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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01315145
Other study ID # MiDAS III
Secondary ID
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


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
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