Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2026-03-03 @ 6:45 PM
Study NCT ID:
NCT02139527
Status:
TERMINATED
Last Update Posted:
2014-05-15
First Post:
2014-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CARES Lumbar Artificial Disc Registry
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059145', 'term': 'Total Disc Replacement'}], 'ancestors': [{'id': 'D019643', 'term': 'Arthroplasty, Replacement'}, {'id': 'D001178', 'term': 'Arthroplasty'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'Low enrollment and follow-up data on enrolled patients.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-13', 'studyFirstSubmitDate': '2014-02-11', 'studyFirstSubmitQcDate': '2014-05-13', 'lastUpdatePostDateStruct': {'date': '2014-05-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Oswestry Disability Index (ODI) Score', 'timeFrame': '3, 6, 12, 24, 36, 48, and 60 months post operative', 'description': 'The ODI assesses several domains of function affected by low back pain. A change of 15 points from baseline is considered a clinical meaningful difference for the individual. The change from pre operative baseline to each follow-up assessment will be calculated.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['arthroplasty', 'spinal', 'CHARITE', 'PRODISC-L', 'PRODISC', 'disc', 'replacement', 'lumbar'], 'conditions': ['Lumbar Degenerative Disc Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of the registry is to assess outcomes following treatment with lumbar total disc replacement (TDR) in patients outside the clinical trial setting.', 'detailedDescription': 'The purpose of this study is to capture outcomes associated with use of total disc replacement (TDR) in patients treated with either the CHARITE™ Artificial Disc or the PRODISC®-L Total Disc Replacement may be included in the registry.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients that undergo lumbar total disc replacement (TDR); this includes patients treated with either the CHARITE disc or the ProDisc-L disc', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Treated with the lumbar TDR.\n* Signed IRB approved consent document.\n\nKey Exclusion Criteria:\n\n* None known.'}, 'identificationModule': {'nctId': 'NCT02139527', 'briefTitle': 'CARES Lumbar Artificial Disc Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'DePuy Spine'}, 'officialTitle': 'The Centers for Arthroplasty Research and Education in Spine (CARES) Lumbar Artificial Disc Registry Protocol', 'orgStudyIdInfo': {'id': '06-CAD-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Total Disc Replacement', 'type': 'DEVICE', 'otherNames': ['CHARITE™ Artificial Disc', 'PRODISC®-L Total Disc Replacement']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'DePuy Spine', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}