FractureFREEUSNCT01071733
Fracture Evaluated in Emergency Room by Ultra Sound
An observational study of Fracture and Ultrasonography, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of this study is to compare fracture diagnostic, conventional x-ray versus ultrasound. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fracture, Ultrasonography
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2009to Dec 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients in emergency room
Who may be able to join
- Recent trauma to the wrist, ankle or fingers
- clinical exam by ER staff and x-ray indication.
- informed concent
Who cannot join
- open fracture
- wounds
- unstable fractures requiring cast immobilisation before x-ray
- multi traumatised patients
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare fracture diagnostic, conventional x-ray versus ultrasound.
Read the detailed description
to compare fracture diagnostic, conventional x-ray versus ultrasound in an emergency room department.
- Conditions
- Fracture, Ultrasonography
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ultrasound wrist | Not described | |
| ultrasound finger | Not described | |
| ultrasound ankle | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2010 (estimated)
- Study startDec 2009
- Primary completionSep 2013 (estimated)
- Study completionDec 2013 (estimated)
Why it stopped: study was never initiated due to logistic causes
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FractureStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mogens P Jensen, phd, md, Study director, Dep. of Reumatology, Aarhus University Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01071733
- Sponsor's protocol ID
- FREEUS
- Acronym
- FREEUS
- Status last verified
- Sep 2012
- First submitted
- 18 Feb 2010
- Last updated
- 20 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fracture Evaluated in Emergency Room by Ultra Sound
- ClinicalTrials.gov ID
- NCT01071733
- Acronym / sponsor ID
- FREEUS / FREEUS
- Conditions
- Fracture, Ultrasonography
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: study was never initiated due to logistic causes
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 19 Feb 2010 (estimated)
- 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.
The purpose of this study is to compare fracture diagnostic, conventional x-ray versus ultrasound.
Detailed description
to compare fracture diagnostic, conventional x-ray versus ultrasound in an emergency room department.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ultrasound wrist | – | – |
| ultrasound finger | – | – |
| ultrasound ankle | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients in emergency room
Key inclusion criteria (3 listed)
- Recent trauma to the wrist, ankle or fingers
- clinical exam by ER staff and x-ray indication.
- informed concent
Key exclusion criteria (4 listed)
- open fracture
- wounds
- unstable fractures requiring cast immobilisation before x-ray
- multi traumatised patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2017.
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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.
Mogens P Jensen, phd, md study director
Dep. of Reumatology, Aarhus University Hospital, Denmark
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 Fracture and Ultrasonography, run by University of Aarhus at 1 site in Denmark.
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 3 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: withdrawn, as of the sponsor's last update on 20 Nov 2017. 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 Denmark. 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 was withdrawn before enrolling participants, so there are no results.
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.
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 20 Nov 2017.