Tranexamic Acid Prophylaxis for Heterotopic Ossification in Elbow Fracture-Dislocation Surgery

Tranexamic Acid Prophylaxis for Heterotopic Ossification in Elbow Fracture-Dislocation Surgery: A Prospective Randomized Trial

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.

Study Overview

• Status: Completed
• Conditions: Elbow Dislocation; Heterotopic Ossification
• Intervention / Treatment: Drug: with Tranexamic acid

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Be'er Ya'aqov, Israel, 70300
    • Assaf Harofeh Medical Center (Yitzhak Shamir Medical Center)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. traumatic non-pathological elbow fracture-dislocation.
2. age 18 years or older.
3. presentation within 2 weeks of injury.
4. Willingness to participate in the study

Exclusion Criteria:

1. Inability to provide consent for research participation.
2. Active infection in the operated limb.
3. Previous hip fracture.
4. Head injury.
5. History of deep vein thrombosis (DVT).
6. History of venous thromboembolism (VTE).
7. Ischemic heart event within the last six months.
8. Stroke (CVA) within the last six months.
9. Coagulopathies.
10. Pregnancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: With tranexamic acid; 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; Patients undergoing surgery for elbow fracture-dislocation randomized to be treated with tranexamic acid intravenous intraoperatively
No Intervention: Without tranexamic acid; Patient undergoing surgery for elbow fracture-dislocation randomized to be treated without tranexamic acid intraoperatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 weeks- 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	2 weeks - 1 year

Collaborators and Investigators

• Sponsor: Assaf-Harofeh Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2016
• Primary Completion (Actual): September 3, 2023
• Study Completion (Actual): September 3, 2023

Study Registration Dates

• First Submitted: September 26, 2023
• First Submitted That Met QC Criteria: October 15, 2023
• First Posted (Actual): October 18, 2023

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 15, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fractures, Bone; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Arm Injuries; Elbow Injuries; Joint Dislocations; Fracture Dislocation; Ossification, Heterotopic; Elbow Fractures; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: 0052-16-ASF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No