Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2026-01-01 @ 8:47 AM
Study NCT ID:
NCT05258435
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-22
First Post:
2022-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Assessment of the Safety and Performance of the NuVasive Simplify Disc
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': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 131}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-02-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2022-02-08', 'studyFirstSubmitQcDate': '2022-02-16', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Composite Success', 'timeFrame': '10 years', 'description': 'Individual patient success for the primary endpoint will be assessed at 120 months and is defined as follows:\n\n1. Improvement on the Neck Disability Index (NDI) of at least 15 percentage points compared to baseline (pre-op), and\n2. No device failures by month 120, and\n3. No secondary surgical intervention (SSI) at the index level (i.e., revision, removal, reoperation, or supplemental fixation) by month 120.'}], 'secondaryOutcomes': [{'measure': 'Percentage of subjects meeting the minimal clinically important difference (MCID) for NDI at each annual timepoint', 'timeFrame': '10 years', 'description': 'Neck Disability Index; scale is reported in a range from 0-100, with 0 consistent with best ability to function and 100 worst ability to function.'}, {'measure': 'Percentage of subjects meeting MCID for Visual Analog Scale (VAS) for each of the following pain locations and each annual timepoint: neck and arm pain, neck only pain, left arm pain, and right arm pain', 'timeFrame': '10 years', 'description': 'Visual Analog Scale, scale is reported in a range from 0 to 100, with 0 consistent with no pain and 100 with most pain'}, {'measure': 'Motor status at each annual timepoint compared to baseline', 'timeFrame': '10 years', 'description': 'A change of one or more grade levels in muscle strength will be regarded as clinically significant.'}, {'measure': 'Sensory status at each annual timepoint compared to baseline', 'timeFrame': '10 years', 'description': 'Sensation will be graded as normal or abnormal (diminished or absent). Any changes from abnormal to normal or absent to diminished will be regarded as clinically significant improvement.'}, {'measure': 'Treatment satisfaction questionnaire at each annual timepoint', 'timeFrame': '10 years', 'description': 'Responses range from very dissatisfied to very satisfied'}, {'measure': 'SF-12v2® Health Survey at each annual timepoint compared to baseline', 'timeFrame': '10 years', 'description': 'The SF-12 is a multipurpose short form survey with 12 questions selected from the SF-36 Health Survey. The questions were combined, scored and weighted to create mental and physical functioning and overall health-related quality of life. Higher scores indicate better outcomes. Scores range from 0-15.'}, {'measure': 'Dysphagia Handicap Index1 (DHI) at each annual timepoint compared to baseline', 'timeFrame': '10 years', 'description': 'DHI is scored from 0-100, with a higher score indicative of a less desirable outcome.'}, {'measure': 'Disc height at each annual timepoint will be compared to baseline', 'timeFrame': '10 years', 'description': 'Average disc height is calculated as the simple average of the anterior and posterior disc heights'}, {'measure': 'Adjacent level disc degeneration (ALDD) at each annual timepoint will be compared to baseline', 'timeFrame': '10 years', 'description': 'ALDD is graded in accordance with definitions adapted from Kellgren and Lawrence: None; Doutbtful;Minimal;Moderate;Severe'}, {'measure': 'Displacement or migration of the Simplify Disc at each annual timepoint will be compared to the post-op timepoint in the IDE study (NCT02667067)', 'timeFrame': '10 years', 'description': 'Device migration assesses significant movement of the implant postoperatively'}, {'measure': 'Range of motion (ROM) at each annual timepoint compared to baseline', 'timeFrame': '10 years', 'description': 'Changes of \\>3 mm will be considered significant due to the margin of error in radiographic determination of displacement distances.'}, {'measure': 'Rate of adverse events attributable to Simplify Disc, or use of additional NuVasive instruments, implants, or technologies at each annual timepoint', 'timeFrame': '10 years', 'description': 'Number of adverse events related to Simplify Disc or additional NuVasive products'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Cervical Disc Disease', 'Degenerative Disc Disease']}, 'descriptionModule': {'briefSummary': 'A prospective, multicenter post-market clinical follow-up study to evaluate the 10-year long-term safety and effectiveness of the Simplify Disc in subjects who were enrolled in the post approval study (NCT04630626).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population includes subjects treated with the NuVasive Simplify Disc in IDE study (NCT02667067) and followed in the PAS (NCT04630626).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject was enrolled in the Simplify Disc post approval study (NCT04630626) at a participating study site\n2. Subject understands the conditions of enrollment and is willing to sign an informed consent form to participate in the study\n\nExclusion Criteria:\n\n1. Subject had an SSI at the index level during the post approval study (NCT04630626)\n2. Subject was withdrawn or withdrew consent to participate in the post approval study (NCT04630626)'}, 'identificationModule': {'nctId': 'NCT05258435', 'briefTitle': 'Long-term Assessment of the Safety and Performance of the NuVasive Simplify Disc', 'organization': {'class': 'INDUSTRY', 'fullName': 'Globus Medical Inc'}, 'officialTitle': 'Long-term Assessment of the Safety and Performance of the NuVasive Simplify Disc', 'orgStudyIdInfo': {'id': 'NUVA.TDR0921'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Simplify Disc', 'description': 'Extended follow-up of subjects treated with the Simplify Disc during IDE G140154 and followed in the post-approval study NCT04630626.', 'interventionNames': ['Device: NuVasive Simplify Cervical Artificial Disc']}], 'interventions': [{'name': 'NuVasive Simplify Cervical Artificial Disc', 'type': 'DEVICE', 'description': 'Simplify Disc is a weight-bearing cervical artificial disc implant consisting of PEEK (polyetheretherketone) endplates and one semi-constrained, fully articulating, mobile Zirconia Toughened Alumina ceramic (ZTA) core.', 'armGroupLabels': ['Simplify Disc']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92686', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Hoag Orthopedics', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '90403', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'The Spine Institute for Spine Restoration', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '80229', 'city': 'Thornton', 'state': 'Colorado', 'country': 'United States', 'facility': 'Spine Education and Research', 'geoPoint': {'lat': 39.86804, 'lon': -104.97192}}, {'zip': '34232', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Kennedy-White Orthopaedic Center', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '60201', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'NorthShore University Health System', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '46032', 'city': 'Carmel', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana Spine Group', 'geoPoint': {'lat': 39.97837, 'lon': -86.11804}}, {'zip': '71101', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Spine Institute of Louisiana', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolina Neurosurgery and Spine Associates', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '75001', 'city': 'Addison', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Spine Consultants', 'geoPoint': {'lat': 32.96179, 'lon': -96.82917}}, {'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Back Institute', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NuVasive', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}