Cast or Operation for Medial Epicondyle Fracture Treatment in Children (COMET)

Study Details

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

Conditions: Fracture Elbow

Study ID

ORT23136 (2022-4916_COMET)

Study Description

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 Requirements

Inclusion Criteria

  • Provision of signed and dated informed consent form by parent or legal guardian and signed assent form if participant is older than 12 years.
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Male or female, aged 7-17 years inclusive
  • Diagnosis of medial epicondyle fracture with any amount of displacement
  • Fracture is acute (occurred within 10 days of assignment of treatment arm)
  • Ability to take oral medication and be willing to adhere to the immobilization regimen

Exclusion Criteria

  • Medial epicondyle fragment that is incarcerated within joint
  • Presence of other fractures about the ipsilateral elbow
  • Presence of pathologic fracture, open fracture
  • Have metabolic or neuromuscular diagnosis
  • 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.

Principal Investigator

Monica Payares-Lizano

More Information


This page was last updated on: 3/30/2026 10:07:15 AM