Pediatric Fracture Diagnosis by Ultrasound Compared to X-ray Clinical Trial
— FRUSKIOfficial title:
Non-inferiority of Ultrasound for the Diagnosis of Upper Extremity Fractures in Children
Verified date | April 2024 |
Source | University Children's Hospital Basel |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study evaluates the sensitivity of Ultrasound for Diagnostic of Fractures of the upper extremity compared to conventional x-ray in Children 0-18.
Status | Completed |
Enrollment | 428 |
Est. completion date | May 18, 2021 |
Est. primary completion date | May 18, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 18 Years |
Eligibility | Inclusion Criteria: - Patients presenting to the emergency room of the UKBB with a history of acute trauma to the upper extremities and suspected fracture of a long bone - Age 0-18 years Exclusion Criteria: - Patient needing immediate medical attention (triage score 1 or 2) - Severely displaced or open fractures - Patient with neurovascular compromise distally to the suspected fracture. - Patient with imaging studies obtained prior to the emergency room visit - Patient with prior fracture of the affected area - Patient with known allergy to ultrasound gel. - Patient with suspected 'battered child' diagnosis. - Unavailability of a study investigator able to perform the ultrasound examination within a reasonable time frame (15 min; see also 3.2). |
Country | Name | City | State |
---|---|---|---|
Switzerland | University Childrens Hospital for both Basel cantons | Basel | BS |
Lead Sponsor | Collaborator |
---|---|
University Children's Hospital Basel |
Switzerland,
Troxler D, Sanchez C, de Trey T, Mayr J, Walther M. Non-Inferiority of Point-of-Care Ultrasound Compared to Radiography to Diagnose Upper Extremity Fractures in Children. Children (Basel). 2022 Sep 30;9(10):1496. doi: 10.3390/children9101496. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensitivity | Sensitivity of Ultrasound diagnostic compared to X-ray | 1 year | |
Secondary | Pain level | Pain during Ultrasound imaging compared to X-ray imaging | 1 year | |
Secondary | Time | Time necessary for Ultrasound imaging compared to X-ray imaging | 1 year | |
Secondary | Displacement | Specification of Displacement measures by Ultrasound imaging compared to X-ray imaging. | 2 years |