Evaluating outcomes of surgical treatment for clavicle fractures
A Multi-Centre Prospective Cohort Study of Surgically Treated Displaced Mid-diaphyseal Clavicle Fractures
University of Calgary · NCT05867355
This study is testing how well different surgical methods for fixing broken collarbones work and how often the hardware needs to be removed, while helping patients start moving again right after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 111 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Calgary (other) |
| Locations | 1 site (Calgary, Alberta) |
| Trial ID | NCT05867355 on ClinicalTrials.gov |
What this trial studies
This prospective, multi-centre study investigates the clinical, radiographic, and patient-reported outcomes following surgical fixation of displaced mid-diaphyseal clavicle fractures. It aims to compare implant removal rates between different surgical techniques over a two-year follow-up period. The study will involve 11 sites across Canada and will focus on observing surgical decision-making and the rationale for implant removal. Patients will be encouraged to begin immediate range of motion and weightbearing post-operatively, with assessments conducted at each follow-up visit.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have undergone surgical fixation for a displaced mid-diaphyseal clavicle fracture.
Not a fit: Patients with pathological fractures, clavicle non-unions, or other significant upper extremity injuries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve surgical techniques and outcomes for patients with clavicle fractures.
How similar studies have performed: Other studies have shown promising results with similar surgical approaches, but this study aims to provide comprehensive data across multiple techniques.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Calgary, Alberta
- Foothills Medical Centre — Calgary, Alberta, Canada (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Clavicle Fracture