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

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.

Study Overview

• Status: Completed
• Conditions: Lumbar Spinal Stenosis
• Intervention / Treatment: Drug: Epidural Steroid Injection; Procedure: Percutaneous Lumbar Decompression

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.

• Study Type: Interventional
• Enrollment (Actual): 138
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85050
      • Hope Research Institute
    • Scottsdale, Arizona, United States, 85257
      • Center for Pain and Supportive Care
  • California
    • Aptos, California, United States, 95003
      • Pain Clinic of Monterey Bay
    • Chula Vista, California, United States, 91914
      • Pain Control Associates of San Diego
    • Solana Beach, California, United States, 92075
      • Navarro Pain Control Group, Inc.
    • Walnut Creek, California, United States, 94598
      • IPM Medical Group, Inc.
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • The GW Pain Center
  • Florida
    • Aventura, Florida, United States, 33108
      • Interventional Pain Physicians of South Florida
    • Bradenton, Florida, United States, 34209
      • Coastal Orthopedics and Sports Medicine
    • Fort Lauderdale, Florida, United States, 33334
      • Holy Cross Interventional Spine & Pain Medicine Center
    • Merritt Island, Florida, United States, 32953
      • Space Coast Pain Institute
  • Illinois
    • Bloomington, Illinois, United States, 61701
      • Millennium Pain Center
  • Kentucky
    • Frankfort, Kentucky, United States, 40601
      • Commonwealth Pain Specialists, PLLC
  • Maryland
    • Baltimore, Maryland, United States, 21211
      • The Spine Center Baltimore
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
      • Michigan Pain Specialists
    • Brownstown Twp., Michigan, United States, 48183
      • Michigan Interventional Pain Center
  • Missouri
    • Crystal City, Missouri, United States, 63019
      • Occupational and Pain Management Professionals
  • Nevada
    • Las Vegas, Nevada, United States, 89149
      • Lab2Marche' LLC
  • New Jersey
    • Voorhees, New Jersey, United States, 08043
      • Virtua Pain and Spine Specialists
  • New York
    • Stony Brook, New York, United States, 11794
      • Stony Brook University Medical Center
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • The Center for Clinical Research, LLC
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic Foundation
  • Oregon
    • Eugene, Oregon, United States, 97401
      • NeuroSpine Institute
  • Texas
    • Tyler, Texas, United States, 75701
      • Axis Spine Care
    • Webster, Texas, United States, 77598
      • Space City Pain Specialists, LLP
  • West Virginia
    • Charleston, West Virginia, United States, 25301
      • The Center for Pain Relief, Inc.
    • Huntington, West Virginia, United States, 25702
      • The Center for Pain relief Tri-State

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Percutaneous Lumbar Decompression; Patients receiving percutaneous decompression using the mild® Device Kit.	Procedure: Percutaneous Lumbar Decompression; The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue.; Other Names: mild procedure; mild lumbar decompression
Active Comparator: Lumbar Epidural Steroid Injection; Injection of epidural steroids into the lumbar spine	Drug: Epidural Steroid Injection; Injection of epidural steroids into the lumbar spine; Other Names: ESI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With a 2-point Improvement in Visual Analogue Scale	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.	16 weeks

Collaborators and Investigators

• Sponsor: Vertos Medical, Inc.
• Investigators: Principal Investigator: Nagy Mekhail, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: March 11, 2011
• First Submitted That Met QC Criteria: March 11, 2011
• First Posted (Estimate): March 15, 2011

Study Record Updates

• Last Update Posted (Estimate): August 31, 2015
• Last Update Submitted That Met QC Criteria: August 19, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Stenosis
• Other Study ID Numbers: MiDAS III