Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-02-21 @ 6:53 PM
Study NCT ID:
NCT01979094
Status:
TERMINATED
Last Update Posted:
2024-03-05
First Post:
2013-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spinal Arthrodesis and Spinal Arthroplasty Database Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1296}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Process changes. New data base will be activated', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-01-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-03', 'studyFirstSubmitDate': '2013-10-24', 'studyFirstSubmitQcDate': '2013-11-07', 'lastUpdatePostDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-11-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-01-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical prospective review- Prospective Database study for future studies', 'timeFrame': '5 years', 'description': 'Collecting clinical measurements. Examples of these clinical measurements are the VAS Pain Scale, SF-36, NDI, and ODI.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Spine Condition']}, 'descriptionModule': {'briefSummary': 'To collect and organize data into a repository for future research.', 'detailedDescription': "To collect and organize data into a repository from the Principal Investigator's (H. Francis Farhadi, MD, PhD) patients who are undergoing spinal arthrodesis and/or spinal arthroplasty procedures at Ohio State University for future research, as yet to be identified. This comprehensive database of patients will allow for gathering of relevant information for potential future research use."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Spinal arthrodesis and/or spinal arthroplasty can be performed through either anterior, posterior, or lateral approaches for a variety of traumatic, degenerative, or deformity conditions.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must have had or will undergo a spinal arthrodesis and/or spinal arthroplasty procedure at Ohio State University\n\nExclusion Criteria:\n\n* N/A'}, 'identificationModule': {'nctId': 'NCT01979094', 'briefTitle': 'Spinal Arthrodesis and Spinal Arthroplasty Database Study', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'General Spinal Arthrodesis and Spinal Arthroplasty Database', 'orgStudyIdInfo': {'id': '2013H0104'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'spinal arthrodesis and/or arthroplasty procedures'}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State Unviersity', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'H. Francis Farhadi, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stephanus Viljoen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Stephanus Viljoen', 'investigatorAffiliation': 'Ohio State University'}}}}