Evaluation of the Use of Tranexamic Acid in Tibial Osteotomies
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Monocompartimental Tibiofemoral Osteoarthritis
- Osteoarthritis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Triple (Participant, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 70 years
- Gender
- Both males and females
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 blee...
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
Tracking Information
- NCT #
- NCT04785651
- Collaborators
- Not Provided
- Investigators
- Not Provided