Skip to main content
Clinical Trials/NCT04992533
NCT04992533
Unknown
Not Applicable

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

Qilu Hospital of Shandong University1 site in 1 country50 target enrollmentNovember 30, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Knee Osteoarthritis
Sponsor
Qilu Hospital of Shandong University
Enrollment
50
Locations
1
Primary Endpoint
Thigh pain measured by Visual Analogue Scale Postoperative Week 4
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 30, 2019
End Date
December 30, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 1.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

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

Outcomes

Primary Outcomes

Thigh pain measured by Visual Analogue Scale Postoperative Week 4

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: The third day after operation

Total blood loss preoperative blood volume =(preoperative hematocrit-postoperative Hematocrit) + transfusion volume.

Volume of drainage

Time Frame: Postoperative Day One

Reactive blood loss

Thigh pain measured by Visual Analogue Scale Postoperative Day 1

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Study Sites (1)

Loading locations...

Similar Trials