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| Name | Class |
|---|---|
| University Hospital Dresden | OTHER |
| Helios Klinikum Berlin-Buch | OTHER |
| Abteilung für Orthopädie und Unfallchirurgie BG Unfallklinik Duisburg | UNKNOWN |
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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:
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| 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) |
| 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 |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Timo Munz, Dr. med. | Contact | 0049-30-450666875 | timo.munz@charite.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum St. Marien Amberg | Not yet recruiting | Amberg | 92224 | Germany |
All IPD collected throughout the trial.
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.
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.
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| University Hospital Freiburg |
| OTHER |
| Universitätsklinikum Hamburg-Eppendorf | OTHER |
| Klinikum Kassel | OTHER |
| Vivantes Hospital Berlin Neukölln | UNKNOWN |
| Klinikum Stuttgart | OTHER |
| Klinikum Chemnitz gGmbH | OTHER |
| University Hospital Lübeck | OTHER |
| University Hospital Tuebingen | OTHER |
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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) |
| Day 1 (On the day of enrollment in the study in the emergency department) |
| Vivantes Klinikum Neukölln | Recruiting | Berlin | 12351 | Germany |
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| Helios Klinikum Berlin-Buch | Not yet recruiting | Berlin | 13125 | Germany |
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| Charité - Universitätsmedizin Berlin | Recruiting | Berlin | 13353 | Germany |
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| Klinikum Chemnitz | Not yet recruiting | Chemnitz | 09116 | Germany |
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| Universitätsklinikum Carl Gustav Carus Dresden | Not yet recruiting | Dresden | 01307 | Germany |
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| BG Klinikum Duisburg | Not yet recruiting | Duisburg | 47249 | Germany |
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| Universitätsklinikum Freiburg | Not yet recruiting | Freiburg im Breisgau | 79106 | Germany |
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| Universitätsklinikum Hamburg-Eppendorf | Not yet recruiting | Hamburg | 20251 | Germany |
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| Klinikum Kassel | Not yet recruiting | Kassel | 34125 | Germany |
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| Universitätsklinikum Schleswig-Holstein Campus Lübeck | Not yet recruiting | Lübeck | 23562 | Germany |
|
| Klinikum Stuttgart | Not yet recruiting | Stuttgart | 70174 | Germany |
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| Universitätsklinikum Tübingen | Not yet recruiting | Tübingen | 72076 | Germany |
|
| ID | Term |
|---|---|
| D000092482 | Elbow Fractures |
| D000092483 | Humeral Fractures, Distal |
| D011885 | Radius Fractures |
| D000092470 | Olecranon Fracture |
| ID | Term |
|---|---|
| D000092464 | Elbow Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
| D006810 | Humeral Fractures |
| D005543 | Forearm Injuries |
| D014458 | Ulna Fractures |
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