The MOTION Study - Treatment of LSS With the MILD Procedure

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.