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Cast or Operation for Medial Epicondyle Fracture Treatment in Children

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

Who can join

Ages 7 to 17 · All sexes

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.

About the study

This protocol describes a multicenter, prospective randomized and patient preference cohort superiority trial of medial epicondyle fracture treatments comparing functional outcomes between children treated with operative reduction and fixation or non-operative immobilization.

What is being tested

• open reduction and internal fixation (ORIF) (procedure)
• cast immobilization (procedure)

Sponsor: Joseph Janicki · Participants: 334 · Started: Oct 28, 2022

Contact the study team

• Jamie Burgess, PhD · Phone: 312-227-6531
• Michelle Adzido, MA · Phone: 312-227-2492

Official record on ClinicalTrials.gov — NCT05131672

Locations in the U.S.

Conditions

• Elbow Fractures

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.