Applicability of the Ottawa Ankle Rules
Primary Purpose
Ankle Fracture, Ankle Sprain
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Ottawa ankle rules
Sponsored by
About this trial
This is an interventional diagnostic trial for Ankle Fracture
Eligibility Criteria
Inclusion Criteria:
- ankle trauma
Exclusion Criteria:
- unwilling to participate
Sites / Locations
- Hadassah Medical Organization, Jerusalem, Israel
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Emergency
Orthopedic residents
Arm Description
Outcomes
Primary Outcome Measures
Amount of patients sent to xrays
Secondary Outcome Measures
missed fractures
Full Information
NCT ID
NCT01561365
First Posted
March 18, 2012
Last Updated
March 21, 2012
Sponsor
Hadassah Medical Organization
1. Study Identification
Unique Protocol Identification Number
NCT01561365
Brief Title
Applicability of the Ottawa Ankle Rules
Official Title
Applicability of the Ottawa Ankle Rules to Exclude Fractures of the Ankle and Midfoot - Comparison to Orthopedic Residents Routine.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
May 2004 (Actual)
Study Completion Date
May 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hadassah Medical Organization
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this prospective study was to compare outcomes in patients handled by emergency physician according to OAR versus by an orthopedic resident.
92 consecutive patients with ankle injuries attending our emergency department were divided in two groups. The study group comprised 32 patients who arrived during the morning shift and were examined by an emergency physician according to OAR. Patients discharged without an x-ray were followed in the clinic or by telephone communication. The control group constituted 60 patients who were examined during the evening and night shifts by orthopedic residents unaware of this study.
Detailed Description
Objective. Ankle and midfoot injuries are common orthopedic complaints, both in general medicine and orthopedic practice. The percentage of fractures among these injuries is small, however many will undergo x-ray. Ottawa ankle rules (OAR) are clinical guidelines for determining whether to use radiography in such cases. The aim of this prospective study was to compare outcomes in patients handled by emergency physician according to OAR versus by an orthopedic resident. Also, we validated the applicability of OAR in an emergency department in our country.
Methods. 92 consecutive patients with ankle injuries attending our emergency department were divided in two groups. The study group comprised 32 patients who arrived during the morning shift and were examined by an emergency physician according to OAR. Patients discharged without an x-ray were followed in the clinic or by telephone communication. The control group constituted 60 patients who were examined during the evening and night shifts by orthopedic residents unaware of this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Fracture, Ankle Sprain
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Emergency
Arm Type
Experimental
Arm Title
Orthopedic residents
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Ottawa ankle rules
Other Intervention Name(s)
OAR
Intervention Description
Ottawa ankle rules implementation
Primary Outcome Measure Information:
Title
Amount of patients sent to xrays
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
missed fractures
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ankle trauma
Exclusion Criteria:
unwilling to participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonid Kandel, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Organization, Jerusalem, Israel
City
Jerusalem
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Applicability of the Ottawa Ankle Rules
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