The Vertos MILD™ Preliminary Patient Evaluation Study

Study Overview
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Brief Summary
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This is a single-center, open label, prospective clinical study to assess the clinical application and functional outcomes of symptomatic patients undergoing the Minimally Invasive Lumbar Decompression (MILD™) treatment for lumbar spinal stenosis. In this study, patient-reported outcomes over a 3 month period following treatment will be collected by the investigator. Periodic surveys for each study subject's pain, functional status, quality of life and physical examination will track outcomes following MILD™ treatment.

Detailed Description
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The Vertos MILD™ devices are used for image-guided Minimally Invasive Lumbar Decompression, referred to as the MILD™ procedure. This percutaneous procedure is performed under fluoroscopic image guidance through a dorsal approach to the spine. Lumbar decompression is performed through the removal of tissue and bone, where indicated. All procedures are conducted in accordance with the product labeling and indications for use. A minimum of ten up to a maximum of twenty-five adult patients will be enrolled and followed for a period of up to 6 months. Patients with symptomatic lumbar spinal stenosis who meet the study enrollment criteria will be offered the MILD™ procedure as an alternative to surgery or continued standard non-surgical medical management.

Official Title
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A Single-center, Prospective, Clinical Study to Assess the Clinical Application and Outcomes of Minimally Invasive Lumbar Decompression With the MILD™ Devices in Patients With Symptomatic Central Foraminal Lumbar Spinal Stenosis.

Conditions
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Lumbar Spinal Stenosis

Intervention / Treatment
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* Device: Minimally Invasive Lumbar Decompression (MILD™)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic lumbar spinal stenosis (LSS) primarily caused by dorsal element hypertrophy. Prior failure of conservative therapy. Radiologic evidence of LSS (L3-L5), Ligamentum flavum > 2.5 mm, confirmed by pre op MRI and/or CT. Central canal cross sectional area < 100mm2. Anterior listhesis < 2 - 3mm. Able to walk at least 10 feet unaided before being limited by pain. Available to complete 12 weeks of follow-up. A signed Informed Consent Form is obtained from the patient. Adults ≥ 18 years of age. Exclusion Criteria: Prior surgery at intended treatment level. History of recent spinal fractures with concurrent pain symptoms. Disabling back or leg pain from causes other than LSS (e.g. acute compression fracture, metabolic neuropathy, or vascular claudication symptoms, etc.). Significant disk protrusion or osteophyte formation. Excessive facet hypertrophy. 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 within prior three weeks. Inability of the patient to lie prone for any reason with anesthesia support (e.g. chronic obstructive pulmonary disease (COPD), obesity, etc.). Any potential wound healing pathologies that may compromise outcomes, including: diabetes, excessive smoking history, cancer, connective tissue diseases, recent spine radiation and severe COPD. Dementia and/or inability to give informed consent. Pregnancy.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Percutaneous Lumbar Decompression procedure<br>mild percutaneous lumbar decompression procedure | Device: Minimally Invasive Lumbar Decompression (MILD™)<br>* The arthroscopic devices in this study are specialized surgical instruments intended to be used to perform percutaneous lumbar decompressive procedures for the treatment of various spinal conditions.<br>* Other names: Vertos Bone Sculpter Rongeur;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Back Pain as Measured by a 10-point Visual Analog Scale (VAS). | Clinical relevance established by change of two points or more on a ten point scale where zero represents no pain and ten represents worst pain imaginable. Mean change from baseline to Month 6 was reported with a positive number representing the baseline value minus the 6 month value. | Baseline and Six Months | 
| Function as Measured Subjectively by the Oswestry Disability Index Patient Questionnaire | Oswestry Disability Index (ODI) is used to measure permanent functional disability through a series of questions which characterize the disturbance of activities of daily living resulting from chronic back pain. The questionnaire is divided into 10 topics including pain intensity , personal care, lifting, walking, sitting, standing, sleeping, social life, traveling and employment/homemaking. Each topic is rated 0 (no pain or no limitation) to 5 (high pain or very limited physically). The worst possible score is 50 (100% disability) and best would be zero (0% disability), thus a higher ODI score indicates greater disability. | Baseline and Month 6 | 
| Quality of Life as Measured by the PCS Subscale of the Short-form 12 Question (SF-12) Survey. | The 12-question SF-12v2 Health Survey is a validated generic measure of health status & outcomes, as opposed to one that targets a specific age, disease, or treatment group. The Physical Component Summary (PCS)takes into account the correlations among the Physical Functioning (PF), Role Physical (RP), Bodily Pain (BP), General Health (GH), and Vitality (VT)SF-12v2 Health Survey scales to show the broad impact on PCS. Norm-based scoring is used so each scale has the same mean (50 points) and the same standard deviation (10 points) as the general US population in 1998. Scores below 50 indicate a decline in health status, with lower scores representing worse health status. Minimally Important Difference (MID) is a measure of true clinical relevance of a difference, with suggested MID for the Physical Component Summary (PCS) being 2 to 3 points. Change from baseline to 6 months is presented, where a positive value represents the 6 month value minus the baseline value. | Baseline and Six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spine Surgery, Spinal Stenosis, Lumbar Spinal Stenosis, Laminotomy, Laminectomy