A-MAV™ Anterior Motion Segment Replacement
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed Description
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: A-MAV™disc
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Device: A-MAV™ disc
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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- 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 [24 Months]
Secondary Outcome Measures
- 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 [24 Months]
Eligibility Criteria
Criteria
Inclusion Criteria:
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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:
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instability as defined by > 5° angulation
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osteophyte formation of facet joints or vertebral endplates
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decreased disc height, on average by >2mm, relative to the next adjacent vertebral segment
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scarring/thickening of ligamentum flavum, annulus fibrosis, or facet joint capsule
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herniated nucleus pulposus
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facet joint degeneration/changes
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vacuum phenomenon
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Has single-level symptomatic degenerative involvement from L4-S1 requiring surgical treatment
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Has intact facet joints at the involved vertebral levels documented by CT and/or MRI
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Has preop Oswestry score≥30
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Has preop back pain score ≥8
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Age 18 to 70 yrs, inclusive and is skeletally mature
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Has not responded to non-operative treatment for 6 mos
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If child-bearing potential, patient is non-pregnant, non-nursing, and agrees not to become pregnant for 1 yr after surgery
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Is willing and able to comply with the study plan and sign the Patient Informed Consent Form
Exclusion Criteria:
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Has primary diagnosis of a spinal disorder other than DDD at involved level
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Had previous anterior lumbar spinal surgery at involved level
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Had previous posterior lumbar spinal fusion surgical procedure at involved level
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Had prior posterior lumbar surgery resulting in significant muscle/ligament morbidity, not including facet saving techniques
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Requires surgical intervention at more than 1 lumbar level
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Has severe pathology of facet joints of involved vertebral bodies
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Has facet arthritis or any posterior element insufficiency
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Has spondylolisthesis
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Has mid-sagittal stenosis of <8mm, based on remaining canal diameter
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Has rotatory scoliosis at involved level
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Has lumbar scoliosis with >11° sagittal plane deformity
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Had previous trauma to L4, L5, or S1 levels in compression or burst
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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
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Had previous lumbar spinal fusion at adjacent level
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Bone growth stimulator use in spine
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Has obesity defined by BMI greater than or equal to 40
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Has arachnoiditis
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Has a non-contained or extruded herniated nucleus pulposus with acute nerve root compression
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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
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Has overt or active bacterial infection, either local or systemic and/or potential for bacteremia
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Has presence or prior history of malignancy (except for basal cell carcinoma of skin)
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Has documented metal allergy, titanium alloy intolerance or cobalt-chrome-molybdenum alloy
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Is mentally incompetent. If questionable, obtain psych consult
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Has a Waddell Signs of Inorganic Behavior score of 3 or greater
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Has chronic or acute renal and/or hepatic failure or prior history of renal and/or hepatic parenchymal disease
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Is prisoner
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Is pregnant
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Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug abuse
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Has history of autoimmune disease
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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
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Has history of any endocrine or metabolic disorder known to affect osteogenesis
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Has any disease that would preclude accurate clinical evaluation
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Hughston Clinic | Columbus | Georgia | United States | 31908 |
2 | Orthopedic Center of St. Louis | Chesterfield | Missouri | United States | 63017 |
3 | Central Texas Spine | Austin | Texas | United States | 78731 |
Sponsors and Collaborators
- Medtronic Spinal and Biologics
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- P04-05