MiDAS III (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, observational clinical study to compare patient outcomes following treatment with either the mild® procedure or epidural steroid injection in patients with moderate to severe lumbar spinal stenosis exhibiting neurogenic claudication.

Detailed Description
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The study was initially designed as a randomized trial. Due to difficulty of enrollment, the study was amended and converted to an observational comparative study with study arm being self-selected by the patient.

Official Title
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MiDAS III (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: Percutaneous Lumbar Decompression
* Drug: Epidural Steroid Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Lumbar spinal stenosis (LSS) with neurogenic claudication where the Visual Analog Scale (VAS) of back and leg pain average is ≥ 5. Prior failure of conservative therapy. Oswestry Disability Index (ODI) score of ≥ 31%. Radiologic evidence of LSS, with unilateral or bilateral ligamentum flavum ≥ 4.1mm confirmed by pre-op MRI performed within 6-12 months of baseline visit. Able to walk ≥ 10 feet before being limited by pain. Available to complete 24-months of follow-up. Adults ≥ 50 years of age. Exclusion Criteria: Prior surgery at intended treatment level. History of spinal fractures with current related pain symptoms. Motor deficit or disabling back and/or leg pain from causes other than LSS neurogenic claudication (e.g. acute compression fracture, metabolic neuropathy, vascular claudication symptoms, etc.). Significant/symptomatic disc protrusion or osteophyte formation judged by the Investigator as possible confounding factor to study results. Excessive facet hypertrophy judged by the Investigator as possible confounding factor to study results. Significant symptomatic foraminal stenosis. Confirmed anterior or retro-listhesis ≥ 3mm. Bleeding disorders and/or current use of anti-coagulants with the inability to withhold anticoagulants for required time prior to procedure. Able to walk ≥ 200 yards unaided in erect non-flexed position before being limited by pain. Able to stand ≥ 15 minutes in erect, non-flexed position before being limited by pain. Use of acetylsalicylic acid (ASA) and/or non-steroidal anti-inflammatory drug (NSAID) within 7 days of treatment. Pregnant and/or breastfeeding. Body mass index (BMI) ≥ 32 as calculated using the patient's weight multiplied by 703 then divided by height in inches squared. Epidural steroid, systemic steroid or any spine interventional procedure within prior six weeks of study procedure. Dementia and/or inability to give informed consent and to understand and complete follow-up patient reported outcomes forms. Inability of the patient to lie prone for any reason with anesthesia support (e.g. chronic obstructive pulmonary disease (COPD), obesity, etc.). On (or pending) Workman's Compensation or known to be considering litigation associated with back pain. Unable to tolerate MRI (pacemaker, spinal cord stimulator, etc.). Intrathecal pump. Any medical condition determined by the Investigator that would not allow subject to fulfill trial requirements or safely tolerate procedures in this study.

Ages Eligible for Study
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Minimum Age: 50 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Percutaneous Lumbar Decompression<br>Patients receiving percutaneous decompression using the mild® Device Kit. | Procedure: Percutaneous Lumbar Decompression<br>* The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue.<br>* Other names: mild lumbar decompression;|
| Active Comparator: Lumbar Epidural Steroid Injection<br>Injection of epidural steroids into the lumbar spine | Drug: Epidural Steroid Injection<br>* Injection of epidural steroids into the lumbar spine<br>* Other names: ESI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With a 2-point Improvement in Visual Analogue Scale | The primary endpoint for evaluating effectiveness will be the proportion of subjects in each group achieving at least a 2-point improvement from baseline in the Visual Analog Scale. | 16 weeks |