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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

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

Recruiting
5-15 years
All
Phase N/A

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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).

Eligibility

Inclusion Criteria:

Patients will be consecutively selected among those attending the Faculty of Odontology, University Complutense (Madrid, Spain) looking for orthodontic therapy.

The inclusion criteria will be as follows:

  • patients requiring maxillary and/or mandible orthodontic treatment;
  • patients with permanent dentition in stage 5 or 6 of the cervical vertebral maturation method as described by Baccetti et al. (2002);
  • minimal to moderate maxillary and/or mandibular anterior crowding at baseline (arch length discrepancy from 3-8 mm); and
  • adequate oral health (i.e. periodontal health, absence of periapical infections and untreated caries).

Exclusion Criteria:

  • subjects with periodontitis stage III or IV (Papapanou et al., 2018);
  • subjects with poor oral hygiene (represented as full-mouth plaque scores (FMPS) \>25%);
  • ongoing chronic drug therapy influencing bone metabolism (e.g. steroids, immunosuppressors or antiresorptive drugs);
  • subjects with uncontrolled systemic diseases (e.g. diabetes);
  • pregnancy and
  • subjects not willing to comply with the study visits

Study details
    Elbow Fractures
    Distal Humerus Fracture
    Pediatric Trauma
    Radius Fracture
    Olecranon Fracture
    Supracondylar Humerus Fracture

NCT07429344

Timo Munz

13 May 2026

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