Tourniquet vs. no Tourniquet During High Tibial Osteotomy

Study Overview
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Brief Summary
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The purpose of this study is to correlate functional outcomes and perioperative complications with tourniquet use during high tibial osteotomy.

Detailed Description
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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.

Official Title
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Tourniquet vs. no Tourniquet During High Tibial Osteotomy：A Randomized Controlled Trial

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Procedure: Long-duration tourniquet
* Procedure: Short-duration tourniquet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1.Simple knee medial compartment osteoarthritis High tibial osteotomy. 2. With varus deformity, medial proximal tibia angle <85° 3. Unilateral High tibial osteotomy 4. Informed consent: Participants must be able to understand and voluntarily sign a written informed consent and follow the research protocol and interview process Exclusion Criteria: 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Long-duration tourniquet<br>Tourniquets inflated before arthroscopic exploration and deflated after high tibial osteotomy | Procedure: Long-duration tourniquet<br>* Tourniquet is used in arthroscopic exploration and high tibial osteotomy<br>|
| Experimental: Short-duration tourniquet<br>Tourniquet should be inflated before arthroscopic exploration and deflated immediately after the exploration | Procedure: Short-duration tourniquet<br>* Tourniquet is only used for arthroscopic exploration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative blood loss | 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 | within operation | 
| Postoperative blood loss | Total blood loss preoperative blood volume =(preoperative hematocrit-postoperative Hematocrit) + transfusion volume. | The third day after operation | 
| Volume of drainage | Reactive blood loss | Postoperative Day One | 
| Thigh pain measured by Visual Analogue Scale Postoperative Day 1 | 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. | 1 day after surgery | 
| Thigh pain measured by Visual Analogue Scale Postoperative Day 2 | 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. | 2 day after surgery | 
| Thigh pain measured by Visual Analogue Scale Postoperative Day 3 | 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. | 3 day after surgery | 
| Thigh pain measured by Visual Analogue Scale Postoperative Day 5 | 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. | 5 day after surgery | 
| Thigh pain measured by Visual Analogue Scale Postoperative Week 1 | 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. | 1 week after surgery | 
| Thigh pain measured by Visual Analogue Scale Postoperative Week 4 | 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. | 4 week after surgery | 
| Thigh pain measured by Visual Analogue Scale Postoperative Week 12 | 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. | 12 week after surgery | 
| Crus pain measured by Visual Analogue Scale Postoperative Day 1 | 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. | 1 day after surgery | 
| Crus pain measured by Visual Analogue Scale Postoperative Day 2 | 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. | 2 day after surgery | 
| Crus pain measured by Visual Analogue Scale Postoperative Day 3 | 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. | 3 day after surgery | 
| Crus pain measured by Visual Analogue Scale Postoperative Day 5 | 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. | 5 day after surgery | 
| Crus pain measured by Visual Analogue Scale Postoperative Week 1 | 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. | 1 week after surgery | 
| Crus pain measured by Visual Analogue Scale Postoperative Week 4 | 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. | 4 week after surgery | 
| Crus pain measured by Visual Analogue Scale Postoperative Week 12 | 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. | 12 week after surgery |