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.
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
Open fracture
Pathological fracture
Fracture seen > 28 days after injury
Associated neurovascular injury
Parallel
Dual Mini-fragment Plating
Procedure/SurgeryPatients randomized to dual mini-fragment plating will undergo clavicle fixation using any configuration of 2.0-mm, 2.4-mm and 2.7-mm limited contact dynamic compression (LC-DCP), locking compression (LCP) or reconstruction plates (i.e., 2.4-mm superior and 2.7-mm anteroinferior). One of the two plates used must be a LC-DCP or LCP plate. Surgeons will contour the mini-fragment plate intraoperatively to fit each patient's anatomy.
Single Precontoured Plating
Procedure/SurgeryPatients randomized to a single plate construct will undergo fixation using an anatomically precontoured (superior or anterior-inferior) clavicle plate.
Removal of hardware at two years of follow-up
The proportion of people that had their clavicle hardware removed by the two year follow-up.
Radiographic union
Complete cortical bridging between the proximal and distal fragments on both views.
Reoperation causes other than hardware removal
The proportion of people undergoing reoperation for reasons other than hardware removal.
Adverse events/complications
Any event that necessitates another operative procedure or additional medical treatment. Nonunion will be defined as a lack of radiographic healing with clinical evidence of pain and motion at the fracture site at one year. Complex regional pain syndrome will be diagnosed by the presence of dysesthesia and hyperesthesia extending into the hand of the operative limb, with associated vasomotor changes, skin atrophy and diffuse osteopenia.
Operative duration
Time between skin incision to skin closure
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Sunnybrook Health Sciences Centre
Lead sponsor
Canadian Orthopaedic Trauma Society
Collaborator
