Elbow PainNCT07212036
The Utilization of Ultrasound to Diagnose Pediatric Elbow Fractures
A study testing Ultrasound of the elbow and X-ray of elbow in people with Elbow Pain and Supracondylar Humerus Fracture, run by Nemours Children's Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Elbow Pain, Supracondylar Humerus Fracture, Radial Head Fractures
- What is being tested?
- Ultrasound of the elbow and X-ray of elbow
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2025to 2 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Pediatric patient with elbow pain
Who cannot join
- 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)
Show all 11Show fewer
- Obvious fracture
- Open wound at or around the elbow
- Pain and swelling without trauma
- Concerns for tumor or infection
- Suspected nursemaid's elbow
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Nemours Children's Hospital
Orlando, Florida, 32827
Jason Malone, DO, 407-319-3487, jason.malone@nemours.org
About this study
Official title: 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.
Read the 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.
- Conditions
- Elbow Pain, Supracondylar Humerus Fracture, Radial Head Fractures, Radial Head or Neck Fractures, Elbow Dislocation, Humerus Fractures
- Being tested
- Ultrasound of the elbow, X-ray of elbow
- 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
- Medical subject headings
- Radial Head and Neck Fractures, Humeral Fractures, Elbow Fractures, Monteggia's Fracture, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound of the elbowDiagnostic test
An ultrasound of the elbow obtained of pediatric patients with elbow pain
X-ray of elbowDiagnostic test
An x-ray of the elbow obtained of pediatric patients with elbow pain
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Diagnostic Test: X-ray of elbow |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 1
Secondary outcomes (2)
Length of Stay
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.
Measured: Day1
Pain During Imaging Procedure
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2025
- Study start22 Jul 2025
- Primary completion1 Sep 2027 (estimated)
- Study completion2 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Elbow PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Malone, Nemours Children's Clinic
- Investigators
- Jason B Malone, DO, Principal investigator, Nemours Children's Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07212036
- Sponsor's protocol ID
- 2051060
- Status last verified
- Jan 2026
- First submitted
- 8 Sep 2025
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 26752721Crowther 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.
PubMed 19468873Hall 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.
PubMed 12244457Avci 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.
PubMed 27645809Lee 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.
PubMed 31080032Mettler 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.
PubMed 18566177Burnier 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.
PubMed 27697406Eckert 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.
PubMed 27278028Rabiner 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.
PubMed 23142008Kraus 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.
PubMed 17763294
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utilization of Ultrasound to Diagnose Pediatric Elbow Fractures: Evaluation of Cost Savings, Radiation Exposure, and Patient Satisfaction
- ClinicalTrials.gov ID
- NCT07212036
- Acronym / sponsor ID
- 2051060
- Conditions
- Elbow Pain, Supracondylar Humerus Fracture, Radial Head Fractures, Radial Head or Neck Fractures, Elbow Dislocation, Humerus Fractures
- Keywords
- elbow pain, elbow fracture, supracondylar humerus fracture, pediatric, lateral humeral condyle fracture, radial head fracture, radial neck fracture, monteggia fracture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Study start
- 22 Jul 2025 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 2 Sep 2027 (estimated)
- First posted
- 21 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients elbow pain diagnosed with ultrasound | Experimental | Diagnostic Test: Ultrasound of the elbowPatients with elbow pain will receive an ultrasound of the elbow to evaluate for the present of an elbow fractures, hemarthrosis and/or lipohemarthrosis |
| Patient elbow pain diagnosed with x-ray | Active comparator | Diagnostic Test: X-ray of elbowPatients 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. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Pediatric patient with elbow pain
Key exclusion criteria (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound of the elbowAn ultrasound of the elbow obtained of pediatric patients with elbow pain | Diagnostic test | Patients elbow pain diagnosed with ultrasound |
| X-ray of elbowAn x-ray of the elbow obtained of pediatric patients with elbow pain | Diagnostic test | Patient elbow pain diagnosed with x-ray |
Primary outcome
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.
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.
2 secondary outcomes
Length of Stay
Time frame: Day1
Pain During Imaging Procedure
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Background: PubMed 26752721Thukral BB. Problems and preferences in pediatric imaging. Indian J Radiol Imaging. 2015 Oct-Dec;25(4):359-64. doi: 10.4103/0971-3026.169466.
- Background: PubMed 19468873Crowther 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.
- Background: PubMed 12244457Hall 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.
- Background: PubMed 27645809Avci 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.
- Background: PubMed 31080032Lee 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.
- Background: PubMed 18566177Mettler 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.
- Background: PubMed 27697406Burnier 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.
- Background: PubMed 27278028Eckert 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.
- Background: PubMed 23142008Rabiner 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.
- Background: PubMed 17763294Kraus 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jason B Malone, DO principal investigator
Nemours Children's Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound of the elbow and X-ray of elbow in people with Elbow Pain and Supracondylar Humerus Fracture, run by Nemours Children's Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jason Malone, DO (407-319-3487, jason.malone@nemours.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Satisfaction (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07212036, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.