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

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

Study Overview

• Status: Completed
• Conditions: Pediatric Fracture Diagnosis by Ultrasound Compared to X-ray
• Intervention / Treatment: Diagnostic test: Ultrasound

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 428
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • BS
    • Basel, BS, Switzerland, 4056
      • University Childrens Hospital for both Basel cantons

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ultrasound + X-ray; Ultrasound first then x-ray examination	Diagnostic test: Ultrasound; Ultrasound imaging for fracture diagnosis before conventional X-ray

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity	Sensitivity of Ultrasound diagnostic compared to X-ray	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain level	Pain during Ultrasound imaging compared to X-ray imaging	1 year
Time	Time necessary for Ultrasound imaging compared to X-ray imaging	1 year
Displacement	Specification of Displacement measures by Ultrasound imaging compared to X-ray imaging.	2 years

Collaborators and Investigators

• Sponsor: University Children's Hospital Basel

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2020
• Primary Completion (Actual): May 18, 2021
• Study Completion (Actual): May 18, 2021

Study Registration Dates

• First Submitted: February 26, 2020
• First Submitted That Met QC Criteria: February 26, 2020
• First Posted (Actual): February 28, 2020

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 7, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Ultrasound; Pediatric; Diagnosis; Fracture; X-ray
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Disease; Fractures, Bone
• Other Study ID Numbers: UKBB-2020/001; 2020-00032 (Registry Identifier: BASEC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No