Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-25 @ 6:59 PM
Study NCT ID:
NCT03998904
Status:
UNKNOWN
Last Update Posted:
2019-06-26
First Post:
2019-06-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Muscle Preservation Hamstring Graft for ACL Reconstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 28}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2020-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-06-25', 'studyFirstSubmitDate': '2019-06-25', 'studyFirstSubmitQcDate': '2019-06-25', 'lastUpdatePostDateStruct': {'date': '2019-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SNQ value of MRI', 'timeFrame': '6 months', 'description': 'signal of ACL graft-signal of quadriceps tendon/singal of background'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Graft Healing']}, 'descriptionModule': {'briefSummary': '* Muscle derived stem cell is a better source of stem cells than a tendon tissue\n* Preservation of muscle derived stem cell may enhance bone-tendon integration and ligamentization of ACL hamstring graft'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary ACL reconstruction using autogenous hamstring graft\n\nExclusion Criteria:\n\n* Combined meniscal or ligament surgery\n* Combined osteoarthritis (KL grade II or more)\n* chondral injury more than grade 2\n* Refuse to undergo MRI'}, 'identificationModule': {'nctId': 'NCT03998904', 'briefTitle': 'Muscle Preservation Hamstring Graft for ACL Reconstruction', 'organization': {'class': 'OTHER', 'fullName': 'Hanyang University Seoul Hospital'}, 'officialTitle': 'Muscle Preservation Hamstring Graft for ACL Reconstruction: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'muscle preservation study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Muscle preservation', 'description': 'Muscle preservation for hamsting graft', 'interventionNames': ['Procedure: Muscle preservation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'None preservation', 'description': 'No muscle preservation for hamstring graft', 'interventionNames': ['Procedure: No muscle preservation']}], 'interventions': [{'name': 'Muscle preservation', 'type': 'PROCEDURE', 'description': 'Muscle preservation during graft preparation of hamstring graft', 'armGroupLabels': ['Muscle preservation']}, {'name': 'No muscle preservation', 'type': 'PROCEDURE', 'description': 'No muscle preservation during graft preparation of hamstring graft', 'armGroupLabels': ['None preservation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'JIN KYU LEE', 'role': 'CONTACT'}], 'facility': 'Hanyang University Seoul Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'JIN KYU LEE, MD', 'role': 'CONTACT', 'email': 'gaia-silver@hnamail.net', 'phone': '820222908485'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'no planned for now'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanyang University Seoul Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'JIN KYU LEE', 'investigatorAffiliation': 'Hanyang University Seoul Hospital'}}}}