The Effect of Point-of-care Ultrasound Guidance for Distal Radius Fracture Reduction
Primary Purpose
Point-of-care Ultrasound, Distal Radius Fracture
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Point-of-care ultrasound
Closed fracture reduction
Sponsored by
About this trial
This is an interventional treatment trial for Point-of-care Ultrasound, Distal Radius Fracture
Eligibility Criteria
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
Sites / Locations
- St. Joseph's Health Care LondonRecruiting
- London Health Sciences CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard of care
Experimental Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Residual dorsal angulation
Secondary Outcome Measures
Need for orthopaedic surgery within 6 weeks of injury
To be acquired via electronic patient charting
Physician satisfaction: post-reduction questionnaire
Full Information
NCT ID
NCT02962206
First Posted
November 2, 2016
Last Updated
June 20, 2018
Sponsor
Marcus Van Aarsen
Collaborators
Lawson Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02962206
Brief Title
The Effect of Point-of-care Ultrasound Guidance for Distal Radius Fracture Reduction
Official Title
The Effect of Point-of-care Ultrasound Guidance for Distal Radius Fracture Reduction
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 10, 2017 (Actual)
Primary Completion Date
June 18, 2018 (Actual)
Study Completion Date
June 30, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marcus Van Aarsen
Collaborators
Lawson Health Research Institute
4. Oversight
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Point-of-care Ultrasound, Distal Radius Fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard of care
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Point-of-care ultrasound
Other Intervention Name(s)
POCUS
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Closed fracture reduction
Intervention Description
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
Primary Outcome Measure Information:
Title
Residual dorsal angulation
Time Frame
Collected at the same-day post-reduction xray. Data will be aggregated over 1 year
Secondary Outcome Measure Information:
Title
Need for orthopaedic surgery within 6 weeks of injury
Description
To be acquired via electronic patient charting
Time Frame
To be assessed 6 weeks post-injury. Data will be aggregated over the 1 year study period
Title
Physician satisfaction: post-reduction questionnaire
Time Frame
Questionnaire to be administered immediately after reduction. Data to be aggregated during the 1 year study period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
St. Joseph's Health Care London
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristine P Van Aarsen, MSc
Phone
519-685-8500
Ext
76089
Email
kristine.vanaarsen@lhsc.on.ca
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristine P Van Aarsen, MSc
Phone
519-685-8500
Ext
76089
Email
kristine.vanaarsen@lhsc.on.ca
12. IPD Sharing Statement
Learn more about this trial
The Effect of Point-of-care Ultrasound Guidance for Distal Radius Fracture Reduction
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