Clinical Research Directory

Inclusion Criteria: * Patients experiencing neurogenic claudication symptoms for at least 3 months duration. * LSS with neurogenic claudication * Radiologic evidence of LSS with unilateral or bilateral ligamentum flavum ≥ 2.5mm confirmed by pre-op MRI or CT performed within 12 months of baseline visit. * Patients with comorbid conditions commonly associated with spinal stenosis, such as osteophytes, facet hypertrophy, minor spondylolisthesis (Grade I without instability), foraminal stenosis, and/or disk protrusion may be included unless the treating physician has determined that the condition is too advanced. * Stable opioid intake with no change during 30 days prior to enrollment. * Available to complete all follow-up visits. Exclusion Criteria: * ODI Score \< 31 (0-100 ODI Scale). * NPRS Score \< 5 (0-10 NPRS Scale). * Lumbar epidural injections during eight weeks prior to study enrollment. * Baseline analgesic medication greater than 90 milligram morphine equivalent (MME). * Prior surgery at the same treatment level. * Previously received interspinous spacer at the same treatment level. * Previously received intradiscal procedure at the same treatment level. * Previously received vertebral augmentation procedure at the same treatment level. * Previously received the MILD procedure at the same treatment level. * Received radiofrequency ablation at the same or the adjacent levels within 6 months prior to study enrollment. * History of spinal fractures with current related pain symptoms. * Grade II or higher spondylolisthesis. * Motor deficit or disabling back and/or leg pain from causes other than LSS neurogenic claudication (e.g. acute compression fracture, metabolic neuropathy, or vascular claudication symptoms, etc.). * Unable to walk ≥ 10 feet unaided before being limited by pain. In this context, 'unaided' means without the use of a cane, walker, railing, wall, another person or any other means of walking assistance. * Previously randomized and/or treated in this clinical study. * Epidural lipomatosis (if it is deemed to be a significant contributor of canal narrowing by the physician). * On (or pending) Workman's Compensation or known to be considering litigation associated with back pain.