Osteoarthritis, Knee
Conditions
Brief summary
This study aims to examine whether tranexamic acid has an meaningful clinical effect on blood loss after high tibial osteotomy. This study design is a double-blind randomized controlled trial. The patients were randomly assigned to intervention or usual care groups. Intervention patients receive tranexamic acid 2g for 10 minutes just before surgery. Primary outcome is hemoglobin level preoperatively, postoperative 1 day, 2 days, 3 days, 2 weeks. Secondary outcome included hematocrit level, hemovac drainage, total blood loss, need for transfusion, deep vein thrombosis, Visual Analog Pain Scale, and wound complication.
Detailed description
High tibial osteotomy is proved treatment option for medial compartment osteoarthritis of knee joint. Especially, open wedge high tibial osteotomy might cause moderate amount of bleeding and hematoma formation. Bleeding and hematoma could be a reason of soft tissue infection and wound complications. Tranexamic acid (TXA) is a medication used to treat or prevent excessive blood loss from major trauma, postpartum bleeding, surgery, tooth removal, nosebleeds, and heavy menstruation. The objective of the study is to test whether preoperative tranexamic acid could reduce the postoperative complications due to bleeding.
Interventions
PROCEDUREHigh tibial osteotomy
Treatment option for medial compartment osteoarthritis of knee
DRUGTranexamic acid
Medication used to treat or prevent excessive blood loss from major trauma, postpartum bleeding, surgery, tooth removal, nosebleeds, and heavy menstruation
Sponsors
The Catholic University of Korea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients for high tibial osteotomy * Having medicare insurance * Accepted patients
Exclusion criteria
* History of lower extremity infection or neurologic problems * Inflammatory arthritis * Using thrombins * History of treatment for anemia * History of thromboembolic event * Chronic kidney disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin level | Change from Baseline Hemoglbin level at postoperative 1 day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Need for transfusion Deep vein thrombosis | Until postoperative 2 weeks | — |
| Visual Analog Pain Scale [0 - 10] | Preoperative & postoperative 1, 2, 3 days, 2 weeks | Higher scores mean worse outcome |
| Number of Participants with Need for transfusion | Postoperative 1, 2, 3 days | — |
| Amount of Hemovac drainage | Postoperative 1, 2, 3 days | CC |
| Total blood loss | Postoperative 1, 2, 3 days | CC |
| Hematocrit level | Preoperative & postoperative 1, 2, 3 days, 2 weeks | — |
Countries
South Korea
Outcome results
None listed