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Ultrasound Assisted Distal Radius Fracture Reduction

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by University of British Columbia.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Andrew Skinner, University of British Columbia
ClinicalTrials.gov Identifier:
NCT01561573
First received: March 16, 2012
Last updated: April 21, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Colles Fracture
Point of Care Ultrasound
Emergency Ultrasound
Device: Point of care ultrasound
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Ultrasound Assisted Distal Radius Fracture Reduction

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Efficacy of Point of care ultrasound in Identifying colles fracture reduction [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Physicians performing Bedside ultrasound of colles fractures will be asked to complete likert scales on the adequacy of fracture reduction with ultrasound


Secondary Outcome Measures:
  • Number of reduction attempts affected by ultrasound [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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

  • Time to imaging [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 136
Study Start Date: April 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01561573

Contacts
Contact: Andrew Skinner, MD 6046197384

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

No publications provided

Responsible Party: Andrew Skinner, Dr. William Andrew Skinner, University of British Columbia
ClinicalTrials.gov Identifier: NCT01561573     History of Changes
Other Study ID Numbers: SPH-POCUS-2012
Study First Received: March 16, 2012
Last Updated: April 21, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of British Columbia:
Point of Care Ultrasound
Emergency Ultrasound
Colles Fracture
Fracture Reduction
Bedside Ultrasound

Additional relevant MeSH terms:
Colles' Fracture
Emergencies
Fractures, Bone
Radius Fractures
Arm Injuries
Disease Attributes
Forearm Injuries
Pathologic Processes
Wounds and Injuries

ClinicalTrials.gov processed this record on November 24, 2014