Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-03-06 @ 7:57 AM
Study NCT ID:
NCT02941120
Status:
COMPLETED
Last Update Posted:
2019-12-03
First Post:
2016-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-interventional Study With NOVOCART® Inject in the Reconstruction of the Knee Cartilage Defects
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 245}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2019-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-02', 'studyFirstSubmitDate': '2016-10-18', 'studyFirstSubmitQcDate': '2016-10-19', 'lastUpdatePostDateStruct': {'date': '2019-12-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of adverse drug reaction/serious adverse drug reaction', 'timeFrame': 'Up to 24 months', 'description': 'Number of adverse drug reaction/serious adverse drug reaction as a measurement of safety'}], 'secondaryOutcomes': [{'measure': 'Outcome of IKDC 2000', 'timeFrame': 'Up to 24 months', 'description': 'Outcome of the IKDC 2000 as measurements of symptoms and function'}, {'measure': 'Outcome of KOOS', 'timeFrame': 'Up to 24 months', 'description': 'Outcome of KOOS as measurements of symptoms and function'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cartilage defect', 'Knee', 'ACT (Autologous chondrocyte implantation)', 'NOVOCART® Inject'], 'conditions': ['Cartilage Disease']}, 'descriptionModule': {'briefSummary': 'Retrospective non-interventional study to evaluate safety and efficacy of NOVOCART® Inject in patients with full-thickness cartilage defects in the knee joint.', 'detailedDescription': 'Retrospective and multicenter non-interventional study to evaluate safety and efficacy of NOVOCART® Inject in patients with localized full-thickness cartilage defects in the knee joint.\n\nSafety: Measuring the number of adverse drug reactions/serious adverse drug reactions since treatment and up to the present time.\n\nEfficacy: Evaluate symptoms and functional status at the present time using IKDC 2000 (International Knee Documentation Committee) and KOOS (Knee injury osteoarthritis outcome score).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '14 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Orthopaedic clinics', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male and female patients\n* juvenile patients with closed epiphysial plate\n* insulated full-thickness cartilage damage of the knee Joint, ICRS (International Cartilage Repair Society) grade 3-4\n* defect size ≥ 2.5 and ≤ 10 cm2\n* intact or reconstructed bony subchondral plate\n* in the case of deep bony substance defects, additional bony reconstruction is needed\n\nExclusion Criteria:\n\n* radiographic signs of osteoarthritis of Kellgren and Lawrence \\> 2\n* joint stiffness\n* arthrofibrosis\n* malalignment in the knee (valgus- or varus deformity) \\> 3° (correction contemporary to the ACT)\n* insufficient reconstructed ligaments (correction contemporary to the ACT)\n* defective position patella (correction contemporary to the ACT)\n* sled prosthesis implants or carbon pin\n* inflammatory joint diseases (f.e. rheumatoid arthritis)\n* corresponding cartilage defects ("kissing lesions")\n* more than two independent cartilage defects in one knee\n* primary cartilage reconstructive treatment in children and juvenile with open epiphysial plate\n* diffuse chondromalacia\n* congenital or gained deformity of patella'}, 'identificationModule': {'nctId': 'NCT02941120', 'acronym': 'RENOVO', 'briefTitle': 'Non-interventional Study With NOVOCART® Inject in the Reconstruction of the Knee Cartilage Defects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tetec AG'}, 'officialTitle': 'Retrospective Observational Study for Reconstruction of Localized, Full-thickness Cartilage Defects in the Knee Joint With In-situ Polymerizable and Chondrocyte Populated Biomaterial (NOVOCART® Inject)', 'orgStudyIdInfo': {'id': 'AAG-O-H-1521'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'NOVOCART® Inject patients', 'description': 'Patients who where treated with NOVOCART® Inject autologous chondrocyte implantation in the knee joint.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '61348', 'city': 'Bad Homburg', 'country': 'Germany', 'facility': 'Hochtaunus-Kliniken gGmbH Krankenhaus Bad Homburg', 'geoPoint': {'lat': 50.22683, 'lon': 8.61816}}, {'zip': '79194', 'city': 'Gundelfingen', 'country': 'Germany', 'facility': 'Gelenk-Klinik Gundelfingen', 'geoPoint': {'lat': 48.04246, 'lon': 7.8657}}, {'zip': '65779', 'city': 'Kelkheim', 'country': 'Germany', 'facility': 'Orthopädische Praxisklinik im Zentrum', 'geoPoint': {'lat': 50.13703, 'lon': 8.4502}}, {'zip': '71706', 'city': 'Markgröningen', 'country': 'Germany', 'facility': 'Orthopädische Klinik Markgröningen gGmbH', 'geoPoint': {'lat': 48.90493, 'lon': 9.08059}}, {'zip': '48165', 'city': 'Münster', 'country': 'Germany', 'facility': 'Dr. med. Michael Moraldo, Dr. med. Sebastian Lauber', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '26452', 'city': 'Sande', 'country': 'Germany', 'facility': 'Nordwest-Krankenhaus Sanderbusch gGmbH', 'geoPoint': {'lat': 53.50489, 'lon': 8.01418}}, {'zip': '04808', 'city': 'Wurzen', 'country': 'Germany', 'facility': 'Muldentalkliniken GmbH Krankenhaus Wurzen', 'geoPoint': {'lat': 51.3707, 'lon': 12.73939}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tetec AG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Aesculap AG', 'class': 'INDUSTRY'}, {'name': 'Winicker Norimed GmbH', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}