Operative Versus Nonoperative Treatment of Pediatric Medial Epicondyle Fractures (COMET Trial - Cast or Operation for Medial Epicondyle Fracture Treatment in Children)
Ann & Robert H Lurie Children's Hospital of Chicago
Summary
This protocol describes a multicenter, prospective randomized superiority trial of medial epicondyle fracture treatments comparing functional outcomes between children treated with operative reduction and fixation or non-operative immobilization.
Description
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 nearl…
Eligibility
- Age range
- 7–17 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Provision of signed and dated informed consent form by parent or legal guardian and signed assent form if participant is older than 12 years. 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged 7-17 years inclusive 4. Diagnosis of medial epicondyle fracture with any amount of displacement 5. Fracture is acute (occurred within 10 days of assignment of treatment arm) 6. Ability to take oral medication and be willing to adhere to the immobilization regimen Exclusion Criteria: 1. Medial epicondyl…
Interventions
- Procedureopen reduction and internal fixation (ORIF)
open reduction and internal fixation with pin or screw fixation
- Procedurecast immobilization
immobilization in a cast without reduction
Location
- Lurie Children's HospitalChicago, Illinois