Using Tranexamic Acid to Reduce Complications in Knee Osteotomy Surgery
Evaluation of the Use of Tranexamic Acid in Tibial Osteotomies: a Randomised Controlled Clinical Trial.
This study is testing if giving tranexamic acid during knee surgery can help reduce bleeding and improve recovery for people with knee osteoarthritis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Istituto Ortopedico Rizzoli Academic / other |
| Locations | 1 site (Bologna) |
| Trial ID | NCT04785651 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of tranexamic acid in reducing bleeding, pain, and wound complications during tibial osteotomies for patients with tibiofemoral osteoarthritis. A total of 84 patients will be randomly assigned to receive either tranexamic acid or a placebo during their surgical procedure. The study will follow patients for up to 60 days post-surgery to assess outcomes related to bleeding and recovery. This approach aims to provide evidence for the safety and efficacy of tranexamic acid in this surgical context.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 18 to 70 with single-part tibiofemoral osteoarthritis requiring corrective osteotomy.
Not a fit: Patients with contraindications to tranexamic acid, severe obesity, or incapacitating conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications for patients undergoing tibial osteotomies.
How similar studies have performed: Previous studies have shown the safety and efficacy of tranexamic acid in reducing peri-operative bleeding, but this is the first randomized trial specifically addressing its use in tibial osteotomies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or female patients aged between 18 and 70 years; 2. Single-part tibiofemoral osteoarthritis (K-L 1-3), axial deviation \> 5°; 3. Surgical indication for corrective osteotomy; 4. Isolated osteotomy surgical procedure. Exclusion Criteria: 1. Contraindication criteria for the administration of tranexamic acid, as assessed by the Anaesthesia and Resuscitation specialist during the pre-operative visit. The following will be considered absolute contraindications: epilepsy, thrombophilia and known allergy to the active substance, severe renal insufficiency and acute venous or arterial thrombosis, while the following will be considered relative contraindications: coronary stents in patients who have discontinued treatment with antiplatelet agents and previous deep vein thrombosis; 2. Known pro-thrombotic conditions (coagulation factor mutations, pregnancy status, previous pulmonary thromboembolism); 3. BMI \> 40; 4. Incapacitated patients; 5. Patients abusing alcoholic beverages, drugs or medication. 6. Patients who are pregnant or breastfeeding.
Where this trial is running
Bologna
- Istituto Ortopedico Rizzoli — Bologna, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.