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EASY Algorithm Trial (Elbow Trauma Assessment Using Sonography in Children and Youth) Diagnostic Accuracy and Safety of Point-of-care Ultrasound as a Screening Tool for Suspected Elbow Fractures in Children Aged 5 to 15 Years: a Multicenter Prospective Cohort Study

ConditionsElbow FracturesDistal Humerus FracturePediatric TraumaRadius FractureOlecranon FractureSupracondylar Humerus Fracture
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age5-15
SponsorTimo Munz

About this trial

The goal of this observational study is to learn about the safety and accuracy of ultrasound as a screening tool to detect broken bones (fractures) in the elbow area in children and youth aged 5 to 15 years. The main question it aims to answer is:

\- Can ultrasound reliably show that there is a fracture in the elbow area after an accident?

Participants will:

* Have an ultrasound of their elbow to look for fluid in the joint. * Have standard X-rays of their elbow to check if there is a fracture. * Have their medical records checked and answer a phone call 6 weeks later to see how their elbow has healed (only if no fracture was found during the first visit).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

children and adolescents aged 5-15 years with anamnestic and clinically justified need for the exclusion of a fracture after elbow trauma

Disqualifiers

elbow trauma as part of a polytrauma,

parents' insufficient German language skills (spoken or written),

trauma more than 72 hours ago,

presentation at the emergency room with current, post-traumatic external X-ray images of the affected elbow joint from another clinic or practice,

Trial population

All children and adolescents who present to the emergency departments of the participating hospitals with elbow pain following an accident will be screened for inclusion in the study during the study period until the statistically determined required number of cases has been reached.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Sensitivity of sonographic joint effusion

Sensitivity of sonographic joint effusion examination following a standardized procedure and uniform training of the physicians performing the examination in the detection of radiologically confirmed elbow fractures, as assessed by blinded experts.

Time frame
Day 1 (On the day of enrollment in the study in the emergency department)

Secondary outcomes

1

Time required for ultrasound examination

The total time for performing and evaluating the ultrasound examination is measured.

Time frame
Day 1 (On the day of enrollment in the study in the emergency department)
2

The additional time patients spend in the emergency room due to X-ray examinations

The time that patients and their relatives spend additionally in the emergency room due to X-ray imaging is measured. The time at which the family leaves the treatment room after the ultrasound is noted. Then the time at which the family re-enters the treatment room after the X-ray is performed is noted. The difference is the additional time patients spend in the emergency room due to X-ray imaging.

Time frame
Day 1 (On the day of enrollment in the study in the emergency department)
3

Radiation dose from X-ray imaging (dose area product)

The radiation dose of the initial radiological imaging (dose area product) is recorded.

Time frame
Day 1 (On the day of enrollment in the study in the emergency department)
4

The initial assessment of the X-ray images by the attending physician in the emergency department

The exact fracture type determined by the attending physician in the emergency department.

Time frame
Day 1 (On the day of enrollment in the study in the emergency department)

Other outcomes

1

Potential confounders of the primary outcome

Potential confounders of the patients include age, sex assigned at birth, gender identity, pre-existing conditions, location of the accident (in daycare/school or outside of these settings), accident mechanism, swelling of the affected elbow, hematoma of the affected elbow, other fractures caused by the same trauma, and the time interval since the trauma. Potential confounders of the attending physician in the emergency room, who is performing the sonography include previous experience with ultrasound imaging of fractures, the physician's area of expertise, and level of training.

Time frame
Day 1 (On the day of enrollment in the study in the emergency department)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Timo Munz

Lead sponsor

Charite University, Berlin, Germany

Sponsor institution

University Hospital Dresden

Collaborator

Helios Klinikum Berlin-Buch

Collaborator

Abteilung für Orthopädie und Unfallchirurgie BG Unfallklinik Duisburg

Collaborator

University Hospital Freiburg

Collaborator

Universitätsklinikum Hamburg-Eppendorf

Collaborator

Klinikum Kassel

Collaborator

Vivantes Hospital Berlin Neukölln

Collaborator

Klinikum Stuttgart

Collaborator

Klinikum Chemnitz gGmbH

Collaborator

University Hospital Lübeck

Collaborator

University Hospital Tuebingen

Collaborator

Source ClinicalTrials.gov
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