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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSunnybrook Health Sciences Centre

About this trial

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

Qualifiers

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

Disqualifiers

Open fracture

Pathological fracture

Fracture seen > 28 days after injury

Associated neurovascular injury

Trial design

Treatments tested in this trial

  • Dual Mini-fragment Plating
  • Single Precontoured Plating

Treatment groups

66 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Sunnybrook Health Sciences Centre

Lead sponsor

Canadian Orthopaedic Trauma Society

Collaborator