Surgically Treated Displaced Mid-diaphyseal Clavicle Fractures

NCT05867355 — Unknown, 111 participants, University of Calgary

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A Multi-Centre Prospective Cohort Study of Surgically Treated Displaced Mid-diaphyseal Clavicle Fractures

Registry	NCT05867355
Status	Unknown
Study type	Observational
Enrollment	111 (Estimated)
Sponsor	University of Calgary (Other); collaborators: Unity Health Toronto, Winnipeg Regional Health Authority, Thunder Bay Regional Health Sciences Centre, Montreal General Hospital, Queen Elizabeth II Health Sciences Centre
Conditions	Clavicle Fracture
Interventions	surgical fixation (Procedure)
Dates	start 2021-03-22, primary completion 2025-06-01 (estimated), completion 2025-12-01 (estimated), first posted 2023-05-22, last updated 2023-05-22
Locations	1 site in Canada

-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.

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+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.

+Arms and interventions

surgical fixation (Procedure): compare implant removal rates between surgical fixation techniques.

+Outcome measures

Primary outcomes

Determine implant removal rates [4 years]: To report implant removal rates in an appropriately powered prospective cohort study.
Identify rationale for implant removal [4 years]: To report rationale for implant removal in an appropriately powered prospective cohort study.

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
Foothills Medical Centre	Calgary, Alberta	Canada	Recruiting