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

NCT06088407 | Completed DMC

• 1 other identifier: 0052-16-ASF
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Elbow Dislocation; Heterotopic Ossification

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Functional elbow Range of motion assessment

  2 weeks - 1 year

• Heterotopic Ossification Classification System Score

  2 weeks - 1 year

Study Arms (2)

With tranexamic acid

EXPERIMENTAL

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

Without tranexamic acid

NO INTERVENTION

Patient undergoing surgery for elbow fracture-dislocation randomized to be treated without tranexamic acid intraoperatively

Interventions

with Tranexamic acid DRUG

Patients undergoing surgery for elbow fracture-dislocation randomized to be treated with tranexamic acid intravenous intraoperatively

With tranexamic acid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Inability to provide consent for research participation.
• Active infection in the operated limb.
• Previous hip fracture.
• Head injury.
• History of deep vein thrombosis (DVT).
• History of venous thromboembolism (VTE).
• Ischemic heart event within the last six months.
• Stroke (CVA) within the last six months.
• Coagulopathies.
• Pregnancy.

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Sites (1)

Assaf Harofeh Medical Center (Yitzhak Shamir Medical Center)

Be’er Ya‘aqov, 70300, Israel

Location

MeSH Terms

Conditions

Ossification, Heterotopic

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 18, 2023
• Study Start: February 21, 2016
• Primary Completion: September 3, 2023
• Study Completion: September 3, 2023
• Last Updated: October 18, 2023

Record last verified: 2023-10

Locations

IL (1)