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Applicability of the Ottawa Ankle Rules

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ClinicalTrials.gov Identifier: NCT01561365
Recruitment Status : Completed
First Posted : March 23, 2012
Last Update Posted : March 23, 2012
Sponsor:
Information provided by (Responsible Party):
KANDEL, Hadassah Medical Organization

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.


Condition or disease Intervention/treatment Phase
Ankle Fracture Ankle Sprain Behavioral: Ottawa ankle rules Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Applicability of the Ottawa Ankle Rules to Exclude Fractures of the Ankle and Midfoot - Comparison to Orthopedic Residents Routine.
Study Start Date : October 2003
Actual Primary Completion Date : May 2004
Actual Study Completion Date : May 2004

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Emergency Behavioral: Ottawa ankle rules
Ottawa ankle rules implementation
Other Name: OAR

Experimental: Orthopedic residents Behavioral: Ottawa ankle rules
Ottawa ankle rules implementation
Other Name: OAR




Primary Outcome Measures :
  1. Amount of patients sent to xrays [ Time Frame: 2 hours ]

Secondary Outcome Measures :
  1. missed fractures [ Time Frame: 2 weeks ]


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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ankle trauma

Exclusion Criteria:

  • unwilling to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01561365


Locations
Israel
Hadassah Medical Organization, Jerusalem, Israel
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Leonid Kandel, MD Hadassah Medical Center

Responsible Party: KANDEL, Orthopediv Surgeon, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01561365     History of Changes
Other Study ID Numbers: Ottawarules
First Posted: March 23, 2012    Key Record Dates
Last Update Posted: March 23, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
Ankle Injuries
Ankle Fractures
Leg Injuries
Wounds and Injuries
Fractures, Bone