Comparing two methods for fixing broken collarbones
Official title: A Prospective Randomized Trial Comparing Dual Mini-Fragment Plating to Single Precontoured Plating of Acute Midshaft Clavicle Fractures: A Pilot Study
Run by Sunnybrook Health Sciences Centre · NCT05231343 · Data updated 2026-11-12
This study is testing whether using two small plates instead of one for fixing broken collarbones helps patients heal better and reduces the chances of needing more surgery later.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 66 (estimated) |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Status | Recruiting |
| Started | April 4, 2022 |
| Main results expected | January 2027 |
| Study ends | January 2028 |
| Registry record updated | May 24, 2023 |
| Trial ID | NCT05231343 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 to 65 with completely displaced midshaft clavicle fractures suitable for surgical fixation.
✕Probably not a fit
Patients with open fractures, significant medical comorbidities, or those unable to comply with follow-up may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to compare the effectiveness of dual mini-fragment plating versus single precontoured plating for treating acute displaced midshaft clavicle fractures. The study will assess rates of reoperation due to implant irritation, as well as the rates of fracture union and complications. By utilizing a randomized approach, the trial seeks to provide high-quality evidence on which plating technique may offer better outcomes for patients. The goal is to determine if the dual plating method can reduce the need for hardware removal while maintaining similar healing rates.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced need for reoperation in patients with clavicle fractures.
How similar studies have gone: While there is growing literature on dual plating techniques, this study represents a novel approach in directly comparing these methods in a randomized controlled setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Between 18 and 65 years of age * A completely displaced midshaft fracture of the clavicle (no cortical contact between the main proximal and distal fragments (AO/OTA 15.2A/B/C) * Fracture amenable to plate fixation with a minimum of three screws in each proximal and distal fragment Exclusion Criteria: * Open fracture * Pathological fracture * Fracture seen \> 28 days after injury * Associated neurovascular injury * Associated head injury (Glasgow Coma Scale \< 12) * Concomitant ipsilateral upper extremity fracture * Significant medical comorbidities (i.e., ASA grade IV and V) * Inability to comply with follow-up and * Lack of consent
Where it's running
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Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada Recruiting
Study contacts
- Principal investigator: Ujash Sheth, MD MSc FRCSC — Sunnybrook Health Sciences Centre
- Study coordinator: Sara Aman, BSc
- Email: orthores@sunnybrook.ca
- Phone: 416-480-4285
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.