RecruitingNot Applicable

Cast or Operation for Medial Epicondyle Fracture Treatment in Children

United States334 participantsStarted 2022-10-28

Plain-language summary

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.

Who can participate

Age range

7 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

pediatric upper extremity function PROMIS computer adaptive test (PROMIS UE CAT)

Timeframe: 1 year follow-up

Trial details

NCT IDNCT05131672

SponsorJoseph Janicki

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-12-31

Contact for this trial

Jamie Burgess, PhD

312-227-6531 jburgess@luriechildrens.org

View on ClinicalTrials.gov More Fracture Elbow trials