Tourniquet vs. no Tourniquet During High Tibial Osteotomy

Not Applicable

• Conditions: Knee Osteoarthritis
• Interventions: Procedure: Short-duration tourniquet; Procedure: Long-duration tourniquet

• Registration Number: NCT04992533
• Lead Sponsor: Qilu Hospital of Shandong University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2019-11-30
• Status Verified: 2021-03
• Study First Submitted: 2021-07-28
• Study First Submitted QC: 2021-07-28
• Last Update Submitted: 2021-07-28
• Study First Posted: 2021-08-05
• Last Update Posted: 2021-08-05
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Short-duration tourniquet	Short-duration tourniquet	Tourniquet should be inflated before arthroscopic exploration and deflated immediately after the exploration
Long-duration tourniquet	Long-duration tourniquet	Tourniquets inflated before arthroscopic exploration and deflated after high tibial osteotomy

Primary Outcome Measures

Name	Time	Method
Thigh pain measured by Visual Analogue Scale Postoperative Week 4	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	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	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	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	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	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	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	The third day after operation	Total blood loss preoperative blood volume =(preoperative hematocrit-postoperative Hematocrit) + transfusion volume.
Volume of drainage	Postoperative Day One	Reactive blood loss
Thigh pain measured by Visual Analogue Scale Postoperative Day 1	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	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	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	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	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	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	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	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.

Trial Locations

Locations (1)

Qilu hospital of Shandong University; 🇨🇳 Jinan, Shandong, China