Clinical trial NCT06088407: Tranexamic Acid Prophylaxis for Heterotopic Ossification in Elbow Fracture-Dislocation Surgery
Official title: Tranexamic Acid Prophylaxis for Heterotopic Ossification in Elbow Fracture-Dislocation Surgery: A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elbow Dislocation
Heterotopic Ossification
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2023-10-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Presence of Heterotopic Ossification in plain radiographs
timeFrame: 2 weeks- 1 year
Secondary outcomes:
measure: Functional elbow Range of motion assessment
timeFrame: 2 weeks - 1 year
measure: Heterotopic Ossification Classification System Score
timeFrame: 2 weeks - 1 year
Other outcomes:
Locations:
city: Be'er Ya'aqov
country: Israel
facility: Assaf Harofeh Medical Center (Yitzhak Shamir Medical Center)
Study officials:
References: