Comparing two methods for fixing broken collarbones
A Prospective Randomized Trial Comparing Dual Mini-Fragment Plating to Single Precontoured Plating of Acute Midshaft Clavicle Fractures: A Pilot Study
NA · Sunnybrook Health Sciences Centre · NCT05231343
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Sunnybrook Health Sciences Centre (other) |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05231343 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 65 with completely displaced midshaft clavicle fractures suitable for surgical fixation.
Not a fit: Patients with open fractures, significant medical comorbidities, or those unable to comply with follow-up may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Toronto, Ontario
- 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
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, Orthogonal plating, Hardware removal, Reoperation