Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-30 @ 3:53 AM
Study NCT ID:
NCT07370493
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-01-27
First Post:
2025-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrospective Analysis of Patients Implanted With 2 Levels of Prodisc® C Vivo Devices
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-22', 'studyFirstSubmitDate': '2025-11-13', 'studyFirstSubmitQcDate': '2026-01-22', 'lastUpdatePostDateStruct': {'date': '2026-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the Occurrence of Secondary Surgical Interventions in Patients Treated with prodisc® C Vivo at 2 Levels', 'timeFrame': '10 year post-operative screening of prodisc C Vivo patients implanted from JAN 2010 to present', 'description': 'The primary objective of the study is to evaluate the post-operative performance of the prodisc® C Vivo after implantation by the occurrence of secondary surgical interventions in patients treated with prodisc® C Vivo at 2 levels. The State of the Art (SOTA) will be used as the comparison data collected in this study.'}], 'secondaryOutcomes': [{'measure': 'Assessment to demonstrate the continuous clinical and radiographic status of the prodisc C Vivo implants allowing characterization of performance of the device by nominal variables (percentages) based on ADEs, SSIs, PROs, and SF 12 data collection', 'timeFrame': '10 Year Post-operative 10 year post-operative screening of prodisc C Vivo patients implanted from JAN 2010 to present', 'description': 'Nominal variables will be presented as count (percent). For numerical variables, the results will be presented as minimum, 25th percentile, mean, standard deviation, median, 75th percentile and maximum. Frequency tables for system organ class and preferred terms will be compiled based on participants experiencing an ADE (Adverse Device Event), and on the number of ADEs (from initial surgery to present, including intraoperative and post-operative complications). These percentage variables will include multiple data collection factors, such as the number and proportions of patients with no secondary surgical interventions (SSIs) (revision, removal, re-operation, supplemental fixation) at the index level(s) from initial surgery to present, Patient Reported Outcome (PRO) assessments, and self-assessment of Health Surveys (SF 12).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Degenerative disc disease', 'cervical spine degenerative disc disease', 'Cervical Total Disc Arthroplasty', 'Symptomatic Cervical Disc Disease'], 'conditions': ['Degenerative Disc Disease', 'Cervical Spine Degenerative Disease', 'Symptomatic Cervical Disc Disease', 'Cervical Spine Degenerative Disc Disease']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to evaluate the safety and post-operative performance profile of the prodisc® C Vivo after implantation in comparison to the relevant clinical literature.', 'detailedDescription': "The primary objective of the study is to evaluate (estimate) the post-operative performance of prodisc® C Vivo overall, after implantation. Post-operative device performance will be estimated using Patient Reported Outcomes (PROs) and radiographic data derived from the patient's surgical charts and medical history.\n\nThe secondary objectives of this study are to assess:\n\n* patients with no secondary surgical interventions (SSIs), i.e. revision, removal, re-operation, supplemental fixation at the index level(s)\n* the rates of ADEs inclusive of intraoperative and post-operative complications\n* Patient Reported Outcomes (PROs)\n* Outcome self-assessment of Health Survey (SF 12 or 36 as available)"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of patients treated with prodisc® C Vivo implants at 2 levels in the cervical spine for the treatment of SCDD.\n\nPatients who underwent the initial surgery with the device, from 2010 until 2024 will be considered eligible for this study.\n\nPatients who are excluded from this study and their reason will be noted.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* In order for a patient's data to be included in this study, he/she has to meet the indications and not possess any of the specific or general contraindications listed in the Instructions For Use (IFU).\n* They must provide written informed consent with appropriate documentation noted in source documentation (prospective cohort only).\n\nExclusion Criteria:\n\n-There are no additional exclusion criteria."}, 'identificationModule': {'nctId': 'NCT07370493', 'briefTitle': 'Retrospective Analysis of Patients Implanted With 2 Levels of Prodisc® C Vivo Devices', 'organization': {'class': 'INDUSTRY', 'fullName': 'Centinel Spine'}, 'officialTitle': 'A Multicenter, Retrospective Analysis to Evaluate Radiographic Outcomes and Safety Profiles Along Prospective Follow-Up Periods for Patients Implanted With 2 Levels of Prodisc® C Vivo Devices.', 'orgStudyIdInfo': {'id': 'VAL-P-0190'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Retrospective chart review', 'description': 'Retrospective chart review of patients treated with prodisc® C Vivo at 2 contiguous levels.', 'interventionNames': ['Device: Prodisc C Vivo']}, {'label': 'Prospective follow-up', 'description': 'Prospective follow-up of patients treated with prodisc® C Vivo at 2 contiguous levels.', 'interventionNames': ['Device: Prodisc C Vivo']}], 'interventions': [{'name': 'Prodisc C Vivo', 'type': 'DEVICE', 'description': 'The prodisc® C Vivo device is a non-keeled cervical disc replacement prosthesis. The device is modular intervertebral disc prostheses designed to replace a diseased and/or a degenerated disc of the cervical spine in SCDD patients, thereby restoring disc height, biomechanical stability and allowing the potential for motion at the affected vertebral segment.', 'armGroupLabels': ['Prospective follow-up', 'Retrospective chart review']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45661', 'city': 'Recklinghausen', 'country': 'Germany', 'facility': 'ONZ Spine', 'geoPoint': {'lat': 51.61379, 'lon': 7.19738}}], 'overallOfficials': [{'name': 'James Kuras, MS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centinel Spine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centinel Spine', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Avania', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}