Actively Recruiting

Age: 5Years - 15Years
All Genders
ID07429344

EASY Algorithm Trial to Evaluate Ultrasound Accuracy and Safety as a Screening Tool for Suspected Elbow Fractures in Children Aged 5 to 15 Years

Led by Timo Munz · Updated on 2026-04-08

543

Participants Needed

13

Research Sites

10 weeks

Total Duration

On this page

Sponsors

T

Timo Munz

Lead Sponsor

U

University Hospital Dresden

Collaborating Sponsor

AI-Summary

What this Trial Is About

This observational study focuses on children and adolescents aged 5 to 15 years who have experienced an elbow injury. The main goal is to evaluate the safety and accuracy of using ultrasound as a screening tool to detect fractures in the elbow area after an accident. Researchers want to determine if ultrasound can reliably identify the presence of a fracture compared to standard X-rays. Participants will undergo an ultrasound examination of the injured elbow to check for fluid in the joint, which may indicate a fracture. They will also have standard X-rays taken of the elbow to confirm if a fracture is present. If no fracture is found during the first visit, participants will be followed up with a phone call six weeks later to assess how their elbow has healed. During the study, medical records will be reviewed and various measurements will be taken, including the sensitivity of ultrasound in detecting joint fluid, time required for ultrasound, radiation dose from X-rays, and initial X-ray assessments by physicians. Participants with no confirmed fractures will be evaluated for pain, arm function, and any additional medical visits or imaging after six weeks. The total participation time includes the initial visit and the follow-up phone call after six weeks.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 5Years - 15Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children and adolescents aged 5 to 15 years
  • Clinical need to rule out a fracture after elbow trauma
Not Eligible

You will not qualify if you...

  • Elbow injury as part of a multiple trauma
  • Insufficient German language skills by parents (spoken or written)
  • Injury occurred more than 72 hours before study enrollment
  • Current post-traumatic external X-ray images 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
  • Abnormal peripheral circulation, motor function, or sensation in the affected arm

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) in the emergency department on the day of enrollment

Diagnostic Evaluation

Duration - 1 day

Participants undergo ultrasound and X-ray examinations on the day of enrollment to assess for suspected elbow fractures.

1 visit (in-person) in the emergency department on the day of enrollment

Long-term Monitoring

Duration - 42 days (+/- 3 days)

Participants without radiographically confirmed fractures are monitored for pain, upper extremity function, and possible further imaging over approximately 6 weeks.

Follow-up assessments around 6 weeks after enrollment

Trial Site Locations

Total: 13 locations

1

Klinikum St. Marien Amberg

Amberg, Germany, 92224

Not Yet Recruiting

2

Vivantes Klinikum Neukölln

Berlin, Germany, 12351

Actively Recruiting

3

Helios Klinikum Berlin-Buch

Berlin, Germany, 13125

Not Yet Recruiting

4

Charité - Universitätsmedizin Berlin

Berlin, Germany, 13353

Actively Recruiting

5

Klinikum Chemnitz

Chemnitz, Germany, 09116

Not Yet Recruiting

6

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, Germany, 01307

Not Yet Recruiting

7

BG Klinikum Duisburg

Duisburg, Germany, 47249

Not Yet Recruiting

8

Universitätsklinikum Freiburg

Freiburg im Breisgau, Germany, 79106

Not Yet Recruiting

9

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany, 20251

Not Yet Recruiting

10

Klinikum Kassel

Kassel, Germany, 34125

Not Yet Recruiting

11

Universitätsklinikum Schleswig-Holstein Campus Lübeck

Lübeck, Germany, 23562

Not Yet Recruiting

12

Klinikum Stuttgart

Stuttgart, Germany, 70174

Not Yet Recruiting

13

Universitätsklinikum Tübingen

Tübingen, Germany, 72076

Not Yet Recruiting

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Research Team

T

Timo Munz, Dr. med.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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