The MOTION Study - Treatment of LSS With the MILD Procedure

The study will follow participants treated in the MILD plus CMM group and crossover participants for up to 5 years on annual bases.

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.