Evaluation of the Use of Tranexamic Acid in Tibial Osteotomies

  • STATUS
    Recruiting
  • End date
    Feb 22, 2025
  • participants needed
    84
  • sponsor
    Istituto Ortopedico Rizzoli
Updated on 19 March 2021

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

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 interposition of tissue (autologous bone, heterologous bone or bone substitute).

Even though excessive bleeding is not a frequent complication, the blood loss and formation of subcutaneous haematoma can determinate more post-interventional pain, wound suffering and the risk of infections.

Tranexamic acid is an antifibrinolytic agent and its use in proximal tibia osteotomies has been retrospectively evaluated in a number of papers, all of which agree on its safety and efficacy in terms of reducing peri-operative bleeding. However, to date there have been no randomised clinical trials demonstrating its superiority in terms of reducing bleeding, subcutaneous haematoma and wound complications in proximal tibia osteotomies.

This is 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

Details
Condition Arthritis, Osteoarthritis, Arthritis and Arthritic Pain, Arthritis and Arthritic Pain (Pediatric), degenerative arthritis, Monocompartimental Tibiofemoral Osteoarthritis
Treatment Tibial osteotomy with Tranexamic acid, Tibial osteotomy without Tranexamic acid
Clinical Study IdentifierNCT04785651
SponsorIstituto Ortopedico Rizzoli
Last Modified on19 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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