Point-of-care Ultrasound, Distal Radius FractureNCT02962206
The Effect of Point-of-care Ultrasound Guidance for Distal Radius Fracture Reduction
A study testing Point-of-care ultrasound and Closed fracture reduction in people with Point-of-care Ultrasound, Distal Radius Fracture, run by Marcus Van Aarsen at 2 sites in Canada.
Trial summary
Distal radius (Colle's) fractures in adult patients are commonly reduced in the emergency department before casting. Standard of care currently requires that x-rays be performed before and after fracture reduction, and inadequate reductions may be subject to repeat attempts and are at a higher risk to require surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Point-of-care Ultrasound, Distal Radius Fracture
- What is being tested?
- Point-of-care ultrasound and Closed fracture reduction
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesCanada
- Study dates
- 10 Jan 2017to 30 Jun 2018
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- radiographically confirmed distal radius fracture
Who cannot join
- patients who do not consent
- patients with multiple acute injuries, open fractures, or other local fractures evident (a simple ulnar styloid fracture will not be considered an exclusion criterion)
- patients with neurovascular compromise
- patients with bilateral distal radius fractures
- patients with minimally displaced distal radius fractures that do not require closed reduction before casting
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
St. Joseph's Health Care London
London, Ontario, N6A 4V2
London Health Sciences Centre
London, Ontario, N6A 5W9
About this study
Distal radius (Colle's) fractures in adult patients are commonly reduced in the emergency department before casting. Standard of care currently requires that x-rays be performed before and after fracture reduction, and inadequate reductions may be subject to repeat attempts and are at a higher risk to require surgery. This study will assess the use of point-of-care ultrasound (POCUS) in addition to standard care as a tool to decrease the angulation at the fracture site after a reduction is performed. If this angulation is decreased, it would suggest that POCUS for distal radius fracture reduction could decrease the number of failed reduction attempts and therefore the number of repeated reduction attempts.
- Being tested
- Point-of-care ultrasound, Closed fracture reduction
- Medical subject headings
- Wrist Fractures
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 POCUS
After the fracture reduction maneouver, the physician will assess residual dorsal angulation using point-of-care ultrasound. If deemed adequate, the physician will progress to immobilization. If the reduction is not adequate, the physician will attempt further reduction at their discretion.
Closed fracture reductionProcedure or surgery
The distal radius fracture will be reduced with using a combination of local anesthetic, sedation, reduction maneouvers and immobiliazation at the discretion of the treating physician
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Active comparator | Patients will undergo standard closed fracture reduction. The sedation type, reduction method, and immobilization method will be at the discretion of the treating physician. Point-of-care ultrasound will not be used. Receives: Procedure: Closed fracture reduction |
| Experimental Group | Experimental | Patients will undergo standard closed fracture reduction with the addition of point-of-care ultrasound use to assess post-reduction dorsal angulation. The sedation type, reduction method, and immobilization method will be at the discretion of the treating physician. Receives: Device: Point-of-care ultrasound; Procedure: Closed fracture reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual dorsal angulation
Measured: Collected at the same-day post-reduction xray. Data will be aggregated over 1 year
Secondary outcomes (2)
Need for orthopaedic surgery within 6 weeks of injury
To be acquired via electronic patient charting
Measured: To be assessed 6 weeks post-injury. Data will be aggregated over the 1 year study period
Physician satisfaction: post-reduction questionnaire
Measured: Questionnaire to be administered immediately after reduction. Data to be aggregated during the 1 year study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2016 (estimated)
- Study start10 Jan 2017
- Primary completion18 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Point-of-care Ultrasound, 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marcus Van Aarsen
- Sponsor type
- University, hospital or other
- Collaborators
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Responsible party
- Sponsor-investigator, Marcus Van Aarsen, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02962206
- Sponsor's protocol ID
- 107331
- Status last verified
- Jul 2024
- First submitted
- 2 Nov 2016
- Last updated
- 29 Jul 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Point-of-care Ultrasound Guidance for Distal Radius Fracture Reduction
- ClinicalTrials.gov ID
- NCT02962206
- Acronym / sponsor ID
- 107331
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Marcus Van AarsenUniversity, hospital or other
- Collaborators
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Study start
- 10 Jan 2017 (actual)
- Primary completion
- 18 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 11 Nov 2016 (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.
Distal radius (Colle's) fractures in adult patients are commonly reduced in the emergency department before casting. Standard of care currently requires that x-rays be performed before and after fracture reduction, and inadequate reductions may be subject to repeat attempts and are at a higher risk to require surgery. This study will assess the use of point-of-care ultrasound (POCUS) in addition to standard care as a tool to decrease the angulation at the fracture site after a reduction is performed. If this angulation is decreased, it would suggest that POCUS for distal radius fracture reduction could decrease the number of failed reduction attempts and therefore the number of repeated reduction attempts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | Active comparator | Procedure: Closed fracture reductionPatients will undergo standard closed fracture reduction. The sedation type, reduction method, and immobilization method will be at the discretion of the treating physician. Point-of-care ultrasound will not be used. |
| Experimental Group | Experimental | Device: Point-of-care ultrasound, Procedure: Closed fracture reductionPatients will undergo standard closed fracture reduction with the addition of point-of-care ultrasound use to assess post-reduction dorsal angulation. The sedation type, reduction method, and immobilization method will be at the discretion of the treating physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- radiographically confirmed distal radius fracture
Key exclusion criteria (5 listed)
- patients who do not consent
- patients with multiple acute injuries, open fractures, or other local fractures evident (a simple ulnar styloid fracture will not be considered an exclusion criterion)
- patients with neurovascular compromise
- patients with bilateral distal radius fractures
- patients with minimally displaced distal radius fractures that do not require closed reduction before casting
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: POCUSAfter the fracture reduction maneouver, the physician will assess residual dorsal angulation using point-of-care ultrasound. If deemed adequate, the physician will progress to immobilization. If the reduction is not adequate, the physician will attempt further reduction at their discretion. | Device | Experimental Group |
| Closed fracture reductionThe distal radius fracture will be reduced with using a combination of local anesthetic, sedation, reduction maneouvers and immobiliazation at the discretion of the treating physician | Procedure or surgery | Experimental Group, Standard of care |
Primary outcome
Residual dorsal angulation
Time frame: Collected at the same-day post-reduction xray. Data will be aggregated over 1 year
2 secondary outcomes
Need for orthopaedic surgery within 6 weeks of injury
Time frame: To be assessed 6 weeks post-injury. Data will be aggregated over the 1 year study period
Physician satisfaction: post-reduction questionnaire
Time frame: Questionnaire to be administered immediately after reduction. Data to be aggregated during the 1 year study period
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 29 Jul 2024.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Point-of-care ultrasound and Closed fracture reduction in people with Point-of-care Ultrasound, Distal Radius Fracture, run by Marcus Van Aarsen at 2 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 1 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: finished, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
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?
Residual dorsal angulation (time frame: Collected at the same-day post-reduction xray. Data will be aggregated over 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 29 Jul 2024.