Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-24 @ 11:49 PM
NCT ID:
NCT04785651
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04785651
Study Brief:
Protocol Section:
NCT04785651