Ignite Creation Date:
2025-12-24 @ 4:33 PM
Ignite Modification Date:
2026-02-28 @ 10:53 PM
Study NCT ID:
NCT01982266
Status:
TERMINATED
Last Update Posted:
2016-05-18
First Post:
2013-11-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective, Multicenter, Single Arm Feasibility Study of the Safety and Performance of GRADION™ Hip Total Cartilage Replacement (TCR)™ in the Treatment of Degenerative Joint Disease of the Hip
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'Device failure', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-16', 'studyFirstSubmitDate': '2013-11-01', 'studyFirstSubmitQcDate': '2013-11-06', 'lastUpdatePostDateStruct': {'date': '2016-05-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Degenerative Joint Disease of the Hip']}, 'descriptionModule': {'briefSummary': 'This is a prospective, multicenter, single arm feasibility study of the safety and performance of the GRADION™ Hip Total Cartilage Replacement (TCR)™ in patients who require cartilage replacement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary hip surgery for Noninflammatory Degenerative Joint Disease (NIDJD) such as osteo/degenerative arthritis, and is indicated for cartilage replacement\n* Skeletally mature or at least 18 years of age and has normal anatomy\n* Patient signs the Informed Consent form\n* Failed medical management\n* There will be size limitations on patients also - available size range is 46mm-54mm.\n\nExclusion Criteria:\n\n* Allergic to polyether urethane, sodium polyacrylate, bone cement or any of its components\n* Previous fusion, acute femoral neck fracture and/or above knee amputation\n* Revision of any previous hip procedure\n* Slipped capital femoral epiphysis (SCFE)\n* Rheumatoid arthritis\n* AVN'}, 'identificationModule': {'nctId': 'NCT01982266', 'briefTitle': 'A Prospective, Multicenter, Single Arm Feasibility Study of the Safety and Performance of GRADION™ Hip Total Cartilage Replacement (TCR)™ in the Treatment of Degenerative Joint Disease of the Hip', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biomimedica, Inc'}, 'officialTitle': 'A Prospective, Multicenter, Single Arm Feasibility Study of the Safety and Performance of GRADION™ Hip Total Cartilage Replacement (TCR)™ in the Treatment of Degenerative Joint Disease of the Hip', 'orgStudyIdInfo': {'id': 'EP052'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GRADION™ Hip Total Cartilage Replacement (TCR)™', 'interventionNames': ['Device: GRADION™ Hip Total Cartilage Replacement (TCR)™']}], 'interventions': [{'name': 'GRADION™ Hip Total Cartilage Replacement (TCR)™', 'type': 'DEVICE', 'armGroupLabels': ['GRADION™ Hip Total Cartilage Replacement (TCR)™']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6815', 'city': 'Arnhem', 'country': 'Netherlands', 'facility': 'Rijnstate Arnhem', 'geoPoint': {'lat': 51.98, 'lon': 5.91111}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biomimedica, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}