Ultrasound Assisted Distal Radius Fracture Reduction

NCT ID: NCT01561573

Last Updated: 2012-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Colles Fracture Point of Care Ultrasound Emergency Ultrasound

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Ultrasound colles fracture

This is a single arm study

Group Type OTHER

Point of care ultrasound

Intervention Type DEVICE

A bedside ultrasound machine will be used to image the colles fracture during the fracture reduction process.

Interventions

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Point of care ultrasound

A bedside ultrasound machine will be used to image the colles fracture during the fracture reduction process.

Intervention Type DEVICE

Other Intervention Names

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Ultrasound Machines used in the study will include Sonosite micromaxx Sonosite M-Turbo Ultrasonix Sonixtouch Ultrasonix Sonixtablet Esaote MyLab Five Esaote MyLab 25 Gold

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Andrew Skinner

Dr. William Andrew Skinner

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrew Skinner, MD

Role: PRINCIPAL_INVESTIGATOR

St. Paul's Hospital

Steve Socransky, MD

Role: STUDY_DIRECTOR

Sudbury Regional Hospital

Ray Wiss, MD

Role: STUDY_DIRECTOR

Sudbury Regional Hospital

Locations

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Foothills Medical Center

Calgary, Alberta, Canada

Site Status NOT_YET_RECRUITING

Namnaimo General Hospital

Nanaimo, British Columbia, Canada

Site Status NOT_YET_RECRUITING

St. Paul's Hospital

Vancouver, British Columbia, Canada

Site Status RECRUITING

Saint John Regional Hospital

Saint John, New Brunswick, Canada

Site Status RECRUITING

St. John's Health Science Center

St. John's, Newfoundland and Labrador, Canada

Site Status RECRUITING

Dartmouth General Hospital

Dartmouth, Nova Scotia, Canada

Site Status NOT_YET_RECRUITING

Sudbury Regional Hospital

Greater Sudbury, Ontario, Canada

Site Status RECRUITING

Toronto East General Hospital

Toronto, Ontario, Canada

Site Status NOT_YET_RECRUITING

Countries

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Canada

Central Contacts

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Andrew Skinner, MD

Role: CONTACT

6046197384

Facility Contacts

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Mark Bromley, MD

Role: primary

Ben Ho, MD

Role: primary

Andrew Skinner, MD

Role: primary

6046197384

Paul Atkinson, MD

Role: primary

Andrew Smith, MD

Role: primary

Chuck Wurster, MD

Role: primary

Steve Socransky, MD

Role: primary

7055618760

Paul Hannam, MD

Role: primary

Other Identifiers

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SPH-POCUS-2012

Identifier Type: -

Identifier Source: org_study_id

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