Applicability of the Ottawa Ankle Rules

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
KANDEL, Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01561365
First received: March 18, 2012
Last updated: March 21, 2012
Last verified: March 2012
  Purpose

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 Intervention
Ankle Fracture
Ankle Sprain
Behavioral: Ottawa ankle rules

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Amount of patients sent to xrays [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • missed fractures [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 92
Study Start Date: October 2003
Study Completion Date: May 2004
Primary Completion Date: May 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ankle trauma

Exclusion Criteria:

  • unwilling to participate
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: KANDEL, Orthopediv Surgeon, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01561365     History of Changes
Other Study ID Numbers: Ottawarules
Study First Received: March 18, 2012
Last Updated: March 21, 2012
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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

ClinicalTrials.gov processed this record on August 19, 2014