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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

March 16, 2012
April 21, 2012
April 2012
December 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01561573 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Ultrasound Assisted Distal Radius Fracture Reduction
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.

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.
Interventional
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Colles Fracture
  • Point of Care Ultrasound
  • Emergency Ultrasound
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
Ultrasound colles fracture
This is a single arm study
Intervention: Device: Point of care ultrasound
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
136
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
19 Years and older
No
Contact: Andrew Skinner, MD 6046197384
Canada
 
NCT01561573
SPH-POCUS-2012
No
Andrew Skinner, University of British Columbia
University of British Columbia
Not Provided
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
University of British Columbia
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP