Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-27 @ 11:16 PM
Study NCT ID:
NCT05910060
Status:
UNKNOWN
Last Update Posted:
2023-06-18
First Post:
2023-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ankle Trauma in Children, Application of Ottawa Ankle Rules From 5 Years Old, What is the Impact
Sponsor:
Central Hospital, Nancy, France
Organization:
Study Overview
Official Title:
Ankle Trauma in Children, Application of Ottawa Ankle Rules From 5 Years Old, What is the Impact
Status:
UNKNOWN
Status Verified Date:
2023-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OTTAWAKIDS
Brief Summary:
Ankle sprain in children is a very common pathology. Currently in France, a standard X-ray is done in almost all cases. However, the literature has for several years validated the consideration of the Ottawa ankle rules in children to avoid the realization of these X-rays.
Our study is an evaluation of clinical practice. The aim is to assess the impact of the implementation of a new protocol using the Ottawa ankle rules from the age of 5. In particular, radiographic sparing and absence of diagnostic error.
Our study is an evaluation of clinical practice. The aim is to assess the impact of the implementation of a new protocol using the Ottawa ankle rules from the age of 5. In particular, radiographic sparing and absence of diagnostic error.
Detailed Description:
Main objective: To compare the rate of X-rays performed before and after implementation of the protocol in pediatric emergencies.
Secondary objectives (if applicable):
* Compare the time spent in the emergency room of patients before and after implementation of the protocol
* Evaluate the gain in terms of cost for the healthcare system
* Evaluate the adherence of caregivers to compliance with the protocol
* Evaluate the decrease in the rate of X-rays performed in different age groups.
* Evaluation of the consultation rate in the month for the same reason
Primary endpoint = X-ray rate as a % of X-rays performed on the number of children presenting to pediatric emergencies over the period studied (before implementation of the protocol in a similar period = May to October 2022 / after implementation of the protocol = May to October 2023) Secondary endpoints =
* Time spent in the emergency room in min
* Estimation of the cost for the healthcare system by taking the cost of an x-ray and evaluating the gain on the reduction in the rate of x-rays performed (number of x-rays - cost of an x-ray)
* Evaluation of caregiver compliance by measuring the number of X-rays performed outside the protocol (X-ray performed despite the absence of Ottawa criteria)
* X-ray rate by age group
* Spontaneous reconsultation rate within 1 month
Secondary objectives (if applicable):
* Compare the time spent in the emergency room of patients before and after implementation of the protocol
* Evaluate the gain in terms of cost for the healthcare system
* Evaluate the adherence of caregivers to compliance with the protocol
* Evaluate the decrease in the rate of X-rays performed in different age groups.
* Evaluation of the consultation rate in the month for the same reason
Primary endpoint = X-ray rate as a % of X-rays performed on the number of children presenting to pediatric emergencies over the period studied (before implementation of the protocol in a similar period = May to October 2022 / after implementation of the protocol = May to October 2023) Secondary endpoints =
* Time spent in the emergency room in min
* Estimation of the cost for the healthcare system by taking the cost of an x-ray and evaluating the gain on the reduction in the rate of x-rays performed (number of x-rays - cost of an x-ray)
* Evaluation of caregiver compliance by measuring the number of X-rays performed outside the protocol (X-ray performed despite the absence of Ottawa criteria)
* X-ray rate by age group
* Spontaneous reconsultation rate within 1 month
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: