Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2025-12-30 @ 11:23 AM
Study NCT ID:
NCT00635934
Status:
COMPLETED
Last Update Posted:
2018-09-18
First Post:
2008-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A-MAV™ Anterior Motion Segment Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013122', 'term': 'Spinal Diseases'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'dispFirstSubmitDate': '2018-09-13', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-13', 'studyFirstSubmitDate': '2008-03-07', 'dispFirstSubmitQcDate': '2018-09-13', 'studyFirstSubmitQcDate': '2008-03-13', 'dispFirstPostDateStruct': {'date': '2018-09-18', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2018-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-03-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Success= Oswestry Disability Index success; Maintenance or improvement in neurological status; No serious AE classified as implant or implant/surgical procedure associated; No additional surgical procedure classified as a failure', 'timeFrame': '24 Months'}], 'secondaryOutcomes': [{'measure': "Disc height; SF-36; Back Pain Status; Leg Pain Status; Patient Satisfaction; Patient Global Perceived Effect; Other Measurements-Radiographic; Return to Work; Doctor's Perception of Results", 'timeFrame': '24 Months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Lumbar Degenerative Disc Disease at One Level from L4-S1'], 'conditions': ['Spinal Diseases']}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical trial is to collect safety and effectiveness data concerning the A-MAV™ Anterior Motion Segment Replacement device as a method of treating patients with lumbar degenerative disc disease at one level from L4-S1. Overall success will be the primary clinical endpoint.', 'detailedDescription': 'For this clinical trial, there is only one treatment group- patients receiving the A-MAV™ Anterior Motion Segment Replacement via an anterior surgical approach in the lumbar region of the spine from L4-S1.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has back and/or radicular pain with degeneration of the disc as confirmed by patient history, physical examination, and radiographic studies with one or more of the following factors:\n\n * instability as defined by \\> 5° angulation\n * osteophyte formation of facet joints or vertebral endplates\n * decreased disc height, on average by \\>2mm, relative to the next adjacent vertebral segment\n * scarring/thickening of ligamentum flavum, annulus fibrosis, or facet joint capsule\n * herniated nucleus pulposus\n * facet joint degeneration/changes\n * vacuum phenomenon\n* Has single-level symptomatic degenerative involvement from L4-S1 requiring surgical treatment\n* Has intact facet joints at the involved vertebral levels documented by CT and/or MRI\n* Has preop Oswestry score≥30\n* Has preop back pain score ≥8\n* Age 18 to 70 yrs, inclusive and is skeletally mature\n* Has not responded to non-operative treatment for 6 mos\n* If child-bearing potential, patient is non-pregnant, non-nursing, and agrees not to become pregnant for 1 yr after surgery\n* Is willing and able to comply with the study plan and sign the Patient Informed Consent Form\n\nExclusion Criteria:\n\n* Has primary diagnosis of a spinal disorder other than DDD at involved level\n* Had previous anterior lumbar spinal surgery at involved level\n* Had previous posterior lumbar spinal fusion surgical procedure at involved level\n* Had prior posterior lumbar surgery resulting in significant muscle/ligament morbidity, not including facet saving techniques\n* Requires surgical intervention at more than 1 lumbar level\n* Has severe pathology of facet joints of involved vertebral bodies\n* Has facet arthritis or any posterior element insufficiency\n* Has spondylolisthesis\n* Has mid-sagittal stenosis of \\<8mm, based on remaining canal diameter\n* Has rotatory scoliosis at involved level\n* Has lumbar scoliosis with \\>11° sagittal plane deformity\n* Had previous trauma to L4, L5, or S1 levels in compression or burst\n* Meets any of the following criteria: Previous diagnosis of osteoporosis, osteopenia, or osteomalacia; postmenopausal Non-Black female over 60 yrs of age and weighs less than 140 pounds; postmenopausal female that has sustained a non-traumatic hip, spine or wrist fracture; male over age 60 that has sustained a non-traumatic hip or spine fracture. If Yes to any of these, a DEXA scan is required. If level of BMD is -3.5 or lower or -2.5 or lower with vertebral crush fracture, the patient is excluded\n* Had previous lumbar spinal fusion at adjacent level\n* Bone growth stimulator use in spine\n* Has obesity defined by BMI greater than or equal to 40\n* Has arachnoiditis\n* Has a non-contained or extruded herniated nucleus pulposus with acute nerve root compression\n* Has condition that requires postop medications that interfere with bone metabolism, such as chronic steroid use or prolonged use of non-steroidal anti-inflammatory drugs, excluding routine perioperative, non-steroidal anti-inflammatory drugs. Does not include low dose aspirin for prophylactic anticoagulation\n* Has overt or active bacterial infection, either local or systemic and/or potential for bacteremia\n* Has presence or prior history of malignancy (except for basal cell carcinoma of skin)\n* Has documented metal allergy, titanium alloy intolerance or cobalt-chrome-molybdenum alloy\n* Is mentally incompetent. If questionable, obtain psych consult\n* Has a Waddell Signs of Inorganic Behavior score of 3 or greater\n* Has chronic or acute renal and/or hepatic failure or prior history of renal and/or hepatic parenchymal disease\n* Is prisoner\n* Is pregnant\n* Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug abuse\n* Has history of autoimmune disease\n* Has received treatment with an investigational therapy within 30 days prior to implantation surgery or treatment is planned during 24 months following the implantation surgery\n* Has history of any endocrine or metabolic disorder known to affect osteogenesis\n* Has any disease that would preclude accurate clinical evaluation'}, 'identificationModule': {'nctId': 'NCT00635934', 'briefTitle': 'A-MAV™ Anterior Motion Segment Replacement', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Spinal and Biologics'}, 'officialTitle': 'A Prospective, Non-Randomized Pilot Clinical Investigation of the A-MAV™ Anterior Motion Segment Replacement in Patients With Lumbar Degenerative Disc Disease', 'orgStudyIdInfo': {'id': 'P04-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A-MAV™disc', 'interventionNames': ['Device: A-MAV™ disc']}], 'interventions': [{'name': 'A-MAV™ disc', 'type': 'DEVICE', 'otherNames': ['A-MAV™'], 'description': 'The A-MAV™ device is a spinal arthroplasy system intended to replace a damaged spinal disc. It is inserted using an anterior surgical approach and aims to reduce low back pain and maintain disc height at the affected level.', 'armGroupLabels': ['A-MAV™disc']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31908', 'city': 'Columbus', 'state': 'Georgia', 'country': 'United States', 'facility': 'Hughston Clinic', 'geoPoint': {'lat': 32.46098, 'lon': -84.98771}}, {'zip': '63017', 'city': 'Chesterfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Orthopedic Center of St. Louis', 'geoPoint': {'lat': 38.66311, 'lon': -90.57707}}, {'zip': '78731', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Central Texas Spine', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Spinal and Biologics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}