Ultrasound Assisted Distal Radius Fracture Reduction

Phase 1

• Conditions: Colles Fracture; Emergency Ultrasound; Point of Care Ultrasound
• Interventions: Device: Point of care ultrasound

• Registration Number: NCT01561573
• Lead Sponsor: University of British Columbia

Brief Summary

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

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 Timeline

• Study First Submitted: 2012-03-16
• Study First Submitted QC: 2012-03-21
• Study First Posted: 2012-03-23
• Status Verified: 2012-04
• Study Start: 2012-04
• Last Update Submitted: 2012-04-21
• Last Update Posted: 2012-04-24
• Primary Completion: 2012-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 136

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ultrasound colles fracture	Point of care ultrasound	This is a single arm study

Primary Outcome Measures

Name	Time	Method
Efficacy of Point of care ultrasound in Identifying colles fracture reduction	1 year	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

Name	Time	Method
Number of reduction attempts affected by ultrasound	1 year	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	1 year	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

Trial Locations

Locations (8)

Namnaimo General Hospital; 🇨🇦 Nanaimo, British Columbia, Canada

St. John's Health Science Center; 🇨🇦 St. John's, Newfoundland and Labrador, Canada

Saint John Regional Hospital; 🇨🇦 Saint John, New Brunswick, Canada

Foothills Medical Center; 🇨🇦 Calgary, Alberta, Canada

St. Paul's Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Dartmouth General Hospital; 🇨🇦 Dartmouth, Nova Scotia, Canada

Toronto East General Hospital; 🇨🇦 Toronto, Ontario, Canada

Sudbury Regional Hospital; 🇨🇦 Sudbury, Ontario, Canada