Surgically Treated Displaced Mid-diaphyseal Clavicle Fractures

Recruiting

• Conditions: Clavicle Fracture

• Registration Number: NCT05867355
• Lead Sponsor: University of Calgary

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.

Study Timeline

• Study Start: 2021-03-22
• Status Verified: 2023-05
• Study First Submitted: 2023-05-04
• Study First Submitted QC: 2023-05-19
• Last Update Submitted: 2023-05-19
• Study First Posted: 2023-05-22
• Last Update Posted: 2023-05-22
• Primary Completion: 2025-06-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 111

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identify rationale for implant removal	4 years	To report rationale for implant removal in an appropriately powered prospective cohort study.
Determine implant removal rates	4 years	To report implant removal rates in an appropriately powered prospective cohort study.

Trial Locations

Locations (1)

Foothills Medical Centre; 🇨🇦 Calgary, Alberta, Canada