Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-27 @ 5:22 AM
Study NCT ID:
NCT05794594
Status:
COMPLETED
Last Update Posted:
2023-04-03
First Post:
2023-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
3D Printed Personalized Extendable Prosthesis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-30', 'studyFirstSubmitDate': '2023-03-18', 'studyFirstSubmitQcDate': '2023-03-30', 'lastUpdatePostDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence', 'timeFrame': '7years', 'description': 'Osteosarcoma recurrence rate'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteosarcoma in Children']}, 'descriptionModule': {'briefSummary': 'The goal of this type of observational study is to investigate the preliminary effect of 3D printed personalized extendable prosthesis replacement on limb salvage in children with osteosarcoma. The main question it aims to answer is:\n\nIs 3D printed personalized extendable prosthesis replacement has a good outcome in limb salvage pediatric osteosarcoma？', 'detailedDescription': 'Osteosarcoma is one of the most common primary malignant bone tumors in children and adolescents. In this study, the investigators try to investigate the preliminary effect of 3D printed personalized extendable prosthesis replacement on limb salvage in children with osteosarcoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'children with osteosarcoma undergoing prosthesis replacement or limb amputation were admitted to our hospital', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* tumors of the extremities, with moderate soft-tissue invasion\n* the neurovascular bundle is not invaded, and the tumor can be excised totally\n* no metastatic lesions or metastases can be cured\n\nExclusion Criteria:\n\n* recurrent tumors\n* poorly differentiated tumors\n* poor soft-tissue conditions\n* neurovascular invasion around tumors\n* ineffective chemotherapy with metastasis'}, 'identificationModule': {'nctId': 'NCT05794594', 'briefTitle': '3D Printed Personalized Extendable Prosthesis', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Chongqing Medical University"}, 'officialTitle': '3D Printed Personalized Extendable Prosthesis Replacement for Limb Preservation in Children With Osteosarcoma: a Preliminary Study', 'orgStudyIdInfo': {'id': 'CHChongqingMU-2'}}, 'armsInterventionsModule': {'armGroups': [{'label': '3D printed', 'description': '3D printed personalized extendable prosthesis replacement for limb preservation in children with osteosarcoma', 'interventionNames': ['Device: 3D printed personalized extendable prosthesis']}, {'label': 'amputation', 'description': 'patients had undergone amputation of the limbs'}], 'interventions': [{'name': '3D printed personalized extendable prosthesis', 'type': 'DEVICE', 'description': '3D printed personalized extendable prosthesis replacement for limb preservation in children', 'armGroupLabels': ['3D printed']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400014', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'facility': "Children's Hospital of Chongqing Medical University", 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'overallOfficials': [{'name': 'Yuxi Su', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Chongqing Medical University"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yuxi Su', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': "Children's Hospital of Chongqing Medical University", 'investigatorFullName': 'Yuxi Su', 'investigatorAffiliation': "Children's Hospital of Chongqing Medical University"}}}}