Operative Versus Nonoperative Treatment of Pediatric Medial Epicondyle Fractures (COMET Trial - Cast or Operation for Medial Epicondyle Fracture Treatment in Children)

INTRODUCTION

Fractures of the medial epicondyle are a common pediatric injury, with an estimated annual incidence of 40-60/100,000 per year. The typical mechanism is a fall onto an outstretched hand, creating a valgus load at the elbow leading to avulsion of the epicondyle from pull of either the flexor-pronator mass or ulnar collateral ligament. This injury is most frequent in children between the ages of 9 and 14, and is 4 times more likely in boys. Medial epicondyle fractures are associated with elbow dislocation in about 50% of cases, and ulnar nerve dysfunction is reported to occur nearly 10% of the time. No standard of care for medial epicondyle fractures exists, as similar outcomes have been demonstrated in observational studies with both operative and nonoperative treatment. Historically, most treatment has been nonsurgical, with immobilization of the injured elbow in a long-arm cast until healing. Increasingly, however, these injuries are being treated with surgical intervention, which in most cases consists of a single screw affixing the bony piece back to its donor site on the humerus.

No prospective studies have previously been performed evaluating the treatment of medial epicondyle fractures in children. All of the current literature on this issue has serious methodological limitations, such as lack of appropriate controls, retrospective assembly of cohorts, unstandardized assessment of outcomes, and irregular assessment of negative outcomes and adverse events. A 2009 systematic review of the literature identified 14 studies in which a comparison between operative and nonoperative treatment of medial epicondyle fractures in children or adolescents was performed. Of these, all were retrospective and observational in nature, with varying outcome measures utilized in the presentation of results.

There is considerable debate among clinicians as to the optimal management of medial epicondyle fractures, however, despite the lack of clear evidence of benefit, increasingly these injuries are being managed operatively. Explanations for the trend toward surgery focus on the athletic demands of children and adolescents, and the expectations of patients, parents, and coaches of early mobilization and return to sport. Because of the ongoing uncertainty as to best practice, a randomized trial is both ethical and indicated. High-quality data is necessary to better inform the decision regarding surgery and ensure both safe and effective treatment.

SAFETY OVERSIGHT