Distal Radius FracturePhase 2NCT01823692
Evaluating Validity of Ultrasonography in Determining Distal Radius Fracture Reduction
A Phase 2 study testing ultrasonography in people with Distal Radius Fracture, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study is to evaluate whether ultrasonography guidance compare with the simple radiography aids in determining the adequacy of distal radius fracture reduction. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- ultrasonography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteIran
- Study dates
- Sep 2011to Sep 2011
- Phase
- Phase 2
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- > 21 years old and a diagnosing of a distal radius fracture based on simple radiography.
Who cannot join
- Open fractures
- more than 20 degree angulation
- joint internal involvement, communicated and along with Neurovascular compromised fractures
- patient's surgery due to other causes
- need to stay in the ICU and not being able to be treated at the same time for distal radius fracture
- patient's refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Accuracy of Ultrasonography in Determining the Adequacy of Distal Radius Fracture Reduction
The purpose of this study is to evaluate whether ultrasonography guidance compare with the simple radiography aids in determining the adequacy of distal radius fracture reduction.
Read the detailed description
Distal radius fracture is one of the most common causes for visiting the emergency department. Nowadays, simple radiography is used as a control standard for evaluating reduction of distal radius fractures. The disadvantages include time wasting, frequent x-ray exposures and use of more sedation in determining adequate reduction, made scientists to evaluate alternative method such as ultrasonography which fast, easy and less dangerous were considered as advantages. The investigators goal was to identify whether ultrasonography guidance compare with the simple radiography aids in determining the adequacy of distal radius fracture reduction.
- Conditions
- Distal Radius Fracture
- Being tested
- ultrasonography
- Keywords
- Radius Fracture, Sensitivity, Reduction, Adequacy
- Medical subject headings
- Wrist Fractures, Radius Fractures, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasonographyOther
after manipulation and reduction were performed by single emergency medicine specialist under Bier block regional anesthesia or procedural sedation-analgesia, The ultrasonography was performed by the single emergency department physician in a long axis both in a anterioposterior and lateral views in determining whether the distal and proximal distal to a fracture was in a straight line (less than 3 mm difference) or not?
| Study group | Role | What they receive |
|---|---|---|
| Distal Radius Fracture | Other | after manipulation and reduction were performed by single emergency medicine specialist under Bier block regional anesthesia or procedural sedation-analgesia, The ultrasonography was performed by the single emergency department physician in a long axis both in a anterioposterior and lateral views in determining whether the distal and proximal distal to a fracture was in a straight line (less than 3 mm difference) or not? Receives: Other: ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
adequacy of distal radius fracture reduction
after manipulation and reduction were performed by single emergency medicine specialist under Bier block regional anesthesia or procedural sedation-analgesia, The ultrasonography was performed by the single emergency department physician in a long axis both in a anterioposterior and lateral views in determining whether the distal and proximal distal to a fracture was in a straight line (less than 3 mm difference) or not?
Measured: at 5 min after admission time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study startSep 2011
- Primary completionSep 2011
- Study completionSep 2011
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.
- 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamidreza Shemshaki, Isfahan University of Medical Sciences
- Investigators
- Hamidreza Shemshaki, MD, Principal investigator, Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01823692
- Sponsor's protocol ID
- ASD-1213-75
- Status last verified
- Mar 2013
- First submitted
- 30 Mar 2013
- Last updated
- 4 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Accuracy of Ultrasonography in Determining the Adequacy of Distal Radius Fracture Reduction
- ClinicalTrials.gov ID
- NCT01823692
- Acronym / sponsor ID
- ASD-1213-75
- Conditions
- Distal Radius Fracture
- Keywords
- Radius Fracture, Sensitivity, Reduction, Adequacy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 4 Apr 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 ultrasonography guidance compare with the simple radiography aids in determining the adequacy of distal radius fracture reduction.
Detailed description
Distal radius fracture is one of the most common causes for visiting the emergency department. Nowadays, simple radiography is used as a control standard for evaluating reduction of distal radius fractures. The disadvantages include time wasting, frequent x-ray exposures and use of more sedation in determining adequate reduction, made scientists to evaluate alternative method such as ultrasonography which fast, easy and less dangerous were considered as advantages. The investigators goal was to identify whether ultrasonography guidance compare with the simple radiography aids in determining the adequacy of distal radius fracture reduction.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Distal Radius Fracture | Other | Other: ultrasonographyafter manipulation and reduction were performed by single emergency medicine specialist under Bier block regional anesthesia or procedural sedation-analgesia, The ultrasonography was performed by the single emergency department physician in a long axis both in a anterioposterior and lateral views in determining whether the distal and proximal distal to a fracture was in a straight line (less than 3 mm difference) or not? |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- > 21 years old and a diagnosing of a distal radius fracture based on simple radiography.
Key exclusion criteria (6 listed)
- Open fractures
- more than 20 degree angulation
- joint internal involvement, communicated and along with Neurovascular compromised fractures
- patient's surgery due to other causes
- need to stay in the ICU and not being able to be treated at the same time for distal radius fracture
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 |
|---|---|---|
| ultrasonographyafter manipulation and reduction were performed by single emergency medicine specialist under Bier block regional anesthesia or procedural sedation-analgesia, The ultrasonography was performed by the single emergency department physician in a long axis both in a anterioposterior and lateral views in determining whether the distal and proximal distal to a fracture was in a straight line (less than 3 mm difference) or not? | Other | Distal Radius Fracture |
Primary outcome
adequacy of distal radius fracture reduction
Time frame: at 5 min after admission time
after manipulation and reduction were performed by single emergency medicine specialist under Bier block regional anesthesia or procedural sedation-analgesia, The ultrasonography was performed by the single emergency department physician in a long axis both in a anterioposterior and lateral views in determining whether the distal and proximal distal to a fracture was in a straight line (less than 3 mm difference) or not?
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 4 Apr 2013.
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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.
Hamidreza Shemshaki, MD principal investigator
Isfahan University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ultrasonography in people with Distal Radius Fracture, run by Isfahan University of Medical Sciences at 1 site in Iran.
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 6 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 4 Apr 2013. 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 Iran. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
adequacy of distal radius fracture reduction (time frame: at 5 min after admission time). 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 4 Apr 2013.