Ultrasound Assisted Distal Radius Fracture Reduction

Point of Care Ultrasound Clinical Trial

Official title:

Ultrasound Assisted Distal Radius Fracture Reduction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01561573
• Other study ID #: SPH-POCUS-2012
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: March 16, 2012
• Last updated: April 21, 2012
• Start date: April 2012
• Est. completion date: December 2012

Study information

• Verified date: April 2012
• Source: University of British Columbia
• Contact: Andrew Skinner, MD
• Phone: 6046197384
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 136
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colles Fracture
• Colles' Fracture
• Emergencies
• Emergency Ultrasound
• Fractures, Bone
• Point of Care Ultrasound
• Radius Fractures

Intervention

Device:
• Point of care ultrasound
A bedside ultrasound machine will be used to image the colles fracture during the fracture reduction process.

Locations

Country	Name	City	State
Canada	Foothills Medical Center	Calgary	Alberta
Canada	Dartmouth General Hospital	Dartmouth	Nova Scotia
Canada	Namnaimo General Hospital	Nanaimo	British Columbia
Canada	Saint John Regional Hospital	Saint John	New Brunswick
Canada	St. John's Health Science Center	St. John's	Newfoundland and Labrador
Canada	Sudbury Regional Hospital	Sudbury	Ontario
Canada	Toronto East General Hospital	Toronto	Ontario
Canada	St. Paul's Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No