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Sponsored by: |
The Hospital for Sick Children |
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Information provided by: | The Hospital for Sick Children |
ClinicalTrials.gov Identifier: | NCT00785876 |
Ankle injuries are a very common injury in children. Each year approximately 35000 kids present to Ontario emergency departments (ED) with this problem. Right now, about 90% of these children get x-rays of the injured ankle, even though only 12% of these x-rays show a break in the bone. Some excellent research has created some rules that doctors can use to help them decide which children really need x-rays. Unfortunately, even though these rules have been proven to safely reduce x-rays by as much as two-thirds, most doctors are not using these rules.
Therefore, this study will be the first to put the best paediatric ankle x-ray rule, the Low Rick Ankle Rule, into physician practice in EDs. Our main goal is to determine how much we can reduce ankle x-ray rates in EDs that use this rule regularly versus those that do not. If we show that doctors can safely use this rule regularly and the number of ankle x-rays will be significantly less, this will lessen unnecessary potentially harmful radiation exposure in children, these children will spend less time in an ED, and the health care system will save money.
Condition | Intervention |
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Ankle Injury |
Other: LRAR Implementation |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Controlled Radiography for Ankle Injury Cases in Kids in the Emergency Department: Implementation of the Low Risk Ankle Rule |
Estimated Enrollment: | 3000 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: No Intervention
Control Sites
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2: Experimental
Intervention Sites
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Other: LRAR Implementation
Pre-LRAR - no changes in the usual procedures for the first 26 weeks except for flagging of all paediatric charts with ankle injuries, ED documentation which will not refer to the LRAR and phone follow up. Post-LRAR: At 27 weeks, in addition to the aforementioned ED collection sheet and phone follow up, the implementation strategy for the LRAR rule and related management will be introduced at the intervention hospitals. |
Ages Eligible for Study: | 3 Years to 16 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kathy Boutis, MD | 416-813-8982 | kleanthi.boutis@sickkids.ca |
Canada, Ontario | |
The Hospital for Sick Children | Recruiting |
Toronto, Ontario, Canada | |
Contact: Kathy Boutis 416-813-8982 kleanthi.boutis@sickkids.ca | |
Principal Investigator: Kathy Boutis | |
North York General Hospital | Recruiting |
Toronto, Ontario, Canada | |
Children's Hospital of Eastern Ontario | Recruiting |
Ottawa, Ontario, Canada | |
Toronto East General Hospital | Recruiting |
Toronto, Ontario, Canada |
Principal Investigator: | Kathy Boutis, MD | The Hospital for Sick Children |
Responsible Party: | The Hospital for Sick Children ( Kathy Boutis/Principal Investigator ) |
Study ID Numbers: | 1000012792 |
Study First Received: | November 4, 2008 |
Last Updated: | November 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00785876 |
Health Authority: | Canada: Ethics Review Committee |
Paediatric Emergency Department Ankle Injury Low risk ankle rule |
Caseins Ankle Injuries Wounds and Injuries |
Disorders of Environmental Origin Emergencies Leg Injuries |