NCT05231343 Comparing Dual Mini-fragment Plating to Single Precontoured Plating of Acute Midshaft Clavicle Fractures Trial
| NCT ID | NCT05231343 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sunnybrook Health Sciences Centre |
| Condition | Clavicle Fracture |
| Study Type | INTERVENTIONAL |
| Enrollment | 66 participants |
| Start Date | 2022-04-04 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 66 participants in total. It began in 2022-04-04 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The rate of surgical fixation of fractures of the collarbone (i.e., midshaft clavicle) has exponentially increased in recent years; however, the rate of repeat procedures for removal of these implants (i.e., plates) due to irritation remains high. Despite technological advances in implant design, nearly one in four patients with a surgically fixed collarbone ultimately undergoes removal of their implant. More recently, there has been a growing body of literature demonstrating the effectiveness of using two smaller caliber plates, which have been found to have similar rates of implant removal. As such, the proposed randomized clinical trial seeks to be the first level I study to directly compare dual mini-fragment plating of acute displaced midshaft clavicle fractures to single precontoured plating. The investigators hypothesize that dual mini-fragment plating will result in lower rates of reoperation with similar rates of union and complication.
Eligibility 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
Contact & Investigator
Ujash Sheth, MD MSc FRCSC
PRINCIPAL INVESTIGATOR
Sunnybrook Health Sciences Centre
Frequently Asked Questions
Who can join the NCT05231343 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Clavicle Fracture. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05231343 currently recruiting?
Yes, NCT05231343 is actively recruiting participants. Contact the research team at orthores@sunnybrook.ca for enrollment information.
Where is the NCT05231343 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT05231343 clinical trial?
NCT05231343 is sponsored by Sunnybrook Health Sciences Centre. The principal investigator is Ujash Sheth, MD MSc FRCSC at Sunnybrook Health Sciences Centre. The trial plans to enroll 66 participants.