The Utilization of Ultrasound to Diagnose Pediatric Elbow Fractures

January 27, 2026 updated by: Jason Malone, Nemours Children's Clinic

The Utilization of Ultrasound to Diagnose Pediatric Elbow Fractures: Evaluation of Cost Savings, Radiation Exposure, and Patient Satisfaction

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The goal of this study is to evaluate whether the use of point-of-care ultrasonography (PoCUS) for elbow trauma evaluation results in less radiation exposure, less cost of treatment and shorter length of stay in Emergency Room (ER) than use of radiography. The study team will use PoCUS to screen for isolated elbow fractures presented to the ER. The researchers will compare cost of treatment both for patients and health care system and length of stay in both the groups. This study will also evaluate whether the use of PoCUS alleviates discomfort to pediatric patients and increases satisfaction of the families as compared to the use of radiography. Family satisfaction surveys and patient pain surveys will act as direct measures of family satisfaction. The study team will use length of stay and cost of treatment as indirect measures of satisfaction. The researchers will compare amount of comfort and satisfaction with and without the use of PoCUS to evaluate the overall patient comfortability and patient satisfaction. The researchers hypothesize that the use of PoCUS will reduce time of emergency department length of stay, radiation exposure, pain or discomfort and cost, and will increase patient's and family satisfaction.

Study Type

Interventional

Enrollment (Estimated)

225

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32827
        • Recruiting
        • Nemours Children's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Diagnostic test: Ultrasound of the elbow
An ultrasound of the elbow obtained of pediatric patients with elbow pain
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.
Diagnostic test: X-ray of elbow
An x-ray of the elbow obtained of pediatric patients with elbow pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Satisfaction
Time Frame: Day 1
The patient satisfaction scores will be collected by the research assistant using the Emergency Department Consumer Assessment of Healthcare Providers and Systems Survey (ED CAHPS Survey) Version 1.0. The survey will be scored based on the recommended guidelines from CAHPS. Please see the attached scoring guidelines for further information.
Day 1
cost of treatment
Time Frame: Day 1

Cost of treatment: will be based from hospital charges in United States Dollars (USD). The cost will be based off the cash charge for the 3-4 view x-rays of the elbow. This information is readily available online and is currently $652.00

. It would be impossible to base from reimbursement as each insurance provider reimburses at a different rate. No cost will be assigned for the ultrasound as it is a point of care (POC) device that has no charge.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Stay
Time Frame: Day1
calculated and recorded in EPIC. The time in minutes will be calculated from from the start when the patient is registered in the ED. All patients are registered and triaged when they enter the ED lobby. The time in ED in Epic is then stopped when the patient is discharged by the nurse.
Day1
Pain During Imaging Procedure
Time Frame: Day 1
Patient pain scores who are younger than 3 years will be collected by using The FLACC score (for face, legs, activity, cry, concealability) The pain scores will be collected using the Wong-Baker FACES Pain Rating Scale for patients ages equal to and greater than 3 years old.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nemours Children's Clinic

Investigators

  • Principal Investigator: Jason B Malone, DO, Nemours Children's Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2025

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 2, 2027

Study Registration Dates

First Submitted

September 8, 2025

First Submitted That Met QC Criteria

September 30, 2025

First Posted (Actual)

October 21, 2025

Study Record Updates

Last Update Posted (Actual)

January 29, 2026

Last Update Submitted That Met QC Criteria

January 27, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2051060

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Supracondylar Humerus Fracture

Clinical Trials on Ultrasound of the elbow

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Algeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe