Clinical trial NCT04785651: Evaluation of the Use of Tranexamic Acid in Tibial Osteotomies
Official title: Evaluation of the Use of Tranexamic Acid in Tibial Osteotomies: a Randomised Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Monocompartimental Tibiofemoral Osteoarthritis
Osteoarthritis
Keywords: tibial osteotomy
tranexamic acid
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2021-03-08
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Perioperative blood loss (haemoglobin balance):
timeFrame: Basal vs the first post operative day
Secondary outcomes:
measure: Postoperative transfusion rate
timeFrame: Perioperative time and postoperative time ( up to 60 days)
measure: Postoperative blood loss
timeFrame: Postoperatively (up to 2 days)
measure: Blood loss after discharge
timeFrame: at 5 and 15 days post hospital discharge
measure: International Knee Documentation Committee objective
timeFrame: Baseline, 30 and 60 days post treatment
measure: Visual Analogue Scale - Pain
timeFrame: baseline, 1 day post-treatment, 2 days post-treatment, 1 month, 2 months);
measure: Soft tissue status
timeFrame: perioperatively, 30 and 60 days
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.