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

Primary Purpose

Elbow Dislocation, Heterotopic Ossification

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
with Tranexamic acid
Sponsored by
Assaf-Harofeh Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Elbow Dislocation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Assaf Harofeh Medical Center (Yitzhak Shamir Medical Center)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

With tranexamic acid

Without tranexamic acid

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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)

Full Information

First Posted
September 26, 2023
Last Updated
October 15, 2023
Sponsor
Assaf-Harofeh Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT06088407
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
February 21, 2016 (Actual)
Primary Completion Date
September 3, 2023 (Actual)
Study Completion Date
September 3, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assaf-Harofeh Medical Center

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elbow Dislocation, Heterotopic Ossification

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
With tranexamic acid
Arm Type
Experimental
Arm Description
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.
Arm Title
Without tranexamic acid
Arm Type
No Intervention
Arm Description
Patient undergoing surgery for elbow fracture-dislocation randomized to be treated without tranexamic acid intraoperatively
Intervention Type
Drug
Intervention Name(s)
with Tranexamic acid
Intervention Description
Patients undergoing surgery for elbow fracture-dislocation randomized to be treated with tranexamic acid intravenous intraoperatively
Primary Outcome Measure Information:
Title
Presence of Heterotopic Ossification in plain radiographs
Description
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
Secondary Outcome Measure Information:
Title
Functional elbow Range of motion assessment
Description
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
Title
Heterotopic Ossification Classification System Score
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: traumatic non-pathological elbow fracture-dislocation. age 18 years or older. presentation within 2 weeks of injury. Willingness to participate in the study Exclusion Criteria: 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.
Facility Information:
Facility Name
Assaf Harofeh Medical Center (Yitzhak Shamir Medical Center)
City
Be'er Ya'aqov
ZIP/Postal Code
70300
Country
Israel

12. IPD Sharing Statement

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

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