Evaluation of the Use of Tranexamic Acid in Tibial Osteotomies
Key facts
- Who runs it
- Istituto Ortopedico Rizzoli
- Where
- Italy1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Terminated
- People taking part
- 49 people enrolled
- Started
- 22 Feb 2021
- Ended
- 9 May 2025
- Type of study
- Interventional, 2 groups
- Treatments tested
- Tibial osteotomy with Tranexamic acid
- Tibial osteotomy without Tranexamic acid
- Record updated
- 22 July 2025
- Why it stopped
- Patient enrollment was proceeding slower than planned
Who can take part
- Age
- 18 years to 70 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- Male or female patients aged between 18 and 70 years
- Single-part tibiofemoral osteoarthritis (K-L 1-3), axial deviation > 5°
- Surgical indication for corrective osteotomy
- Isolated osteotomy surgical procedure
Who cannot take part
- 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
- Known pro-thrombotic conditions (coagulation factor mutations, pregnancy status, previous pulmonary thromboembolism)
- Patients abusing alcoholic beverages, drugs or medication
- BMI > 40
- Incapacitated patients
- Patients who are pregnant or breastfeeding
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
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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
The 2 groups in the trial
- Tranexamic armTreatment being tested
Patients in this arm will undergo to a tibial osteotomy in combination with the anti-fibrinolytic agent Tranexamic acid.
Treatment: Tibial osteotomy with Tranexamic acid
- control armOther group
Patients in this arm will undergo to a tibial osteotomy without the use of Tranexamic acid
Treatment: Tibial osteotomy without Tranexamic acid
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Evaluation of the Use of Tranexamic Acid in Tibial Osteotomies: a Randomised Controlled Clinical Trial.
- Record updated
- 22 July 2025