An interventional study of with Tranexamic acid in Elbow Dislocation and Heterotopic Ossification, sponsored by Assaf-Harofeh Medical Center. Completed at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-18.
Sponsored by Assaf-Harofeh Medical Center · Not applicable, Interventional, and Prevention
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.
190 studies on the registry are indexed under Joint Dislocations; 39 are open to participants now.
This study's enrollment of 50 is close to the median of 53 across 120 interventional studies indexed under Joint Dislocations.
Browse Joint Dislocations studies →Assaf-Harofeh Medical Center is the lead sponsor of 258 studies on the registry; 40 are open to participants now.
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Exclusion Criteria:
Patient undergoing surgery for elbow fracture-dislocation randomized to be treated with tranexamic acid intraoperatively. The patients received intravenous 1 gram tranexamic acid in 100ml normal saline 30 minutes before skin incision and a second dose of intravenous 1 gram tranexamic acid in 100 ml of normal saline during wound closure.
Drug: with Tranexamic acid
Patient undergoing surgery for elbow fracture-dislocation randomized to be treated without tranexamic acid intraoperatively
Patients undergoing surgery for elbow fracture-dislocation randomized to be treated with tranexamic acid intravenous intraoperatively
Presence of Heterotopic Ossification in plain radiographs
Heterotopic Ossification presence, defined as new bone formation that had not been present in the imaging studies made at the time of the injury
Time frame: 2 weeks- 1 year
Functional elbow Range of motion assessment
Elbow range of motion throughout the follow-up. The range of motion of the elbow was evaluated in degrees using a full circle goniometer (Jamar, Duluth, Minnesota, United States). Functional range of motion was classified as 30-130 degrees of extension-flexion according to the description by Morrey et al (A biomechanical study of normal functional elbow motion. B F Morrey, L J Askew, E Y Chao. J Bone Joint Surg Am. 1981 Jul;63(6):872-7.). Patients with worse range of motion then 30-130 degrees (larger then 30 degrees extension and lower then 130 degrees of flexion) were classified as patients with non-functional elbow range of motion.
Time frame: 2 weeks - 1 year
Heterotopic Ossification Classification System Score
Heterotopic Ossification Classification System by Hastings and Graham (The classification and treatment of heterotopic ossification about the elbow and forearm. H Hastings 2nd, T J Graham. Hand Clin. 1994 Aug;10(3):417-37.). The score is between I-III, where I means radiographic heterotopic ossification without elbow motion limitations (better outcome) and III means radiographic heterotopic ossification with no elbow motion (worse outcome)
Time frame: 2 weeks - 1 year
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Assaf-Harofeh Medical Center