- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02962206
The Effect of Point-of-care Ultrasound Guidance for Distal Radius Fracture Reduction
July 25, 2024 updated by: Marcus Van Aarsen
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 Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
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London, Ontario, Canada, N6A 5W9
- London Health Sciences Centre
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London, Ontario, Canada, N6A 4V2
- St. Joseph's Health Care London
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- radiographically confirmed distal radius fracture
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Standard of care
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.
|
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
|
|
Experimental: Experimental Group
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.
|
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
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Residual dorsal angulation
Time Frame: Collected at the same-day post-reduction xray. Data will be aggregated over 1 year
|
Collected at the same-day post-reduction xray. Data will be aggregated over 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
To be acquired via electronic patient charting
|
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
|
Questionnaire to be administered immediately after reduction. Data to be aggregated during the 1 year study period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 10, 2017
Primary Completion (Actual)
June 18, 2018
Study Completion (Actual)
June 30, 2018
Study Registration Dates
First Submitted
November 2, 2016
First Submitted That Met QC Criteria
November 10, 2016
First Posted (Estimated)
November 11, 2016
Study Record Updates
Last Update Posted (Actual)
July 29, 2024
Last Update Submitted That Met QC Criteria
July 25, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 107331
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.