MiDAS I (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study
- Conditions
- Lumbar Spinal Stenosis
- Interventions
- Procedure: Interlaminar Decompression
- Registration Number
- NCT00956631
- Lead Sponsor
- Vertos Medical, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 78
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description interlaminar decompression Interlaminar Decompression Commercially available product (mild® Device Kit) used to perform interlaminar decompression
- Primary Outcome Measures
Name Time Method Mean Change in Back Pain as Measured by a 10-point Visual Analog Scale (VAS). Baseline and Six Months 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (13)
NEA Clinic
🇺🇸Jonesboro, Arkansas, United States
Lab2Marche, LLC
🇺🇸Las Vegas, Nevada, United States
UCLA
🇺🇸Los Angeles, California, United States
Scripps, Division of Orthopedic Surgery
🇺🇸San Diego, California, United States
Your Pain Care
🇺🇸Temecula, California, United States
Napa Pain Institute
🇺🇸Napa, California, United States
Coastal Orthopedics & Sports Medicine
🇺🇸Bradenton, Florida, United States
UCSD
🇺🇸San Diego, California, United States
South Florida Spine Institute
🇺🇸Miami Beach, Florida, United States
Rainer Vogel, MD LTD
🇺🇸Henderson, Nevada, United States
The Spine Center
🇺🇸Baltimore, Maryland, United States
MedCentral Health System
🇺🇸Mansfield, Ohio, United States
Orthopedic Associates of the Greater Lehigh Valley
🇺🇸Easton, Pennsylvania, United States