Evaluation of the Use of Tranexamic Acid in Tibial Osteotomies

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Monocompartimental Tibiofemoral Osteoarthritis, Osteoarthritis

Intervention / Treatment
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* Drug: Tibial osteotomy with Tranexamic acid
* Procedure: Tibial osteotomy without Tranexamic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients aged between 18 and 70 years; Single-part tibiofemoral osteoarthritis (K-L 1-3), axial deviation > 5°; Surgical indication for corrective osteotomy; Isolated osteotomy surgical procedure. Exclusion Criteria: 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; Known pro-thrombotic conditions (coagulation factor mutations, pregnancy status, previous pulmonary thromboembolism); BMI > 40; Incapacitated patients; Patients abusing alcoholic beverages, drugs or medication. Patients who are pregnant or breastfeeding.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tranexamic arm<br>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<br>* 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.<br>|
| Other: control arm<br>Patients in this arm will undergo to a tibial osteotomy without the use of Tranexamic acid | Procedure: Tibial osteotomy without Tranexamic acid<br>* Patients in this arm will undergo to the tibial osteotomy procedure as by clinical practice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative blood loss (haemoglobin balance): | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tibial osteotomy, tranexamic acid