Elbow DislocationNCT06088407
Tranexamic Acid Prophylaxis for Heterotopic Ossification in Elbow Fracture-Dislocation Surgery
A study testing with Tranexamic acid in people with Elbow Dislocation and Heterotopic Ossification, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elbow Dislocation, Heterotopic Ossification
- What is being tested?
- with Tranexamic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- 21 Feb 2016to 3 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- traumatic non-pathological elbow fracture-dislocation.
- age 18 years or older.
- presentation within 2 weeks of injury.
- Willingness to participate in the study
Who cannot join
- 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).
Show all 10Show fewer
- Ischemic heart event within the last six months.
- Stroke (CVA) within the last six months.
- Coagulopathies.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Assaf Harofeh Medical Center (Yitzhak Shamir Medical Center)
Be’er Ya‘aqov, 70300
About this study
Official title: 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.
Read more
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
- Being tested
- with Tranexamic acid
- Medical subject headings
- Ossification, Heterotopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
with Tranexamic acidDrug
Patients undergoing surgery for elbow fracture-dislocation randomized to be treated with tranexamic acid intravenous intraoperatively
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: with Tranexamic acid |
| Without tranexamic acid | No intervention | Patient undergoing surgery for elbow fracture-dislocation randomized to be treated without tranexamic acid intraoperatively |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 weeks- 1 year
Secondary outcomes (2)
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.
Measured: 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)
Measured: 2 weeks - 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start21 Feb 2016
- Primary completion3 Sep 2023
- Study completion3 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elbow DislocationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06088407
- Sponsor's protocol ID
- 0052-16-ASF
- Status last verified
- Oct 2023
- First submitted
- 26 Sep 2023
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tranexamic Acid Prophylaxis for Heterotopic Ossification in Elbow Fracture-Dislocation Surgery: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT06088407
- Acronym / sponsor ID
- 0052-16-ASF
- Conditions
- Elbow Dislocation, Heterotopic Ossification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- 21 Feb 2016 (actual)
- Primary completion
- 3 Sep 2023 (actual)
- Study completion
- 3 Sep 2023 (actual)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With tranexamic acid | Experimental | Drug: with Tranexamic acidPatient 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. |
| Without tranexamic acid | No intervention | –Patient undergoing surgery for elbow fracture-dislocation randomized to be treated without tranexamic acid intraoperatively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- traumatic non-pathological elbow fracture-dislocation.
- age 18 years or older.
- presentation within 2 weeks of injury.
- Willingness to participate in the study
Key exclusion criteria (10 listed)
- Inability to provide consent for research participation.
- Active infection in the operated limb.
- Previous hip fracture.
- Head injury.
- History of deep vein thrombosis (DVT).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| with Tranexamic acidPatients undergoing surgery for elbow fracture-dislocation randomized to be treated with tranexamic acid intravenous intraoperatively | Drug | With tranexamic acid |
Primary outcome
Presence of Heterotopic Ossification in plain radiographs
Time frame: 2 weeks- 1 year
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 secondary outcomes
Functional elbow Range of motion assessment
Time frame: 2 weeks - 1 year
Heterotopic Ossification Classification System Score
Time frame: 2 weeks - 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing with Tranexamic acid in people with Elbow Dislocation and Heterotopic Ossification, run by Assaf-Harofeh Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Heterotopic Ossification in plain radiographs (time frame: 2 weeks- 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.