MiDAS III (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study (MiDAS III)
Primary Purpose
Lumbar Spinal Stenosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Percutaneous Lumbar Decompression
Epidural Steroid Injection
Sponsored by
About this trial
This is an interventional treatment trial for Lumbar Spinal Stenosis
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.
Sites / Locations
- HOPE Research Institute
- Center for Pain and Supportive Care
- Pain Clinic of Monterey Bay
- Pain Control Associates of San Diego
- Navarro Pain Control Group, Inc.
- IPM Medical Group, Inc.
- The GW Pain Center
- Interventional Pain Physicians of South Florida
- Coastal Orthopedics and Sports Medicine
- Holy Cross Interventional Spine & Pain Medicine Center
- Space Coast Pain Institute
- Millennium Pain Center
- Commonwealth Pain Specialists, PLLC
- The Spine Center Baltimore
- Michigan Pain Specialists
- Michigan Interventional Pain Center
- Occupational and Pain Management Professionals
- Lab2Marche' LLC
- Virtua Pain and Spine Specialists
- Stony Brook University Medical Center
- The Center for Clinical Research, LLC
- The Cleveland Clinic Foundation
- Neurospine Institute
- Axis Spine Care
- Space City Pain Specialists, LLP
- The Center for Pain Relief, Inc.
- The Center for Pain relief Tri-State
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Percutaneous Lumbar Decompression
Lumbar Epidural Steroid Injection
Arm Description
Patients receiving percutaneous decompression using the mild® Device Kit.
Injection of epidural steroids into the lumbar spine
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01315145
Brief Title
MiDAS III (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study
Acronym
MiDAS III
Official Title
MiDAS III (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vertos Medical, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spinal Stenosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
138 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Percutaneous Lumbar Decompression
Arm Type
Active Comparator
Arm Description
Patients receiving percutaneous decompression using the mild® Device Kit.
Arm Title
Lumbar Epidural Steroid Injection
Arm Type
Active Comparator
Arm Description
Injection of epidural steroids into the lumbar spine
Intervention Type
Procedure
Intervention Name(s)
Percutaneous Lumbar Decompression
Other Intervention Name(s)
mild procedure, mild lumbar decompression
Intervention Description
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
Drug
Intervention Name(s)
Epidural Steroid Injection
Other Intervention Name(s)
ESI
Intervention Description
Injection of epidural steroids into the lumbar spine
Primary Outcome Measure Information:
Title
Percentage of Participants With a 2-point Improvement in Visual Analogue Scale
Description
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.
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nagy Mekhail, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
HOPE Research Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
Facility Name
Center for Pain and Supportive Care
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85257
Country
United States
Facility Name
Pain Clinic of Monterey Bay
City
Aptos
State/Province
California
ZIP/Postal Code
95003
Country
United States
Facility Name
Pain Control Associates of San Diego
City
Chula Vista
State/Province
California
ZIP/Postal Code
91914
Country
United States
Facility Name
Navarro Pain Control Group, Inc.
City
Solana Beach
State/Province
California
ZIP/Postal Code
92075
Country
United States
Facility Name
IPM Medical Group, Inc.
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
The GW Pain Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Interventional Pain Physicians of South Florida
City
Aventura
State/Province
Florida
ZIP/Postal Code
33108
Country
United States
Facility Name
Coastal Orthopedics and Sports Medicine
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209
Country
United States
Facility Name
Holy Cross Interventional Spine & Pain Medicine Center
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
Facility Name
Space Coast Pain Institute
City
Merritt Island
State/Province
Florida
ZIP/Postal Code
32953
Country
United States
Facility Name
Millennium Pain Center
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61701
Country
United States
Facility Name
Commonwealth Pain Specialists, PLLC
City
Frankfort
State/Province
Kentucky
ZIP/Postal Code
40601
Country
United States
Facility Name
The Spine Center Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21211
Country
United States
Facility Name
Michigan Pain Specialists
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
Michigan Interventional Pain Center
City
Brownstown Twp.
State/Province
Michigan
ZIP/Postal Code
48183
Country
United States
Facility Name
Occupational and Pain Management Professionals
City
Crystal City
State/Province
Missouri
ZIP/Postal Code
63019
Country
United States
Facility Name
Lab2Marche' LLC
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89149
Country
United States
Facility Name
Virtua Pain and Spine Specialists
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
The Center for Clinical Research, LLC
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Neurospine Institute
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Axis Spine Care
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Space City Pain Specialists, LLP
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
The Center for Pain Relief, Inc.
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25301
Country
United States
Facility Name
The Center for Pain relief Tri-State
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25702
Country
United States
12. IPD Sharing Statement
Learn more about this trial
MiDAS III (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study
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