Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-24 @ 11:49 PM
NCT ID:
NCT04785651
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:
NCT04785651
Study Brief:
Protocol Section:
NCT04785651