Tourniquet vs. no Tourniquet During High Tibial Osteotomy

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

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

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Procedure: Long-duration tourniquet; Procedure: Short-duration tourniquet

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Peilai Liu, MD; Phone Number: 053182166541; Email: gklpl@163.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250014
      • Recruiting
      • Qilu Hospital of Shandong University
      • Contact: songlin Li, MD; Phone Number: 15634057227; Email: bysonglin@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Long-duration tourniquet; Tourniquets inflated before arthroscopic exploration and deflated after high tibial osteotomy	Procedure: Long-duration tourniquet; Tourniquet is used in arthroscopic exploration and high tibial osteotomy
EXPERIMENTAL: Short-duration tourniquet; Tourniquet should be inflated before arthroscopic exploration and deflated immediately after the exploration	Procedure: Short-duration tourniquet; Tourniquet is only used for arthroscopic exploration

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University

Publications and helpful links

General Publications

• Goel R, Rondon AJ, Sydnor K, Blevins K, O'Malley M, Purtill JJ, Austin MS. Tourniquet Use Does Not Affect Functional Outcomes or Pain After Total Knee Arthroplasty: A Prospective, Double-Blinded, Randomized Controlled Trial. J Bone Joint Surg Am. 2019 Oct 16;101(20):1821-1828. doi: 10.2106/JBJS.19.00146.
• Jawhar A, Stetzelberger V, Kollowa K, Obertacke U. Tourniquet application does not affect the periprosthetic bone cement penetration in total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2019 Jul;27(7):2071-2081. doi: 10.1007/s00167-018-5330-7. Epub 2018 Dec 11.
• Wang K, Ni S, Li Z, Zhong Q, Li R, Li H, Ke Y, Lin J. The effects of tourniquet use in total knee arthroplasty: a randomized, controlled trial. Knee Surg Sports Traumatol Arthrosc. 2017 Sep;25(9):2849-2857. doi: 10.1007/s00167-015-3964-2. Epub 2016 Jan 8.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 30, 2019
• Primary Completion (ANTICIPATED): December 30, 2021
• Study Completion (ANTICIPATED): December 30, 2021

Study Registration Dates

• First Submitted: July 28, 2021
• First Submitted That Met QC Criteria: July 28, 2021
• First Posted (ACTUAL): August 5, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 5, 2021
• Last Update Submitted That Met QC Criteria: July 28, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Respiratory System Agents; Sympathomimetics; Vasoconstrictor Agents; Nasal Decongestants; Oxymetazoline
• Other Study ID Numbers: Qilu200326

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The datasets used and/or analysed during the current study are available from the overall study officials on reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No