Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-26 @ 12:52 AM
Study NCT ID:
NCT00140634
Status:
COMPLETED
Last Update Posted:
2021-05-11
First Post:
2005-08-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Objectives of the Cartilage Repair Registry is to Report Long Term Efficacy and Safety of Cartilage Repair Procedures in Registry Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002357', 'term': 'Cartilage Diseases'}], 'ancestors': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004343', 'term': 'Drug Implants'}], 'ancestors': [{'id': 'D003692', 'term': 'Delayed-Action Preparations'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2233}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1995-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-10', 'studyFirstSubmitDate': '2005-08-31', 'studyFirstSubmitQcDate': '2005-08-31', 'lastUpdatePostDateStruct': {'date': '2021-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physician assessment of effectiveness of autologous chondrocyte implantation', 'timeFrame': '6 month post implantation', 'description': 'Overall assessment of the patient by the physician based on knee examination and progress of rehabilitation'}, {'measure': 'Physician assessment of effectiveness of autologous chondrocyte implantation', 'timeFrame': '12 month post implantation', 'description': 'Overall assessment of the patient by the physician based on knee examination and progress of rehabilitation'}, {'measure': 'Physician assessment of effectiveness of autologous chondrocyte implantation', 'timeFrame': '24 month post implantation', 'description': 'Overall assessment of the patient by the physician based on knee examination and progress of rehabilitation'}], 'secondaryOutcomes': [{'measure': 'Patient assessment of effectiveness of autologous chondrocyte implantation', 'timeFrame': '6 month post implantation', 'description': 'Overall assessment of the patient by the patient based on pain, swelling, giving-way, grinding, stiffness, catching and locking and quantity of exercise'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Articular Cartilage', 'Cartilage Diseases']}, 'descriptionModule': {'briefSummary': 'The objectives of the Cartilage Repair Registry is to report the long term efficacy and safety of cartilage repair procedures in Registry patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Registry of patients with diagnosis of chondral injury.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All registry patients meeting the cohort definition at the pre-operative visit will be included on the overall summary tables for the patient cohort\n\nExclusion Criteria:\n\n* All registry patients meeting the cohort definition at the pre-operative visit will be included on the overall summary tables for the patient cohort'}, 'identificationModule': {'nctId': 'NCT00140634', 'briefTitle': 'The Objectives of the Cartilage Repair Registry is to Report Long Term Efficacy and Safety of Cartilage Repair Procedures in Registry Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vericel Corporation'}, 'officialTitle': 'Cartilage Repair Registry', 'orgStudyIdInfo': {'id': 'Cartilage Repair Registry'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Carticel (autologous cultured chondrocyte) implantation', 'type': 'BIOLOGICAL', 'description': 'Each Carticel vial of autologous cultured chondrocytes contains approximately 12 million cells implanted into the defect and secured with a periosteal flap.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02142', 'city': 'Cambridge', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Registry contains data from patients whom were implanted by 1123 surgeons in the U.S. and also data captured on patients treated by 154 surgeons in 15 other countries.', 'geoPoint': {'lat': 42.3751, 'lon': -71.10561}}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Genzyme, a Sanofi Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vericel Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}