Fractures in ChildrenFRUSKI-WristNCT07046793
Fracture Ultrasound in Kids Wirst Trial (FRUSKI-Wrist)
An observational study of Fractures in Children, run by David Troxler at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Fractures in Children
- What is being tested?
- POCUS
- How many people
- 815 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 May 2022to 10 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with wrist trauma
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- POCUS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POCUSDiagnostic test
Ultrasound screening of the distal forearm.
What is being measured
The primary outcome is the main question the study is designed to answer.
Fracture yes/no as final diagnosis
Measured: at 4 weeks from inclusion
Possible unstable fracture as final diagnosis
Measured: 4 weeks from inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start1 May 2022
- Primary completion10 Apr 2025
- Study completion10 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fractures in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 815 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Troxler
- Sponsor type
- University, hospital or other
- Collaborators
- Luzerner Kantonsspital, Insel Gruppe AG, University Hospital Bern, University Hospital, Geneva, La Tour Hospital, Hôpital Fribourgeois, University Children's Hospital Basel
- Responsible party
- Sponsor-investigator, David Troxler, University Children's Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07046793
- Sponsor's protocol ID
- 2022-00376
- Acronym
- FRUSKI-Wrist
- Status last verified
- Jul 2025
- First submitted
- 29 Jun 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fracture Ultrasound in Kids Wirst Trial (FRUSKI-Wrist)
- ClinicalTrials.gov ID
- NCT07046793
- Acronym / sponsor ID
- FRUSKI-Wrist / 2022-00376
- Conditions
- Fractures in Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 815 participants (actual)
- Lead sponsor
- David TroxlerUniversity, hospital or other
- Collaborators
- Luzerner Kantonsspital, Insel Gruppe AG, University Hospital Bern, University Hospital, Geneva, La Tour Hospital, Hôpital Fribourgeois, University Children's Hospital Basel
- Study start
- 1 May 2022 (actual)
- Primary completion
- 10 Apr 2025 (actual)
- Study completion
- 10 Apr 2025 (actual)
- First posted
- 2 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with wrist trauma
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| POCUSUltrasound screening of the distal forearm. | Diagnostic test | – |
Primary outcome
Fracture yes/no as final diagnosis
Time frame: at 4 weeks from inclusion
Possible unstable fracture as final diagnosis
Time frame: 4 weeks from inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fractures in Children, run by David Troxler at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fracture yes/no as final diagnosis (time frame: at 4 weeks from inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.