Ignite Creation Date:
2025-12-24 @ 9:39 PM
Ignite Modification Date:
2025-12-25 @ 7:22 PM
Study NCT ID:
NCT00215332
Status:
COMPLETED
Last Update Posted:
2015-04-13
First Post:
2005-09-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CHARITE™ vs. ALIF 5-Year Follow-up
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055959', 'term': 'Intervertebral Disc Degeneration'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 367}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-10', 'studyFirstSubmitDate': '2005-09-14', 'studyFirstSubmitQcDate': '2005-09-14', 'lastUpdatePostDateStruct': {'date': '2015-04-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Success', 'timeFrame': '5 Years', 'description': 'ODI Improvement greater than or equal to 15 points from baseline No device failures (i.e., revision, re-operation, supplemental fixation, or removal) No major complications Maintenance or improvement in neurological status compared to baseline.'}], 'secondaryOutcomes': [{'measure': 'Secondary Endpoints', 'timeFrame': '5 Years', 'description': 'Components of the Overall Success definition (neurological and ODI scores) Visual Analog Scale (VAS) Disc height Range of Motion Migration of the device Radiolucency'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['arthroplasty', 'lumbar', 'disc'], 'conditions': ['Degenerative Disc Disease']}, 'descriptionModule': {'briefSummary': 'To assess the clinical and radiographic outcomes through 5-years following treatment with CHARITÉ™ Artificial Disc vs. the BAK Cage for treatment of degenerative disc disease at one level (L4-S1).', 'detailedDescription': 'This study is an extension out to 5 year follow-up of a randomized comparative IDE trial of the CHARITÉ™ Artificial Disc vs. ALIF with the BAK cage for treatment of degenerative disc disease. The original 2-year trial demonstrated non-inferiority of the CHARITÉ™ compared to ALIF.\n\nThis extension will continue to follow-up the original outcome measures and will also examine adjacent segment progression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participated in either the training or randomized arm of the CHARITÉ Artificial Disc IDE study,\n* Still have the original implant they received in their index surgery.\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT00215332', 'briefTitle': 'CHARITE™ vs. ALIF 5-Year Follow-up', 'organization': {'class': 'INDUSTRY', 'fullName': 'DePuy Spine'}, 'officialTitle': 'Five-year Follow-up of the CHARITÉ™ Artificial Disc Compared to Anterior Lumbar Interbody Fusion With the BAK Cage.', 'orgStudyIdInfo': {'id': 'P040006'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Training- CHARITE', 'description': 'Non-Randomized Training (TDR with CHARITE)', 'interventionNames': ['Device: CHARITE']}, {'label': 'CHARITE', 'description': 'Randomized Subjects treated by Lumbar Total Disc Replacment with CHARITE', 'interventionNames': ['Device: CHARITE']}, {'label': 'Control', 'description': 'Randomized Subjects treated by ALIF with BAK cage'}], 'interventions': [{'name': 'CHARITE', 'type': 'DEVICE', 'description': 'Lumbar Total Disc Replacement', 'armGroupLabels': ['CHARITE', 'Training- CHARITE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Charite Site 13', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '80401', 'city': 'Golden', 'state': 'Colorado', 'country': 'United States', 'facility': 'Charite Site 06', 'geoPoint': {'lat': 39.75554, 'lon': -105.2211}}, {'zip': '60640', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Charite Site 11', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Charite Site 03', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '21204', 'city': 'Towson', 'state': 'Maryland', 'country': 'United States', 'facility': 'Charite Site 02', 'geoPoint': {'lat': 39.4015, 'lon': -76.60191}}, {'zip': '02120', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Charite Site 15', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '14094', 'city': 'Lockport', 'state': 'New York', 'country': 'United States', 'facility': 'Charite Site 14', 'geoPoint': {'lat': 43.17061, 'lon': -78.69031}}, {'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Charite Site 10', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '43214', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Charite Site 07', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'Charite Site 01', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}], 'overallOfficials': [{'name': 'Daniel H Stoutenburgh', 'role': 'STUDY_DIRECTOR', 'affiliation': 'DePuy Spine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'DePuy Spine', 'class': 'INDUSTRY'}}}}