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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversité de Montréal

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults 18 years or older with an acute elbow fracture and/or dislocation less than a week old

Open surgery as the chosen treatment

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Biomarkers evaluation

    Other intervention

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

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Elbow fracture1 intervention
Group B: Elbow fracture and peripheral nerve injury1 intervention
Group C: Ebow fracture and TBI1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

PREE

The PREE is a validated patient-reported outcome measure designed to assess pain and functional limitations related to elbow disorders. It consists of 20 items divided into two subscales: Pain Subscale (5 items): Measures pain intensity during various activities. Function Subscale (15 items): Assesses difficulty in performing specific and usual daily activities. Each item is rated on a scale from 0 (no pain or difficulty) to 10 (worst pain or complete inability). A total score out of 100 is calculated by combining both subscales with equal weighting. Higher scores indicate greater pain and disability. Method of Measurement: Self-administered questionnaire completed by participants.

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

Range of motion

Participant will undergo a range of motion evaluation of the elbow at each time frame, if possible. ROM evaluation will include flexion, extension, pronation and supination. Evaluation will be done with a numeric goniometer by a physicial therapist and evaluate in degree

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

Pain assessment

Visual analog pain scale from 0 to 10. 0 would be no pain, 10 worst pain

Time frame
Baseline, preop, 2 weeks, 3-6-12 months
4

Opioïds consumption

Daily medication diary

Time frame
Recorded once per day from baseline through 12months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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