MiDAS II (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study

MiDAS II (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study

This is a multi-center, prospective, patient outcomes assessment of Minimally Invasive Lumbar Decompression with the Mild® devices in patients with symptomatic central canal spinal stenosis.

Inclusion Criteria:

• Symptomatic lumbar spinal stenosis (LSS) primarily caused by dorsal element hypertrophy.
• Prior failure of conservative therapy and Oswestry Disability Index (ODI) score > 20%.
• Radiologic evidence of lumbar spinal stenosis (LSS), ligamentum flavum hypertrophy (typically > 2.5 mm), confirmed by pre-op MRI and/or CT.
• Central canal cross sectional area clearly reduced per MRI/CT report.
• If present, anterior listhesis preferred ≤ 5.0mm and deemed stable by Investigator.
• Able to walk at least 10 feet unaided before being limited by pain.
• Available to complete 26 weeks of follow-up.
• A signed Informed Consent Form is obtained from the patient.
• Adults at least 18 years of age.

Exclusion Criteria:

• Prior surgery at intended treatment level.
• Compound fracture with interspinal retropulsion contributing to spinal stenosis.
• Disabling back or leg pain from causes other than LSS (e.g. acute compression fracture, metabolic neuropathy, or vascular claudication symptoms, etc.).
• Disc protrusion or osteophyte formation severe enough to confound study outcome.
• Facet hypertrophy severe enough to confound study outcome.
• Bleeding disorders and/or current use of anti-coagulants.
• Use of acetylsalicylic acid (ASA) and/or non-steroidal anti-inflammatory drug (NSAID) within 5 days of treatment.
• Epidural steroid administration within prior three weeks (of procedure).
• Inability of the patient to lie prone for any reason with anesthesia support (e.g.chronic obstructive pulmonary disease (COPD), obesity, etc.).
• Metabolic wound healing pathologies deemed by Investigator to compromise study outcomes.
• Dementia and/or inability to give informed consent.
• Pregnant and/or breastfeeding.
• On Workman's Compensation or considering litigation associated with back pain.