Clinical trial NCT04992533: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2021-08-05
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Intraoperative blood loss
timeFrame: within operation
measure: Postoperative blood loss
timeFrame: The third day after operation
measure: Volume of drainage
timeFrame: Postoperative Day One
measure: Thigh pain measured by Visual Analogue Scale Postoperative Day 1
timeFrame: 1 day after surgery
measure: Thigh pain measured by Visual Analogue Scale Postoperative Day 2
timeFrame: 2 day after surgery
measure: Thigh pain measured by Visual Analogue Scale Postoperative Day 3
timeFrame: 3 day after surgery
measure: Thigh pain measured by Visual Analogue Scale Postoperative Day 5
timeFrame: 5 day after surgery
measure: Thigh pain measured by Visual Analogue Scale Postoperative Week 1
timeFrame: 1 week after surgery
measure: Thigh pain measured by Visual Analogue Scale Postoperative Week 4
timeFrame: 4 week after surgery
measure: Thigh pain measured by Visual Analogue Scale Postoperative Week 12
timeFrame: 12 week after surgery
measure: Crus pain measured by Visual Analogue Scale Postoperative Day 1
timeFrame: 1 day after surgery
measure: Crus pain measured by Visual Analogue Scale Postoperative Day 2
timeFrame: 2 day after surgery
measure: Crus pain measured by Visual Analogue Scale Postoperative Day 3
timeFrame: 3 day after surgery
measure: Crus pain measured by Visual Analogue Scale Postoperative Day 5
timeFrame: 5 day after surgery
measure: Crus pain measured by Visual Analogue Scale Postoperative Week 1
timeFrame: 1 week after surgery
measure: Crus pain measured by Visual Analogue Scale Postoperative Week 4
timeFrame: 4 week after surgery
measure: Crus pain measured by Visual Analogue Scale Postoperative Week 12
timeFrame: 12 week after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu hospital of Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Peilai Liu, MD
role: STUDY_CHAIR
References:
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.
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.
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.