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

NCT07259382 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2026-04-28

No results posted yet for this study

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).

Conditions

  • Elbow Dislocation
  • Elbow Fractures
  • Inflammation Biomarkers
  • TBI Traumatic Brain Injury
  • Nerve Injury

Interventions

OTHER

Biomarkers evaluation

Participants will undergo blood test that evaluate several inflammatory biomarkers before and after the surgery

Sponsors & Collaborators

  • Université de Montréal

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2028-12-31
Completion
2030-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07259382 on ClinicalTrials.gov