Neuro-Inflammation in Extremity Trauma: Risk Verification in Elbow Trauma: The NERVE Study
Starting soon
Conditions studied: Elbow Dislocation, Elbow Fractures, Inflammation Biomarkers, TBI Traumatic Brain Injury, Nerve Injury
In brief
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).
Key facts
- Study ID
- NCT07259382
- Run by
- Université de Montréal
- People needed
- 60
- Starts
- 2026-06-01
- Expected to finish
- 2030-12-31
- Last updated by the study team
- 2026-04-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adults 18 years or older with an acute elbow fracture and/or dislocation less than a week old
- Open surgery as the chosen treatment
You may not qualify if…
- 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.
Full record on ClinicalTrials.gov
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