Sports Injuries in ChildrenOTTAWAKIDSNCT05910060
Ankle Trauma in Children, Application of Ottawa Ankle Rules From 5 Years Old, What is the Impact
An observational study of Sports Injuries in Children, run by Central Hospital, Nancy, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Sports Injuries in Children
- What is being tested?
- OTTAWA ANKLE RULES
- How many people
- 600 participants
- Where
- 1 siteFrance
- Study dates
- 31 May 2023to Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 5 to 18 years old consulting in pediatric emergency in Nancy children hospital for ankle injury
Who may be able to join
- 5 to 18 years old
- consulting in pediatric emergency in Nancy children hospital
- for ankle injury
Who cannot join
- Constitutional bone disease Polytrauma Inability to assess the patient (inebriated, altered consciousness, neurosensitive disease, intoxication) Non-acquired walking Injury more than 10 days old Patient re-consults for the same injury previously assessed in the same centre Patient with previous radiographs prior to consultation Open fracture Sensory or vascular deficit Haemophilia Metabolic disease with proven osteopenia
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
children hospital Nancy
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54500
Amélie GATIN, 0383154727, a.gatin@chru-nancy.fr
Anne BORSA DORION, 0383154727, a.borsa-dorion@chru-nancy.fr
About this study
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.
Read the 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
- Conditions
- Sports Injuries in Children
- Being tested
- OTTAWA ANKLE RULES
- Keywords
- ankle children Ottawa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OTTAWA ANKLE RULESDiagnostic test
count the ottawa score and do an x-ray if the score is greater than or equal to 1
| Study group | Role | What they receive |
|---|---|---|
| before protocol | patients between 5 and 18 years of age consulting the paediatric emergency department for ankle trauma, before protocol implementation. | |
| after protocol | patients between 5 and 18 years of age consulting the paediatric emergency department for ankle trauma, after the implementation of the protocol Receives: Diagnostic Test: OTTAWA ANKLE RULES |
What is being measured
The primary outcome is the main question the study is designed to answer.
COMPARISON of the rate of x-rays
COMPARISON of the rate of x-rays as a % of x-rays performed among the number of children presenting to paediatric emergency departments over the period studied before and after implementation of the protoc
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start31 May 2023
- Primary completion31 Oct 2023 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sports Injuries in ChildrenStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GATIN Amélie, Central Hospital, Nancy, France
- Investigators
- Amélie GATIN, MD, Principal investigator, Central Hospital, Nancy, FranceEthan JEOL, Principal investigator, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05910060
- Sponsor's protocol ID
- 2022PI174
- Acronym
- OTTAWAKIDS
- Status last verified
- Jun 2023
- First submitted
- 9 Jun 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ankle Trauma in Children, Application of Ottawa Ankle Rules From 5 Years Old, What is the Impact
- ClinicalTrials.gov ID
- NCT05910060
- Acronym / sponsor ID
- OTTAWAKIDS / 2022PI174
- Conditions
- Sports Injuries in Children
- Keywords
- ankle children Ottawa
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 31 May 2023 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| before protocol | – | –patients between 5 and 18 years of age consulting the paediatric emergency department for ankle trauma, before protocol implementation. |
| after protocol | – | Diagnostic Test: OTTAWA ANKLE RULESpatients between 5 and 18 years of age consulting the paediatric emergency department for ankle trauma, after the implementation of the protocol |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 5 to 18 years old consulting in pediatric emergency in Nancy children hospital for ankle injury
Key inclusion criteria (3 listed)
- 5 to 18 years old
- consulting in pediatric emergency in Nancy children hospital
- for ankle injury
Key exclusion criteria (1 listed)
- Constitutional bone disease Polytrauma Inability to assess the patient (inebriated, altered consciousness, neurosensitive disease, intoxication) Non-acquired walking Injury more than 10 days old Patient re-consults for the same injury previously assessed in the same centre Patient with previous radiographs prior to consultation Open fracture Sensory or vascular deficit Haemophilia Metabolic disease with proven osteopenia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OTTAWA ANKLE RULEScount the ottawa score and do an x-ray if the score is greater than or equal to 1 | Diagnostic test | after protocol |
Primary outcome
COMPARISON of the rate of x-rays
Time frame: 4 month
COMPARISON of the rate of x-rays as a % of x-rays performed among the number of children presenting to paediatric emergency departments over the period studied before and after implementation of the protoc
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amélie GATIN, MD principal investigator
Central Hospital, Nancy, France
Ethan JEOL principal investigator
Central Hospital, Nancy, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sports Injuries in Children, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amélie GATIN (0383154727, a.gatin@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COMPARISON of the rate of x-rays (time frame: 4 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.