Fracture Ultrasound in Kids Wirst Trial (FRUSKI-Wrist)

NCT07046793 | Completed

• 1 other identifier: 2022-00376
• Study Type: observational
• Target: 815
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fractures in Children

Outcome Measures

Primary Outcomes (2)

• Fracture yes/no as final diagnosis

  at 4 weeks from inclusion

• Possible unstable fracture as final diagnosis

  4 weeks from inclusion

Interventions

POCUS DIAGNOSTIC_TEST

Ultrasound screening of the distal forearm.

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children with wrist trauma

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• David Troxler: lead
• Luzerner Kantonsspital: collaborator
• Insel Gruppe AG, University Hospital Bern: collaborator
• University Hospital, Geneva: collaborator
• La Tour Hospital: collaborator
• Hôpital Fribourgeois: collaborator
• University Children's Hospital Basel: collaborator

Study Sites (1)

Kinderspital zentralschweiz

Lucerne, Switzerland

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor Investigator

Study Record Dates

• First Submitted: June 29, 2025
• First Posted: July 2, 2025
• Study Start: May 1, 2022
• Primary Completion: April 10, 2025
• Study Completion: April 10, 2025
• Last Updated: July 24, 2025

Record last verified: 2025-07

Locations

CH (1)