Ultrasound for Elbow Fractures

Overseen By Jason Malone, DO

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Nemours Children's Clinic

Disqualifiers: Polytrauma, Deformity, Tumor, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

225 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether ultrasounds can improve care for children with elbow pain in the emergency room, compared to x-rays. The researchers aim to determine if ultrasounds can reduce costs, lower radiation exposure, shorten emergency visits, and boost patient satisfaction. Children visiting the ER with elbow pain may qualify for this study, unless they have multiple injuries or certain obvious fractures. Participants will have their elbow examined with either an ultrasound or a traditional x-ray. As an unphased trial, this study offers an opportunity to contribute to innovative research that could enhance emergency care for children.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that ultrasound is safe for diagnosing elbow fractures in pediatric patients?

Research has shown that using ultrasound to check for elbow fractures in children is generally safe. Unlike x-rays, ultrasounds do not involve radiation, eliminating the risk of radiation exposure. Ultrasounds are painless and provide quick results, enhancing patient comfort. No major safety concerns have been reported with using ultrasounds for this purpose. Evidence strongly suggests that ultrasound is well-tolerated and safe for diagnosing elbow fractures in children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using ultrasound to diagnose elbow fractures because it offers a non-invasive, radiation-free alternative to traditional X-rays. Unlike X-rays, which require exposure to radiation, ultrasound uses sound waves to create images, making it safer, especially for repeat evaluations. Additionally, ultrasound can detect soft tissue conditions like hemarthrosis or lipohemarthrosis, which X-rays might miss. This approach not only enhances diagnostic accuracy but also adds a layer of safety for patients.

What evidence suggests that using ultrasound for diagnosing elbow fractures in pediatric patients is effective?

Research has shown that using ultrasound to detect elbow fractures in children is both effective and efficient. In this trial, some participants will have their elbow pain diagnosed with ultrasound, which can accurately identify fractures that other methods might miss. This is particularly beneficial because ultrasounds do not expose patients to radiation, unlike x-rays. Additionally, ultrasounds can be faster, reducing waiting time in the emergency room. In some cases, a quick bedside ultrasound detected fractures initially overlooked. Overall, ultrasound serves as a valuable tool for detecting elbow fractures in children. Meanwhile, other participants in this trial will have their elbow pain diagnosed using x-ray, the standard method for evaluating fractures. ^{1 6 7 8 9}

Who Is on the Research Team?

Jason B Malone, DO

Principal Investigator

Nemours Children's Health

Are You a Good Fit for This Trial?

This trial is for children who come to the emergency room with elbow pain due to various types of fractures or dislocations. The study aims to include those who need imaging tests like an ultrasound or X-ray to diagnose their condition.

Inclusion Criteria

My child is experiencing elbow pain.

Exclusion Criteria

Polytrauma (more than one injury)

I have a deformity in my arm or elbow.

My skin is puckered or indented.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Diagnosis

Participants are assigned to either the ultrasound group or x-ray group for diagnosis of elbow fractures

1 day

1 visit (in-person)

Follow-up

Participants are monitored for patient satisfaction, cost of treatment, length of stay, and pain during imaging procedure

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Ultrasound
• X-ray

Trial Overview The study is testing whether using ultrasound for diagnosing elbow fractures in kids is as effective as traditional X-rays. It looks at cost, radiation exposure, time in the ER, and how happy patients are with their care.

How Is the Trial Designed?

Group I: Patients elbow pain diagnosed with ultrasound Experimental Treatment 1 Intervention

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 II: Patient elbow pain diagnosed with x-ray Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Nemours Children's Clinic

Lead Sponsor

Trials

128

Recruited

18,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12144939/

Utility of point-of-care ultrasound for the diagnosis of elbow ... In the study, the elbow POCUS showed a positive result on 2 patients who weren't diagnosed initially on the emergency traumatology department.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0735675723007003/pdf

The diagnostic value of sonographic findings in pediatric ... Sonography is a beneficial imaging modality for detecting elbow fractures in children, considering the lack of radiation exposure and time efficiency.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38142484/

The diagnostic value of sonographic findings in pediatric ... Conclusions: Sonography is a valuable diagnostic tool for the assessment of pediatric elbow injuries, and it can be capable of confirmation or ...

4. annemergmed.com annemergmed.com/article/S0196-0644(12)01297-8/pdf

Accuracy of Point-of-Care Ultrasonography for Diagnosis of ... Conclusion: Point-of-care ultrasonography is highly sensitive for elbow fractures, and a negative ultrasonographic result may reduce the need ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05602077

NCT05602077 | Accuracy of Sonography in Elbow Trauma The effectiveness of ultrasound in the detection of fractures in adults with suspected upper or lower limb injury: a systematic review and subgroup meta ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05870345

Pocket Sized Ultrasound (PsUS) and Pediatric Elbow ... The main purpose of this project is to investigate the accuracy of pocket-sized ultrasound (PsUS) in the diagnosis of pediatric elbow fractures.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0196064419302288

Diagnostic Performance of Ultrasonography for Detection ... The present meta-analysis revealed that ultrasonography performed well for detecting pediatric elbow fracture (sensitivity 96%, specificity 89%).

8. researchgate.net researchgate.net/publication/390524922_A_cross-sectional_study_to_determine_the_health_outcomes_benefits_of_using_ultrasound_in_the_treatment_of_elbow_fractures

(PDF) A cross-sectional study to determine the health ... (PDF) A cross-sectional study to determine the health outcomes benefits of using ultrasound in the treatment of elbow fractures.

9. ijspt.scholasticahq.com ijspt.scholasticahq.com/article/74018-the-use-of-msk-ultrasound-in-the-evaluation-of-elbow-ulnar-collateral-ligament-injuries

The Use of MSK Ultrasound in the Evaluation of Elbow ... Since MSK-US is not a radiation-based technology, its use is generally safe and painless for patients. Coupled with fast results and a smaller ...