A Multi-Centre Prospective Cohort Study of Surgically Treated Displaced Mid-diaphyseal Clavicle Fractures
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Clavicle Fracture
- Sponsor
- University of Calgary
- Enrollment
- 111
- Locations
- 1
- Primary Endpoint
- Identify rationale for implant removal
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Prism Schneider
Orthopedic Trauma Research Lead
University of Calgary
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.
Outcomes
Primary Outcomes
Identify rationale for implant removal
Time Frame: 4 years
To report rationale for implant removal in an appropriately powered prospective cohort study.
Determine implant removal rates
Time Frame: 4 years
To report implant removal rates in an appropriately powered prospective cohort study.