Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2026-01-02 @ 1:36 AM
Study NCT ID:
NCT05220969
Status:
COMPLETED
Last Update Posted:
2022-02-02
First Post:
2022-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Total Genotype Score, Growth, Maturation and Loading Exposure as Risk Factors for Injury in Elite Male Youth Football
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013180', 'term': 'Sprains and Strains'}, {'id': 'D013708', 'term': 'Tendon Injuries'}, {'id': 'D020022', 'term': 'Genetic Predisposition to Disease'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D004198', 'term': 'Disease Susceptibility'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-21', 'studyFirstSubmitDate': '2022-01-21', 'studyFirstSubmitQcDate': '2022-01-21', 'lastUpdatePostDateStruct': {'date': '2022-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fracture Injury Risk', 'timeFrame': '8 Years', 'description': 'Did the risk of fracture differ between total genotype risk score categories? was this affected by maturation?'}, {'measure': 'Non-Contact Injury Risk', 'timeFrame': '8 Years', 'description': 'Did the risk of non-contact injury differ between total genotype risk score categories? was this affected by maturation, and loading?'}, {'measure': 'Non-Contact Muscle Injury Risk', 'timeFrame': '8 Years', 'description': 'Did the risk of non-contact muscle injury differ between total genotype risk score categories? was this affected by maturation, and loading?'}, {'measure': 'Tendon Injury Risk', 'timeFrame': '8 Years', 'description': 'Did the risk of tendon injury differ between total genotype risk score categories? was this affected by maturation, and loading?'}, {'measure': 'Ligament Injury Risk', 'timeFrame': '8 Years', 'description': 'Did the risk of ligament injury differ between total genotype risk score categories? was this affected by maturation?'}, {'measure': 'Apophysitis Injury Risk', 'timeFrame': '8 Years', 'description': 'Did the risk of ligament injury differ between total genotype risk score categories? was this affected by maturation?'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fractures in Children', 'Apophysitis', 'Muscle Strain', 'Ligament Injury', 'Tendon Injuries', 'Genetic Predisposition']}, 'descriptionModule': {'briefSummary': 'A total genotype risk score was generated based on the findings of previous research for non-contact injury, non-contact muscle injury, tendon injury, ligament injury, fracture injury and apophysitis injury. This score was then compared with the incidence of injury between those with high, medium and low risk scores for each injury. The influence of different rates of growth, stages of physical maturation and loading exposure were then also included in the risk model to see if any interaction effects could be observed between genetic risk score and susceptibility to injury in different categories of growth, maturation and loading exposure.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Elite male football players aged 12-40', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elite male football players\n\nExclusion Criteria:\n\n* Female\n* non-elite'}, 'identificationModule': {'nctId': 'NCT05220969', 'briefTitle': 'Total Genotype Score, Growth, Maturation and Loading Exposure as Risk Factors for Injury in Elite Male Youth Football', 'organization': {'class': 'OTHER', 'fullName': "St Mary's University College"}, 'officialTitle': 'Total Genotype Score, Growth, Maturation and Loading Exposure as Risk Factors for Injury in Elite Male Youth Football', 'orgStudyIdInfo': {'id': 'SMEC_2019-20_003'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Elite male youth footballers', 'description': 'Elite male youth footballers at an English championship / premier league football club', 'interventionNames': ['Genetic: Total Genotype Risk Score']}], 'interventions': [{'name': 'Total Genotype Risk Score', 'type': 'GENETIC', 'description': 'A total genotype risk score has been generated based on the results of previously observed genetic association studies', 'armGroupLabels': ['Elite male youth footballers']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'KT3 6PT', 'city': 'London', 'state': 'New Malden', 'country': 'United Kingdom', 'facility': 'Fulham Football Club', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'TW1 4SX', 'city': 'London', 'state': 'Twickenham', 'country': 'United Kingdom', 'facility': "St Mary's University, Twickenham", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St Mary's University College", 'class': 'OTHER'}, 'collaborators': [{'name': 'Fulham Football Club', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}