Tourniquet vs. no Tourniquet During High Tibial Osteotomy

NCT04992533 | Unknown

• 1 other identifier: Qilu200326
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (17)

• 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

Study Arms (2)

Long-duration tourniquet

ACTIVE COMPARATOR

Tourniquets inflated before arthroscopic exploration and deflated after high tibial osteotomy

Procedure: Long-duration tourniquet

Short-duration tourniquet

EXPERIMENTAL

Tourniquet should be inflated before arthroscopic exploration and deflated immediately after the exploration

Procedure: Short-duration tourniquet

Interventions

Long-duration tourniquet PROCEDURE

Tourniquet is used in arthroscopic exploration and high tibial osteotomy

Long-duration tourniquet

Short-duration tourniquet PROCEDURE

Tourniquet is only used for arthroscopic exploration

Short-duration tourniquet

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients who underwent other knee surgery within 6 months
• Preoperative combined anemia (Hb\<100g/l)
• Patients with severe cardiovascular, hepatic, renal and hematopoietic diseases

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu hospital of Shandong University

Jinan, Shandong, 250014, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 31626006 BACKGROUND

• 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.

  PMID: 30539303 BACKGROUND

• 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.

  PMID: 26745962 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Peilai Liu, MD

  Qilu Hospital of Shandong University

  STUDY CHAIR

Central Study Contacts

Songlin Li, MD

CONTACT

053182166541; bysonglin@126.com

Peilai Liu, MD

CONTACT

053182166541; gklpl@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: August 5, 2021
• Study Start: November 30, 2019
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: August 5, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)