Distal Radius FractureNCT03396965
Mini-C-Arm for Distal Radius Fractures in Adults
A study testing Mini-c-arm in people with Distal Radius Fracture, run by University of Cincinnati.
Trial summary
Determine efficacy of the use of mini-c-arm fluoroscopy for the closed reduction of isolated distal radius fractures in adult patients in the emergency department setting. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- Mini-c-arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- May 2015to May 2017
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Closed distal radius fracture requiring reduction
Who cannot join
- Open, other ipsilateral upper extremity fractures, pregnant, incarcerated, less than 18 yo
About this study
Official title: The Efficacy of Mini-c-arm Fluoroscopy for the Closed Reduction of Distal Radius Fractures in Adults
Determine efficacy of the use of mini-c-arm fluoroscopy for the closed reduction of isolated distal radius fractures in adult patients in the emergency department setting.
- Conditions
- Distal Radius Fracture
- Being tested
- Mini-c-arm
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini-c-armOther
Fluoroscopy used to aid reduction of distal radius fracture
| Study group | Role | What they receive |
|---|---|---|
| Mini-c-arm | Experimental | Fluoroscopically aided reductions Receives: Other: Mini-c-arm |
| Standard | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction quality
Fracture alignment measured on post-reduction radiographs
Measured: Immediately post reduction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2018
- Study startMay 2015
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FractureStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Patients randomized to fluoroscopically-aided reduction of fracture, versus no fluoroscopic guidance
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven Dailey, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03396965
- Sponsor's protocol ID
- 2014-6554
- Status last verified
- Jan 2018
- First submitted
- 5 Jan 2018
- Last updated
- 16 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Mini-c-arm Fluoroscopy for the Closed Reduction of Distal Radius Fractures in Adults
- ClinicalTrials.gov ID
- NCT03396965
- Acronym / sponsor ID
- 2014-6554
- Conditions
- Distal Radius Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 11 Jan 2018 (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.
Determine efficacy of the use of mini-c-arm fluoroscopy for the closed reduction of isolated distal radius fractures in adult patients in the emergency department setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients randomized to fluoroscopically-aided reduction of fracture, versus no fluoroscopic guidance
| Arm | Type | Receives |
|---|---|---|
| Mini-c-arm | Experimental | Other: Mini-c-armFluoroscopically aided reductions |
| Standard | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Closed distal radius fracture requiring reduction
Key exclusion criteria (1 listed)
- Open, other ipsilateral upper extremity fractures, pregnant, incarcerated, less than 18 yo
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 |
|---|---|---|
| Mini-c-armFluoroscopy used to aid reduction of distal radius fracture | Other | Mini-c-arm |
Primary outcome
Reduction quality
Time frame: Immediately post reduction
Fracture alignment measured on post-reduction radiographs
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 16 Jan 2018.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Mini-c-arm in people with Distal Radius Fracture, run by University of Cincinnati.
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 1 inclusion and 1 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 16 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Reduction quality (time frame: Immediately post reduction). 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 16 Jan 2018.