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

Not Applicable

Completed

Conditions: Lumbar Spinal Stenosis

Interventions: Drug: Epidural Steroid Injection
Procedure: Percutaneous Lumbar Decompression

Registration Number: NCT01315145

Lead Sponsor: Vertos Medical, Inc.

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 138

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lumbar Epidural Steroid Injection	Epidural Steroid Injection	Injection of epidural steroids into the lumbar spine
Percutaneous Lumbar Decompression	Percutaneous Lumbar Decompression	Patients receiving percutaneous decompression using the mild® Device Kit.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With a 2-point Improvement in Visual Analogue Scale	16 weeks	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.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (27): Stony Brook University Medical Center
🇺🇸
Stony Brook, New York, United States
The Center for Clinical Research, LLC
🇺🇸
Winston-Salem, North Carolina, United States
Neurospine Institute
🇺🇸
Eugene, Oregon, United States
Lab2Marche' LLC
🇺🇸
Las Vegas, Nevada, United States
Virtua Pain and Spine Specialists
🇺🇸
Voorhees, New Jersey, United States
The Center for Pain relief Tri-State
🇺🇸
Huntington, West Virginia, United States
Center for Pain and Supportive Care
🇺🇸
Scottsdale, Arizona, United States
HOPE Research Institute
🇺🇸
Phoenix, Arizona, United States
IPM Medical Group, Inc.
🇺🇸
Walnut Creek, California, United States
Pain Control Associates of San Diego
🇺🇸
Chula Vista, California, United States
Pain Clinic of Monterey Bay
🇺🇸
Aptos, California, United States
Navarro Pain Control Group, Inc.
🇺🇸
Solana Beach, California, United States
The GW Pain Center
🇺🇸
Washington, District of Columbia, United States
Coastal Orthopedics and Sports Medicine
🇺🇸
Bradenton, Florida, United States
Interventional Pain Physicians of South Florida
🇺🇸
Aventura, 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
Holy Cross Interventional Spine & Pain Medicine Center
🇺🇸
Fort Lauderdale, Florida, United States
The Spine Center Baltimore
🇺🇸
Baltimore, Maryland, United States
Michigan Interventional Pain Center
🇺🇸
Brownstown Twp., Michigan, United States
Michigan Pain Specialists
🇺🇸
Ann Arbor, Michigan, United States
Occupational and Pain Management Professionals
🇺🇸
Crystal City, Missouri, United States
The Cleveland Clinic Foundation
🇺🇸
Cleveland, Ohio, United States
Axis Spine Care
🇺🇸
Tyler, Texas, United States
Space City Pain Specialists, LLP
🇺🇸
Webster, Texas, United States
The Center for Pain Relief, Inc.
🇺🇸
Charleston, West Virginia, United States