Comparative Study of Sham Versus Mild® Procedure in Patients Diagnosed With Symptomatic Lumbar Central Canal Stenosis

Not Applicable

Completed

Interventions: Device: Percutaneous Lumbar Decompression
Device: Sham lumbar decompression

Brief Summary: This is a single-center, randomized, prospective, double-blind, clinical study to assess the clinical application and outcomes with mild® devices versus sham in patients with symptomatic moderate to severe central canal spinal stenosis. Sham patients were eligible to choose to cross-over and have the actual decompression procedure after week 6 exam.

Recruitment & Eligibility

Inclusion Criteria

Symptomatic and lumbar spine stenosis (LSS) primarily caused by dorsal element hypertrophy.
Prior failure of conservative therapy and Oswestry Disability Index (ODI) Score of >20%.
Radiologic evidence of LSS, ligamentum flavum hypertrophy (typically > 2.5mm)confirmed by pre op MRI and/or CT.
Central canal cross sectional area clearly reduced per MRI/CT report.
If present, anterior listhesis ≤ 5.0mm (preferred) and stable.
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 subject.
Adults at least 18 years of age.

Exclusion Criteria

Prior surgery at intended treatment level.
History of recent spinal fractures with concurrent pain symptoms as determined by the Investigator.
Disabling back or leg pain from causes other than LSS (e.g. acute compression fracture, metabolic neuropathy, or vascular claudication symptoms, etc.).
Disk 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 (NSAID) within five days of treatment.
Epidural steroid administration within prior 3 weeks(of procedure or sham)
Inability of the subject 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 outcome.
Dementia and/or inability to give informed consent.
Pregnancy and/or breastfeeding.
On Workman's Compensation or considering litigation associated with back pain.

Arm && Interventions

Group	Intervention	Description
Decompression with mild® Device Kit	Percutaneous Lumbar Decompression	Fluoroscopically guided percutaneous lumbar decompression using the Vertos mild® Device Kit for bone and tissue removal to decompress the targeted stenosed level(s).
Sham lumbar decompression	Sham lumbar decompression	Sham procedure of fluoroscopically guided percutaneous placement of mild® Device Kit instrumentation with no removal of bone or tissue.

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS) <=4	Week 6 to 12 & Year One After Sham to mild x-over	VAS as measured on a 10-point scale. A score of 4 or less after treatment is considered favorable, as it indicates pain is less than the "moderate to severe" categories represented by scores of 5 to 10. All patients in each arm who reported a pain score of 4 or less at Week 6-12 and Year 1 are reported below.
Visual Analog Scale (VAS) Mean Improvement	Baseline and Year 1	VAS ten point scale where 0 = no pain and 10 represents worst pain imaginable. Mean improvement of two or more points is considered clinically relevant. The mean improvement from Baseline to Year-1 is presented below for the two treatment groups.

Secondary Outcome Measures