EASY Algorithm: Bedside ultrasound to screen children aged 5 to 15 for elbow fractures
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 by the German Section for Pediatric Traumatology (SKT)
This project will test whether a quick bedside ultrasound can reliably show or rule out elbow fractures in children aged 5 to 15 after an injury.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 543 (estimated) |
| Ages | 5 Years to 15 Years |
| Sex | All |
| Sponsor | Charite University, Berlin, Germany Academic / other |
| Locations | 13 sites (Amberg and 12 other locations) |
| Trial ID | NCT07429344 on ClinicalTrials.gov |
What this trial studies
This is a multicenter prospective cohort study across German hospitals that compares point-of-care (bedside) ultrasound to standard X-rays for children with recent elbow injuries. Clinicians will use ultrasound to look for joint fluid or other signs suggesting an elbow fracture, and all participants will receive standard elbow X‑rays as the reference test. Medical records will be reviewed and children without fractures at the visit will receive a 6‑week follow-up call to check healing and safety. The aim is to determine how accurately and safely ultrasound can be used as a screening tool to reduce unnecessary X‑rays and speed up care.
Who should consider this trial
Good fit: Children and adolescents aged 5 to 15 who present within 72 hours after an isolated elbow injury and whose clinical exam warrants fracture exclusion are ideal candidates.
Not a fit: Children with polytrauma, visible deformity, open fractures, compromised circulation or neurologic status, presentation more than 72 hours after injury, or whose parents lack sufficient German language skills are unlikely to benefit from the ultrasound screening in this protocol.
Why it matters
Potential benefit: If successful, this approach could allow quicker, radiation-free screening to rule out many elbow fractures in children.
How similar studies have performed: Several single-center studies and small pediatric series have shown promising accuracy for point-of-care ultrasound in detecting long-bone and elbow fractures, but larger multicenter prospective data remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Amberg and 12 other locations
- Klinikum St. Marien Amberg — Amberg, Germany (Not_yet_recruiting)
- Vivantes Klinikum Neukölln — Berlin, Germany (Recruiting)
- Helios Klinikum Berlin-Buch — Berlin, Germany (Not_yet_recruiting)
- Charité - Universitätsmedizin Berlin — Berlin, Germany (Recruiting)
- Klinikum Chemnitz — Chemnitz, Germany (Not_yet_recruiting)
- Universitätsklinikum Carl Gustav Carus Dresden — Dresden, Germany (Not_yet_recruiting)
- BG Klinikum Duisburg — Duisburg, Germany (Not_yet_recruiting)
- Universitätsklinikum Freiburg — Freiburg im Breisgau, Germany (Not_yet_recruiting)
- Universitätsklinikum Hamburg-Eppendorf — Hamburg, Germany (Not_yet_recruiting)
- Klinikum Kassel — Kassel, Germany (Not_yet_recruiting)
- Universitätsklinikum Schleswig-Holstein Campus Lübeck — Lübeck, Germany (Not_yet_recruiting)
- Klinikum Stuttgart — Stuttgart, Germany (Not_yet_recruiting)
- Universitätsklinikum Tübingen — Tübingen, Germany (Not_yet_recruiting)
Study contacts
- Study coordinator: Timo Munz, Dr. med.
- Email: timo.munz@charite.de
- Phone: 0049-30-450666875
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.