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Recruiting NCT07429344

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

— Observational Elbow Fractures Distal Humerus Fracture Pediatric Trauma Radius Fracture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Elbow Fractures, Distal Humerus Fracture, Pediatric Trauma, Radius Fracture. Basic parameters: 5 years — 15 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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 by the German Section for Pediatric Traumatology (SKT)

Overview

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).

Primary outcome measures

  • Sensitivity of sonographic joint effusion [Time frame: Day 1 (On the day of enrollment in the study in the emergency department)]
Secondary outcome measures (11)
  • Time required for ultrasound examination [Time frame: 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 [Time frame: Day 1 (On the day of enrollment in the study in the emergency department)]
  • Radiation dose from X-ray imaging (dose area product) [Time frame: 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 [Time frame: Day 1 (On the day of enrollment in the study in the emergency department)]
  • Treatment of the injury [Time frame: 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 [Time frame: 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 [Time frame: Day 1 (On the day of enrollment in the study in the emergency department)]
  • Interrater reliability of ultrasound findings [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Day 39-45 (42 days (+/- 3 days) after the day of enrollment in the study in the emergency department)]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 13 centers
  • Klinikum St. Marien Amberg — Amberg
  • Vivantes Klinikum Neukölln — Berlin
  • Helios Klinikum Berlin-Buch — Berlin
  • Charité - Universitätsmedizin Berlin — Berlin
  • Klinikum Chemnitz — Chemnitz
  • Universitätsklinikum Carl Gustav Carus Dresden — Dresden
  • BG Klinikum Duisburg — Duisburg
  • Universitätsklinikum Freiburg — Freiburg im Breisgau
  • … and 5 more centers

Identifiers

NCT: NCT07429344 · EA2/215/25

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗