MiDAS I (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, clinical study to assess the clinical application and outcomes of MILD® Interlaminar Decompression in patients with symptomatic lumbar spinal stenosis.

Key facts

Study ID

NCT00956631

Run by

Vertos Medical, Inc.

People needed

78

Starts

2008-07-01

Expected to finish

2012-04-01

Last updated by the study team

2013-04-04

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.
• 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.

You may not qualify if…

• 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.

Where it is running

• NEA Clinic — Jonesboro, Arkansas, United States
• UCLA — Los Angeles, California, United States
• Napa Pain Institute — Napa, California, United States
• Scripps, Division of Orthopedic Surgery — San Diego, California, United States
• UCSD — San Diego, California, United States
• Your Pain Care — Temecula, California, United States
• Coastal Orthopedics & Sports Medicine — Bradenton, Florida, United States
• South Florida Spine Institute — Miami Beach, Florida, United States
• The Spine Center — Baltimore, Maryland, United States
• Rainer Vogel, MD LTD — Henderson, Nevada, United States
• Lab2Marche, LLC — Las Vegas, Nevada, United States
• MedCentral Health System — Mansfield, Ohio, United States
• Orthopedic Associates of the Greater Lehigh Valley — Easton, Pennsylvania, United States

Full record on ClinicalTrials.gov

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