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Comparing Dual Mini-fragment Plating to Single Precontoured Plating of Acute Midshaft Clavicle Fractures Trial

Clavicle Fracture

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.

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    18 to 65

Participation 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

Study Location

Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences Centre
Toronto, Ontario
Canada

Contact Study Team

Backup Contact

Katrine Milner, BSc

[email protected]
Primary Contact

Alicia Alvares, BSc

[email protected]
416-480-4285
Study Sponsored By
Sunnybrook Health Sciences Centre
Participants Required
More Information
Study ID: NCT05231343