Comparing cast versus surgery for treating elbow fractures in children
Official title: Operative Versus Nonoperative Treatment of Pediatric Medial Epicondyle Fractures (COMET Trial - Cast or Operation for Medial Epicondyle Fracture Treatment in Children)
Run by Ann & Robert H Lurie Children's Hospital of Chicago · NCT05131672 · Data updated 2026-11-12
This study is testing whether treating elbow fractures in kids with surgery works better than using a cast to see which method helps them heal and function better.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 7 Years to 17 Years |
| Sex | All |
| Enrollment | 334 (estimated) |
| Sponsor | Ann & Robert H Lurie Children's Hospital of Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Status | Recruiting |
| Started | October 28, 2022 |
| Main results expected | December 31, 2030 |
| Study ends | July 31, 2031 |
| Registry record updated | July 1, 2026 |
| Trial ID | NCT05131672 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 7-17 with an acute medial epicondyle fracture that has occurred within the last 10 days.
✕Probably not a fit
Patients with incarcerated fragments, other fractures in the same elbow, or those with metabolic or neuromuscular disorders may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter, prospective randomized trial aims to evaluate the functional outcomes of two treatment methods for medial epicondyle fractures in children: operative reduction and fixation versus non-operative immobilization. The study will enroll children aged 7-17 who have sustained an acute medial epicondyle fracture and will compare the effectiveness of these two approaches. By addressing the lack of standard care and previous methodological limitations in existing literature, this trial seeks to provide clearer guidance on the best treatment options for this common pediatric injury.
Why it matters
Potential benefit: If successful, this study could establish a more effective treatment protocol for medial epicondyle fractures in children, potentially improving recovery outcomes.
How similar studies have gone: This approach is novel as no prospective studies have previously evaluated treatment options for medial epicondyle fractures in children.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Lurie Children's Hospital
Chicago, Illinois, United States Recruiting
Study contacts
- Principal investigator: Joseph Janicki, MD — Ann and Robert H. Lurie Hospital Chicago
- Study coordinator: Jamie Burgess, PhD
- Email: jburgess@luriechildrens.org
- Phone: 312-227-6531
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.