Clinical trial NCT01561573: Ultrasound Assisted Distal Radius Fracture Reduction
Official title: Ultrasound Assisted Distal Radius Fracture Reduction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Colles Fracture
Point of Care Ultrasound
Emergency Ultrasound
Keywords: Point of Care Ultrasound
Emergency Ultrasound
Colles Fracture
Fracture Reduction
Bedside Ultrasound
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2012-03-23
Enrollment: 136
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

Primary outcomes:
measure: Efficacy of Point of care ultrasound in Identifying colles fracture reduction
timeFrame: 1 year
Secondary outcomes:
measure: Number of reduction attempts affected by ultrasound
timeFrame: 1 year
measure: Time to imaging
timeFrame: 1 year
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Center
state: Alberta
city: Nanaimo
country: Canada
facility: Namnaimo General Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Saint John
country: Canada
facility: Saint John Regional Hospital
state: New Brunswick
city: St. John's
country: Canada
facility: St. John's Health Science Center
state: Newfoundland and Labrador
city: Dartmouth
country: Canada
facility: Dartmouth General Hospital
state: Nova Scotia
city: Sudbury
country: Canada
facility: Sudbury Regional Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto East General Hospital
state: Ontario
Study officials:
affiliation: St. Paul's Hospital
name: Andrew Skinner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sudbury Regional Hospital
name: Steve Socransky, MD
role: STUDY_DIRECTOR
affiliation: Sudbury Regional Hospital
name: Ray Wiss, MD
role: STUDY_DIRECTOR
References: