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

NCT07429344 | Recruiting DMC

• 1 other identifier: EA2/215/25
• Study Type: observational
• Target: 543
• Locations: 1 country
• Sites: 13

Brief 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).

Conditions

Distal Humerus Fracture; Pediatric Trauma; Radius Fracture; Elbow Fractures; Olecranon Fracture; Supracondylar Humerus Fracture

Keywords

EASY Algorithm Trial; pediatric trauma; Diagnostic accuracy; point-of-care ultrasound; elbow fractures; children; Elbow Trauma Assessment using Sonography in Children and Youth; German Section for Pediatric Traumatology (SKT); screening tool; supracondylar humerus fracture

Outcome Measures

Primary Outcomes (1)

• Sensitivity of sonographic joint effusion

  Sensitivity of sonographic joint effusion examination following a standardized procedure and uniform training of the physicians performing the examination in the detection of radiologically confirmed elbow fractures, as assessed by blinded experts.

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

Secondary Outcomes (11)

• Time required for ultrasound examination

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

• The additional time patients spend in the emergency room due to X-ray examinations

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

• Radiation dose from X-ray imaging (dose area product)

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

• The initial assessment of the X-ray images by the attending physician in the emergency department

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

• Treatment of the injury

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

Other Outcomes (1)

• Potential confounders of the primary outcome

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

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All children and adolescents who present to the emergency departments of the participating hospitals with elbow pain following an accident will be screened for inclusion in the study during the study period until the statistically determined required number of cases has been reached.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Tuebingen: collaborator
• Timo Munz: lead
• University Hospital Dresden: collaborator
• Helios Klinikum Berlin-Buch: collaborator
• Abteilung für Orthopädie und Unfallchirurgie BG Unfallklinik Duisburg: collaborator
• University Hospital Freiburg: collaborator
• Universitätsklinikum Hamburg-Eppendorf: collaborator
• Klinikum Kassel: collaborator
• Vivantes Hospital Berlin Neukölln: collaborator
• Klinikum Stuttgart: collaborator
• Klinikum Chemnitz gGmbH: collaborator
• University Hospital Lübeck: collaborator

Study Sites (13)

Klinikum St. Marien Amberg

Amberg, 92224, Germany

NOT YET RECRUITING

Vivantes Klinikum Neukölln

Berlin, 12351, Germany

RECRUITING

Helios Klinikum Berlin-Buch

Berlin, 13125, Germany

NOT YET RECRUITING

Charité - Universitätsmedizin Berlin

Berlin, 13353, Germany

RECRUITING

Klinikum Chemnitz

Chemnitz, 09116, Germany

NOT YET RECRUITING

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, 01307, Germany

NOT YET RECRUITING

BG Klinikum Duisburg

Duisburg, 47249, Germany

NOT YET RECRUITING

Universitätsklinikum Freiburg

Freiburg im Breisgau, 79106, Germany

NOT YET RECRUITING

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20251, Germany

NOT YET RECRUITING

Klinikum Kassel

Kassel, 34125, Germany

NOT YET RECRUITING

Universitätsklinikum Schleswig-Holstein Campus Lübeck

Lübeck, 23562, Germany

NOT YET RECRUITING

Klinikum Stuttgart

Stuttgart, 70174, Germany

NOT YET RECRUITING

Universitätsklinikum Tübingen

Tübingen, 72076, Germany

NOT YET RECRUITING

MeSH Terms

Conditions

Elbow Fractures; Humeral Fractures, Distal; Radius Fractures; Olecranon Fracture

Condition Hierarchy (Ancestors)

Elbow Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone; Humeral Fractures; Forearm Injuries; Ulna Fractures

Central Study Contacts

Timo Munz, Dr. med.

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. med. Timo Munz, Principal Investigator

Study Record Dates

• First Submitted: February 15, 2026
• First Posted: February 24, 2026
• Study Start: March 2, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): January 15, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Individual participant data will be made available beginning 6 months following the publication of the primary manuscript in a peer-reviewed journal. To ensure long-term reproducibility and transparency, the data will be hosted in a permanent data repository \[e.g., Zenodo\] with no set expiration date.
• Access Criteria: De-identified individual participant data and supporting documents (Protocol, SAP, Analytic Code) will be made available to qualified researchers for legitimate scientific purposes. Access will be managed through a restricted-access data repository \[e.g., Zenodo\]. To obtain access, researchers must submit a formal request through the repository's 'Request Access' feature, including a brief research proposal and a statistical analysis plan. Requests will be reviewed by the study investigators to ensure scientific merit and ethical compliance. Upon approval, and following the signing of a Data Access Agreement to protect participant confidentiality, the data will be released directly through the repository platform.

Locations

DE (13)