Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2026-01-03 @ 8:18 PM
Study NCT ID:
NCT03162666
Status:
WITHDRAWN
Last Update Posted:
2021-08-23
First Post:
2017-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Outcomes Using an Expandable Spacer
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': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'The participating party (Rush) stopped the study because of logistic issues.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-11-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-17', 'studyFirstSubmitDate': '2017-05-17', 'studyFirstSubmitQcDate': '2017-05-19', 'lastUpdatePostDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Radiographic Analysis', 'timeFrame': 'Pre-Op, 6weeks, 12 weeks, 6months, 12 months, 24 months', 'description': 'Global and Segmental Lumbar Lordosis in degrees'}], 'secondaryOutcomes': [{'measure': 'Complications', 'timeFrame': 'Intra-operative, any time post-op upto 24 months', 'description': 'Surgical or device related complications'}, {'measure': 'Change in Patient Reported Outcomes as a number score', 'timeFrame': 'Pre-Op, 6weeks, 12 weeks, 6months, 12 months, 24 months', 'description': 'Visual Analog Scale, Oswestry Disability Index, Short Form 12, PROMIS'}, {'measure': 'Peri operative clinical parameters', 'timeFrame': 'Intra-Operative', 'description': 'Estimated Blood Loss in cc'}, {'measure': 'Clinical parameters in days', 'timeFrame': 'Immediate Post-operative', 'description': 'Length of Hospital Stay'}, {'measure': 'Peri operative clinical parameters in mgs', 'timeFrame': 'Immediate Post-operative', 'description': 'Narcotic Consumption'}, {'measure': 'Intra-Operative clinical parameters in minutes', 'timeFrame': 'Intra-Operative', 'description': 'Operative Time'}, {'measure': 'Changes in Radiographic Analysis in percentage', 'timeFrame': '6weeks, 12 weeks, 6months, 12 months, 24 months', 'description': 'Fusion Rates'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Degenerative Disc Disease']}, 'descriptionModule': {'briefSummary': 'This study is a post-market clinical follow-up study. The data collected from this study will serve the purpose of confirming safety and performance of the ALTERA™ Expandable implant.', 'detailedDescription': "The evaluation is based on the following elements.\n\n1. Safety as measured by the rate of serious operative and post-operative complications.\n2. Subjects quality of life, measured by health-related quality of life questionnaires and Subject-reported outcome measures up to 24 months following the procedure, as compared to Subject's preoperative baseline.\n3. Global and segmental lumbar lordosis (LL)\n\nPatients will be followed upto 24 months post-operative"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients that present to Rush University Medical Center', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult (18-70 y/o)\n* Male or Female\n* With the following conditions of the lumbar spine as confirmed by advanced imaging (CT or MRI), who is a candidate for primary spinal fusion procedure according to acceptable criteria for such medical conditions:\n\n * Degenerative disc disease with up to Grade I spondylolisthesis\n * Spondylolisthesis\n* Failure of at least 6-months conservative treatment\n* BMI \\< 40\n* Subject to approve no pregnancy during the 24 months of study and no participation in other studies in parallel to this one\n* Ability to read, understand, and sign informed consent\n\nExclusion Criteria:\n\n* Infection, local to the operative site\n* Signs of local inflammation\n* Fever or leukocytosis\n* Pregnancy\n* Significant mental disorder or condition that could compromise the Subject's ability to remember and comply with preoperative and postoperative instructions (e.g. current treatment for a psychiatric/psychosocial disorder, senile dementia, Alzheimer's disease, traumatic head injury)\n* Prior surgical procedure (with the exception of decompression only procedure) at the index level(s) using the desired operative approach\n* Prior fusion procedure at an adjacent level\n* Any other condition which would preclude the potential benefit of spinal implant surgery, such as the presence of tumors or congenital abnormalities, fracture local to the operating site, elevation of segmentation rate unexplained by other diseases, elevation of white blood count (WBC), or a marked left shift in the WBC differential count\n* Neuromuscular disorder that would engender unacceptable risk of instability, implant fixation failure, or complications in postoperative care\n* Active local infection in or near the operative region\n* Active systemic infection and/or disease\n* Severe osteoporosis or insufficient bone density, which in the medical opinion of the physician precludes surgery or contraindicates instrumentation\n* Endocrine or metabolic disorders known to affect osteogenesis (e.g. Paget's disease, renal osteodystrophy, hypothyroidism)\n* Systemic disease that requires the chronic administration of nonsteroidal anti-inflammatory or steroidal drugs\n* Suspected or documented allergy or intolerance to implant's materials\n* Symptomatic cardiac disease\n* Subject unwilling to cooperate with postoperative instructions.\n* Any case where the implant components selected for use would be too large or too small to achieve a successful result.\n* Subject having inadequate tissue coverage over the operative site or inadequate bone stock or quality.\n* Any Subject in which implant utilization would interfere with anatomical structures or expected physiological performance.\n* Prior fusion at the level to be treated.\n* Back VAS \\< 4/10"}, 'identificationModule': {'nctId': 'NCT03162666', 'briefTitle': 'Patient Outcomes Using an Expandable Spacer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Globus Medical Inc'}, 'officialTitle': 'Post-market Surveillance Study of Altera™ Minimally Invasive Articulating Expandable Spacer in a TLIF Interbody Fusion Device', 'orgStudyIdInfo': {'id': 'RGC16-001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ALTERA', 'type': 'DEVICE', 'description': 'degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. with up to grade 1 spondylolisthesis'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Kern Singh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rush Univeristy Medical Center Orthopedic Surgeon'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Globus Medical Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}