Fracture Ultrasound in Kids Wirst Trial (FRUSKI-Wrist)

NCT ID: NCT07046793

Last Updated: 2025-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

815 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-01

Study Completion Date

2025-04-10

Brief Summary

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This is a multicenter combined diagnostic accuracy study and observational prospective cohort.

Part one aims to confirm non-inferiority of POCUS for the detection of distal forearm fractures compared to X-ray.

Part two aims to confirm non-inforiority of POCUS compared to x-ray for the detection of potentially unstable forearm fractures needing follow up imaging.

Detailed Description

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Conditions

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Fractures in Children

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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POCUS

Ultrasound screening of the distal forearm.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients presenting to the emergency room of a study hospital with an acute trauma to the wrist and suspected fracture of the wrist consulted by a trained study examiner.
* Age 0-18 years Depending on the result

Exclusion Criteria

* Patient needing immediate medical attention (triage score 1 or 2) as well as severely displaced or open fractures or 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 wrist within the last 24 months
* Patient refusing participation / missing informed consent.
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Luzerner Kantonsspital

OTHER

Sponsor Role collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role collaborator

University Hospital, Geneva

OTHER

Sponsor Role collaborator

La Tour Hospital

OTHER

Sponsor Role collaborator

Hopital Cantonal Fribourgeois

UNKNOWN

Sponsor Role collaborator

University Children's Hospital Basel

OTHER

Sponsor Role collaborator

David Troxler

OTHER

Sponsor Role lead

Responsible Party

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David Troxler

Sponsor Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Kinderspital zentralschweiz

Lucerne, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2022-00376

Identifier Type: -

Identifier Source: org_study_id

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