Fracture and Neurological Injury (FIRE)

Fracture and Neurological Injury: Prospective Multicentre Study on Risk Factors of Complications and Opioid Intake in Elbow Trauma

The goal of the project is to describe novel factors affecting outcome after elbow fracture surgery with an in-depth evaluation of the role played by neuro inflammation from concomitant peripheral nerve injury or head injury in elbow fracture outcomes.

Among all upper limb fractures, elbow trauma is the most frequently associated with a severe impact on patient function and quality of life. One of the main reasons for poor outcomes is the complexity of the elbow joint, which involves three bones and two planes of motion, essential to position the hand in space. The flexion extension axis is crucial for eating and hygiene, while forearm pro-supination is mandatory for most professions, from office work to manual labour.

Study Overview

• Status: Withdrawn
• Conditions: Elbow Fracture; Neurologic Deficits
• Intervention / Treatment: Procedure: Elbow surgery for fracture

Detailed Description

Elbow fractures are a challenging clinical problem. The advancement of science and technology has made major contributions to improve outcomes. Nonetheless, even with an anatomical restoration of the bone architecture, many patients stay with major limitations and pain. In clinical practice, it is striking to see how two patients with a similar elbow injury can exhibit completely opposite presentations: one who has completely healed from his/her injury and the other who has a stiff and painful elbow. The reasons for these changeable outcomes are unclear.

The investigator hypothesize that many of the answers will be related to the neurological system. This would explain why most studies strictly focusing on the orthopedic component of upper limb injury have yielded little improvement in preventing the adverse outcomes experienced by patients.

Following surgical treatment of an elbow fracture, patients often present with complications. Indeed, one third of patients complain of ulnar nerve symptoms after distal humerus fracture fixation, and 50% of patients treated surgically for elbow fracture-dislocations will have disabling stiffness and heterotopic ossification (HO). HO results from resident cells of mesenchymal origin in soft tissues transforming into bone. Furthermore, approximately half of all patients with fractures feel significant pain leading to persistent narcotic intake 3 months post injury; 40% will suffer from a neuropathic type of pain, which is poorly controlled by narcotic medication. Opioid usage is also related to increased sensitivity to pain (hyperalgesia) and dissatisfaction. Complications from opioids prolonged usage are numerous, from constipation to death due to an overdose. Canada is second worldwide, behind the United States, when it comes to opioid use and mortality secondary to opioid use. The majority of opioid dependant users were first exposed to these substances through medical prescriptions. This makes it imperative to improve the scinetific community understanding of pain mechanisms and find alternative treatments to opiates in the management of these injuries.

In view of these observations, the investigator's research must focus on something other than "satisfactory radiological results" in patients with elbow injuries. To this end, a multidisciplinary approach is needed. The investigators oversee research in elbow trauma, neurotrauma and have an expertise in upper limb evaluation. To improve the understanding of the underlying physiological principles that contribute to pain and chronic stiffness, one of the topics targeted by the investigator is the role of neuro-inflammation (NI) in chronic pain and functional limitation in elbow trauma. The surgical factors that increase NI will allow surgeons to choose different therapeutic options and develop novel treatments.

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients presenting with elbow fracture that needs to be treated surgically.

Description

Inclusion Criteria:

• Adult 18 years or older with an acute elbow fracture and dislocation less than a week old
• Open or arthroscopic surgery as the chosen treatment

Exclusion Criteria:

• Patient with a history of ipsilateral trauma, neurological disorder or major pathology.
• 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 a historic of TBI
• Patient with chronic medicated pain

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pilot group; Group of 40 patients that will act as observationnal group for this study	Procedure: Elbow surgery for fracture; This group will undergo a surgery in order to fix a broken elbow.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of inflammatory factors with blood tests	interleukins, P substance, TNF alpha, osteopontin, S100B, NSE, GFAP	Pre-op
Measurement of inflammatory factors with blood tests	interleukins, P substance, TNF alpha, osteopontin, S100B, NSE, GFAP	During surgery
Measurement of inflammatory factors with blood tests	interleukins, P substance, TNF alpha, osteopontin, S100B, NSE, GFAP	3 months post-op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quick-DASH	Quick-DASH outcome measures (scores range from 0 (no disability) to 100 (most severe disability))	Baseline, 2 weeks post-op, 3-6-12 months post-op
Patient rated elbow evaluation (PREE)	20 item questionnaire allowing patients to rate their levels of elbow pain and disability from 0 to 100 (0= no disability)	Baseline, 2 weeks post-op, 3-6-12 months post-op
Range of motion	Evaluation of the elbow range of motion with goniometer by a train physical therapist	Baseline, 2 weeks post-op, 3-6-12 months post-op
McGill Pain Questionnaire (MPQ-Short Form V2)	Self-reported measure of pain. No scale	Baseline, 2 weeks post-op, 3-6-12 months post-op
Neuropathic pain questionnaire (SLANSS)	questionnaire designed to identify pain of predominantly neuropathic origin. A score over 12 signals a predominantly neuropathic type of pain	Baseline, 2 weeks post-op, 3-6-12 months post-op
Euro-Qol Group 5Q5D	Questionnaire evaluating qaulity of life. No scale	Baseline, 2 weeks post-op, 3-6-12 months post-op
Tourniquet	Verify our capacity to identify whether the use of tourniquet has an impact on neuroinflammation	Per-op
Nerve dissection	Verify our capacity to identify whether the nerve dissection has an impact on neuroinflammation	Pero-op

Collaborators and Investigators

• Sponsor: Université de Montréal
• Investigators: Principal Investigator: Dominique Rouleau, MD, Université de Montréal

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: September 9, 2021
• First Submitted That Met QC Criteria: September 29, 2021
• First Posted (Actual): October 12, 2021

Study Record Updates

• Last Update Posted (Estimated): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: traumatic brain injury; heterotopic ossification
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Arm Injuries; Elbow Injuries; Fractures, Bone; Trauma, Nervous System; Neurologic Manifestations; Elbow Fractures
• Other Study ID Numbers: FIRE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No