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

Study Overview
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Brief Summary
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This is a multi-center, prospective, clinical study to assess the clinical application and outcomes of MILD® Interlaminar Decompression in patients with symptomatic lumbar spinal stenosis.

Official Title
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MiDAS I (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study

Conditions
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Lumbar Spinal Stenosis

Intervention / Treatment
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* Procedure: Interlaminar Decompression


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 > 2.5mm, confirmed by pre-op MRI and/or CT. Central canal cross sectional area ≤ 100 square mm. Anterior listhesis ≤ 5.0mm. Able to walk at least 10 feet unaided before being limited by pain. Available to complete 12 weeks of follow-up. Consistent with the intended labeling statement for use. Able to use all package components to perform the procedure. A signed Informed Consent Form is obtained from the patient. 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 / symptomatic disk protrusion or osteophyte formation. Excessive / symptomatic 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. Intended treatment that is defined by the product labeling contraindications. 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: interlaminar decompression<br>Commercially available product (mild® Device Kit) used to perform interlaminar decompression | Procedure: Interlaminar Decompression<br>* The MILD® devices used in this study are specialized surgical instruments intended to be used to perform percutaneous lumbar decompression.<br>* Other names: percutaneous decompression;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Back Pain as Measured by a 10-point Visual Analog Scale (VAS). | The 10-point Visual Analog Scale rates 'no pain' as zero and 'worst pain imaginable' as ten. Visual analog scores of mean improvement greater than or equal to 2.0 are clinically relevant. The change from baseline to six months is reported below, where a positive value represents the baseline value minus the 6 month value. | Baseline and Six Months | 

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