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The Utilization of Ultrasound to Diagnose Pediatric Elbow Fractures

NCT ID: NCT07212036

Last Updated: 2025-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

225 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2027-09-02

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Keywords

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Ultrasound of the elbow

Intervention Type DIAGNOSTIC_TEST

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

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.

Group Type ACTIVE_COMPARATOR

X-ray of elbow

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Ultrasound of the elbow

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

Intervention Type DIAGNOSTIC_TEST

X-ray of elbow

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nemours Children's Clinic

OTHER

Sponsor Role lead

Responsible Party

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Jason Malone

Pediatric Orthopedic Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jason B Malone, DO

Role: PRINCIPAL_INVESTIGATOR

Nemours Children's Health

Locations

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Nemours Children's Hospital

Orlando, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jason Malone, DO

Role: CONTACT

Phone: 407-319-3487

Email: [email protected]

Facility Contacts

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Jason Malone, DO

Role: primary

References

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Beaumont WH. Additives in feed and the E.E.C. Vet Rec. 1973 Jan 27;92(4):103. doi: 10.1136/vr.92.4.103-a. No abstract available.

Reference Type BACKGROUND
PMID: 4693383 (View on PubMed)

Brogan M, Chakeres DW. Computed tomography and magnetic resonance imaging of the normal anatomy of the temporal bone. Semin Ultrasound CT MR. 1989 Jun;10(3):178-94.

Reference Type BACKGROUND
PMID: 2697336 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12244457 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27645809 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31080032 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18566177 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27697406 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27278028 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23142008 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17763294 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19468873 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form: Seven to Eleven Year old Assent

View Document

Document Type: Informed Consent Form: Parental Permission

View Document

Document Type: Informed Consent Form: Informed Consent

View Document

Document Type: Informed Consent Form: Children's Assent 12-17 years old

View Document

Other Identifiers

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2051060

Identifier Type: -

Identifier Source: org_study_id