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Tourniquet vs. no Tourniquet During High Tibial Osteotomy

Primary Purpose

Knee Osteoarthritis

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Long-duration tourniquet
Short-duration tourniquet
Sponsored by
Qilu Hospital of Shandong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Qilu hospital of Shandong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Long-duration tourniquet

Short-duration tourniquet

Arm Description

Tourniquets inflated before arthroscopic exploration and deflated after high tibial osteotomy

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

Outcomes

Primary Outcome Measures

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
Postoperative blood loss
Total blood loss preoperative blood volume =(preoperative hematocrit-postoperative Hematocrit) + transfusion volume.
Volume of drainage
Reactive blood loss
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
July 28, 2021
Last Updated
July 28, 2021
Sponsor
Qilu Hospital of Shandong University
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1. Study Identification

Unique Protocol Identification Number
NCT04992533
Brief Title
Tourniquet vs. no Tourniquet During High Tibial Osteotomy
Official Title
Tourniquet vs. no Tourniquet During High Tibial Osteotomy：A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 30, 2019 (Actual)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qilu Hospital of Shandong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Long-duration tourniquet
Arm Type
Active Comparator
Arm Description
Tourniquets inflated before arthroscopic exploration and deflated after high tibial osteotomy
Arm Title
Short-duration tourniquet
Arm Type
Experimental
Arm Description
Tourniquet should be inflated before arthroscopic exploration and deflated immediately after the exploration
Intervention Type
Procedure
Intervention Name(s)
Long-duration tourniquet
Intervention Description
Tourniquet is used in arthroscopic exploration and high tibial osteotomy
Intervention Type
Procedure
Intervention Name(s)
Short-duration tourniquet
Intervention Description
Tourniquet is only used for arthroscopic exploration
Primary Outcome Measure Information:
Title
Intraoperative blood loss
Description
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
Time Frame
within operation
Title
Postoperative blood loss
Description
Total blood loss preoperative blood volume =(preoperative hematocrit-postoperative Hematocrit) + transfusion volume.
Time Frame
The third day after operation
Title
Volume of drainage
Description
Reactive blood loss
Time Frame
Postoperative Day One
Title
Thigh pain measured by Visual Analogue Scale Postoperative Day 1
Description
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.
Time Frame
1 day after surgery
Title
Thigh pain measured by Visual Analogue Scale Postoperative Day 2
Description
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.
Time Frame
2 day after surgery
Title
Thigh pain measured by Visual Analogue Scale Postoperative Day 3
Description
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.
Time Frame
3 day after surgery
Title
Thigh pain measured by Visual Analogue Scale Postoperative Day 5
Description
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.
Time Frame
5 day after surgery
Title
Thigh pain measured by Visual Analogue Scale Postoperative Week 1
Description
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.
Time Frame
1 week after surgery
Title
Thigh pain measured by Visual Analogue Scale Postoperative Week 4
Description
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.
Time Frame
4 week after surgery
Title
Thigh pain measured by Visual Analogue Scale Postoperative Week 12
Description
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.
Time Frame
12 week after surgery
Title
Crus pain measured by Visual Analogue Scale Postoperative Day 1
Description
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.
Time Frame
1 day after surgery
Title
Crus pain measured by Visual Analogue Scale Postoperative Day 2
Description
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.
Time Frame
2 day after surgery
Title
Crus pain measured by Visual Analogue Scale Postoperative Day 3
Description
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.
Time Frame
3 day after surgery
Title
Crus pain measured by Visual Analogue Scale Postoperative Day 5
Description
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.
Time Frame
5 day after surgery
Title
Crus pain measured by Visual Analogue Scale Postoperative Week 1
Description
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.
Time Frame
1 week after surgery
Title
Crus pain measured by Visual Analogue Scale Postoperative Week 4
Description
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.
Time Frame
4 week after surgery
Title
Crus pain measured by Visual Analogue Scale Postoperative Week 12
Description
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.
Time Frame
12 week after surgery

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Songlin Li, MD
Phone
053182166541
Email
bysonglin@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Peilai Liu, MD
Phone
053182166541
Email
gklpl@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peilai Liu, MD
Organizational Affiliation
Qilu Hospital of Shandong University
Official's Role
Study Chair
Facility Information:
Facility Name
Qilu hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250014
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
songlin Li, MD
Phone
15634057227
Email
bysonglin@126.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The datasets used and/or analysed during the current study are available from the overall study officials on reasonable request.
Citations:
PubMed Identifier
31626006
Citation
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.
Results Reference
background
PubMed Identifier
30539303
Citation
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.
Results Reference
background
PubMed Identifier
26745962
Citation
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.
Results Reference
background

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Tourniquet vs. no Tourniquet During High Tibial Osteotomy

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