Recruiting

Ultrasound vs. X-Rays

Sponsor:

Nemours Children's Clinic

Code:

NCT07212036

Conditions

Elbow Pain

Supracondylar Humerus Fracture

Radial Head Fractures

Radial Head or Neck Fractures

Elbow Dislocation

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Accepted

Interventions

Ultrasound of the elbow

X-ray of elbow

Study Details

Brief summary:

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.

Conditions

Elbow Pain

Supracondylar Humerus Fracture

Radial Head Fractures

Radial Head or Neck Fractures

Elbow Dislocation

Study ID

NCT07212036

Start date

Jul 22, 2025

Status verified date

Jan, 2026

Completion date

Sep 2, 2027

Anticipated

Primary completion date

Sep 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Accepted

Inclusion Criteria:

• Pediatric patient with elbow pain

Exclusion Criteria:

  • Polytrauma (more than one injury)
  • Deformity of the arm including the elbow
  • Pain in any other location than the elbow
  • Pain in other parts of the same limb including the, wrist, forearm, shoulder, hand
  • Pain in other limbs,
  • Puckering of the skin (skin indentation)
  • Obvious fracture
  • Open wound at or around the elbow
  • Pain and swelling without trauma
  • Concerns for tumor or infection
  • Suspected nursemaid's elbow

Study Design

Enrollment

225 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

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.

Interventions

Ultrasound of the elbow

An ultrasound of the elbow obtained of pediatric patients with elbow pain

X-ray of elbow

An x-ray of the elbow obtained of pediatric patients with elbow pain

Primary outcome measure

  • Patient Satisfaction [ Time Frame: Day 1 ]
  • cost of treatment [ Time Frame: Day 1 ]

Central Contacts and Locations

Central contacts

Jason Malone, DO

407-319-3487jason.malone@nemours.org

Locations

Nemours Children's Hospital

Recruiting

Orlando, Florida, United States, 32827

Contacts

Jason Malone, DO

407-319-3487jason.malone@nemours.org

More Information

Sponsor

Nemours Children's Clinic

Last update posted

Jan 29, 2026

Last verified

Jan, 2026

Keywords

  • elbow pain
  • elbow fracture
  • supracondylar humerus fracture
  • pediatric
  • lateral humeral condyle fracture
  • radial head fracture
  • radial neck fracture
  • monteggia fracture
  • elbow dislocation
  • radial head dislocation
  • emergency department
  • ultrasound

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nemours Children's Clinic on 2026-01-29.