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Contact UsCast 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
More Information
To learn more visit:
https://clinicaltrials.gov/study/NCT05131672
This page was last updated on: 3/30/2026 10:07:15 AM