Tourniquet vs. no Tourniquet During High Tibial Osteotomy：A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Thigh pain measured by Visual Analogue Scale Postoperative Week 4
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Secondary Outcomes
No secondary outcomes reported