Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05910060 |
| Other study ID # |
2022PI174 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 31, 2023 |
| Est. completion date |
February 2024 |
Study information
| Verified date |
June 2023 |
| Source |
Central Hospital, Nancy, France |
| Contact |
Amélie GATIN |
| Phone |
0383154727 |
| Email |
a.gatin[@]chru-nancy.fr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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
