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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
Biomarkers evaluation
Other interventionParticipants will undergo blood test that evaluate several inflammatory biomarkers before and after the surgery
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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
Pain assessment
Visual analog pain scale from 0 to 10. 0 would be no pain, 10 worst pain
Opioïds consumption
Daily medication diary
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: