Vertos Mild - Post Market Patient Outcomes

Single - Center, Prospective, Patient Outcomes Assessment of Minimally Invasive Lumbar Decompression With the Mild Devices in Patients With Symptomatic Central Canal Stenosis.

This is a single-center study evaluating the outcomes of patients with painful lumbar spinal stenosis who were treated with the mild procedure (minimally invasive lumbar decompression. The patients will be followed for 6 months after the procedure.

Approximately 50 patients at a single center will be enrolled and followed for a period of up to 26 weeks. Adult patients with symptomatic lumbar spinal stenosis who meet the enrollment criteria will be offered the mild procedure as an alternative to surgery or continued standard non-surgical medical management.

Inclusion Criteria:

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

Exclusion Criteria:

• Prior surgery at the intended treatment level
• Compound fracture with intraspinal retropulsion contributing to spinal stenosis
• Disabling back or leg pain from causes other than lumbar spinal stenosis
• 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 steroids with 3 weeks prior to procedure
• Inability of patient to lie prone for any reason with anesthesia support
• Metabolic wound healing pathologies that may be deemed by the Investigator to compromise the 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