Status:
TERMINATED
Evaluation of the Use of Tranexamic Acid in Tibial Osteotomies
Lead Sponsor:
Istituto Ortopedico Rizzoli
Conditions:
Monocompartimental Tibiofemoral Osteoarthritis
Osteoarthritis
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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. Al...
Detailed Description
Tibial osteotomies represents a well-established treatment option for the medial femorotibial knee arthrosis. Osteotomy can be performed in minus or in plus, at the latter case with or without interp...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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);
- BMI \> 40;
- Incapacitated patients;
- Patients abusing alcoholic beverages, drugs or medication.
- Patients who are pregnant or breastfeeding.
Key Trial Info
Start Date :
February 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 9 2025
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT04785651
Start Date
February 22 2021
End Date
May 9 2025
Last Update
July 22 2025
Active Locations (1)
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1
Istituto Ortopedico Rizzoli
Bologna, Italy, 40136