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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
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ankle Fracture

Eligibility Criteria

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

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

First Posted
March 18, 2012
Last Updated
March 21, 2012
Sponsor
Hadassah Medical Organization
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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

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Applicability of the Ottawa Ankle Rules

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