Cast or Operation for Medial Epicondyle Fracture Treatment in Children
Trial Parameters
Brief 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.
Eligibility Criteria
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 epicondyle fragment that is incarcerated within joint 2. Presence of other fractures about the ipsilateral elbow 3. Presence of pathologic fracture, open fracture 4. Have metabolic or neuromuscular diagnosis 5. Patient and parents are unable to adhere to procedures or complete follow-up due to insufficient comprehension of consent form or surveys or developmental delay.