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Ultrasound Assisted Distal Radius Fracture Reduction

Primary Purpose

Colles Fracture, Point of Care Ultrasound, Emergency Ultrasound

Status
Unknown status
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Point of care ultrasound
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colles Fracture focused on measuring Point of Care Ultrasound, Emergency Ultrasound, Colles Fracture, Fracture Reduction, Bedside Ultrasound

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Foothills Medical Center
  • Namnaimo General Hospital
  • St. Paul's HospitalRecruiting
  • Saint John Regional HospitalRecruiting
  • St. John's Health Science CenterRecruiting
  • Dartmouth General Hospital
  • Sudbury Regional HospitalRecruiting
  • Toronto East General Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Ultrasound colles fracture

Arm Description

This is a single arm study

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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

Full Information

First Posted
March 16, 2012
Last Updated
April 21, 2012
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT01561573
Brief Title
Ultrasound Assisted Distal Radius Fracture Reduction
Official Title
Ultrasound Assisted Distal Radius Fracture Reduction
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Unknown status
Study Start Date
April 2012 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colles Fracture, Point of Care Ultrasound, Emergency Ultrasound
Keywords
Point of Care Ultrasound, Emergency Ultrasound, Colles Fracture, Fracture Reduction, Bedside Ultrasound

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
136 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound colles fracture
Arm Type
Other
Arm Description
This is a single arm study
Intervention Type
Device
Intervention Name(s)
Point of care ultrasound
Other Intervention Name(s)
Ultrasound Machines used in the study will include, Sonosite micromaxx, Sonosite M-Turbo, Ultrasonix Sonixtouch, Ultrasonix Sonixtablet, Esaote MyLab Five, Esaote MyLab 25 Gold
Intervention Description
A bedside ultrasound machine will be used to image the colles fracture during the fracture reduction process.
Primary Outcome Measure Information:
Title
Efficacy of Point of care ultrasound in Identifying colles fracture reduction
Description
Physicians performing Bedside ultrasound of colles fractures will be asked to complete likert scales on the adequacy of fracture reduction with ultrasound
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Number of reduction attempts affected by ultrasound
Description
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 Frame
1 year
Title
Time to imaging
Description
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
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrew Skinner, MD
Phone
6046197384
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Skinner, MD
Organizational Affiliation
St. Paul's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Steve Socransky, MD
Organizational Affiliation
Sudbury Regional Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ray Wiss, MD
Organizational Affiliation
Sudbury Regional Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Foothills Medical Center
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N2T9
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Bromley, MD
Email
markobromley@gmail.com
Facility Name
Namnaimo General Hospital
City
Nanaimo
State/Province
British Columbia
ZIP/Postal Code
V9S 2B7
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ben Ho, MD
Email
hoben@shaw.ca
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z1Y6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Skinner, MD
Phone
6046197384
First Name & Middle Initial & Last Name & Degree
Andrew Skinner, MD
Facility Name
Saint John Regional Hospital
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L4L2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Atkinson, MD
Email
pandjatkinson@googlemail.com
Facility Name
St. John's Health Science Center
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Smith, MD
Email
ajjsmith1@yahoo.com
Facility Name
Dartmouth General Hospital
City
Dartmouth
State/Province
Nova Scotia
ZIP/Postal Code
B2Y3S3
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chuck Wurster, MD
Email
cwurster@me.com
Facility Name
Sudbury Regional Hospital
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E5J1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steve Socransky, MD
Phone
7055618760
First Name & Middle Initial & Last Name & Degree
Steve Socransky, MD
First Name & Middle Initial & Last Name & Degree
Ray Wiss, MD
Facility Name
Toronto East General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4C3E7
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Hannam, MD
Email
phann@tegh.on.ca

12. IPD Sharing Statement

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Ultrasound Assisted Distal Radius Fracture Reduction

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