Dual Mini-fragment Plating: Patients 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: Patients randomized to a single plate construct will undergo fixation using an anatomically precontoured (superior or anterior-inferior) clavicle plate.
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.
| Facility | City | Region | Status |
|---|---|---|---|
| Sunnybrook Health Sciences Centre | Toronto | Ontario | Recruiting |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05231343 on ClinicalTrials.gov ↗ ← All trials in Canada