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

Point-of-care Ultrasound, Distal Radius Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02962206
• Other study ID #: 107331
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: June 2018
• Source: Western University, Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2018
• Est. primary completion date: June 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Point-of-care Ultrasound, Distal Radius Fracture
• Radius Fractures

Intervention

Device:
• Point-of-care ultrasound
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.

Procedure:
• Closed fracture reduction
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

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario
Canada	St. Joseph's Health Care London	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Marcus Van Aarsen	Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Residual dorsal angulation		Collected at the same-day post-reduction xray. Data will be aggregated over 1 year
Secondary	Need for orthopaedic surgery within 6 weeks of injury	To be acquired via electronic patient charting	To be assessed 6 weeks post-injury. Data will be aggregated over the 1 year study period
Secondary	Physician satisfaction: post-reduction questionnaire		Questionnaire to be administered immediately after reduction. Data to be aggregated during the 1 year study period