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

Primary Purpose

Lumbar Spinal Stenosis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Interlaminar Decompression
Sponsored by
Vertos Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Spinal Stenosis focused on measuring Spinal Stenosis, Lumbar Spinal Stenosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Symptomatic Lumbar Spinal Stenosis (LSS) primarily caused by dorsal element hypertrophy.
  • Prior failure of conservative therapy.
  • Radiologic evidence of LSS (L3-L5), Ligamentum flavum > 2.5mm, confirmed by pre-op MRI and/or CT.
  • Central canal cross sectional area ≤ 100 square mm.
  • Anterior listhesis ≤ 5.0mm.
  • Able to walk at least 10 feet unaided before being limited by pain.
  • Available to complete 12 weeks of follow-up.
  • Consistent with the intended labeling statement for use.
  • Able to use all package components to perform the procedure.
  • A signed Informed Consent Form is obtained from the patient.

Exclusion Criteria:

  • Prior surgery at intended treatment level.
  • History of recent spinal fractures with concurrent pain symptoms.
  • Disabling back or leg pain from causes other than LSS (e.g. acute compression fracture, metabolic neuropathy, or vascular claudication symptoms, etc.).
  • Significant / symptomatic disk protrusion or osteophyte formation.
  • Excessive / symptomatic facet hypertrophy.
  • Bleeding disorders and/or current use of anti-coagulants.
  • Use of acetylsalicylic acid (ASA) and/or non-steroidal anti-inflammatory drug (NSAID) within 5 days of treatment.
  • Epidural steroids within prior three weeks.
  • Inability of the patient to lie prone for any reason with anesthesia support (e.g. chronic obstructive pulmonary disease (COPD), obesity, etc.).
  • Any potential wound healing pathologies that may compromise outcomes, including diabetes, excessive smoking history, cancer, connective tissue diseases, recent spine radiation and severe COPD.
  • Dementia and/or inability to give informed consent.
  • Pregnancy.
  • Intended treatment that is defined by the product labeling contraindications.
  • On Workman's Compensation or considering litigation associated with back pain.

Sites / Locations

  • NEA Clinic
  • UCLA
  • Napa Pain Institute
  • Scripps, Division of Orthopedic Surgery
  • UCSD
  • Your Pain Care
  • Coastal Orthopedics & Sports Medicine
  • South Florida Spine Institute
  • The Spine Center
  • Rainer Vogel, MD LTD
  • Lab2Marche, LLC
  • MedCentral Health System
  • Orthopedic Associates of the Greater Lehigh Valley

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

interlaminar decompression

Arm Description

Commercially available product (mild® Device Kit) used to perform interlaminar decompression

Outcomes

Primary Outcome Measures

Mean Change in Back Pain as Measured by a 10-point Visual Analog Scale (VAS).
The 10-point Visual Analog Scale rates 'no pain' as zero and 'worst pain imaginable' as ten. Visual analog scores of mean improvement greater than or equal to 2.0 are clinically relevant. The change from baseline to six months is reported below, where a positive value represents the baseline value minus the 6 month value.

Secondary Outcome Measures

Full Information

First Posted
August 7, 2009
Last Updated
February 21, 2013
Sponsor
Vertos Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00956631
Brief Title
MiDAS I (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study
Acronym
MiDAS I
Official Title
MiDAS I (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (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, clinical study to assess the clinical application and outcomes of MILD® Interlaminar Decompression in patients with symptomatic lumbar spinal stenosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spinal Stenosis
Keywords
Spinal Stenosis, Lumbar Spinal Stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
interlaminar decompression
Arm Type
Other
Arm Description
Commercially available product (mild® Device Kit) used to perform interlaminar decompression
Intervention Type
Procedure
Intervention Name(s)
Interlaminar Decompression
Other Intervention Name(s)
mild® Device Kit, percutaneous decompression
Intervention Description
The MILD® devices used in this study are specialized surgical instruments intended to be used to perform percutaneous lumbar decompression.
Primary Outcome Measure Information:
Title
Mean Change in Back Pain as Measured by a 10-point Visual Analog Scale (VAS).
Description
The 10-point Visual Analog Scale rates 'no pain' as zero and 'worst pain imaginable' as ten. Visual analog scores of mean improvement greater than or equal to 2.0 are clinically relevant. The change from baseline to six months is reported below, where a positive value represents the baseline value minus the 6 month value.
Time Frame
Baseline and Six Months
Other Pre-specified Outcome Measures:
Title
Function Measure Oswestry Disability Index (ODI). Measures Permanent Functional Disability Through Questions Which Characterize Disturbance of Activities of Daily Living (ADL) Resulting From Chronic Back Pain. Higher Scores Indicate Greater Disability.
Description
Change from baseline to month six is reported below, where a positive value represents baseline value minus 6 month value. The questionnaire is divided into 10 topics including pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, traveling and employment/homemaking. Each topic is rated 0 (no pain or no limitation)to 5 (high pain or very limited physically) based on typical pain and/or physical limitations. The worst possible score is 50 (100 % disability) and best would be zero (0% disability).
Time Frame
Baseline and Six months
Title
Quality of Life Physical Component Score (PCS) as Measured by the 12-question Short Form Survey Version 2 (SF-12v2). Change From Baseline Mean to Six Month Mean is Reported Below. A Positive Value Represents the 6 Month Value Minus the Baseline Value.
Description
Minimally Important Difference (MID) is a measure of true clinical relevance of a difference. The MID for mean Physical Component Score (PCS) improvement is 2 to 3 points. SF-12v2 is a validated tool that uses norm-based scoring to determine treatment outcomes & is a generic measure, as opposed to one that targets a specific age, disease, or treatment group. The SF-12v2 asks for patient views about their health to determine how they feel & how well they are able to conduct their usual activities. The data for the 2 summary scales and 8 survey scales are normalized so each scale has the same mean (50 points) & the same standard deviation (10 points) in the general 1998 U.S. population. By using this method, anytime a scale is below 50, health status is below average, & each point is one-tenth of a standard deviation. The PCS summary measure takes into account the correlations among the Health Survey scales, & shows the broad impact which was of interest in this study.
Time Frame
Baseline and Six Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Symptomatic Lumbar Spinal Stenosis (LSS) primarily caused by dorsal element hypertrophy. Prior failure of conservative therapy. Radiologic evidence of LSS (L3-L5), Ligamentum flavum > 2.5mm, confirmed by pre-op MRI and/or CT. Central canal cross sectional area ≤ 100 square mm. Anterior listhesis ≤ 5.0mm. Able to walk at least 10 feet unaided before being limited by pain. Available to complete 12 weeks of follow-up. Consistent with the intended labeling statement for use. Able to use all package components to perform the procedure. A signed Informed Consent Form is obtained from the patient. Exclusion Criteria: Prior surgery at intended treatment level. History of recent spinal fractures with concurrent pain symptoms. Disabling back or leg pain from causes other than LSS (e.g. acute compression fracture, metabolic neuropathy, or vascular claudication symptoms, etc.). Significant / symptomatic disk protrusion or osteophyte formation. Excessive / symptomatic facet hypertrophy. Bleeding disorders and/or current use of anti-coagulants. Use of acetylsalicylic acid (ASA) and/or non-steroidal anti-inflammatory drug (NSAID) within 5 days of treatment. Epidural steroids within prior three weeks. Inability of the patient to lie prone for any reason with anesthesia support (e.g. chronic obstructive pulmonary disease (COPD), obesity, etc.). Any potential wound healing pathologies that may compromise outcomes, including diabetes, excessive smoking history, cancer, connective tissue diseases, recent spine radiation and severe COPD. Dementia and/or inability to give informed consent. Pregnancy. Intended treatment that is defined by the product labeling contraindications. On Workman's Compensation or considering litigation associated with back pain.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Caraway, MD
Organizational Affiliation
The Center for Pain Relief Tri-State, PLLC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bohdan W Chopko, MD
Organizational Affiliation
MedCentral Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
NEA Clinic
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Napa Pain Institute
City
Napa
State/Province
California
ZIP/Postal Code
94558
Country
United States
Facility Name
Scripps, Division of Orthopedic Surgery
City
San Diego
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
UCSD
City
San Diego
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Your Pain Care
City
Temecula
State/Province
California
ZIP/Postal Code
92591
Country
United States
Facility Name
Coastal Orthopedics & Sports Medicine
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209
Country
United States
Facility Name
South Florida Spine Institute
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
The Spine Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21211
Country
United States
Facility Name
Rainer Vogel, MD LTD
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89074
Country
United States
Facility Name
Lab2Marche, LLC
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89149
Country
United States
Facility Name
MedCentral Health System
City
Mansfield
State/Province
Ohio
ZIP/Postal Code
44903
Country
United States
Facility Name
Orthopedic Associates of the Greater Lehigh Valley
City
Easton
State/Province
Pennsylvania
ZIP/Postal Code
18045
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20648206
Citation
Chopko B, Caraway DL. MiDAS I (mild Decompression Alternative to Open Surgery): a preliminary report of a prospective, multi-center clinical study. Pain Physician. 2010 Jul-Aug;13(4):369-78. Erratum In: Pain Physician. 2012 Jul-Aug;15(4):349.
Results Reference
derived

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

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