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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2024-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-16', 'studyFirstSubmitDate': '2023-06-09', 'studyFirstSubmitQcDate': '2023-06-16', 'lastUpdatePostDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'COMPARISON of the rate of x-rays', 'timeFrame': '4 month', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ankle children Ottawa'], 'conditions': ['Sports Injuries in Children']}, 'descriptionModule': {'briefSummary': '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.\n\nOur 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.', 'detailedDescription': 'Main objective: To compare the rate of X-rays performed before and after implementation of the protocol in pediatric emergencies.\n\nSecondary objectives (if applicable):\n\n* Compare the time spent in the emergency room of patients before and after implementation of the protocol\n* Evaluate the gain in terms of cost for the healthcare system\n* Evaluate the adherence of caregivers to compliance with the protocol\n* Evaluate the decrease in the rate of X-rays performed in different age groups.\n* Evaluation of the consultation rate in the month for the same reason\n\nPrimary 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 =\n\n* Time spent in the emergency room in min\n* 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)\n* Evaluation of caregiver compliance by measuring the number of X-rays performed outside the protocol (X-ray performed despite the absence of Ottawa criteria)\n* X-ray rate by age group\n* Spontaneous reconsultation rate within 1 month'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '5 to 18 years old consulting in pediatric emergency in Nancy children hospital for ankle injury', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 5 to 18 years old\n* consulting in pediatric emergency in Nancy children hospital\n* for ankle injury\n\nExclusion Criteria:\n\nConstitutional 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'}, 'identificationModule': {'nctId': 'NCT05910060', 'acronym': 'OTTAWAKIDS', 'briefTitle': 'Ankle Trauma in Children, Application of Ottawa Ankle Rules From 5 Years Old, What is the Impact', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Ankle Trauma in Children, Application of Ottawa Ankle Rules From 5 Years Old, What is the Impact', 'orgStudyIdInfo': {'id': '2022PI174'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'before protocol', 'description': 'patients between 5 and 18 years of age consulting the paediatric emergency department for ankle trauma, before protocol implementation.'}, {'label': 'after protocol', 'description': 'patients between 5 and 18 years of age consulting the paediatric emergency department for ankle trauma, after the implementation of the protocol', 'interventionNames': ['Diagnostic Test: OTTAWA ANKLE RULES']}], 'interventions': [{'name': 'OTTAWA ANKLE RULES', 'type': 'DIAGNOSTIC_TEST', 'description': 'count the ottawa score and do an x-ray if the score is greater than or equal to 1', 'armGroupLabels': ['after protocol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54500', 'city': 'Vandœuvre-lès-Nancy', 'state': 'Meurthe-et-Moselle', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Amélie GATIN', 'role': 'CONTACT', 'email': 'a.gatin@chru-nancy.fr', 'phone': '0383154727'}, {'name': 'Anne BORSA DORION', 'role': 'CONTACT', 'email': 'a.borsa-dorion@chru-nancy.fr', 'phone': '0383154727'}, {'name': 'Ethan JEOL', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'children hospital Nancy', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], 'centralContacts': [{'name': 'Amélie GATIN', 'role': 'CONTACT', 'email': 'a.gatin@chru-nancy.fr', 'phone': '0383154727'}, {'name': 'Anne BORSA DORION', 'role': 'CONTACT', 'email': 'a.borsa-dorion@chru-nancy.fr', 'phone': '0383154727'}], 'overallOfficials': [{'name': 'Amélie GATIN, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Central Hospital, Nancy, France'}, {'name': 'Ethan JEOL', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Central Hospital, Nancy, France'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pediatrician', 'investigatorFullName': 'GATIN Amélie', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}