Distal Humerus Fracture, Elbow Fractures, Olecranon Fracture, Pediatric Trauma, Radius Fracture, Supracondylar Humerus Fracture
Conditions
Keywords
EASY Algorithm Trial, pediatric trauma, Diagnostic accuracy, point-of-care ultrasound, elbow fractures, children, Elbow Trauma Assessment using Sonography in Children and Youth, German Section for Pediatric Traumatology (SKT), screening tool, supracondylar humerus fracture
Brief summary
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).
Interventions
None listed
Sponsors
Timo Munz
University Hospital Dresden
Helios Klinikum Berlin-Buch
Abteilung für Orthopädie und Unfallchirurgie BG Unfallklinik Duisburg
University Hospital Freiburg
Universitätsklinikum Hamburg-Eppendorf
Klinikum Kassel
Vivantes Hospital Berlin Neukölln
Klinikum Stuttgart
Klinikum Chemnitz gGmbH
University Hospital Lübeck
University Hospital Tuebingen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
5 Years to 15 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of sonographic joint effusion | Day 1 (On the day of enrollment in the study in the emergency department) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time required for ultrasound examination | Day 1 (On the day of enrollment in the study in the emergency department) | The total time for performing and evaluating the ultrasound examination is measured. |
| The additional time patients spend in the emergency room due to X-ray examinations | Day 1 (On the day of enrollment in the study in the emergency department) | 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. |
| Radiation dose from X-ray imaging (dose area product) | Day 1 (On the day of enrollment in the study in the emergency department) | The radiation dose of the initial radiological imaging (dose area product) is recorded. |
| The initial assessment of the X-ray images by the attending physician in the emergency department | Day 1 (On the day of enrollment in the study in the emergency department) | The exact fracture type determined by the attending physician in the emergency department. |
| Treatment of the injury | Day 1 (On the day of enrollment in the study in the emergency department) | 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. |
| Exact fracture pattern of the initial X-ray images as determined by blinded experts | Day 1 (On the day of enrollment in the study in the emergency department) | The exact fracture pattern of the X-ray images as determined by blinded experts. |
| Radiographic posterior fat pad signs on the initial 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 taken during the initial presentation at the emergency room, which are assessed by blinded experts. |
| Interrater reliability of ultrasound findings | Day 1 (On the day of enrollment in the study in the emergency department) | The sonographic images from the elbow joint sonography are subsequently re-evaluated by blinded physicians in order to examine interrater variability. |
| Only in cases where there is initially no radiographically confirmed fracture: pain after 6 weeks | Day 39-45 (42 days (+/- 3 days) after the day of enrollment in the study in the emergency department) | 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. |
| Only in cases where there is initially no radiographically confirmed fracture: function of the upper extremity after 6 weeks | Day 39-45 (42 days (+/- 3 days) after the day of enrollment in the study in the emergency department) | 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. |
| Only in cases where there is initially no radiographically confirmed fracture: Medical follow-up appointments and results of possible further radiological imaging | Day 39-45 (42 days (+/- 3 days) after the day of enrollment in the study in the emergency department) | 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. |
Countries
Germany
Contacts
CONTACTTimo Munz, Dr. med.
Outcome results
None listed