Fracture Ultrasound in Kids Wirst Trial (FRUSKI-Wrist) | NCT07046793

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

NCT07046793

Sponsor

David Troxler

Status

Completed

Last Update Posted

Jul 24, 2025Actual

Enrollment

815Actual

Phase

Not provided

Conditions

Fractures in Children

Interventions

POCUS

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2022Actual

Primary Completion Date

Apr 10, 2025Actual

Completion Date

Apr 10, 2025Actual

First Submitted Date

Jun 29, 2025

First Submission Date that Met QC Criteria

Jun 29, 2025

First Posted Date

Jul 2, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 21, 2025

Last Update Posted Date

Jul 24, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

David Troxler, Sponsor Investigator, University Children's Hospital BaselSponsor-Investigator

Lead Sponsor

David TroxlerOTHER

Collaborators

Name	Class
Luzerner Kantonsspital	OTHER
Insel Gruppe AG, University Hospital Bern	OTHER
University Hospital, Geneva	OTHER
La Tour Hospital

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

815Actual

Name	Type	Description	Arm Group Labels	Other Names
POCUS	Diagnostic Test	Ultrasound screening of the distal forearm.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Children with wrist trauma

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kinderspital zentralschweiz		Lucerne			Switzerland