Ultrasound Assisted Distal Radius Fracture Reduction
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colles Fracture Point of Care Ultrasound Emergency Ultrasound |
Device: Point of care ultrasound |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Ultrasound Assisted Distal Radius Fracture Reduction |
- 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
- 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
| Estimated Enrollment: | 136 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Ultrasound colles fracture
This is a single arm study
|
Device: Point of care ultrasound
A bedside ultrasound machine will be used to image the colles fracture during the fracture reduction process.
Other Names:
|
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| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Andrew Skinner, MD | 6046197384 |
| Canada, Alberta | |
| Foothills Medical Center | Not yet recruiting |
| Calgary, Alberta, Canada, T2N2T9 | |
| Contact: Mark Bromley, MD markobromley@gmail.com | |
| Canada, British Columbia | |
| Namnaimo General Hospital | Not yet recruiting |
| Nanaimo, British Columbia, Canada, V9S 2B7 | |
| Contact: Ben Ho, MD hoben@shaw.ca | |
| St. Paul's Hospital | Recruiting |
| Vancouver, British Columbia, Canada, V6Z1Y6 | |
| Contact: Andrew Skinner, MD 6046197384 | |
| Principal Investigator: Andrew Skinner, MD | |
| Canada, New Brunswick | |
| Saint John Regional Hospital | Recruiting |
| Saint John, New Brunswick, Canada, E2L4L2 | |
| Contact: Paul Atkinson, MD pandjatkinson@googlemail.com | |
| Canada, Newfoundland and Labrador | |
| St. John's Health Science Center | Recruiting |
| St. John's, Newfoundland and Labrador, Canada, A1B 3V6 | |
| Contact: Andrew Smith, MD ajjsmith1@yahoo.com | |
| Canada, Nova Scotia | |
| Dartmouth General Hospital | Not yet recruiting |
| Dartmouth, Nova Scotia, Canada, B2Y3S3 | |
| Contact: Chuck Wurster, MD cwurster@me.com | |
| Canada, Ontario | |
| Sudbury Regional Hospital | Recruiting |
| Sudbury, Ontario, Canada, P3E5J1 | |
| Contact: Steve Socransky, MD 7055618760 | |
| Principal Investigator: Steve Socransky, MD | |
| Principal Investigator: Ray Wiss, MD | |
| Toronto East General Hospital | Not yet recruiting |
| Toronto, Ontario, Canada, M4C3E7 | |
| Contact: Paul Hannam, MD phann@tegh.on.ca | |
| 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 |
More Information
No publications provided
| Responsible Party: | Andrew Skinner, Dr. William Andrew Skinner, University of British Columbia |
| ClinicalTrials.gov Identifier: | NCT01561573 History of Changes |
| Other Study ID Numbers: | SPH-POCUS-2012 |
| Study First Received: | March 16, 2012 |
| Last Updated: | April 21, 2012 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by University of British Columbia:
|
Point of Care Ultrasound Emergency Ultrasound Colles Fracture Fracture Reduction Bedside Ultrasound |
Additional relevant MeSH terms:
|
Colles' Fracture Emergencies Fractures, Bone Radius Fractures Wounds and Injuries |
Disease Attributes Pathologic Processes Forearm Injuries Arm Injuries |
ClinicalTrials.gov processed this record on May 16, 2013