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

Completed · Not applicable

Conditions studied: Lumbar Spinal Stenosis

In brief

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.

Key facts

Study ID

NCT01315145

Run by

Vertos Medical, Inc.

People needed

138

Starts

2011-03-01

Expected to finish

2014-05-01

Last updated by the study team

2015-08-31

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• HOPE Research Institute — Phoenix, Arizona, United States
• Center for Pain and Supportive Care — Scottsdale, Arizona, United States
• Pain Clinic of Monterey Bay — Aptos, California, United States
• Pain Control Associates of San Diego — Chula Vista, California, United States
• Navarro Pain Control Group, Inc. — Solana Beach, California, United States
• IPM Medical Group, Inc. — Walnut Creek, California, United States
• The GW Pain Center — Washington D.C., District of Columbia, United States
• Interventional Pain Physicians of South Florida — Aventura, Florida, United States
• Coastal Orthopedics and Sports Medicine — Bradenton, Florida, United States
• Holy Cross Interventional Spine & Pain Medicine Center — Fort Lauderdale, Florida, United States
• Space Coast Pain Institute — Merritt Island, Florida, United States
• Millennium Pain Center — Bloomington, Illinois, United States
• Commonwealth Pain Specialists, PLLC — Frankfort, Kentucky, United States
• The Spine Center Baltimore — Baltimore, Maryland, United States
• Michigan Pain Specialists — Ann Arbor, Michigan, United States
• Michigan Interventional Pain Center — Brownstown Twp., Michigan, United States
• Occupational and Pain Management Professionals — Crystal City, Missouri, United States
• Lab2Marche' LLC — Las Vegas, Nevada, United States
• Virtua Pain and Spine Specialists — Voorhees Township, New Jersey, United States
• Stony Brook University Medical Center — Stony Brook, New York, United States
• The Center for Clinical Research, LLC — Winston-Salem, North Carolina, United States
• The Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Neurospine Institute — Eugene, Oregon, United States
• Axis Spine Care — Tyler, Texas, United States
• Space City Pain Specialists, LLP — Webster, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.