Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2026-01-01 @ 6:46 PM
Study NCT ID:
NCT05566704
Status:
COMPLETED
Last Update Posted:
2025-12-22
First Post:
2022-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrospective Modulus ALIF Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055959', 'term': 'Intervertebral Disc Degeneration'}, {'id': 'D013168', 'term': 'Spondylolisthesis'}, {'id': 'D003251', 'term': 'Constriction, Pathologic'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D013169', 'term': 'Spondylolysis'}, {'id': 'D055009', 'term': 'Spondylosis'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 123}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2022-09-30', 'studyFirstSubmitQcDate': '2022-09-30', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rates of complications attributable to the use of the Modulus ALIF System', 'timeFrame': '12 months'}, {'measure': 'Proportion of subjects with apparent radiographic fusion at 6 months or greater postoperative', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Change in neurologic status, symptoms, and/or subject self-reported clinical outcomes (e.g., pain and disability), as available', 'timeFrame': '12 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Degenerative Disc Disease', 'Spondylolisthesis', 'Stenosis']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the safety and performance of the Modulus ALIF System in patients undergoing anterior lumbar interbody fusion (ALIF) as measured by reported complications, radiographic outcomes, and patient-reported outcomes.', 'detailedDescription': 'Patients considered for this study will have previously undergone surgery for their spinal condition according to the standard of care of the practitioner. All patients at a given site who meet eligibility requirements will be considered for participation in the study. Available progress notes, medical records, patient-reported outcomes, radiographs (plain film and CT scans, if available), and complications will be obtained from the medical records of all enrolled subjects.\n\nThe complication profile and overall performance of the Modulus ALIF System will be assessed using the following:\n\n1. Complications attributable to the use of the Modulus ALIF System as noted in surgical summaries, progress notes, and hospital records; and\n2. Radiographic outcome (fusion) and description of device status from available plain film radiographs and CT scan(s); and\n3. Neurologic status, symptoms, and/or subject self-reported clinical outcomes (e.g., pain and disability), as available'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The analysis population will include all subjects who meet the criteria for enrollment, specifically, those subjects who:\n\n* Satisfied the inclusion and exclusion criteria\n* Previously underwent the surgical procedure as defined in this protocol', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Availability of progress notes and radiographic information preoperatively and a minimum of 6 months following surgery\n2. Male or female patients who are ≥18 years of age at the time of surgery\n3. Had undergone a regiment of at least six (6) months of nonoperative care treatment prior to being treated with the Modulus ALIF system, except in patients with progressive neurological deficits, neurogenic claudication causing significant disability, or developed cauda equine syndrome\n4. Treated with ALIF procedure with the Modulus ALIF System at:\n\n * One or two adjacent lumbar and/or lumbosacral levels for degenerative disc disease (DDD), degenerative spondylolisthesis, or spinal stenosis, or\n * Any number of lumbar and/or lumbosacral levels for degenerative scoliosis (defined as \\>10º coronal curve) or sagittal deformity\n5. Supplemental fixation cleared by the applicable regulatory body for use in the thoracolumbar spine unless the procedure meets all of the following criteria:\n\n * 1-2 levels treated for DDD, and\n * 3 or 4 interfixated screws placed, and\n * Implant lordosis is ≤20°\n\nExclusion Criteria:\n\n1. Patient was a prisoner at the time of Modulus ALIF treatment\n2. Patient was participating in another clinical study during treatment that would confound study data'}, 'identificationModule': {'nctId': 'NCT05566704', 'briefTitle': 'Retrospective Modulus ALIF Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Globus Medical Inc'}, 'officialTitle': 'An Assessment of the Safety and Performance of the Modulus® ALIF System in Patients Undergoing Anterior Lumbar Interbody Fusion', 'orgStudyIdInfo': {'id': 'NUVA.RMA0222'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Modulus ALIF System', 'interventionNames': ['Device: Modulus ALIF System']}], 'interventions': [{'name': 'Modulus ALIF System', 'type': 'DEVICE', 'description': 'The Modulus ALIF System is designed to address lumbar pathologies utilizing interbody placement through an anterior or anterolateral surgical approach. The Modulus ALIF System is an interfixated interbody system available in various shapes and sizes to suit the individual pathology and anatomical conditions of the patient.', 'armGroupLabels': ['Modulus ALIF System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Hoag Orthopedics', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '92121', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Girard Orthopedic Surgeons', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Georgia Spine & Neurosurgery Center', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'OrthoCarolina', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '28401', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Atlantic Brain and Spine', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}], 'overallOfficials': [{'name': 'Kyle Malone, MS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Globus Medical'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NuVasive', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}