- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01561365
Applicability of the Ottawa Ankle Rules
Applicability of the Ottawa Ankle Rules to Exclude Fractures of the Ankle and Midfoot - Comparison to Orthopedic Residents Routine.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Jerusalem, Israel
- Hadassah Medical Organization, Jerusalem, Israel
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ankle trauma
Exclusion Criteria:
- unwilling to participate
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Emergency
|
Ottawa ankle rules implementation
Other Names:
|
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Experimental: Orthopedic residents
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Ottawa ankle rules implementation
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Amount of patients sent to xrays
Time Frame: 2 hours
|
2 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
missed fractures
Time Frame: 2 weeks
|
2 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Leonid Kandel, MD, Hadassah Medical Organization
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ottawarules
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