The Utilization of Ultrasound to Diagnose Pediatric Elbow Fractures

NCT07212036 | Recruiting FDA Device

• 1 other identifier: 2051060
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

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; Humerus Fractures; Jakob II Classification

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

Outcome Measures

Primary Outcomes (2)

• Patient Satisfaction

  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

  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 Outcomes (2)

• Length of Stay

  Day1

• Pain During Imaging Procedure

  Day 1

Study Arms (2)

Patients elbow pain diagnosed with ultrasound

EXPERIMENTAL

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

Patient elbow pain diagnosed with x-ray

ACTIVE COMPARATOR

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

Interventions

Ultrasound of the elbow DIAGNOSTIC_TEST

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

Patients elbow pain diagnosed with ultrasound

X-ray of elbow DIAGNOSTIC_TEST

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

Patient elbow pain diagnosed with x-ray

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pediatric patient with elbow pain

You may not qualify if:

• 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

Sponsors & Collaborators

• Nemours Children's Clinic: lead

Study Sites (1)

Nemours Children's Hospital

Orlando, Florida, 32827, United States

RECRUITING

Related Publications (10)

• Thukral BB. Problems and preferences in pediatric imaging. Indian J Radiol Imaging. 2015 Oct-Dec;25(4):359-64. doi: 10.4103/0971-3026.169466.

  PMID: 26752721 BACKGROUND

• Crowther M. Elbow pain in pediatrics. Curr Rev Musculoskelet Med. 2009 Jun;2(2):83-7. doi: 10.1007/s12178-009-9049-4. Epub 2009 Mar 14.

  PMID: 19468873 BACKGROUND

• Hall EJ. Lessons we have learned from our children: cancer risks from diagnostic radiology. Pediatr Radiol. 2002 Oct;32(10):700-6. doi: 10.1007/s00247-002-0774-8. Epub 2002 Jul 19.

  PMID: 12244457 BACKGROUND

• Avci M, Kozaci N, Beydilli I, Yilmaz F, Eden AO, Turhan S. The comparison of bedside point-of-care ultrasound and computed tomography in elbow injuries. Am J Emerg Med. 2016 Nov;34(11):2186-2190. doi: 10.1016/j.ajem.2016.08.054. Epub 2016 Aug 27.

  PMID: 27645809 BACKGROUND

• Lee SH, Yun SJ. Diagnostic Performance of Ultrasonography for Detection of Pediatric Elbow Fracture: A Meta-analysis. Ann Emerg Med. 2019 Oct;74(4):493-502. doi: 10.1016/j.annemergmed.2019.03.009. Epub 2019 May 9.

  PMID: 31080032 BACKGROUND

• Mettler FA Jr, Huda W, Yoshizumi TT, Mahesh M. Effective doses in radiology and diagnostic nuclear medicine: a catalog. Radiology. 2008 Jul;248(1):254-63. doi: 10.1148/radiol.2481071451.

  PMID: 18566177 BACKGROUND

• Burnier M, Buisson G, Ricard A, Cunin V, Pracros JP, Chotel F. Diagnostic value of ultrasonography in elbow trauma in children: Prospective study of 34 cases. Orthop Traumatol Surg Res. 2016 Nov;102(7):839-843. doi: 10.1016/j.otsr.2016.07.009. Epub 2016 Sep 30.

  PMID: 27697406 BACKGROUND

• Eckert K, Ackermann O, Janssen N, Schweiger B, Radeloff E, Liedgens P. Accuracy of the sonographic fat pad sign for primary screening of pediatric elbow fractures: a preliminary study. J Med Ultrason (2001). 2014 Oct;41(4):473-80. doi: 10.1007/s10396-014-0525-0. Epub 2014 Mar 6.

  PMID: 27278028 BACKGROUND

• Rabiner JE, Khine H, Avner JR, Friedman LM, Tsung JW. Accuracy of point-of-care ultrasonography for diagnosis of elbow fractures in children. Ann Emerg Med. 2013 Jan;61(1):9-17. doi: 10.1016/j.annemergmed.2012.07.112. Epub 2012 Nov 9.

  PMID: 23142008 BACKGROUND

• Kraus R, Berthold LD, von Laer L. [Efficient imaging of elbow injuries in children and adolescents]. Klin Padiatr. 2007 Sep-Oct;219(5):282-7. doi: 10.1055/s-2007-970588. German.

  PMID: 17763294 BACKGROUND

MeSH Terms

Conditions

Radial Head and Neck Fractures; Humeral Fractures; Elbow Fractures; Monteggia's Fracture; Emergencies

Condition Hierarchy (Ancestors)

Elbow Injuries; Arm Injuries; Wounds and Injuries; Radius Fractures; Forearm Injuries; Fractures, Bone; Fracture Dislocation; Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Ulna Fractures; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jason B Malone, DO

  Nemours Children's Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jason Malone, DO

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Orthopedic Surgeon

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: October 21, 2025
• Study Start: July 22, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 2, 2027
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)