NCT01561365

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2003

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2004

Completed
7.9 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 23, 2012

Completed
Last Updated

March 23, 2012

Status Verified

March 1, 2012

Enrollment Period

7 months

First QC Date

March 18, 2012

Last Update Submit

March 21, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • Amount of patients sent to xrays

    2 hours

Secondary Outcomes (1)

  • missed fractures

    2 weeks

Study Arms (2)

Emergency

EXPERIMENTAL
Behavioral: Ottawa ankle rules

Orthopedic residents

EXPERIMENTAL
Behavioral: Ottawa ankle rules

Interventions

Ottawa ankle rules implementation

Also known as: OAR
EmergencyOrthopedic residents

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • ankle trauma

You may not qualify if:

  • unwilling to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization, Jerusalem, Israel

Jerusalem, Israel

Location

MeSH Terms

Conditions

Ankle FracturesAnkle Injuries

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg Injuries

Study Officials

  • Leonid Kandel, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopediv Surgeon

Study Record Dates

First Submitted

March 18, 2012

First Posted

March 23, 2012

Study Start

October 1, 2003

Primary Completion

May 1, 2004

Study Completion

May 1, 2004

Last Updated

March 23, 2012

Record last verified: 2012-03

Locations