Colles FracturePhase 1/2NCT01561573
Ultrasound Assisted Distal Radius Fracture Reduction
A Phase 1/2 study testing Point of care ultrasound in people with Colles Fracture and Point of Care Ultrasound, run by University of British Columbia at 8 sites in Canada.
Trial summary
PURPOSE: to evaluate the utility of bedside ultrasound performed by emergency physicians in the evaluation and reduction of colles fractures as compared with traditional pre and post reduction radiographs. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Colles Fracture, Point of Care Ultrasound, Emergency Ultrasound
- What is being tested?
- Point of care ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 8 sitesCanada
- Study dates
- Apr 2012to Dec 2012
- Phase
- Phase 1/2
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 19 years old
- Able to provide voluntary and informed consent
- Distal radius fracture is the main traumatic injury
- Planned reduction to be performed by the EP
- Treating EP trained to perform EU for fractures OR one of the study authors available to perform EU
Who cannot join
- < 19 years old
- Patient unable to provide voluntary and informed consent
- Distal radius fracture is only one of several significant injuries
- No reduction to be performed by the EP
- EP not trained to perform EU for fractures AND no study author available to perform EU
Trial locations and contacts
8 sites in 1 country.
Andrew Skinner, MD contact
8 sites in 1 country
Canada8 sites, 8 recruiting
- Not yet recruiting
Foothills Medical Center
Calgary, Alberta, T2N2T9
Mark Bromley, MD, markobromley@gmail.com
- Not yet recruiting
Dartmouth General Hospital
Dartmouth, Nova Scotia, B2Y3S3
Chuck Wurster, MD, cwurster@me.com
- Recruiting
Sudbury Regional Hospital
Greater Sudbury, Ontario, P3E5J1
Steve Socransky, MD, 7055618760
Steve Socransky, MD
- Not yet recruiting
Namnaimo General Hospital
Nanaimo, British Columbia, V9S 2B7
Ben Ho, MD, hoben@shaw.ca
- Recruiting
Saint John Regional Hospital
Saint John, New Brunswick, E2L4L2
Paul Atkinson, MD, pandjatkinson@googlemail.com
- Recruiting
St. John's Health Science Center
St. John's, Newfoundland and Labrador, A1B 3V6
Andrew Smith, MD, ajjsmith1@yahoo.com
- Not yet recruiting
Toronto East General Hospital
Toronto, Ontario, M4C3E7
Paul Hannam, MD, phann@tegh.on.ca
- Recruiting
St. Paul's Hospital
Vancouver, British Columbia, V6Z1Y6
Andrew Skinner, MD, 6046197384
Andrew Skinner, MD
About this study
PURPOSE: to evaluate the utility of bedside ultrasound performed by emergency physicians in the evaluation and reduction of colles fractures as compared with traditional pre and post reduction radiographs. With the objectives of assessing Emergency Ultrasounds (EU) utility in guiding reduction attempts of Colles fractures and to compare EU to x-ray for the final assessment of reduction adequacy.
Read the detailed description
The reduction of fractures is a commonly performed procedure in emergency departments (EDs). In most Canadian EDs, reductions are performed by emergency physicians (EPs). The distal radius fracture is the most common fracture requiring reduction. Fracture reduction is time-consuming with several steps required: initial evaluation including x-ray, equipment and personnel gathering, sedation and/or local anesthesia, reduction attempt(s) and splinting/casting, and post-reduction x-rays, with subsequent patient reassessment. These steps have a negative effect on ED patient throughput. Subsequent to the reduction attempt(s), the patient is sent for x-ray often with uncertainty regarding the reduction success. Fluoroscopy is generally not an option for the EP in evaluating accuracy of reduction. If the reduction is not adequate, further reduction attempts are needed. This utilizes more resources, either in the ED or orthopedic clinic or operating room, depending on where further reduction attempts are made.
Emergency ultrasound (EU) in Canada has become a well-established part of emergency medical practice in recent years as evidenced by the latest position statement of the Canadian Association of Emergency Physicians (http://caep.ca/template.asp?id=B5283F4158FB471AA56E480D6277C1AC) and the development of the Canadian Emergency Ultrasound Society (www.ceus.ca). A growing body of literature has shown the utility of EU in the diagnosis and reduction of fractures (1-6). A recent case report (7) showed that EU can be used to aid Colles fracture reduction. Similar to fluoroscopy, EU may be a fast and accurate method of determining successful fracture reduction. Unlike fluoroscopy, EU is available immediately in the ED. EU may also obviate the need for the post-reduction x-ray, particularly in the setting where the patient will have yet another x-ray at the time of orthopedic follow-up to evaluate for interval loss of reduction. Thus, EU has the potential to significantly reduce time to discharge.
Our study has the following objectives:
- To assess EU utility for guiding reduction attempts of distal radius fractures.
- To compare EU to x-ray for the final assessment of reduction adequacy.
- Being tested
- Point of care ultrasound
- Keywords
- Point of Care Ultrasound, Emergency Ultrasound, Colles Fracture, Fracture Reduction, Bedside Ultrasound
- Medical subject headings
- Colles' Fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point of care ultrasoundDevice
Also called Ultrasound Machines used in the study will include, Sonosite micromaxx, Sonosite M-Turbo, Ultrasonix Sonixtouch
A bedside ultrasound machine will be used to image the colles fracture during the fracture reduction process.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound colles fracture | Other | This is a single arm study Receives: Device: Point of care ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Point of care ultrasound in Identifying colles fracture reduction
Physicians performing Bedside ultrasound of colles fractures will be asked to complete likert scales on the adequacy of fracture reduction with ultrasound
Measured: 1 year
Secondary outcomes (2)
Number of reduction attempts affected by ultrasound
The physician is asked to record the number of fracture reduction attempts as guided by the ultrasound image before and after the post reduction X-ray
Measured: 1 year
Time to imaging
The physician performing the bedside ultrasound will record the time on completion of the bedside ultrasound and the time of completion of the post reduction X-ray
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colles FractureStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Skinner, University of British Columbia
- Investigators
- Andrew Skinner, MD, Principal investigator, St. Paul's HospitalSteve Socransky, MD, Study director, Sudbury Regional HospitalRay Wiss, MD, Study director, Sudbury Regional Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01561573
- Sponsor's protocol ID
- SPH-POCUS-2012
- Status last verified
- Apr 2012
- First submitted
- 16 Mar 2012
- Last updated
- 24 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Assisted Distal Radius Fracture Reduction
- ClinicalTrials.gov ID
- NCT01561573
- Acronym / sponsor ID
- SPH-POCUS-2012
- Keywords
- Point of Care Ultrasound, Emergency Ultrasound, Colles Fracture, Fracture Reduction, Bedside Ultrasound
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 23 Mar 2012 (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.
PURPOSE: to evaluate the utility of bedside ultrasound performed by emergency physicians in the evaluation and reduction of colles fractures as compared with traditional pre and post reduction radiographs. With the objectives of assessing Emergency Ultrasounds (EU) utility in guiding reduction attempts of Colles fractures and to compare EU to x-ray for the final assessment of reduction adequacy.
Detailed description
The reduction of fractures is a commonly performed procedure in emergency departments (EDs). In most Canadian EDs, reductions are performed by emergency physicians (EPs). The distal radius fracture is the most common fracture requiring reduction. Fracture reduction is time-consuming with several steps required: initial evaluation including x-ray, equipment and personnel gathering, sedation and/or local anesthesia, reduction attempt(s) and splinting/casting, and post-reduction x-rays, with subsequent patient reassessment. These steps have a negative effect on ED patient throughput. Subsequent to the reduction attempt(s), the patient is sent for x-ray often with uncertainty regarding the reduction success. Fluoroscopy is generally not an option for the EP in evaluating accuracy of reduction. If the reduction is not adequate, further reduction attempts are needed. This utilizes more resources, either in the ED or orthopedic clinic or operating room, depending on where further reduction attempts are made.
Emergency ultrasound (EU) in Canada has become a well-established part of emergency medical practice in recent years as evidenced by the latest position statement of the Canadian Association of Emergency Physicians (http://caep.ca/template.asp?id=B5283F4158FB471AA56E480D6277C1AC) and the development of the Canadian Emergency Ultrasound Society (www.ceus.ca). A growing body of literature has shown the utility of EU in the diagnosis and reduction of fractures (1-6). A recent case report (7) showed that EU can be used to aid Colles fracture reduction. Similar to fluoroscopy, EU may be a fast and accurate method of determining successful fracture reduction. Unlike fluoroscopy, EU is available immediately in the ED. EU may also obviate the need for the post-reduction x-ray, particularly in the setting where the patient will have yet another x-ray at the time of orthopedic follow-up to evaluate for interval loss of reduction. Thus, EU has the potential to significantly reduce time to discharge.
Our study has the following objectives:
- To assess EU utility for guiding reduction attempts of distal radius fractures.
- To compare EU to x-ray for the final assessment of reduction adequacy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound colles fracture | Other | Device: Point of care ultrasoundThis is a single arm study |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- > 19 years old
- Able to provide voluntary and informed consent
- Distal radius fracture is the main traumatic injury
- Planned reduction to be performed by the EP
- Treating EP trained to perform EU for fractures OR one of the study authors available to perform EU
Key exclusion criteria (5 listed)
- < 19 years old
- Patient unable to provide voluntary and informed consent
- Distal radius fracture is only one of several significant injuries
- No reduction to be performed by the EP
- EP not trained to perform EU for fractures AND no study author available to perform EU
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 |
|---|---|---|
| Point of care ultrasoundAlso: Ultrasound Machines used in the study will include, Sonosite micromaxx, Sonosite M-Turbo, Ultrasonix SonixtouchA bedside ultrasound machine will be used to image the colles fracture during the fracture reduction process. | Device | Ultrasound colles fracture |
Primary outcome
Efficacy of Point of care ultrasound in Identifying colles fracture reduction
Time frame: 1 year
Physicians performing Bedside ultrasound of colles fractures will be asked to complete likert scales on the adequacy of fracture reduction with ultrasound
2 secondary outcomes
Number of reduction attempts affected by ultrasound
Time frame: 1 year
Time to imaging
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2012.
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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.
Andrew Skinner, MD contact
Andrew Skinner, MD principal investigator
St. Paul's Hospital
Steve Socransky, MD study director
Sudbury Regional Hospital
Ray Wiss, MD study director
Sudbury Regional Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Point of care ultrasound in people with Colles Fracture and Point of Care Ultrasound, run by University of British Columbia at 8 sites in Canada.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 24 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Canada. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrew Skinner, MD (6046197384), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of Point of care ultrasound in Identifying colles fracture reduction (time frame: 1 year). 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 Apr 2012.