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

Study Overview
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Brief Summary
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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.

Official Title
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Comparative Study of Sham Versus Mild® (Minimally Invasive Lumbar Decompression) Procedure in Patients Diagnosed With Symptomatic Moderate to Severe Lumbar Central Canal Stenosis

Conditions
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Lumbar Spine Stenosis Central Canal

Intervention / Treatment
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* Device: Percutaneous Lumbar Decompression
* Device: Sham lumbar decompression


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Decompression with mild® Device Kit<br>Fluoroscopically guided percutaneous lumbar decompression using the Vertos mild® Device Kit for bone and tissue removal to decompress the targeted stenosed level(s). | Device: Percutaneous Lumbar Decompression<br>* Fluoroscopic percutaneous lumbar decompression of the central spinal canal<br>* Other names: mild® Device Kit percutaneous decompression;|
| Sham Comparator: Sham lumbar decompression<br>Sham procedure of fluoroscopically guided percutaneous placement of mild® Device Kit instrumentation with no removal of bone or tissue. | Device: Sham lumbar decompression<br>* Sham fluoroscopic percutaneous lumbar decompression with no bone or tissue removal.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (VAS) <=4 | Using VAS, pain is measured on a 0 to 10 point scale where 0 represents no pain and 10 indicates severe pain. A post-treatment score of 4 points is the accepted threshold between a mild pain score of 1-3 points and a moderate to severe pain score of 5 to 10 points which represents debilitating pain that would qualify the patient for a different or additional treatment option. All patients in each arm who reported a pain score of 4 or less at six to twelve weeks post-treatment are reported below. | Week 6 to 12 prior to cross-over | 
| Visual Analog Scale (VAS) <=4 | 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. | Week 6 to 12 & Year One After Sham to mild x-over | 
| Visual Analog Scale (VAS) Mean Improvement | 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. | Baseline and Year 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lumbar Spine Stenosis, Decompression