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Male or female, age 21-80 (inclusive) with at least 3 years of life expectancy |
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Subject plans to undergo a one-level Open or Mini-Open TLIF or PLIF procedure (stabilized with pedicle screws) independent of this research protocol |
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Subject is to be treated with on-label use of an FDA-cleared TLIF or PLIF cage(s) and pedicle screw system independent of this research protocol |
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The subject has a primary diagnosis of symptomatic lumbar degeneration with or without foraminal or recess stenosis of the lumbar spine at a single level from L1/L2 to L5/S1 confirmed by subject history and radiographic imaging (CT, MRI, X-rays) with no more than a Grade 1 (<25% translation) spondylolisthesis. Symptomatic lumbar degeneration that may be associated with a co-morbid condition such as |
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Herniated nucleus pulposus |
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Scarring/thickening of the ligamentum flavum, annulus fibrosus, or facet joint capsule |
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Facet joint degeneration/osteophyte formation |
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Spondylosis (defined by the presence of osteophytes) |
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Disc degeneration and/or annular degeneration; and/or |
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Lumbar stenosis defined by spinal cord or nerve root compression |
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Exhausted conservative treatment (e.g. bed rest, physical therapy, medications |
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transcutaneous electrical nerve stimulation (TENS), manipulation, and/or |
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spinal injections) for at least 3 months or has a neurologic emergency |
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Preoperative Oswestry Disability Index score >/= 40/100 at baseline |
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Psychosocially, mentally and physically able and willing to fully comply with this protocol including adhering to follow-up schedule and requirements and filling out forms; and |
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Signed informed consent |
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More than one vertebral level requiring treatment
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Previous instrumented surgery (i.e.: anterior disc replacement, spinal fusion, interspinous device, etc.) at the index lumbar level or an adjacent level
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Degenerative or lytic spondylolisthesis greater than Grade 1 (<25% translation)
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Rotatory scoliosis at the level to be treated
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Congenital bony and/or spinal cord abnormalities at the level to be treated
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Subcaudal defect, disrupting the integrity of the pedicle
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Clinically compromised vertebral bodies at the involved level due to current or past trauma, e.g., by the radiographic appearance of the fracture callus, malunion or nonunion
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Disrupted anterior longitudinal ligament at the index level
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Overlying thoracolumbar kyphosis (greater than or equal to 15 degrees) within one level (includes target and adjacent level) of the level to be treated
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Back pain of unknown etiology without leg pain
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Severe spondylosis at the level to be treated as characterized by any of the
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following
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Autofusion (solid arthrodesis) determined radiographically (CT)
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Totally collapsed disc, or
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Vertebral body that cannot be mobilized
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Unable to undergo a CT scan or other radiograph assessments
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Known allergy to cobalt, chromium, molybdenum, nickel, polyethylene, titanium, or
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Osteopenia: The SCORE/MORES will be utilized for all females age <50 and males age <55 to screen if a DEXA scan is indicated. If SCORE/MORES value ≥ 6, then a DEXA scan is required. A DEXA scan is indicated for all females age ≥50 and all males age ≥55. If DEXA is required, exclusion will be defined as a DEXA bone density measured T score ≤ -1. An existing DEXA is allowed if completed within 6 months of subject screening
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vitamin E
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Has history of any endocrine or metabolic disorder known to affect osteogenesis (e.g.: Paget's disease, renal osteodystrophy, Ehler-Danlos syndrome, or osteogenesis imperfecta)
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Insulin-dependent diabetes mellitus
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Lactating, pregnant or interested in becoming pregnant in the next 3 years
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Active infection - systemic or local
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Any medical condition requiring treatment with any drug known to potentially interfere with bone/soft tissue healing or receiving radiation therapy that is expected to continue for the duration of the study
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Body Mass Index > 40
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Recurrent history of deep vein thrombosis, symptoms of arterial insufficiency, or thromboembolic disease
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Systemic disease including Lupus disease, Reiter's disease, Rheumatoid disease, AIDS, HIV, hepatitis or autoimmune disease that requires immunosuppressive therapy, including biologics, for systemic inflammation
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Spinal tumor
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Active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless he/she has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years
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Any degenerative muscular or neurological condition that would interfere with evaluation of outcomes, including but not limited to Parkinson's disease, amyotrophic lateral sclerosis (ALS), or multiple sclerosis
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Has chronic or acute renal and/or hepatic impairment and/or failure or prior history of renal and/or hepatic parenchymal disease
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Has a Waddell Signs of Inorganic Behavior score of 3 or greater
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In the opinion of the investigator, the subject has a behavioral, cognitive, social or medical problem that may interfere with the assessment of the safety or effectiveness of the device
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Current or recent history of chemical/alcohol abuse or dependency using standard medical definition of Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) code
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Currently pursuing or in active spinal litigation for medical negligence, or trauma, or workers compensation
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Currently smoking or using tobacco products, including e-cigarette products (e.g., vaping); (Use within 30 days of surgery date is considered 'current')
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Is a prisoner, incarcerated, or has been coerced to participate in the study that could impact the validity of results
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Is currently participating in an investigational therapy (device and/or pharmaceutical) within 30 days prior to entering the study or such treatment is planned during the 24 months following enrollment into the study
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