- A primary and predominate diagnosis of discogenic or facet-mediated back pain
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Back or non-radicular leg pain of unknown etiology
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Significant peripheral vascular disease causing vascular claudication
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Significant peripheral neuropathy caused by conditions other than spinal stenosis
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History of fixed or permanent neurologic deficit related to spinal cord injury
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History of any previous surgery at the level(s) planned for treatment or at any level in the lumbosacral spine except for a discectomy or decompression (NOT including epidural injections, rhizotomy or nerve ablation)
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Isthmic spondylolisthesis or spondylolysis at any level in the lumbar spine
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Clinically significant compromise of vertebrae at L1 to S1 levels due to osteoporotic vertebral compression fracture or any traumatic, neoplastic, metabolic or infectious pathology or congenital abnormality
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Spinous process fracture(s) or other posterior element fracture(s) of the segment to be instrumented
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Degenerative lumbar scoliosis with a Cobb angle >10° at the affected motion segment
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Symptomatic lumbar stenosis that is not amenable to a direct decompression
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Anklyosed motion segment at the target operative level
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Severe osteoporosis, defined as history of fragility fracture and DXA T-score < -2.5 or QCT T-score < 80mg/cubic cm. History of a fragility fracture requires that a DXA scan or QCT scan is completed
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Planned hip or knee replacement surgery, severe osteoarthritis or other musculoskeletal pathology of the hip or leg that could preclude reliable patient self reporting assessment scales and/or that would likely progress to surgery during study period
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Please contact study team for more exclusion criteria.
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