Clinical trial NCT05867355: Surgically Treated Displaced Mid-diaphyseal Clavicle Fractures
Official title: A Multi-Centre Prospective Cohort Study of Surgically Treated Displaced Mid-diaphyseal Clavicle Fractures
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Clavicle Fracture
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Unity Health Toronto
name: Winnipeg Regional Health Authority
name: Thunder Bay Regional Health Sciences Centre
name: Montreal General Hospital
name: Queen Elizabeth II Health Sciences Centre
First posted: 2023-05-22
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Skeletally mature, adult participants aged 18 years of age or older, who are treated with surgical fixation for a displaced mid-diaphyseal clavicle fracture. Exclusion criteria: Pathological fractures, clavicle non-unions, current or prior ipsilateral upper extremity injury that may impact functional outcomes, or an inability to consent or complete follow-up.

Brief summary: This prospective, multi-centre study aims to determine clinical, radiographic, and patient-reported outcomes (PROMs) following surgical fixation of displaced mid-diaphyseal clavicle fractures and to compare implant removal rates between techniques within 2-years of the procedure.

Detailed description: Given the substantially lower implant removal rate in combination with a high union rate with the dual mini-fragment technique, we do not believe there is clinical equipoise required for a randomized clinical trial.

This study is a multi-centre, prospective cohort study (11 sites confirmed to date) of all operatively treated clavicle fractures, in order to objectively evaluate all current surgical techniques used across Canada. This pragmatic approach will allow us to observe surgical decision-making, rationale for implant removal, and report on clinical, radiographic, and patient-reported outcomes for all techniques over a 2-year follow-up timeframe, for the first time.

All enrolled patients will be encouraged to begin immediate range of motion as tolerated and weightbearing as tolerated post-operatively. This will be assessed at each follow-up and any reason for delayed motion or weightbearing will be reported.

Eligibility criteria: Inclusion Criteria:

* Treated with surgical fixation for a displace mid-diaphyseal clavicle fracture.
* Aged 18 years of age or older and skeletally mature.
* Enrolled within 21 (+3 days) of injury.
* Willing and able to complete consent and study participation.

Exclusion Criteria:

* Pathological fractures.
* Clavicle non-unions.
* Current or prior ipsilateral upper extremity injury that may impact functional outcomes.
* Polytrauma patients with injuries projected to affect rehabilitation course.
* Active malignancy.
* Inability to provide consent or complete follow-up.
* Incarcerated patients.

Primary outcomes:
measure: Determine implant removal rates
timeFrame: 4 years
measure: Identify rationale for implant removal
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
Study officials:
References: