NCT05075382

Brief Summary

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2022

Typical duration for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 12, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

December 11, 2023

Status Verified

December 1, 2023

Enrollment Period

2.4 years

First QC Date

September 9, 2021

Last Update Submit

December 8, 2023

Conditions

Elbow FractureNeurologic Deficits

Keywords

heterotopic ossificationtraumatic brain injury

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (8)

  • Quick-DASH

    Baseline, 2 weeks post-op, 3-6-12 months post-op

  • Patient rated elbow evaluation (PREE)

    Baseline, 2 weeks post-op, 3-6-12 months post-op

  • Range of motion

    Baseline, 2 weeks post-op, 3-6-12 months post-op

  • McGill Pain Questionnaire (MPQ-Short Form V2)

    Baseline, 2 weeks post-op, 3-6-12 months post-op

  • Neuropathic pain questionnaire (SLANSS)

    Baseline, 2 weeks post-op, 3-6-12 months post-op

  • +3 more secondary outcomes

Study Arms (1)

Pilot group

Group of 40 patients that will act as observationnal group for this study

Procedure: Elbow surgery for fracture

Interventions

Elbow surgery for fracturePROCEDURE

This group will undergo a surgery in order to fix a broken elbow.

Pilot group

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Inflammatory factors (biomarkers, cytokines, chemokine such as interleukins, P substance, TNF alpha, osteopontin, S100B, NSE, GFAP)

MeSH Terms

Conditions

Elbow FracturesNeurologic ManifestationsOssification, HeterotopicBrain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Elbow InjuriesArm InjuriesWounds and InjuriesFractures, BoneNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic ProcessesBrain InjuriesBrain DiseasesCentral Nervous System DiseasesCraniocerebral TraumaTrauma, Nervous System

Study Officials

  • Dominique Rouleau, MD

    Université de Montréal

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 9, 2021

First Posted

October 12, 2021

Study Start

July 1, 2022

Primary Completion

December 1, 2024

Study Completion

December 31, 2025

Last Updated

December 11, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share