Knee Osteoarthritis
Conditions
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.
Interventions
PROCEDURELong-duration tourniquet
Tourniquet is used in arthroscopic exploration and high tibial osteotomy
PROCEDUREShort-duration tourniquet
Tourniquet is only used for arthroscopic exploration
Sponsors
Qilu Hospital of Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative blood loss | 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 | The third day after operation | Total blood loss preoperative blood volume =(preoperative hematocrit-postoperative Hematocrit) + transfusion volume. |
| Volume of drainage | Postoperative Day One | Reactive blood loss |
| Thigh pain measured by Visual Analogue Scale Postoperative Day 1 | 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 | 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 | 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 | 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 | 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. |
| Thigh pain measured by Visual Analogue Scale Postoperative Week 4 | 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 | 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 | 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 | 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 | 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 | 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. |
| Crus pain measured by Visual Analogue Scale Postoperative Week 1 | 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 | 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 | 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. |
Countries
China
Contacts
Primary ContactSonglin Li, MD
Backup ContactPeilai Liu, MD
Outcome results
None listed