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

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
      • London, Ontario, Canada, N6A 5W9
        • London Health Sciences Centre
      • 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:
  • POCUS

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.

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

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.

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