Clinical trial NCT01315145: MiDAS III (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study
Official title: MiDAS III (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Spinal Stenosis
Lead sponsor: Vertos Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2011-03-15
Enrollment: 138
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With a 2-point Improvement in Visual Analogue Scale
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: HOPE Research Institute
state: Arizona
city: Scottsdale
country: United States
facility: Center for Pain and Supportive Care
state: Arizona
city: Aptos
country: United States
facility: Pain Clinic of Monterey Bay
state: California
city: Chula Vista
country: United States
facility: Pain Control Associates of San Diego
state: California
city: Solana Beach
country: United States
facility: Navarro Pain Control Group, Inc.
state: California
city: Walnut Creek
country: United States
facility: IPM Medical Group, Inc.
state: California
city: Washington
country: United States
facility: The GW Pain Center
state: District of Columbia
city: Aventura
country: United States
facility: Interventional Pain Physicians of South Florida
state: Florida
city: Bradenton
country: United States
facility: Coastal Orthopedics and Sports Medicine
state: Florida
city: Fort Lauderdale
country: United States
facility: Holy Cross Interventional Spine & Pain Medicine Center
state: Florida
city: Merritt Island
country: United States
facility: Space Coast Pain Institute
state: Florida
city: Bloomington
country: United States
facility: Millennium Pain Center
state: Illinois
city: Frankfort
country: United States
facility: Commonwealth Pain Specialists, PLLC
state: Kentucky
city: Baltimore
country: United States
facility: The Spine Center Baltimore
state: Maryland
city: Ann Arbor
country: United States
facility: Michigan Pain Specialists
state: Michigan
city: Brownstown Twp.
country: United States
facility: Michigan Interventional Pain Center
state: Michigan
city: Crystal City
country: United States
facility: Occupational and Pain Management Professionals
state: Missouri
city: Las Vegas
country: United States
facility: Lab2Marche' LLC
state: Nevada
city: Voorhees
country: United States
facility: Virtua Pain and Spine Specialists
state: New Jersey
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Winston-Salem
country: United States
facility: The Center for Clinical Research, LLC
state: North Carolina
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Eugene
country: United States
facility: Neurospine Institute
state: Oregon
city: Tyler
country: United States
facility: Axis Spine Care
state: Texas
city: Webster
country: United States
facility: Space City Pain Specialists, LLP
state: Texas
city: Charleston
country: United States
facility: The Center for Pain Relief, Inc.
state: West Virginia
city: Huntington
country: United States
facility: The Center for Pain relief Tri-State
state: West Virginia
Study officials:
affiliation: The Cleveland Clinic
name: Nagy Mekhail, MD
role: PRINCIPAL_INVESTIGATOR
References: