Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Children and adolescents aged 5 to 15 years
- Clinical need to rule out a fracture after elbow trauma
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
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Your Study Journey
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
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
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
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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