Non-inferiority of Ultrasound for the Diagnosis of Upper Extremity Fractures in Children

Pediatric Fracture Diagnosis by Ultrasound Compared to X-ray Clinical Trial

— FRUSKI  

Official title:

Non-inferiority of Ultrasound for the Diagnosis of Upper Extremity Fractures in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04290247
• Other study ID #: UKBB-2020/001
• Secondary ID: 2020-00032
• Status: Completed
• Phase: N/A
• Start date: May 12, 2020
• Est. completion date: May 18, 2021

Study information

• Verified date: April 2024
• Source: University Children's Hospital Basel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the sensitivity of Ultrasound for Diagnostic of Fractures of the upper extremity compared to conventional x-ray in Children 0-18.

Description:

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.

Recruitment information / eligibility

• 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).

Related Conditions & MeSH terms

• Disease
• Fractures, Bone
• Pediatric Fracture Diagnosis by Ultrasound Compared to X-ray

Intervention

Diagnostic Test:
• Ultrasound
Ultrasound imaging for fracture diagnosis before conventional X-ray

Locations

Country	Name	City	State
Switzerland	University Childrens Hospital for both Basel cantons	Basel	BS

Sponsors (1)

Lead Sponsor	Collaborator
University Children's Hospital Basel

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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

Outcome

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