Neuro-Inflammation in Extremity Trauma: Risk Verification in Elbow Trauma: The NERVE Study (NCT07259382) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Neuro-Inflammation in Extremity Trauma: Risk Verification in Elbow Trauma: The NERVE Study
60 participantsStarted 2026-06-01
Plain-language summary
The primary goal of this proposal is to improve the understanding of the mechanisms causing persistent pain and disability in elbow fracture patients and their associated functional limitations. The specific objectives are as follows for elbow fractures:
1\) To describe NI mechanisms using biomarkers; 2) To identify factors related to increased NI biomarkers level; 3) To describe the associations between NI and outcomes; 4) To use these findings to refine a larger fully powered prognostic cohort study Hypotheses
1. Level of neuro-inflammation (NI) biomarkers\* will be significantly higher in patients presenting with both elbow fracture and CNS injury or PNI.
2. Consumption of opioid in mg of morphine equivalent will be higher in patients with a higher level of NI biomarkers.
3. Function, assessed by validated joint and limb specific functional questionnaires and QoL will be worse in patients with a higher level of NI biomarkers.
4. Chronic pain at 3 months will be higher (McGill Pain questionnaire V2, Neuropathic pain questionnaire, NPRS) in patients with a higher level of NI biomarkers.
5. Duration of tourniquet use and nerve dissection will be correlated to elbow fracture outcome with a higher level of NI biomarkers.
* Target biomarkers based on preliminary study will include, but not be limited to: TNFa, IL6, Substance P, IL-1B, TREM-2, IL-16, CCL22, VEGF-a, BMPs (table 1).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults 18 years or older with an acute elbow fracture and/or dislocation less than a week old
* Open surgery as the chosen treatment
Exclusion Criteria:
* Patient with a history of ipsilateral upper limb trauma or pathology, neurological disorder.
* 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 an active inflammatory disease (ex: rheumatoid arthritis)
* Patient using anti-inflammatory drugs or immunosuppressants at the time of the injury.
* Patient with another acute ipsilateral injury to the upper limb
* Polytrauma patients with other injuries than the elbow fracture and concomitant central or peripheral neurological injury.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Biomarkers
Timeframe: Baseline, preoperative, perioperative, immediatly after the intervention, 3months