Elbow FractureFIRENCT05075382
Fracture and Neurological Injury
An observational study of Elbow Fracture and Neurologic Deficits, run by Université de Montréal.
Trial summary
The goal of the project is to describe novel factors affecting outcome after elbow fracture surgery with an in-depth evaluation of the role played by neuro inflammation from concomitant peripheral nerve injury or head injury in elbow fracture outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elbow Fracture, Neurologic Deficits
- What is being tested?
- Elbow surgery for fracture
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2022to 31 Dec 2025
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Patients presenting with elbow fracture that needs to be treated surgically.
Who may be able to join
- Adult 18 years or older with an acute elbow fracture and dislocation less than a week old
- Open or arthroscopic surgery as the chosen treatment
Who cannot join
- Patient with a history of ipsilateral trauma, neurological disorder or major pathology.
- Patient unable to answer questionnaires.
- Patient unavailable for a one-year follow-up, for example from another country.
- Patient with vascular injury or open fracture
- Patient with a historic of TBI
- Patient with chronic medicated pain
About this study
Official title: Fracture and Neurological Injury: Prospective Multicentre Study on Risk Factors of Complications and Opioid Intake in Elbow Trauma
The goal of the project is to describe novel factors affecting outcome after elbow fracture surgery with an in-depth evaluation of the role played by neuro inflammation from concomitant peripheral nerve injury or head injury in elbow fracture outcomes.
Among all upper limb fractures, elbow trauma is the most frequently associated with a severe impact on patient function and quality of life. One of the main reasons for poor outcomes is the complexity of the elbow joint, which involves three bones and two planes of motion, essential to position the hand in space. The flexion extension axis is crucial for eating and hygiene, while forearm pro-supination is mandatory for most professions, from office work to manual labour.
Read the detailed description
Elbow fractures are a challenging clinical problem. The advancement of science and technology has made major contributions to improve outcomes. Nonetheless, even with an anatomical restoration of the bone architecture, many patients stay with major limitations and pain. In clinical practice, it is striking to see how two patients with a similar elbow injury can exhibit completely opposite presentations: one who has completely healed from his/her injury and the other who has a stiff and painful elbow. The reasons for these changeable outcomes are unclear.
The investigator hypothesize that many of the answers will be related to the neurological system. This would explain why most studies strictly focusing on the orthopedic component of upper limb injury have yielded little improvement in preventing the adverse outcomes experienced by patients.
Following surgical treatment of an elbow fracture, patients often present with complications. Indeed, one third of patients complain of ulnar nerve symptoms after distal humerus fracture fixation, and 50% of patients treated surgically for elbow fracture-dislocations will have disabling stiffness and heterotopic ossification (HO). HO results from resident cells of mesenchymal origin in soft tissues transforming into bone. Furthermore, approximately half of all patients with fractures feel significant pain leading to persistent narcotic intake 3 months post injury; 40% will suffer from a neuropathic type of pain, which is poorly controlled by narcotic medication. Opioid usage is also related to increased sensitivity to pain (hyperalgesia) and dissatisfaction. Complications from opioids prolonged usage are numerous, from constipation to death due to an overdose. Canada is second worldwide, behind the United States, when it comes to opioid use and mortality secondary to opioid use. The majority of opioid dependant users were first exposed to these substances through medical prescriptions. This makes it imperative to improve the scinetific community understanding of pain mechanisms and find alternative treatments to opiates in the management of these injuries.
In view of these observations, the investigator's research must focus on something other than "satisfactory radiological results" in patients with elbow injuries. To this end, a multidisciplinary approach is needed. The investigators oversee research in elbow trauma, neurotrauma and have an expertise in upper limb evaluation. To improve the understanding of the underlying physiological principles that contribute to pain and chronic stiffness, one of the topics targeted by the investigator is the role of neuro-inflammation (NI) in chronic pain and functional limitation in elbow trauma. The surgical factors that increase NI will allow surgeons to choose different therapeutic options and develop novel treatments.
- Conditions
- Elbow Fracture, Neurologic Deficits
- Being tested
- Elbow surgery for fracture
- Keywords
- heterotopic ossification, traumatic brain injury
- Medical subject headings
- Elbow Fractures, Neurologic Manifestations, Ossification, Heterotopic, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elbow surgery for fractureProcedure or surgery
This group will undergo a surgery in order to fix a broken elbow.
| Study group | Role | What they receive |
|---|---|---|
| Pilot group | Group of 40 patients that will act as observationnal group for this study Receives: Procedure: Elbow surgery for fracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of inflammatory factors with blood tests
interleukins, P substance, TNF alpha, osteopontin, S100B, NSE, GFAP
Measured: Pre-op
Measurement of inflammatory factors with blood tests
interleukins, P substance, TNF alpha, osteopontin, S100B, NSE, GFAP
Measured: During surgery
Measurement of inflammatory factors with blood tests
interleukins, P substance, TNF alpha, osteopontin, S100B, NSE, GFAP
Measured: 3 months post-op
Secondary outcomes (8)
Quick-DASH
Quick-DASH outcome measures (scores range from 0 (no disability) to 100 (most severe disability))
Measured: Baseline, 2 weeks post-op, 3-6-12 months post-op
Patient rated elbow evaluation (PREE)
20 item questionnaire allowing patients to rate their levels of elbow pain and disability from 0 to 100 (0= no disability)
Measured: Baseline, 2 weeks post-op, 3-6-12 months post-op
Range of motion
Evaluation of the elbow range of motion with goniometer by a train physical therapist
Measured: Baseline, 2 weeks post-op, 3-6-12 months post-op
McGill Pain Questionnaire (MPQ-Short Form V2)
Self-reported measure of pain. No scale
Measured: Baseline, 2 weeks post-op, 3-6-12 months post-op
Neuropathic pain questionnaire (SLANSS)
questionnaire designed to identify pain of predominantly neuropathic origin. A score over 12 signals a predominantly neuropathic type of pain
Measured: Baseline, 2 weeks post-op, 3-6-12 months post-op
Euro-Qol Group 5Q5D
Questionnaire evaluating qaulity of life. No scale
Measured: Baseline, 2 weeks post-op, 3-6-12 months post-op
Tourniquet
Verify our capacity to identify whether the use of tourniquet has an impact on neuroinflammation
Measured: Per-op
Nerve dissection
Verify our capacity to identify whether the nerve dissection has an impact on neuroinflammation
Measured: Pero-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start1 Jul 2022 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Why it stopped: A new version of the study will be submitted
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elbow FractureStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dominique Rouleau, Université de Montréal
- Investigators
- Dominique Rouleau, MD, Principal investigator, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05075382
- Sponsor's protocol ID
- FIRE
- Acronym
- FIRE
- Status last verified
- Dec 2023
- First submitted
- 9 Sep 2021
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fracture and Neurological Injury: Prospective Multicentre Study on Risk Factors of Complications and Opioid Intake in Elbow Trauma
- ClinicalTrials.gov ID
- NCT05075382
- Acronym / sponsor ID
- FIRE / FIRE
- Conditions
- Elbow Fracture, Neurologic Deficits
- Keywords
- heterotopic ossification, traumatic brain injury
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: A new version of the study will be submitted
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 12 Oct 2021 (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.
The goal of the project is to describe novel factors affecting outcome after elbow fracture surgery with an in-depth evaluation of the role played by neuro inflammation from concomitant peripheral nerve injury or head injury in elbow fracture outcomes.
Among all upper limb fractures, elbow trauma is the most frequently associated with a severe impact on patient function and quality of life. One of the main reasons for poor outcomes is the complexity of the elbow joint, which involves three bones and two planes of motion, essential to position the hand in space. The flexion extension axis is crucial for eating and hygiene, while forearm pro-supination is mandatory for most professions, from office work to manual labour.
Detailed description
Elbow fractures are a challenging clinical problem. The advancement of science and technology has made major contributions to improve outcomes. Nonetheless, even with an anatomical restoration of the bone architecture, many patients stay with major limitations and pain. In clinical practice, it is striking to see how two patients with a similar elbow injury can exhibit completely opposite presentations: one who has completely healed from his/her injury and the other who has a stiff and painful elbow. The reasons for these changeable outcomes are unclear.
The investigator hypothesize that many of the answers will be related to the neurological system. This would explain why most studies strictly focusing on the orthopedic component of upper limb injury have yielded little improvement in preventing the adverse outcomes experienced by patients.
Following surgical treatment of an elbow fracture, patients often present with complications. Indeed, one third of patients complain of ulnar nerve symptoms after distal humerus fracture fixation, and 50% of patients treated surgically for elbow fracture-dislocations will have disabling stiffness and heterotopic ossification (HO). HO results from resident cells of mesenchymal origin in soft tissues transforming into bone. Furthermore, approximately half of all patients with fractures feel significant pain leading to persistent narcotic intake 3 months post injury; 40% will suffer from a neuropathic type of pain, which is poorly controlled by narcotic medication. Opioid usage is also related to increased sensitivity to pain (hyperalgesia) and dissatisfaction. Complications from opioids prolonged usage are numerous, from constipation to death due to an overdose. Canada is second worldwide, behind the United States, when it comes to opioid use and mortality secondary to opioid use. The majority of opioid dependant users were first exposed to these substances through medical prescriptions. This makes it imperative to improve the scinetific community understanding of pain mechanisms and find alternative treatments to opiates in the management of these injuries.
In view of these observations, the investigator's research must focus on something other than "satisfactory radiological results" in patients with elbow injuries. To this end, a multidisciplinary approach is needed. The investigators oversee research in elbow trauma, neurotrauma and have an expertise in upper limb evaluation. To improve the understanding of the underlying physiological principles that contribute to pain and chronic stiffness, one of the topics targeted by the investigator is the role of neuro-inflammation (NI) in chronic pain and functional limitation in elbow trauma. The surgical factors that increase NI will allow surgeons to choose different therapeutic options and develop novel treatments.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pilot group | – | Procedure: Elbow surgery for fractureGroup of 40 patients that will act as observationnal group for this study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients presenting with elbow fracture that needs to be treated surgically.
Key inclusion criteria (2 listed)
- Adult 18 years or older with an acute elbow fracture and dislocation less than a week old
- Open or arthroscopic surgery as the chosen treatment
Key exclusion criteria (6 listed)
- Patient with a history of ipsilateral trauma, neurological disorder or major pathology.
- Patient unable to answer questionnaires.
- Patient unavailable for a one-year follow-up, for example from another country.
- Patient with vascular injury or open fracture
- Patient with a historic of TBI
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 |
|---|---|---|
| Elbow surgery for fractureThis group will undergo a surgery in order to fix a broken elbow. | Procedure or surgery | Pilot group |
Primary outcome
Measurement of inflammatory factors with blood tests
Time frame: Pre-op
interleukins, P substance, TNF alpha, osteopontin, S100B, NSE, GFAP
Measurement of inflammatory factors with blood tests
Time frame: During surgery
interleukins, P substance, TNF alpha, osteopontin, S100B, NSE, GFAP
Measurement of inflammatory factors with blood tests
Time frame: 3 months post-op
interleukins, P substance, TNF alpha, osteopontin, S100B, NSE, GFAP
8 secondary outcomes
Quick-DASH
Time frame: Baseline, 2 weeks post-op, 3-6-12 months post-op
Patient rated elbow evaluation (PREE)
Time frame: Baseline, 2 weeks post-op, 3-6-12 months post-op
Range of motion
Time frame: Baseline, 2 weeks post-op, 3-6-12 months post-op
McGill Pain Questionnaire (MPQ-Short Form V2)
Time frame: Baseline, 2 weeks post-op, 3-6-12 months post-op
Neuropathic pain questionnaire (SLANSS)
Time frame: Baseline, 2 weeks post-op, 3-6-12 months post-op
Euro-Qol Group 5Q5D
Time frame: Baseline, 2 weeks post-op, 3-6-12 months post-op
Tourniquet
Time frame: Per-op
Nerve dissection
Time frame: Pero-op
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Elbow Fracture
Active, not recruiting
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Not yet recruiting
Comparison of GMI, PNF, and Standard Care for Post-Traumatic Elbow Stiffness Rehabilitation in Adults
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Recruiting
This is a Study to Find Out Whether Surgery Using a Metal Plate to Fix a Broken Elbow in Older Adults Leads to Better Recovery and Arm Function Compared to Non-surgical Treatment
Olecranon Fracture
Recruiting
The With Or Without Olecranon K-wires Trial
Olecranon Fracture
Not yet recruitingObservational study
Clinical Outcomes After Treatment of Distal Humerus Fractures With the LORRAINE 2.5/3.5 mm Distal Humerus System
Intra-Articular or Extra-Articular Distal Humerus Fracture, Distal Humerus Fracture
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.
Dominique Rouleau, MD principal investigator
Université de Montréal
Questions about this trial
What is this clinical trial studying?
An observational study of Elbow Fracture and Neurologic Deficits, run by Université de Montréal.
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 2 inclusion and 6 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: withdrawn, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Measurement of inflammatory factors with blood tests (time frame: Pre-op). The study lists 3 primary outcomes in all. 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 11 Dec 2023.