Fracture Ultrasound in Kids Wirst Trial (FRUSKI-Wrist) (FRUSKI-Wrist)

July 21, 2025 updated by: David Troxler

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

815

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Lucerne, Switzerland
        • Kinderspital zentralschweiz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Children with wrist trauma

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fracture yes/no as final diagnosis
Time Frame: at 4 weeks from inclusion
at 4 weeks from inclusion
Possible unstable fracture as final diagnosis
Time Frame: 4 weeks from inclusion
4 weeks from inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

David Troxler

Collaborators

University Hospital, Geneva
Luzerner Kantonsspital
La Tour Hospital
University Children's Hospital Basel
Insel Gruppe AG, University Hospital Bern
Hopital Cantonal Fribourgeois

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Actual)

April 10, 2025

Study Completion (Actual)

April 10, 2025

Study Registration Dates

First Submitted

June 29, 2025

First Submitted That Met QC Criteria

June 29, 2025

First Posted (Actual)

July 2, 2025

Study Record Updates

Last Update Posted (Actual)

July 24, 2025

Last Update Submitted That Met QC Criteria

July 21, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-00376

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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