Evaluation of the Use of Tranexamic Acid in Tibial Osteotomies

Not Applicable

Recruiting

• Conditions: Monocompartimental Tibiofemoral Osteoarthritis; Osteoarthritis
• Interventions: Procedure: Tibial osteotomy without Tranexamic acid; Drug: Tibial osteotomy with Tranexamic acid

• Registration Number: NCT04785651
• Lead Sponsor: Istituto Ortopedico Rizzoli

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

Study Timeline

• Study First Submitted: 2021-02-16
• Study Start: 2021-02-22
• Study First Submitted QC: 2021-03-04
• Study First Posted: 2021-03-08
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-07
• Last Update Posted: 2025-03-11
• Primary Completion: 2026-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 84

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control arm	Tibial osteotomy without Tranexamic acid	Patients in this arm will undergo to a tibial osteotomy without the use of Tranexamic acid
Tranexamic arm	Tibial osteotomy with Tranexamic acid	Patients in this arm will undergo to a tibial osteotomy in combination with the anti-fibrinolytic agent Tranexamic acid.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Postoperative blood loss	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);
International Knee Documentation Committee objective	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.
Soft tissue status	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
Postoperative transfusion rate	Perioperative time and postoperative time ( up to 60 days)	the percentage of transfusions carried out in the two treatment groups will be determined;
Blood loss after discharge	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;
Visual Analogue Scale - Pain	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'.

Trial Locations

Locations (1)

Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Italy