Using Tranexamic Acid to Reduce Complications in Knee Osteotomy Surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Istituto Ortopedico Rizzoli
  Bologna, Italy Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.