Evaluation of the Use of Tranexamic Acid in Tibial Osteotomies

• Status: Recruiting
• Trial end date: 2025-02-22
• Target enrollment: 0
• Participant gender: All

Summary

A randomised controlled double-blind clinical trial focused on the evaluation of the effectiveness of the tranexamic acid on bleeding, pain and wound complications reduction in tibial osteotomies.

All the 84 included patients will be randomized in one of the two arms, will undergo to a tibial osteotomy and then will prospectively evaluate at different follow ups until 60 days post-surgery

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Istituto Ortopedico Rizzoli
• Treatments: Tranexamic Acid

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.