Tranexamic Acid Prophylaxis for Heterotopic Ossification in Elbow Fracture-Dislocation Surgery
Status:
Completed
Trial end date:
2023-09-03
Target enrollment:
Participant gender:
Summary
Heterotopic ossification (HO) following elbow fracture-dislocation is a well-recognized
condition that can lead to reduced range of motion, increased pain, and the necessity for
repeat surgeries.
Inflammation serves as a pivotal initiating factor in the formation of (HO) following a
traumatic event. The inflammatory cascade triggered can lead to the dysregulation of tissue
homeostasis, thereby promoting the aberrant formation of ectopic bone. Tranexamic acid (TXA),
a Food and Drug Administration (FDA) approved synthetic antifibrinolytic agent, has garnered
significant attention for its potential to mitigate the inflammatory response in the context
of orthopaedic surgical procedures.
This study aims to investigate the hypothesis that reducing soft tissue hematoma during elbow
fracture-dislocation surgery through the intraoperative administration of TXA, can alleviate
the occurrence or severity of ectopic bone formation.
Methods: A prospective randomized study was conducted on patients with elbow
fracture-dislocation who underwent surgery between 2016 and 2022. A total of 50 patients were
enrolled and randomly assigned to two groups. The first group received 1 gram of intravenous
tranexamic acid before the operation, followed by an additional 1 gram intravenously during
wound closure. The second group did not receive any anti-bleeding medication. Patients were
followed up at intervals of 2 weeks, 6 weeks, 3 months, and as needed after the surgery. At
the end of the follow-up period, there were 23 patients in the first group and 24 in the
second group, with a median follow-up duration of 12.7 months. All patients did not receive
any other form of HO prophylaxis. Postoperative radiographs and clinical outcomes were
assessed and recorded.