Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-26 @ 3:25 AM
Study NCT ID:
NCT04781920
Status:
RECRUITING
Last Update Posted:
2024-08-29
First Post:
2021-02-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Follow-up of Anterior Cruciate Ligament Reconstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070598', 'term': 'Anterior Cruciate Ligament Injuries'}], 'ancestors': [{'id': 'D007718', 'term': 'Knee Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-28', 'studyFirstSubmitDate': '2021-02-25', 'studyFirstSubmitQcDate': '2021-03-01', 'lastUpdatePostDateStruct': {'date': '2024-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analysis of Magnetic Resonance Imaging (MRI) results', 'timeFrame': 'Pre-operative and Month: 12', 'description': 'Collected in medical records'}], 'secondaryOutcomes': [{'measure': 'Analysis of operative report results', 'timeFrame': 'Month: 12', 'description': 'Collected in medical records'}, {'measure': 'Analysis of consultation report', 'timeFrame': 'pre-operative and Months: 1,5 , 3, 6, 12', 'description': 'Collected in medical records'}, {'measure': 'Analysis of isokinetic tests', 'timeFrame': 'Months: 9, 12', 'description': 'Collected in medical records'}, {'measure': 'Analysis of clinical surveys', 'timeFrame': 'pre-operative and Months: 3, 6, 12', 'description': 'Collected in medical records'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anterior Cruciate Ligament', 'reconstruction', 'Operative report', 'Consultation report', 'Isokinetic tests', 'Clinical surveys'], 'conditions': ['Anterior Cruciate Ligament Rupture']}, 'descriptionModule': {'briefSummary': 'Rupture of Anterior Cruciate Ligament (ACL) is a common pathology, but is subject to variability of associated lesions, surgical management and rehabilitation.', 'detailedDescription': 'In this study, a collect data of patients having undergone an Anterior Cruciate Ligament (ACL) reconstruction in order to evaluate the clinical, functional and morphological results of this intervention, in order to improve the management of the patient.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients having undergone an Anterior Cruciate Ligament (ACL) reconstruction will be included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients having undergone an Anterior Cruciate Ligament (ACL) reconstruction\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT04781920', 'briefTitle': 'Follow-up of Anterior Cruciate Ligament Reconstruction', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Follow-up of Anterior Cruciate Ligament Reconstruction', 'orgStudyIdInfo': {'id': 'IRBN162021/CHUSTE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients having undergone an Anterior Cruciate Ligament (ACL) reconstruction', 'description': 'Patients having undergone an ACL reconstruction will be included.', 'interventionNames': ['Other: datas collection']}], 'interventions': [{'name': 'datas collection', 'type': 'OTHER', 'description': 'data collection in history medical : operative report, clinical examination, questionnaires, imaging, isokinetic tests', 'armGroupLabels': ['Patients having undergone an Anterior Cruciate Ligament (ACL) reconstruction']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Saint-Etienne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Thomas NERI, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Rémi PHILIPPOT, MD PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Alban STORDEUR, resident', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Chu Saint-Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'centralContacts': [{'name': 'Thomas NERI, MD', 'role': 'CONTACT', 'email': 'thomas.neri@chu-st-etienne.fr', 'phone': '(0)477127849', 'phoneExt': '+33'}, {'name': 'Alban STORDEUR, resident', 'role': 'CONTACT', 'email': 'alban.stordeur@gmail.com', 'phone': '(0)477127849', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Thomas NERI, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU SAINT-ETIENNE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}