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

NCT07259382 | Not Yet Recruiting

• 1 other identifier: NERVE
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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. 1.Level of neuro-inflammation (NI) biomarkers\* will be significantly higher in patients presenting with both elbow fracture and CNS injury or PNI.
2. 2.Consumption of opioid in mg of morphine equivalent will be higher in patients with a higher level of NI biomarkers.
3. 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. 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. 5.Duration of tourniquet use and nerve dissection will be correlated to elbow fracture outcome with a higher level of NI biomarkers.
6. 6.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

Keywords

Biomarkers; Elbow fracture; elbow dislocation; Nerve injury; TBI

Outcome Measures

Primary Outcomes (1)

• Biomarkers

  Five blood samples per subject will be taken at selected intervals to measure the serum levels of the targeted pro-inflammatory cytokines for the 60 selected patients. A blood sample will be collected at the first appointment before surgery. Preoperative and postoperative blood samples will also be collected in the operating room. The first will be taken before skin asepsis and the second will be taken immediately after application of the final wound dressing. Blood from the fracture site (hematoma) will also be collected when possible. The fifth blood sample will be collected at 3 months of follow up. Samples will be stored in a -70°C freezer in each city and sent every 6 months for analysis to Olink, Montreal. Group dosage will be performed for the NI factors and circulating proteins (e.g. cytokines, chemokines, neuropeptides), such as TNF, IL-1, IL-6, IL-16, osteopontin, S100B, NSE, GFAP, Substance P, TREM-2, CCL22, and BMPs.

  Baseline, preoperative, perioperative, immediatly after the intervention, 3months

Secondary Outcomes (10)

• PREE

  Baseline, preop, 2 weeks, 3-6-12 months

• Range of motion

  Baseline, preop, immediatly after the procedure, 2 weeks, 3-6-12months

• Pain assessment

  Baseline, preop, 2 weeks, 3-6-12 months

• Opioïds consumption

  Recorded once per day from baseline through 12months

• Quick-DASH

  Baseline, preop, 2weeks, 3 months, 6 months, 12 months

Study Arms (3)

Elbow fracture

Patient with an acute, isolated elbow fracture

Other: Biomarkers evaluation

Elbow fracture and peripheral nerve injury

Patient with an acute elbow fracture and a peripheral nerve injury

Other: Biomarkers evaluation

Ebow fracture and TBI

Patient with an acute elbow fracture and a mild TBI

Other: Biomarkers evaluation

Interventions

Biomarkers evaluation OTHER

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

Ebow fracture and TBI; Elbow fracture; Elbow fracture and peripheral nerve injury

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with an acute elbow surgery with an appointment at the Hôpital du Sacré-Coeur de Montréal

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.

Sponsors & Collaborators

• Université de Montréal: lead

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Bloodtest

MeSH Terms

Conditions

Elbow Fractures; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Elbow Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System

Central Study Contacts

Dominique Rouleau, MD, MSc

CONTACT

514-338-2222; dominique_rouleau@yahoo.ca

Karine Tardif

CONTACT

514-338-2222; karine.tardif.cnmtl@ssss.gouv.qc.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic surgeon

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: December 2, 2025
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share