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

Lumbar Spinal Stenosis Clinical Trial

— MiDAS III  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01315145
• Other study ID #: MiDAS III
• Status: Completed
• Phase: N/A
• First received: March 11, 2011
• Last updated: August 19, 2015
• Start date: March 2011
• Est. completion date: May 2014

Study information

• Verified date: August 2015
• Source: Vertos Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lumbar Spinal Stenosis
• Spinal Stenosis

Intervention

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.

Drug:
• Epidural Steroid Injection
Injection of epidural steroids into the lumbar spine

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Vertos Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No