Tourniquet vs. no Tourniquet During High Tibial Osteotomy：A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Thigh pain measured by Visual Analogue Scale Postoperative Week 4
研究概览
简要总结
The purpose of this study is to correlate functional outcomes and perioperative complications with tourniquet use during high tibial osteotomy.
详细描述
Tourniquet is widely used in orthopedic surgery, but its effect and safety in high tibial osteotomy have not been studied. This study evaluated the efficacy and safety of tourniquets by comparing different timing of 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.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Simple knee medial compartment osteoarthritis High tibial osteotomy.
- •With varus deformity, medial proximal tibia angle <85°
- •Unilateral High tibial osteotomy
- •Informed consent: Participants must be able to understand and voluntarily sign a written informed consent and follow the research protocol and interview process
排除标准
- •1.Patients who underwent other knee surgery within 6 months
- •2.Preoperative combined anemia (Hb<100g/l)
- •3.Patients with severe cardiovascular, hepatic, renal and hematopoietic diseases
结局指标
主要结局
Thigh pain measured by Visual Analogue Scale Postoperative Week 4
时间窗: 4 week after surgery
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Thigh pain measured by Visual Analogue Scale Postoperative Week 12
时间窗: 12 week after surgery
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Crus pain measured by Visual Analogue Scale Postoperative Day 1
时间窗: 1 day after surgery
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Crus pain measured by Visual Analogue Scale Postoperative Day 2
时间窗: 2 day after surgery
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Crus pain measured by Visual Analogue Scale Postoperative Day 3
时间窗: 3 day after surgery
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Crus pain measured by Visual Analogue Scale Postoperative Day 5
时间窗: 5 day after surgery
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Intraoperative blood loss
时间窗: within operation
The calculation of intraoperative blood loss includes the fluid in the aspirator bottle minus the flushing fluid used in the operation, plus the net weight added by the gauze pad weighing
Postoperative blood loss
时间窗: The third day after operation
Total blood loss preoperative blood volume =(preoperative hematocrit-postoperative Hematocrit) + transfusion volume.
Volume of drainage
时间窗: Postoperative Day One
Reactive blood loss
Thigh pain measured by Visual Analogue Scale Postoperative Day 1
时间窗: 1 day after surgery
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Thigh pain measured by Visual Analogue Scale Postoperative Day 2
时间窗: 2 day after surgery
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Thigh pain measured by Visual Analogue Scale Postoperative Day 3
时间窗: 3 day after surgery
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Thigh pain measured by Visual Analogue Scale Postoperative Day 5
时间窗: 5 day after surgery
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Thigh pain measured by Visual Analogue Scale Postoperative Week 1
时间窗: 1 week after surgery
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Crus pain measured by Visual Analogue Scale Postoperative Week 1
时间窗: 1 week after surgery
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Crus pain measured by Visual Analogue Scale Postoperative Week 4
时间窗: 4 week after surgery
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Crus pain measured by Visual Analogue Scale Postoperative Week 12
时间窗: 12 week after surgery
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
次要结局
未报告次要终点