We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Applicability of the Ottawa Ankle Rules

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01561365
First Posted: March 23, 2012
Last Update Posted: March 23, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
KANDEL, Hadassah Medical Organization
  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
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.

Resource links provided by NLM:


Further study details as provided by KANDEL, Hadassah Medical Organization:

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

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • ankle trauma

Exclusion Criteria:

  • unwilling to participate
  Contacts and Locations
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
  More Information

Responsible Party: KANDEL, Orthopediv Surgeon, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01561365     History of Changes
Other Study ID Numbers: Ottawarules
First Submitted: March 18, 2012
First Posted: March 23, 2012
Last Update Posted: March 23, 2012
Last Verified: March 2012

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