NCT05131672 · Joseph Janicki
Cast or Operation for Medial Epicondyle Fracture Treatment in Children
(COMET)
What this study is about
This protocol describes a conducted at multiple hospitals, forward-looking randomly assigned and patient preference group of participants superiority trial of medial epicondyle fracture treatments comparing functional outcomes between children treated with operative reduction and fixation or non-operative immobilization.
View original scientific description
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.
Interventions
PROCEDURE
open reduction and internal fixation (ORIF)
open reduction and internal fixation with pin or screw fixation
PROCEDURE
cast immobilization
immobilization in a cast without reduction
Primary outcome measures
pediatric upper extremity function PROMIS computer adaptive test (PROMIS UE CAT)
Time frame: 1 year follow-up
functional and patient reported outcomes
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Chicago, Illinois
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 1, 2026 · Source of record for eligibility and locations