A-MAV™ Anterior Motion Segment Replacement

Exclusion Criteria

• •Has primary diagnosis of a spinal disorder other than DDD at involved level
• •Had previous anterior lumbar spinal surgery at involved level
• •Had previous posterior lumbar spinal fusion surgical procedure at involved level
• •Had prior posterior lumbar surgery resulting in significant muscle/ligament morbidity, not including facet saving techniques
• •Requires surgical intervention at more than 1 lumbar level
• •Has severe pathology of facet joints of involved vertebral bodies
• •Has facet arthritis or any posterior element insufficiency
• •Has spondylolisthesis
• •Has mid-sagittal stenosis of \<8mm, based on remaining canal diameter
• •Has rotatory scoliosis at involved level
• •Has lumbar scoliosis with \>11° sagittal plane deformity
• •Had previous trauma to L4, L5, or S1 levels in compression or burst
• •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
• •Had previous lumbar spinal fusion at adjacent level
• •Bone growth stimulator use in spine
• •Has obesity defined by BMI greater than or equal to 40
• •Has arachnoiditis
• •Has a non-contained or extruded herniated nucleus pulposus with acute nerve root compression
• •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
• •Has overt or active bacterial infection, either local or systemic and/or potential for bacteremia
• •Has presence or prior history of malignancy (except for basal cell carcinoma of skin)
• •Has documented metal allergy, titanium alloy intolerance or cobalt-chrome-molybdenum alloy
• •Is mentally incompetent. If questionable, obtain psych consult
• •Has a Waddell Signs of Inorganic Behavior score of 3 or greater
• •Has chronic or acute renal and/or hepatic failure or prior history of renal and/or hepatic parenchymal disease
• •Is prisoner
• •Is pregnant
• •Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug abuse
• •Has history of autoimmune disease
• •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
• •Has history of any endocrine or metabolic disorder known to affect osteogenesis
• •Has any disease that would preclude accurate clinical evaluation