Evaluation of the Use of Tranexamic Acid in Tibial Osteotomies

July 17, 2025 updated by: Istituto Ortopedico Rizzoli

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40136
        • Istituto Ortopedico Rizzoli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tranexamic arm
Patients in this arm will undergo to a tibial osteotomy in combination with the anti-fibrinolytic agent Tranexamic acid.
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.
Other: control arm
Patients in this arm will undergo to a tibial osteotomy without the use of Tranexamic acid
Procedure: Tibial osteotomy without Tranexamic acid
Patients in this arm will undergo to the tibial osteotomy procedure as by clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perioperative blood loss (haemoglobin balance):
Time Frame: Basal vs the first post operative day
The perioperative blood loss will be estimated by assessing the haemoglobin balance on the first postoperative day
Basal vs the first post operative day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative transfusion rate
Time Frame: Perioperative time and postoperative time ( up to 60 days)
the percentage of transfusions carried out in the two treatment groups will be determined;
Perioperative time and postoperative time ( up to 60 days)
Postoperative blood loss
Time Frame: Postoperatively (up to 2 days)
The perioperative blood loss will be estimated by assessing the blood loss after surgery (through the volume of blood collected by drainage);
Postoperatively (up to 2 days)
Blood loss after discharge
Time Frame: at 5 and 15 days post hospital discharge
Post-discharge blood loss will be estimated by assessing haemoglobin balance at 5 and 15 days post-surgery;
at 5 and 15 days post hospital discharge
International Knee Documentation Committee objective
Time Frame: Baseline, 30 and 60 days post treatment
The objective rating scale has seven parameters related to knee function. The presence of effusions and degree of knee movement are assessed, the worst value of one of these parameters determines the final IKDC grade. There are four grades (A, B, C, D) that identify a knee assessed as normal, near normal, abnormal and severely abnormal, respectively.
Baseline, 30 and 60 days post treatment
Visual Analogue Scale - Pain
Time Frame: baseline, 1 day post-treatment, 2 days post-treatment, 1 month, 2 months);
visual analogue scale consisting of a straight line segment (10 cm long), the ends of which correspond to 'no pain' and 'strongest pain imaginable'.
baseline, 1 day post-treatment, 2 days post-treatment, 1 month, 2 months);
Soft tissue status
Time Frame: perioperatively, 30 and 60 days
The condition of the soft tissues (swelling, surgical haematoma, wound distress) will be documented and analysed between the two groups by means of photographic documentation and through the Hollander Wound Evaluation Scales
perioperatively, 30 and 60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Rizzoli

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2021

Primary Completion (Actual)

May 9, 2025

Study Completion (Actual)

May 9, 2025

Study Registration Dates

First Submitted

February 16, 2021

First Submitted That Met QC Criteria

March 4, 2021

First Posted (Actual)

March 8, 2021

Study Record Updates

Last Update Posted (Actual)

July 22, 2025

Last Update Submitted That Met QC Criteria

July 17, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TXA-HTO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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