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

NCT01315145 | Completed Results DMC

• 1 other identifier: MiDAS III
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 27

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.

Conditions

Lumbar Spinal Stenosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Percutaneous Lumbar Decompression

ACTIVE COMPARATOR

Patients receiving percutaneous decompression using the mild® Device Kit.

Procedure: Percutaneous Lumbar Decompression

Lumbar Epidural Steroid Injection

ACTIVE COMPARATOR

Injection of epidural steroids into the lumbar spine

Drug: Epidural Steroid Injection

Interventions

Percutaneous Lumbar Decompression 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.

Also known as: mild procedure, mild lumbar decompression

Percutaneous Lumbar Decompression

Epidural Steroid Injection DRUG

Injection of epidural steroids into the lumbar spine

Also known as: ESI

Lumbar Epidural Steroid Injection

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vertos Medical, Inc.: lead

Study Sites (27)

HOPE Research Institute

Phoenix, Arizona, 85050, United States

Location

Center for Pain and Supportive Care

Scottsdale, Arizona, 85257, United States

Location

Pain Clinic of Monterey Bay

Aptos, California, 95003, United States

Location

Pain Control Associates of San Diego

Chula Vista, California, 91914, United States

Location

Navarro Pain Control Group, Inc.

Solana Beach, California, 92075, United States

Location

IPM Medical Group, Inc.

Walnut Creek, California, 94598, United States

Location

The GW Pain Center

Washington D.C., District of Columbia, 20037, United States

Location

Interventional Pain Physicians of South Florida

Aventura, Florida, 33108, United States

Location

Coastal Orthopedics and Sports Medicine

Bradenton, Florida, 34209, United States

Location

Holy Cross Interventional Spine & Pain Medicine Center

Fort Lauderdale, Florida, 33334, United States

Location

Space Coast Pain Institute

Merritt Island, Florida, 32953, United States

Location

Millennium Pain Center

Bloomington, Illinois, 61701, United States

Location

Commonwealth Pain Specialists, PLLC

Frankfort, Kentucky, 40601, United States

Location

The Spine Center Baltimore

Baltimore, Maryland, 21211, United States

Location

Michigan Pain Specialists

Ann Arbor, Michigan, 48105, United States

Location

Michigan Interventional Pain Center

Brownstown Twp., Michigan, 48183, United States

Location

Occupational and Pain Management Professionals

Crystal City, Missouri, 63019, United States

Location

Lab2Marche' LLC

Las Vegas, Nevada, 89149, United States

Location

Virtua Pain and Spine Specialists

Voorhees Township, New Jersey, 08043, United States

Location

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

Location

The Center for Clinical Research, LLC

Winston-Salem, North Carolina, 27103, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Neurospine Institute

Eugene, Oregon, 97401, United States

Location

Axis Spine Care

Tyler, Texas, 75701, United States

Location

Space City Pain Specialists, LLP

Webster, Texas, 77598, United States

Location

The Center for Pain Relief, Inc.

Charleston, West Virginia, 25301, United States

Location

The Center for Pain relief Tri-State

Huntington, West Virginia, 25702, United States

Location

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Results Point of Contact

• Title: VP of Clinical Affairs
• Organization: Vertos Medical

kdavis@vertosmed.com

9493490008

Study Officials

• Nagy Mekhail, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2011
• First Posted: March 15, 2011
• Study Start: March 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: August 31, 2015
• Results First Posted: August 19, 2015

Record last verified: 2015-08

Locations

US (27)