The Utilization of Ultrasound to Diagnose Pediatric Elbow Fractures

Part of paid clinical trials in Orlando, Florida.

Sponsor
Nemours Children's Clinic
Study ID
NCT07212036
Status
Recruiting
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Conditions

  • Elbow Dislocation
  • Elbow Pain
  • Humerus Fractures
  • Jakob II Classification
  • Radial Head Fractures
  • Radial Head or Neck Fractures
  • Supracondylar Humerus Fracture

Eligibility Criteria

Sex
ALL
Age
N/A - 18 Years
Healthy Volunteers
Accepted

Interventions

  • Ultrasound of the elbow — DIAGNOSTIC_TEST
    An ultrasound of the elbow obtained of pediatric patients with elbow pain
  • X-ray of elbow — DIAGNOSTIC_TEST
    An x-ray of the elbow obtained of pediatric patients with elbow pain

Study Details

The goal of this intervention trial is to learn if a ultrasound diagnosis of elbow fractures can improve care in pediatric patients seen in the emergency room. The main questions it aims to answer are: The primary outcomes measured are cost of the emergency visit, radiation exposure, time spent in the emergency department and patient satisfaction. Patients who are evaluated with ultrasounds of the elbow will be compared to patients who have x-rays of the elbow. Participants will be assigned either to the ultrasound group or x-rays group when they present with elbow pain.

Key Dates

Start date
Jul 22, 2025
Status verified
Jan 2026
Primary completion
Sep 1, 2027
Completion
Sep 2, 2027

Study Design

Enrollment
225 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Patients elbow pain diagnosed with ultrasound
    Patients with elbow pain will receive an ultrasound of the elbow to evaluate for the present of an elbow fractures, hemarthrosis and/or lipohemarthrosis
  • Active Comparator: Patient elbow pain diagnosed with x-ray
    Patients with elbow pain will review a standard two view elbow x-ray (anterior- posterior and lateral) to evaluate for a fracture around the elbow and/or hemarthrosis.

Primary Outcome Measure

Patient Satisfaction [ Time Frame: Day 1 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Nemours Children's HospitalOrlandoFlorida32827
Jason Malone, DO
[email protected]
407-319-3487

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By research site
Nemours Children's Hospital· Orlando, FL

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