RecruitingNot Applicable

EASY Algorithm Trial (Elbow Trauma Assessment Using Sonography in Children and Youth) Diagnostic Accuracy and Safety of Point-of-care Ultrasound as a Screening Tool for Suspected Elbow Fractures in Children Aged 5 to 15 Years: a Multicenter Prospective Cohort Study

Germany543 participantsStarted 2026-03-02

Plain-language summary

The goal of this observational study is to learn about the safety and accuracy of ultrasound as a screening tool to detect broken bones (fractures) in the elbow area in children and youth aged 5 to 15 years. The main question it aims to answer is: \- Can ultrasound reliably show that there is a fracture in the elbow area after an accident? Participants will: * Have an ultrasound of their elbow to look for fluid in the joint. * Have standard X-rays of their elbow to check if there is a fracture. * Have their medical records checked and answer a phone call 6 weeks later to see how their elbow has healed (only if no fracture was found during the first visit).

Who can participate

Age range

5 Years – 15 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: * children and adolescents aged 5-15 years with anamnestic and clinically justified need for the exclusion of a fracture after elbow trauma Exclusion Criteria: * elbow trauma as part of a polytrauma, * parents' insufficient German language skills (spoken or written), * trauma more than 72 hours ago, * presentation at the emergency room with current, post-traumatic external X-ray images of the affected elbow joint from another clinic or practice, * open fracture of the affected elbow joint, * skin avulsion of the affected elbow joint, * visible deformity of the affected elbow joint, * and pathological status of peripheral circulation, motor function, and/or sensitivity.

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

Sensitivity of sonographic joint effusion

Timeframe: Day 1 (On the day of enrollment in the study in the emergency department)

Trial details

NCT IDNCT07429344

SponsorTimo Munz

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-11-01

Contact for this trial

Timo Munz, Dr. med.

0049-30-450666875 timo.munz@charite.de

View on ClinicalTrials.gov More Elbow Fractures trials