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Evaluation of the Use of Tranexamic Acid in Tibial Osteotomies

NCT04785651 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2025-07-22

No results posted yet for this study

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

Conditions

Interventions

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

Sponsors & Collaborators

  • Istituto Ortopedico Rizzoli

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-22
Primary Completion
2025-05-09
Completion
2025-05-09

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04785651 on ClinicalTrials.gov