All studies
RecruitingOBSERVATIONAL

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

The EASY Algorithm Trial is studying how well ultrasound can find broken bones in the elbow area for children and young people aged 5 to 15. The main goal is to see if ultrasound can be a good first step to check for a fracture after an elbow injury, alongside the usual X-rays. This study will help doctors understand if ultrasound is a safe and accurate way to check for these types of injuries. Participants will have an ultrasound and X-rays of their injured elbow. They'll also have a follow-up call after 6 weeks if no break was found initially, to ensure their elbow has healed well. It's an observational study, meaning researchers are watching and learning, not testing a new treatment.

At a glance

Status
Recruiting
Sponsor
Timo Munz
Enrolment target
543
Start
02 Mar 2026
Estimated completion
15 Jan 2027

What is this study about?

Imagine your child has hurt their elbow, and you're wondering if it's broken. Usually, doctors take an X-ray to find out for sure. This study, called the EASY Algorithm Trial, is looking into whether a different tool, called ultrasound, could also be used to check for broken bones in the elbow in children and young people aged 5 to 15 years old.

Ultrasound uses sound waves to create pictures of the inside of the body. It's often used to look at soft tissues, but this study wants to see if it can reliably spot fluid around the joint, which can be a sign of a fracture, and ultimately the fracture itself. The main aim is to discover if ultrasound is as accurate and safe as X-rays for spotting elbow fractures in children right after an injury.

By taking part, doctors hope to learn if ultrasound could become a helpful first screening tool. This could potentially mean fewer X-rays for some children in the future, if ultrasound proves to be just as good at finding breaks. It’s an observational study, meaning researchers are gathering information and learning, rather than testing a new medicine or treatment.

Key takeaways

  • The study assesses if ultrasound can accurately find elbow fractures in children.
  • It compares ultrasound results with standard X-rays.
  • Children aged 5-15 with suspected elbow fractures can participate.
  • Participation involves an ultrasound, X-rays, and a possible follow-up call.
  • The research aims to improve how doctors diagnose elbow injuries in young people.

Who may be eligible?

This study is looking for children and young people between 5 and 15 years old who have recently hurt their elbow and whose doctor thinks they might have a broken bone.

However, some children won't be able to join. For example, if the elbow injury is part of many injuries at once (like from a major accident), or if the injury happened more than three days ago. Also, if there's a visible bend or twist in the elbow, or if the skin is badly damaged, they can't take part.

It's also important that parents or guardians can understand German, either spoken or written, as this is where the study is being conducted. If your child has already had X-rays of the same elbow injury from another hospital, or if there are problems with their circulation or movement in the injured arm, they won't be suitable for this study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Is your child between 5 and 15 years old?
  2. Has your child recently injured their elbow?
  3. Does your child's doctor think they might have a broken elbow bone?
  4. Did the injury happen within the last 3 days (72 hours)?
  5. Are you able to speak or read German?
Answer every question to see your result.

What does participation involve?

If your child takes part in this study, they will have a few things happen. First, a doctor will use an ultrasound machine to look at their injured elbow. This is a bit like the scans used during pregnancy, where a gel is put on the skin and a small wand is moved over the area.

After the ultrasound, your child will also have standard X-rays of their elbow. This is to compare the ultrasound results with the usual way of checking for fractures. Researchers will also look at your child's medical notes. If no fracture is found during these initial visits, you will receive a phone call about 6 weeks later to check how your child's elbow has healed. There are no medications involved, and the entire process of the study is focused on gathering information about the diagnostic tools.

Potential risks and benefits

Taking part in this study may offer the potential benefit of helping medical science learn more about detecting elbow fractures in children, potentially leading to improved care in the future. The risks associated with ultrasound are very low as it doesn't use radiation. There are minimal risks associated with the standard X-rays, which are part of usual care for suspected fractures. You can decide to stop participating in the study at any time, for any reason, without it affecting your child's medical care.

Locations (13)

  • Klinikum St. Marien Amberg
    Verified postcode
    Amberg, Germany· Not yet recruiting
  • Vivantes Klinikum Neukölln
    Verified postcode
    Berlin, Germany· Recruiting
  • Helios Klinikum Berlin-Buch
    Verified postcode
    Berlin, Germany· Not yet recruiting
  • Charité - Universitätsmedizin Berlin
    Verified postcode
    Berlin, Germany· Recruiting
  • Klinikum Chemnitz
    Verified postcode
    Chemnitz, Germany· Not yet recruiting
  • Universitätsklinikum Carl Gustav Carus Dresden
    Verified postcode
    Dresden, Germany· Not yet recruiting
  • BG Klinikum Duisburg
    Verified postcode
    Duisburg, Germany· Not yet recruiting
  • Universitätsklinikum Freiburg
    Verified postcode
    Freiburg im Breisgau, Germany· Not yet recruiting
  • Universitätsklinikum Hamburg-Eppendorf
    Verified postcode
    Hamburg, Germany· Not yet recruiting
  • Klinikum Kassel
    Verified postcode
    Kassel, Germany· Not yet recruiting
  • Universitätsklinikum Schleswig-Holstein Campus Lübeck
    Verified postcode
    Lübeck, Germany· Not yet recruiting
  • Klinikum Stuttgart
    Verified postcode
    Stuttgart, Germany· Not yet recruiting

Common questions

What is an ultrasound?

An ultrasound uses sound waves to create pictures from inside the body. It’s safe and doesn't use radiation.

Why compare ultrasound to X-rays?

Doctors want to see if ultrasound can be just as good as X-rays at finding elbow fractures in children, possibly reducing the need for X-rays in some cases.

Will my child get special treatment?

No, this study is about checking diagnostic tools, not trying a new treatment. Your child will still receive standard medical care for their injury.

How long does the study last for my child?

The main part is during the initial visit for the injury, with a possible follow-up phone call about 6 weeks later if no fracture was found.

Who is running this study?

This is a research study called the EASY Algorithm Trial, involving several hospitals, aimed at improving how doctors check for elbow injuries.

How to find out more

Timo Munz, Dr. med.

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "EASY Algorithm Trial (Elbow Trauma Assessment Using Sonograp…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.