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

NCT ID: NCT01315145

Last Updated: 2015-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2014-05-31

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.

Conditions

Lumbar Spinal Stenosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Percutaneous Lumbar Decompression

Patients receiving percutaneous decompression using the mild® Device Kit.

Group Type: ACTIVE_COMPARATOR

Percutaneous Lumbar Decompression

Intervention Type: PROCEDURE

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.

Lumbar Epidural Steroid Injection

Injection of epidural steroids into the lumbar spine

Group Type: ACTIVE_COMPARATOR

Epidural Steroid Injection

Intervention Type: DRUG

Injection of epidural steroids into the lumbar spine

Interventions

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.

Intervention Type: PROCEDURE

Epidural Steroid Injection

Injection of epidural steroids into the lumbar spine

Intervention Type: DRUG

Other Intervention Names

mild procedure; mild lumbar decompression; ESI

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vertos Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nagy Mekhail, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

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

The Center for Pain Relief, Inc.

Charleston, West Virginia, United States

The Center for Pain relief Tri-State

Huntington, West Virginia, United States

Countries

United States

Other Identifiers

MiDAS III

Identifier Type: -

Identifier Source: org_study_id