Ultrasound Assisted Distal Radius Fracture Reduction

PURPOSE: to evaluate the utility of bedside ultrasound performed by emergency physicians in the evaluation and reduction of colles fractures as compared with traditional pre and post reduction radiographs. With the objectives of assessing Emergency Ultrasounds (EU) utility in guiding reduction attempts of Colles fractures and to compare EU to x-ray for the final assessment of reduction adequacy.

Study Overview

• Status: Unknown
• Conditions: Point of Care Ultrasound; Colles Fracture; Emergency Ultrasound
• Intervention / Treatment: Device: Point of care ultrasound

Detailed Description

The reduction of fractures is a commonly performed procedure in emergency departments (EDs). In most Canadian EDs, reductions are performed by emergency physicians (EPs). The distal radius fracture is the most common fracture requiring reduction. Fracture reduction is time-consuming with several steps required: initial evaluation including x-ray, equipment and personnel gathering, sedation and/or local anesthesia, reduction attempt(s) and splinting/casting, and post-reduction x-rays, with subsequent patient reassessment. These steps have a negative effect on ED patient throughput. Subsequent to the reduction attempt(s), the patient is sent for x-ray often with uncertainty regarding the reduction success. Fluoroscopy is generally not an option for the EP in evaluating accuracy of reduction. If the reduction is not adequate, further reduction attempts are needed. This utilizes more resources, either in the ED or orthopedic clinic or operating room, depending on where further reduction attempts are made.

Emergency ultrasound (EU) in Canada has become a well-established part of emergency medical practice in recent years as evidenced by the latest position statement of the Canadian Association of Emergency Physicians (http://caep.ca/template.asp?id=B5283F4158FB471AA56E480D6277C1AC) and the development of the Canadian Emergency Ultrasound Society (www.ceus.ca). A growing body of literature has shown the utility of EU in the diagnosis and reduction of fractures (1-6). A recent case report (7) showed that EU can be used to aid Colles fracture reduction. Similar to fluoroscopy, EU may be a fast and accurate method of determining successful fracture reduction. Unlike fluoroscopy, EU is available immediately in the ED. EU may also obviate the need for the post-reduction x-ray, particularly in the setting where the patient will have yet another x-ray at the time of orthopedic follow-up to evaluate for interval loss of reduction. Thus, EU has the potential to significantly reduce time to discharge.

Our study has the following objectives:

• To assess EU utility for guiding reduction attempts of distal radius fractures.
• To compare EU to x-ray for the final assessment of reduction adequacy.

• Study Type: Interventional
• Enrollment (Anticipated): 136
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N2T9
      • Not yet recruiting
      • Foothills Medical Center
      • Contact: Mark Bromley, MD; Email: markobromley@gmail.com
  • British Columbia
    • Nanaimo, British Columbia, Canada, V9S 2B7
      • Not yet recruiting
      • Namnaimo General Hospital
      • Contact: Ben Ho, MD; Email: hoben@shaw.ca
    • Vancouver, British Columbia, Canada, V6Z1Y6
      • Recruiting
      • St. Paul's Hospital
      • Contact: Andrew Skinner, MD; Phone Number: 6046197384
      • Principal Investigator: Andrew Skinner, MD
  • New Brunswick
    • Saint John, New Brunswick, Canada, E2L4L2
      • Recruiting
      • Saint John Regional Hospital
      • Contact: Paul Atkinson, MD; Email: pandjatkinson@googlemail.com
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
      • Recruiting
      • St. John's Health Science Center
      • Contact: Andrew Smith, MD; Email: ajjsmith1@yahoo.com
  • Nova Scotia
    • Dartmouth, Nova Scotia, Canada, B2Y3S3
      • Not yet recruiting
      • Dartmouth General Hospital
      • Contact: Chuck Wurster, MD; Email: cwurster@me.com
  • Ontario
    • Sudbury, Ontario, Canada, P3E5J1
      • Recruiting
      • Sudbury Regional Hospital
      • Contact: Steve Socransky, MD; Phone Number: 7055618760
      • Principal Investigator: Steve Socransky, MD
      • Principal Investigator: Ray Wiss, MD
    • Toronto, Ontario, Canada, M4C3E7
      • Not yet recruiting
      • Toronto East General Hospital
      • Contact: Paul Hannam, MD; Email: phann@tegh.on.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• > 19 years old
• Able to provide voluntary and informed consent
• Distal radius fracture is the main traumatic injury
• Planned reduction to be performed by the EP
• Treating EP trained to perform EU for fractures OR one of the study authors available to perform EU

Exclusion Criteria:

• < 19 years old
• Patient unable to provide voluntary and informed consent
• Distal radius fracture is only one of several significant injuries
• No reduction to be performed by the EP
• EP not trained to perform EU for fractures AND no study author available to perform EU

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Ultrasound colles fracture; This is a single arm study	Device: Point of care ultrasound; A bedside ultrasound machine will be used to image the colles fracture during the fracture reduction process.; Other Names: Ultrasound Machines used in the study will include; Sonosite micromaxx; Sonosite M-Turbo; Ultrasonix Sonixtouch; Ultrasonix Sonixtablet; Esaote MyLab Five; Esaote MyLab 25 Gold

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of Point of care ultrasound in Identifying colles fracture reduction	Physicians performing Bedside ultrasound of colles fractures will be asked to complete likert scales on the adequacy of fracture reduction with ultrasound	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of reduction attempts affected by ultrasound	The physician is asked to record the number of fracture reduction attempts as guided by the ultrasound image before and after the post reduction X-ray	1 year
Time to imaging	The physician performing the bedside ultrasound will record the time on completion of the bedside ultrasound and the time of completion of the post reduction X-ray	1 year

Collaborators and Investigators

• Sponsor: University of British Columbia
• Investigators: Principal Investigator: Andrew Skinner, MD, St. Paul's Hospital; Study Director: Steve Socransky, MD, Sudbury Regional Hospital; Study Director: Ray Wiss, MD, Sudbury Regional Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (ANTICIPATED): December 1, 2012
• Study Completion (ANTICIPATED): December 1, 2012

Study Registration Dates

• First Submitted: March 16, 2012
• First Submitted That Met QC Criteria: March 21, 2012
• First Posted (ESTIMATE): March 23, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): April 24, 2012
• Last Update Submitted That Met QC Criteria: April 21, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: Bedside Ultrasound; Colles Fracture; Point of Care Ultrasound; Emergency Ultrasound; Fracture Reduction
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Disease Attributes; Joint Diseases; Musculoskeletal Diseases; Joint Dislocations; Arm Injuries; Forearm Injuries; Fracture Dislocation; Emergencies; Fractures, Bone; Radius Fractures; Colles' Fracture
• Other Study ID Numbers: SPH-POCUS-2012