NCT07429344
Recruiting
Not Applicable
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)
Timo Munz20 sites in 1 country543 target enrollmentStarted: March 2, 2026Last updated:
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Timo Munz
- Enrollment
- 543
- Locations
- 20
- Primary Endpoint
- Sensitivity of sonographic joint effusion
Overview
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).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 5 Years to 15 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Sensitivity of sonographic joint effusion
Time Frame: Day 1 (On the day of enrollment in the study in the emergency department)
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.
Secondary Outcomes
- 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))
- Exact fracture pattern of the initial X-ray images as determined by blinded experts(Day 1 (On the day of enrollment in the study in the emergency department))
- Radiographic posterior fat pad signs on the initial X-ray images as determined by blinded experts(Day 1 (On the day of enrollment in the study in the emergency department))
- Interrater reliability of ultrasound findings(Day 1 (On the day of enrollment in the study in the emergency department))
- Only in cases where there is initially no radiographically confirmed fracture: pain after 6 weeks(Day 39-45 (42 days (+/- 3 days) after the day of enrollment in the study in the emergency department))
- Only in cases where there is initially no radiographically confirmed fracture: function of the upper extremity after 6 weeks(Day 39-45 (42 days (+/- 3 days) after the day of enrollment in the study in the emergency department))
- Only in cases where there is initially no radiographically confirmed fracture: Medical follow-up appointments and results of possible further radiological imaging(Day 39-45 (42 days (+/- 3 days) after the day of enrollment in the study in the emergency department))
Investigators
Timo Munz
Dr. med. Timo Munz, Principal Investigator
Charite University, Berlin, Germany
Study Sites (20)
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