NCT04785651

Evaluation of the Use of Tranexamic Acid in Tibial Osteotomies

Evaluation of the Use of Tranexamic Acid in Tibial Osteotomies: a Randomised Controlled Clinical Trial.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Istituto Ortopedico Rizzoli · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

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 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

Conditions

• Monocompartimental Tibiofemoral Osteoarthritis
• Osteoarthritis

Interventions

Type	Name	Description
DRUG	Tibial osteotomy with Tranexamic acid	Patients who will be in the treatment arm after randomisation will receive 100ml saline with a dosage of 20 mg/kg tranexamic acid intravenously at induction. An additional administration of tranexamic acid (10 mg/kg in 100ml intravenous saline) will be given as a booster at the end of the surgical procedure. All the patients will undergo to the same tibial osteotomy procedure.
PROCEDURE	Tibial osteotomy without Tranexamic acid	Patients in this arm will undergo to the tibial osteotomy procedure as by clinical practice

Timeline

• Start date: 2021-02-22
• Primary completion: 2025-05-09
• Completion: 2025-05-09
• First posted: 2021-03-08
• Last updated: 2025-07-22

Locations

1 site across 1 country: Italy