Surgically Treated Displaced Mid-diaphyseal Clavicle Fractures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

111 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-22

Study Completion Date

2025-12-01

Brief Summary

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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

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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.

Conditions

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Clavicle Fracture

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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surgical fixation

compare implant removal rates between surgical fixation techniques.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes