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

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)

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)

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)

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)

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Day 39-45 (42 days (+/- 3 days) after the day of enrollment in the study in the emergency department)