NCT07259382: NERVE

Neuro-Inflammation in Extremity Trauma: Risk Verification in Elbow Trauma: The NERVE Study

Not yet recruiting Last updated 2 December 2025

What this trial tests

trial testing Biomarkers evaluation in Elbow Dislocation in 60 participants. Not yet recruiting.

Timeline

1 January 2026

Primary endpoint
31 December 2028

31 December 2030

Quick facts

Lead sponsor	Université de Montréal
Status	Not yet recruiting
Study type	OBSERVATIONAL
Enrollment	60
Start date	1 January 2026
Primary completion	31 December 2028
Estimated completion	31 December 2030

Drugs / interventions tested

• Biomarkers evaluation

Conditions studied

• Elbow Dislocation — all drugs for Elbow Dislocation →
• Elbow Fractures — all drugs for Elbow Fractures →
• Inflammation Biomarkers — all drugs for Inflammation Biomarkers →
• TBI Traumatic Brain Injury — all drugs for TBI Traumatic Brain Injury →

Sponsor

Université de Montréal — full company profile →

Who can join

18 and older, any sex, with Elbow Dislocation or Elbow Fractures. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.