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

Completed · Phase 4

Conditions studied: Lumbar Spinal Stenosis

In brief

This is a multi-center, prospective, patient outcomes assessment of Minimally Invasive Lumbar Decompression with the Mild® devices in patients with symptomatic central canal spinal stenosis.

Key facts

Study ID

NCT01082159

Run by

Vertos Medical, Inc.

People needed

55

Starts

2010-02-01

Expected to finish

2013-01-01

Last updated by the study team

2013-04-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Prior surgery at intended treatment level.
• Compound fracture with interspinal retropulsion contributing to spinal stenosis.
• Disabling back or leg pain from causes other than LSS (e.g. acute compression fracture, metabolic neuropathy, or vascular claudication symptoms, etc.).
• Disc 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 drug (NSAID) within 5 days of treatment.
• Epidural steroid administration within prior three weeks (of procedure).
• Inability of the patient 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 outcomes.
• Dementia and/or inability to give informed consent.
• Pregnant and/or breastfeeding.
• On Workman's Compensation or considering litigation associated with back pain.

Where it is running

• Space Coast Pain Institute — Merritt Island, Florida, United States
• The Spine Center — Baltimore, Maryland, United States
• Occupational and Pain Management Professionals — Festus, Missouri, United States
• Lab2Marche, LLC — Las Vegas, Nevada, United States
• The Cleveland Clinic Foundation — Cleveland, Ohio, United States
• MedCentral Health System — Mansfield, Ohio, United States
• Kenneth Alo, MD, PA-TX — Houston, Texas, United States
• The Center for Pain Relief Tri-State, PLLC — Huntington, West Virginia, United States

Full record on ClinicalTrials.gov

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