Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-29 @ 11:05 AM
Study NCT ID:
NCT05114356
Status:
TERMINATED
Last Update Posted:
2024-07-03
First Post:
2021-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cervical Interbody Fusion Device Patient 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'Sponsor decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-11-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-01', 'studyFirstSubmitDate': '2021-10-20', 'studyFirstSubmitQcDate': '2021-11-01', 'lastUpdatePostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Oswestry Disability Index (ODI)/Neck Disability Index (NDI) Score Range 0-50 at 1 year post-operative from a pre-operative baseline', 'timeFrame': '1 year', 'description': 'ODI/NDI Score Range: 0-50 0-4 No disability 5-14 Mild disability 15-24 Moderate disability 25-34 Severe disability \\>34 Complete disability'}, {'measure': 'Change in VAS Pain at 1 year post-operative from a pre-operative baseline', 'timeFrame': '1 year', 'description': "VAS PAIN SEVERITY SCALE ranges from 0-10. A score of zero (0) means 'no pain' and a ten (10) means 'worst imaginable pain'"}], 'secondaryOutcomes': [{'measure': 'Improvement in patient reported short-form 36 (SF36) scores at 1 year post-operative from a pre-operative baseline', 'timeFrame': '1 year', 'description': 'Questionnaire of generic, coherent, and easily administered quality-of-life measures.'}, {'measure': 'Rate of Successful Fusion Based on Radiological Assessment at 1 Year Post-op', 'timeFrame': '1 year', 'description': 'Assessment of fusion'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Degenerative Disc Disease']}, 'descriptionModule': {'briefSummary': 'The registry has been designed as a prospective, observational program for patients undergoing anterior cervical discectomy and fusion (ACDF) procedures treated with TIDAL cervical interbody fusion device. The ultimate goal of the study is to aid in the development of treatment pathways and improved patient care. All patients who agree to participate in the registry will sign an informed consent form and subsequently be treated by their surgeon with the device in either an inpatient or outpatient facility.', 'detailedDescription': 'The registry is design to collect data prospectively on patients undergoing spinal fusion using the TIDAL cervical interbody fusion device. Patients will be enrolled in the registry after reviewing the protocol with their health care provider and signing the informed consent. Data will be collected at recommended time points based on the standards of care of the participating sites. The registry will serve as a database in which retrospective analysis and exploratory analysis of specific research questions will be answered.\n\nFollow up visits will be defined by the treating physicians based on their standard practice. Typical clinical follow up schedules for patients undergoing this type of surgery are pre-operative and 12 months post-operative.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with degenerative disc disease of the cervical spine, and being surgically treated for degenerative cervical disc disease using a 3D printed titanium interbody cage', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Neck and arm pain for a minimum of 6 weeks before surgery that is recalcitrant to nonoperative treatment modalities, such as physical therapy, reduced activities, and anti-inflammatory medications.\n* Radiographic evidence of cervical disc disease that is documented on dynamic radiographs and magnetic resonance imaging (MRI).\n\nExclusion Criteria:\n\n* Medical condition that required medication, such as steroids or nonsteroidal anti-inflammatory medications, that could interfere with fusion.\n\nThere are no restrictions on sex or ethnicity.'}, 'identificationModule': {'nctId': 'NCT05114356', 'briefTitle': 'Cervical Interbody Fusion Device Patient Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Restor3D'}, 'officialTitle': 'Cervical Interbody Fusion Device Patient Registry', 'orgStudyIdInfo': {'id': 'restor3d-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group', 'description': 'Patients being treated for degenerative disc disease', 'interventionNames': ['Device: TIDAL Cervical Interbody Fusion implant']}], 'interventions': [{'name': 'TIDAL Cervical Interbody Fusion implant', 'type': 'DEVICE', 'description': 'Cervical interbody fusion device', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42001', 'city': 'Paducah', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Orthopaedic Institute of Western Kentucky', 'geoPoint': {'lat': 37.08339, 'lon': -88.60005}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Restor3D', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}