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CompletedNCT04290247FRUSKIUpdated Apr 9, 2024

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

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

Phase
Not applicable
Study type
Interventional
Enrollment
428
Allocation
Not applicable
Ages
Up to 18 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pediatric Fracture Diagnosis by Ultrasound Compared to X-ray

Keywords

  • Pediatric
  • Ultrasound
  • X-ray
  • Fracture
  • Diagnosis
03

In context

Disease

1,327 studies on the registry are indexed under Disease; 596 are open to participants now.

This study's enrollment of 428 is above the median of 80 across 732 interventional studies indexed under Disease.

Browse Disease studies →

Lead sponsor

University Children's Hospital Basel is the lead sponsor of 27 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
428 participants (actual)

Study arms

  • Experimental
    Ultrasound + X-ray

    Ultrasound first then x-ray examination

    Diagnostic Test: Ultrasound

Interventions

  • Diagnostic testUltrasound

    Ultrasound imaging for fracture diagnosis before conventional X-ray

06

What researchers measure

Primary outcomes

  1. Sensitivity

    Sensitivity of Ultrasound diagnostic compared to X-ray

    Time frame: 1 year

Secondary outcomes

  1. Pain level

    Pain during Ultrasound imaging compared to X-ray imaging

    Time frame: 1 year

  2. Time

    Time necessary for Ultrasound imaging compared to X-ray imaging

    Time frame: 1 year

  3. Displacement

    Specification of Displacement measures by Ultrasound imaging compared to X-ray imaging.

    Time frame: 2 years

07

Study locations

1 site
  • University Childrens Hospital for both Basel cantons
    Basel, BS 4056, Switzerland
08

References and documents

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. PubMed 36291432 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04290247
Lead sponsor
University Children's Hospital Basel
Responsible party
David Troxler (Principal Investigator, University Children's Hospital Basel) — Principal investigator
First posted
Feb 28, 2020
Start date
May 12, 2020
Primary completion
May 18, 2021
Completion
May 18, 2021
Last update
Apr 9, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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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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