKA with two different durations of tourniquet use. Investigators aimed to quantify the effect of tourniquet use on reducing blood loss and to evaluate the impact of tourniquet use on functional and clinical outcome.
详细描述
Fifty participants who underwent staged bilateral TKA were recruited in this study. On one side, the tourniquet was inflated immediately before incision and deflated after the hardening of the cement. On the other side the tourniquet was inflated immediately before cement application and deflated after its hardening. Blood loss, operating time, transfusion rate, postoperative pain, limb swelling, deep vein thrombosis (DVT) incidence and clinical outcomes were monitored for comparison.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged 50 years or over
- •classified as American Society of Anesthesiologists ASA 1-2.
排除标准
- •coagulopathy,
- •uncontrolled hypertension,
- •peripheral vascular disease and
- •patients with BMI≥35
结局指标
主要结局
Intraoperative blood loss
时间窗: within operation
次要结局
- Thigh pain measured by Visual Analogue Scale/Score (VAS)(1 day, 2 day, 1 week, 2 week and 6 week after surgery)
- Thigh swelling measured by circumference 10 cm proximal to the patella(1 day, 2 day, 1week, 2 week and 6 week after surgery)
- Postoperative blood loss measured by drainage volume(1 day and 2 day after surgery)
研究者
Wang Kai
resident
Peking University People's Hospital