The Effect of Point-of-care Ultrasound Guidance for Distal Radius Fracture Reduction

NCT02962206 | Completed

• 1 other identifier: 107331
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

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.

Conditions

Point-of-care Ultrasound, Distal Radius Fracture

Outcome Measures

Primary Outcomes (1)

• Residual dorsal angulation

  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 assessed 6 weeks post-injury. Data will be aggregated over the 1 year study period

• Physician satisfaction: post-reduction questionnaire

  Questionnaire to be administered immediately after reduction. Data to be aggregated during the 1 year study period

Study Arms (2)

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.

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.

Device: Point-of-care ultrasound; Procedure: Closed fracture reduction

Interventions

Point-of-care ultrasound DEVICE

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.

Also known as: POCUS

Experimental Group

Closed fracture reduction PROCEDURE

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 Group; Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• radiographically confirmed distal radius fracture

You may not qualify if:

• patients who do not consent
• 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

Sponsors & Collaborators

• Marcus Van Aarsen: lead
• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: collaborator

Study Sites (2)

St. Joseph's Health Care London

London, Ontario, N6A 4V2, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

MeSH Terms

Conditions

Wrist Fractures

Interventions

Closed Fracture Reduction

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

Fracture Fixation; Orthopedic Procedures; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident Physician

Study Record Dates

• First Submitted: November 2, 2016
• First Posted: November 11, 2016
• Study Start: January 10, 2017
• Primary Completion: June 18, 2018
• Study Completion: June 30, 2018
• Last Updated: July 29, 2024

Record last verified: 2024-07

Locations

CA (2)