Wounds and InjuriesVuisTNCT01857570
Volume CT of the Wrist and Carpus After Trauma
An observational study of Wounds and Injuries and Wrist Injuries, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
The purpose of this study is to evaluate whether standard volume computed tomography (CT) has impact on treatment in patients with suspicion of fractures of the wrist and carpus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wounds and Injuries, Wrist Injuries
- What is being tested?
- Volume Computed Tomography of the wrist and carpus
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2013to May 2015
- 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: All consecutive patients who enter the emergency or radiology department of the Radboud University Nijmegen Medical Centre for suspicion on fractures of the wrist and study are eligible for this study.
Who may be able to join
- Patients (18 years and older) who are referred to our hospital for conventional radiography of the wrist and carpus
- Recent trauma mechanism (within 3 days before presentation)
- Clinical suspicion of fractures of the wrist and carpus. The carpus includes all carpal bones, but does not include the metacarpal bones.
Who cannot join
- Patients who were not evaluated by a clinician before imaging was performed.
- Open fractures
- No informed consent or no prospective data collection could be obtained. Informed consent cannot be obtained in case patients do not speak or understand Dutch.
- Patients who cannot be positioned in upright position, immobilized on a spine board or transferred to the intensive care unit and cannot undergo upright CT
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Nijmegen Medical Centre
Nijmegen, 6500 HB
About this study
Official title: Volume CT of the Wrist and Carpus After Trauma: A Pilot Study
The purpose of this study is to evaluate whether standard volume computed tomography (CT) has impact on treatment in patients with suspicion of fractures of the wrist and carpus.
- Conditions
- Wounds and Injuries, Wrist Injuries
- Being tested
- Volume Computed Tomography of the wrist and carpus
- Keywords
- Radius fracture, Scaphoid fracture, Tomography, x-ray computed
- Medical subject headings
- Wounds and Injuries, Wrist Injuries, Radius Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volume Computed Tomography of the wrist and carpusRadiation
| Study group | Role | What they receive |
|---|---|---|
| Adult, clinical suspicion fractures wrist or carpus | - Patients (18 years and older) who are referred to our hospital for conventional radiography of the wrist and carpus Receives: Radiation: Volume Computed Tomography of the wrist and carpus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with prospectively documented treatment changes after CT
This endpoint is defined as presence of difference in predefined treatment regimens before and after CT. These regimens include:
-Conservative treatment on the emergency ward (functional, immobilization with bandage, cast, or closed reduction and cast), closed operative treatment (reduction and cast on operation room, percutaneous pinning, or external fixation), open surgical treatment (dorsal, radial, or palmar exposure with reduction and internal fixation).
Additional regimens include: Second opinion from a colleague or consulting a different specialism.
Measured: within same visit (i.e. in one day)
Secondary outcomes (1)
Diagnostic performance of CT and conventional radiography (CR) for fracture pattern
Fracture patterns are classified according to presence and type of fractured bones, presence of intra-articular components of distal radius fractures (including sigmoid notch involvement), presence of (fracture) dislocation or avulsion fractures of carpal bones. Standard of reference is presence of injuries at imaging, at surgery, and disability complains at 1-year follow up. In case of discrepancy, consensus will be reached at the end of the study by a panel of trauma surgeons and radiologists.
Measured: within the same visit (one day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2013 (estimated)
- Study startJun 2013
- Primary completionApr 2014
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wounds and InjuriesStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mathias Prokop, MD, PhD, Principal investigator, Radboud University Medical CenterMonique Brink, MD, PhD, Study chair, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01857570
- Sponsor's protocol ID
- NL43482.091.13
- Acronym
- VuisT
- Status last verified
- May 2015
- First submitted
- 10 May 2013
- Last updated
- 14 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volume CT of the Wrist and Carpus After Trauma: A Pilot Study
- ClinicalTrials.gov ID
- NCT01857570
- Acronym / sponsor ID
- VuisT / NL43482.091.13
- Conditions
- Wounds and Injuries, Wrist Injuries
- Keywords
- Radius fracture, Scaphoid fracture, Tomography, x-ray computed
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 20 May 2013 (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 evaluate whether standard volume computed tomography (CT) has impact on treatment in patients with suspicion of fractures of the wrist and carpus.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult, clinical suspicion fractures wrist or carpus | – | Radiation: Volume Computed Tomography of the wrist and carpus- Patients (18 years and older) who are referred to our hospital for conventional radiography of the wrist and carpus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients who enter the emergency or radiology department of the Radboud University Nijmegen Medical Centre for suspicion on fractures of the wrist and study are eligible for this study.
Key inclusion criteria (3 listed)
- Patients (18 years and older) who are referred to our hospital for conventional radiography of the wrist and carpus
- Recent trauma mechanism (within 3 days before presentation)
- Clinical suspicion of fractures of the wrist and carpus. The carpus includes all carpal bones, but does not include the metacarpal bones.
Key exclusion criteria (4 listed)
- Patients who were not evaluated by a clinician before imaging was performed.
- Open fractures
- No informed consent or no prospective data collection could be obtained. Informed consent cannot be obtained in case patients do not speak or understand Dutch.
- Patients who cannot be positioned in upright position, immobilized on a spine board or transferred to the intensive care unit and cannot undergo upright CT
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 |
|---|---|---|
| Volume Computed Tomography of the wrist and carpus | Radiation | Adult, clinical suspicion fractures wrist or carpus |
Primary outcome
Proportion of patients with prospectively documented treatment changes after CT
Time frame: within same visit (i.e. in one day)
This endpoint is defined as presence of difference in predefined treatment regimens before and after CT. These regimens include: -Conservative treatment on the emergency ward (functional, immobilization with bandage, cast, or closed reduction and cast), closed operative treatment (reduction and cast on operation room, percutaneous pinning, or external fixation), open surgical treatment (dorsal, radial, or palmar exposure with reduction and internal fixation). Additional regimens include: Second opinion from a colleague or consulting a different specialism.
1 secondary outcome
Diagnostic performance of CT and conventional radiography (CR) for fracture pattern
Time frame: within the same visit (one day)
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 14 May 2015.
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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.
Mathias Prokop, MD, PhD principal investigator
Radboud University Medical Center
Monique Brink, MD, PhD study chair
Radboud University Medical Center
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 Wounds and Injuries and Wrist Injuries, run by Radboud University Medical Center at 1 site in Netherlands.
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: finished, as of the sponsor's last update on 14 May 2015. 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 Netherlands. 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?
Proportion of patients with prospectively documented treatment changes after CT (time frame: within same visit (i.e. in one day)). 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 14 May 2015.