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 (EASY Algorithm)

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 by the German Section for Pediatric Traumatology (SKT)

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).

Study Overview

• Status: Recruiting
• Conditions: Supracondylar Humerus Fracture; Radius Fracture; Olecranon Fracture; Distal Humerus Fracture; Pediatric Trauma; Elbow Fractures

• Study Type: Observational
• Enrollment (Estimated): 543

Contacts and Locations

• Study Contact: Name: Timo Munz, Dr. med.; Phone Number: 0049-30-450666875; Email: timo.munz@charite.de

Study Locations

• Germany
  • Amberg, Germany, 92224
    • Not yet recruiting
    • Klinikum St. Marien Amberg
    • Contact: Christian Uhlmann; Phone Number: 0049 9621 380; Email: uhlmann.christian@Klinikum-Amberg.de
  • Berlin, Germany, 13353
    • Recruiting
    • Charité - Universitätsmedizin Berlin
    • Contact: Timo Munz, Dr. med.; Phone Number: 0049-30-450666875; Email: timo.munz@charite.de
  • Berlin, Germany, 12351
    • Recruiting
    • Vivantes Klinikum Neukölln
    • Contact: Florian Bohm; Phone Number: 0049 30 130140; Email: florian.bohm@vivantes.de
  • Berlin, Germany, 13125
    • Not yet recruiting
    • Helios Klinikum Berlin-Buch
    • Contact: Stefan Gfroerer, Prof. Dr. med. habil.; Phone Number: 0049 30 94010; Email: Stefan.Gfroerer@helios-gesundheit.de
  • Chemnitz, Germany, 09116
    • Not yet recruiting
    • Klinikum Chemnitz
    • Contact: Jurek Schultz, PD Dr. med. habil.; Phone Number: 0049 371 3330; Email: Jurek.Schultz@ukdd.de
  • Dresden, Germany, 01307
    • Not yet recruiting
    • Universitätsklinikum Carl Gustav Carus Dresden
    • Contact: Philipp Schwerk; Phone Number: 0049 351 4580; Email: Philipp.Schwerk@ukdd.de
  • Duisburg, Germany, 47249
    • Not yet recruiting
    • BG Klinikum Duisburg
    • Contact: Christian Illian, Dr. med.; Phone Number: 0049 203 76880; Email: christian.illian@bg-klinikum-duisburg.de
  • Freiburg im Breisgau, Germany, 79106
    • Not yet recruiting
    • Universitätsklinikum Freiburg
    • Contact: Nikos Karvouniaris, Dr. med.; Phone Number: 0049 761 2700; Email: nikos.karvouniaris@uniklinik-freiburg.de
  • Hamburg, Germany, 20251
    • Not yet recruiting
    • Universitätsklinikum Hamburg-Eppendorf
    • Contact: Kristofer Wintges, Dr. med.; Phone Number: 0049 40 74100; Email: kristofer.wintges@uke.de
  • Kassel, Germany, 34125
    • Not yet recruiting
    • Klinikum Kassel
    • Contact: Sebastian Reineke, Dr. med.; Phone Number: 0049 561 9800; Email: Sebastian.Reineke@gnh.net
  • Lübeck, Germany, 23562
    • Not yet recruiting
    • Universitätsklinikum Schleswig-Holstein Campus Lübeck
    • Contact: Ludger Tüshaus, Dr. med.; Phone Number: 0049 451 5000; Email: ludger.tueshaus@uksh.de
  • Stuttgart, Germany, 70174
    • Not yet recruiting
    • Klinikum Stuttgart
    • Contact: Oliver Loose, PD Dr. med.; Phone Number: 0049 711 27801; Email: o.loose@klinikum-stuttgart.de
  • Tübingen, Germany, 72076
    • Not yet recruiting
    • Universitätsklinikum Tübingen
    • Contact: Lukas Bischoff, Dr. med.; Phone Number: 0049 7071 290; Email: lukas.bischoff@med.uni-tuebingen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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,
• open fracture of the affected elbow joint,
• skin avulsion of the affected elbow joint,
• visible deformity of the affected elbow joint,
• and pathological status of peripheral circulation, motor function, and/or sensitivity.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1 (On the day of enrollment in the study in the emergency department)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time required for ultrasound examination	The total time for performing and evaluating the ultrasound examination is measured.	Day 1 (On the day of enrollment in the study in the emergency department)
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.	Day 1 (On the day of enrollment in the study in the emergency department)
Radiation dose from X-ray imaging (dose area product)	The radiation dose of the initial radiological imaging (dose area product) is recorded.	Day 1 (On the day of enrollment in the study in the emergency department)
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.	Day 1 (On the day of enrollment in the study in the emergency department)
Treatment of the injury	In the case of a fracture diagnosed by X-ray, the initial treatment is recorded. If the initial X-ray image shows no fracture, the initial symptomatic treatment is recorded. If there is initially no radiographic evidence of a fracture, a telephone follow-up and file review will be conducted after 6 weeks. Any changes in treatment during the 6 weeks following the initial presentation will be recorded.	Day 1 (On the day of enrollment in the study in the emergency department)
Exact fracture pattern of the initial X-ray images as determined by blinded experts	The exact fracture pattern of the X-ray images as determined by blinded experts.	Day 1 (On the day of enrollment in the study in the emergency department)
Radiographic posterior fat pad signs on the initial X-ray images as determined by blinded experts	Radiographic posterior fat pad signs on the initial X-ray images taken during the initial presentation at the emergency room, which are assessed by blinded experts.	Day 1 (On the day of enrollment in the study in the emergency department)
Interrater reliability of ultrasound findings	The sonographic images from the elbow joint sonography are subsequently re-evaluated by blinded physicians in order to examine interrater variability.	Day 1 (On the day of enrollment in the study in the emergency department)
Only in cases where there is initially no radiographically confirmed fracture: pain after 6 weeks	If no fracture is initially visible on the initial X-ray, a follow-up telephone call is made after 6 weeks. The child's pain is assessed using the PROMIS® Numeric Rating Scale v1.0 - Parent Proxy Pain Intensity 1a. This is a single-item scale for assessing average pain intensity from the parent's perspective (parent proxy), which has been validated for the 5 to 17 age group. The child's average pain intensity is recorded on a numerical scale from 0 ("no pain") to 10 ("the most severe pain imaginable"), taking into account the period of the last seven days.	Day 39-45 (42 days (+/- 3 days) after the day of enrollment in the study in the emergency department)
Only in cases where there is initially no radiographically confirmed fracture: function of the upper extremity after 6 weeks	If no fracture is initially visible on the initial X-ray, a follow-up telephone call is made after 6 weeks: The function of the child's upper extremity is assessed using the PROMIS® Parent Proxy Short Form v2.0 - Upper Extremity questionnaire. This is an official, validated short form derived from the PROMIS® item bank for upper extremity function from the parent's perspective (parent proxy). It assesses the limitations of children (aged 5-17 years) in relation to everyday activities that involve the upper extremities. The eight items are rated on a five-point Likert scale ranging from "No difficulty" to "Could not do." The final result is represented by the T-score-a standardized value with a mean of 50 and a standard deviation of 10.	Day 39-45 (42 days (+/- 3 days) after the day of enrollment in the study in the emergency department)
Only in cases where there is initially no radiographically confirmed fracture: Medical follow-up appointments and results of possible further radiological imaging	After six weeks, the patient file is reviewed for possible re-examination at the study center. In the event of a re-examination, the date, symptoms, and, if applicable, any X-ray imaging, fracture type, and treatment are documented. In addition, the parents are contacted by telephone after six weeks and asked about a possible appointment at an external clinic or doctor's office. If such a referral has taken place, the findings and any changes in treatment are recorded. If a bone fracture has been diagnosed for the first time in an external facility due to the same trauma, the X-ray images and findings are requested to be sent to the local study center so that they can be integrated into the patient file.	Day 39-45 (42 days (+/- 3 days) after the day of enrollment in the study in the emergency department)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1 (On the day of enrollment in the study in the emergency department)

Collaborators and Investigators

• Sponsor: Timo Munz
• Collaborators: University Hospital Tuebingen; University Hospital Freiburg; Universitätsklinikum Hamburg-Eppendorf; Klinikum Kassel; University Hospital Dresden; Klinikum Stuttgart; University Hospital Lübeck; Klinikum Chemnitz gGmbH; Helios Klinikum Berlin-Buch; Vivantes Hospital Berlin Neukölln; Abteilung für Orthopädie und Unfallchirurgie BG Unfallklinik Duisburg

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): January 15, 2027

Study Registration Dates

• First Submitted: February 15, 2026
• First Submitted That Met QC Criteria: February 20, 2026
• First Posted (Actual): February 24, 2026

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: children; Diagnostic accuracy; screening tool; supracondylar humerus fracture; point-of-care ultrasound; elbow fractures; pediatric trauma; EASY Algorithm Trial; Elbow Trauma Assessment using Sonography in Children and Youth; German Section for Pediatric Traumatology (SKT)
• Additional Relevant MeSH Terms: Elbow Injuries; Wounds and Injuries; Fractures, Bone; Arm Injuries; Forearm Injuries; Ulna Fractures; Humeral Fractures; Elbow Fractures; Olecranon Fracture; Humeral Fractures, Distal; Radius Fractures
• Other Study ID Numbers: EA2/215/25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD collected throughout the trial.
• IPD Sharing Time Frame: Individual participant data will be made available beginning 6 months following the publication of the primary manuscript in a peer-reviewed journal. To ensure long-term reproducibility and transparency, the data will be hosted in a permanent data repository [e.g., Zenodo] with no set expiration date.
• IPD Sharing Access Criteria: De-identified individual participant data and supporting documents (Protocol, SAP, Analytic Code) will be made available to qualified researchers for legitimate scientific purposes. Access will be managed through a restricted-access data repository [e.g., Zenodo]. To obtain access, researchers must submit a formal request through the repository's 'Request Access' feature, including a brief research proposal and a statistical analysis plan. Requests will be reviewed by the study investigators to ensure scientific merit and ethical compliance. Upon approval, and following the signing of a Data Access Agreement to protect participant confidentiality, the data will be released directly through the repository platform.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No