An interventional study of Ultrasound in Pediatric Fracture Diagnosis by Ultrasound Compared to X-ray, sponsored by University Children's Hospital Basel. Completed at 1 site in Switzerland. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2024-04-09.
Sponsored by University Children's Hospital Basel · Not applicable, Interventional, and Diagnostic
This study evaluates the sensitivity of Ultrasound for Diagnostic of Fractures of the upper extremity compared to conventional x-ray in Children 0-18.
Fractures of the upper extremity are common in children. Approximately 200 children with a suspected upper extremity fracture are treated every month in the paediatric emergency room (pER) of the University Hospital of Basel-Stadt and Basel-Land (UKBB).
If a fracture is suspected in the emergency room, two separate X-ray images have to be obtained to diagnose or exclude a fracture, according to the current standard operating procedure (SOP). This procedure has several disadvantages as X-ray imaging exposes children to radiation and transfer to the X-ray facility is time-consuming. Depending on the suspected fracture, the broken limb needs to be positioned for the two separate perspectives of the images, resulting in pain.
Furthermore, this procedure is time-consuming as the work routine of the attending emergency room physician is interrupted once the child is sent to the imaging facility and then returns to the emergency room after the procedure. The time between the request of the examination and interpretation of the results is called therapeutic turnaround time or brain-to-brain time.
X-ray images are interpreted by the pER paediatrician, and treatment is based upon this interpretation. A secondary reading by a paediatric radiologist for quality control is only done later on. This procedure has been adopted by several hospitals internationally.
X-ray interpretation by pER paediatricians has been evaluated by various studies, and the accuracy compared to paediatric radiologist interpretation is around 90% in most studies, with extremes ranging from 84% to 99%. In the past few years, ultrasound diagnosis of upper extremity fractures in adults and children has been studied. However, the evidence of its effectiveness is still limited, and its application in routine care is uncommon.
Ultrasound has several advantages over X-ray imaging. It does not expose patients to radiation; devices are mobile, the examination can be performed in the child's preferred antalgic position without moving the affected limb, it is always available, and it can be executed directly by an emergency room physician.
We aim to demonstrate that ultrasound is at least as sensitive as X-ray imaging and is thus non-inferior to the standard-of-care diagnostics with X-ray.
Secondary outcomes include pain and time necessary for ultrasound vs X-ray If non-inferiority can be confirmed in this study, we expect a change in SOPs to replace initial X ray imaging by sonographic fracture diagnosis for simple fractures of the upper-extremity long bones.
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This study's enrollment of 428 is above the median of 80 across 732 interventional studies indexed under Disease.
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Exclusion Criteria:
Ultrasound first then x-ray examination
Diagnostic Test: Ultrasound
Ultrasound imaging for fracture diagnosis before conventional X-ray
Sensitivity
Sensitivity of Ultrasound diagnostic compared to X-ray
Time frame: 1 year
Pain level
Pain during Ultrasound imaging compared to X-ray imaging
Time frame: 1 year
Time
Time necessary for Ultrasound imaging compared to X-ray imaging
Time frame: 1 year
Displacement
Specification of Displacement measures by Ultrasound imaging compared to X-ray imaging.
Time frame: 2 years
Plan to share: No
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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University Children's Hospital Basel