Evaluation of the Use of Tranexamic Acid in Tibial Osteotomies

NCT ID: NCT04785651

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-22
• Study Completion Date: 2025-05-09

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Tranexamic arm

Patients in this arm will undergo to a tibial osteotomy in combination with the anti-fibrinolytic agent Tranexamic acid.

Group Type: EXPERIMENTAL

Tibial osteotomy with Tranexamic acid

Intervention Type: DRUG

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.

control arm

Patients in this arm will undergo to a tibial osteotomy without the use of Tranexamic acid

Group Type: OTHER

Tibial osteotomy without Tranexamic acid

Intervention Type: PROCEDURE

Patients in this arm will undergo to the tibial osteotomy procedure as by clinical practice

Interventions

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.

Intervention Type: DRUG

Tibial osteotomy without Tranexamic acid

Patients in this arm will undergo to the tibial osteotomy procedure as by clinical practice

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Ortopedico Rizzoli

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Istituto Ortopedico Rizzoli

Bologna, , Italy

Countries

Italy

References

Hunt BJ. The current place of tranexamic acid in the management of bleeding. Anaesthesia. 2015 Jan;70 Suppl 1:50-3, e18. doi: 10.1111/anae.12910.

Reference Type: BACKGROUND

PMID: 25440395 (View on PubMed)

Charoencholvanich K, Siriwattanasakul P. Tranexamic acid reduces blood loss and blood transfusion after TKA: a prospective randomized controlled trial. Clin Orthop Relat Res. 2011 Oct;469(10):2874-80. doi: 10.1007/s11999-011-1874-2. Epub 2011 Apr 22.

Reference Type: BACKGROUND

PMID: 21512813 (View on PubMed)

Palanisamy JV, Das S, Moon KH, Kim DH, Kim TK. Intravenous Tranexamic Acid Reduces Postoperative Blood Loss After High Tibial Osteotomy. Clin Orthop Relat Res. 2018 Nov;476(11):2148-2154. doi: 10.1097/CORR.0000000000000378.

Reference Type: BACKGROUND

PMID: 29939895 (View on PubMed)

Other Identifiers

TXA-HTO

Identifier Type: -

Identifier Source: org_study_id