Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-01-02 @ 4:37 PM
Study NCT ID:
NCT05400551
Status:
UNKNOWN
Last Update Posted:
2022-09-23
First Post:
2022-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Craneofacial Injuries in Rink Hockey Athletes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D019066', 'term': 'Facies'}, {'id': 'D001924', 'term': 'Brain Concussion'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}], 'ancestors': [{'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D016489', 'term': 'Head Injuries, Closed'}, {'id': 'D014949', 'term': 'Wounds, Nonpenetrating'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2023-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-21', 'studyFirstSubmitDate': '2022-05-27', 'studyFirstSubmitQcDate': '2022-05-27', 'lastUpdatePostDateStruct': {'date': '2022-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants injured', 'timeFrame': 'september 2022 to march 2023', 'description': 'nº of injuries affecting the head or face per time (X/1000h)'}, {'measure': 'days lost due to injury', 'timeFrame': 'september 2022 to march 2023', 'description': 'nº of days lost due to injury affecting the head or face per time (X days/1000h)'}], 'secondaryOutcomes': [{'measure': 'usage of helmet', 'timeFrame': 'september 2022 to march 2023', 'description': 'characterise if the player was using a helmet or not when the injury happened'}, {'measure': 'situational characteristics of the injury', 'timeFrame': 'september 2022 to march 2023', 'description': 'register when the injury happened (training or game)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rink hockey', 'injury', 'epidemiology', 'burden'], 'conditions': ['Head Injury', 'Face', 'Concussion, Brain']}, 'descriptionModule': {'briefSummary': 'To collect the number of injuries that affect the face and head in rink hockey athletes prospectively during a regular season.', 'detailedDescription': 'To collect the number of injuries that affect the face and head in rink hockey athletes prospectively during a regular season, while collecting athlete´s exposure and specifical injury characteristics (Burden, mechanism, situation, etc)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'athletes that compete in rink hockey, independently of their age or sex', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Compete in a spanish rink hockey league\n* play at least in one game during ther regular season\n\nExclusion Criteria:\n\n* do not accept the participation in the study'}, 'identificationModule': {'nctId': 'NCT05400551', 'briefTitle': 'Craneofacial Injuries in Rink Hockey Athletes', 'organization': {'class': 'OTHER', 'fullName': 'University of Oviedo'}, 'officialTitle': 'Epidemiology of Craneofacial Injuries in Rink Hockey Athletes', 'orgStudyIdInfo': {'id': 'UO2022-01'}}, 'contactsLocationsModule': {'locations': [{'zip': '33006', 'city': 'Oviedo', 'state': 'Principality of Asturias', 'country': 'Spain', 'facility': 'Hugo Olmedillas', 'geoPoint': {'lat': 43.36029, 'lon': -5.84476}}, {'zip': '33006', 'city': 'Oviedo', 'state': 'Principality of Asturias', 'country': 'Spain', 'facility': 'Universidad de Oviedo', 'geoPoint': {'lat': 43.36029, 'lon': -5.84476}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oviedo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Hugo Olmedillas Fernandez', 'investigatorAffiliation': 'University of Oviedo'}}}}