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

Primary Purpose

Lumbar Spinal Stenosis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
lumbar 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 and Oswestry Disability Index (ODI) score > 20%.
  • Radiologic evidence of lumbar spinal stenosis (LSS), ligamentum flavum hypertrophy (typically > 2.5 mm), confirmed by pre-op MRI and/or CT.
  • Central canal cross sectional area clearly reduced per MRI/CT report.
  • If present, anterior listhesis preferred ≤ 5.0mm and deemed stable by Investigator.
  • Able to walk at least 10 feet unaided before being limited by pain.
  • Available to complete 26 weeks of follow-up.
  • A signed Informed Consent Form is obtained from the patient.
  • Adults at least 18 years of age.

Exclusion Criteria:

  • Prior surgery at intended treatment level.
  • Compound fracture with interspinal retropulsion contributing to spinal stenosis.
  • Disabling back or leg pain from causes other than LSS (e.g. acute compression fracture, metabolic neuropathy, or vascular claudication symptoms, etc.).
  • Disc protrusion or osteophyte formation severe enough to confound study outcome.
  • Facet hypertrophy severe enough to confound study outcome.
  • 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 steroid administration within prior three weeks (of procedure).
  • Inability of the patient to lie prone for any reason with anesthesia support (e.g.chronic obstructive pulmonary disease (COPD), obesity, etc.).
  • Metabolic wound healing pathologies deemed by Investigator to compromise study outcomes.
  • Dementia and/or inability to give informed consent.
  • Pregnant and/or breastfeeding.
  • On Workman's Compensation or considering litigation associated with back pain.

Sites / Locations

  • Space Coast Pain Institute
  • The Spine Center
  • Occupational and Pain Management Professionals
  • Lab2Marche, LLC
  • The Cleveland Clinic Foundation
  • MedCentral Health System
  • Kenneth Alo, MD, PA-TX
  • The Center for Pain Relief Tri-State, PLLC

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

lumbar decompression

Arm Description

Percutaneous lumbar decompression with mild® Device Kit.

Outcomes

Primary Outcome Measures

Changes in Back Pain as Measured by a 10-point Visual Analog Scale (VAS).
The 10-point Visual Analog Scale (VAS)rates 'no pain' as zero and 'worst pain imaginable' as ten. VAS mean improvement greater than or equal to 2 points is considered clinically relevant. The change from baseline to Month 6 is presented below where a positive value represents the baseline value minus the 6 month value.
Function as Measured Subjectively by the Oswestry Disability Index Questionnaire
Oswestry Disability Index (ODI) measures permanent functional disability using questions regarding activities of daily living (ADL), specifically disturbance of ADL related to chronic back pain. Higher scores indicate a 'more limited' life. The ten topics of the ODI are rated from zero (no pain/limitation) to five (high pain/very limited physically). The worst possible score is 50 (100% disability) with the best score being zero (0% disability).Change from baseline to 6 months is presented below, where a positive value represents the baseline value minus the 6 month value.
Quality of Life Changes as Determined by Short Form 12-question (SF-12) Survey Specifically Related to Physical Component Score (PCS).
The SF-12 is a validated norm-based scoring tool used to determine treatment outcomes. The PCS summary measure shows the impact of the treatment on the patients abilities to conduct their usual physical activities. Clinical relevance of PCS is established by baseline to post-treatment improvement of 2 to 3 points. Norm-based scoring is used so that each scale has the same mean (50 points) and the same standard deviation (10 points) as the general US population in 1998. Scores below 50 indicate a decline in health status, with lower scores representing worse health status. Minimally Important Difference (MID) is a measure of true clinical relevance of a difference, with suggested MID for the Physical Component Summary (PCS) being 2 to 3 points. Change from baseline to 6 months is presented, where a positive value represents the 6 month value minus the baseline value.

Secondary Outcome Measures

Full Information

First Posted
March 4, 2010
Last Updated
February 21, 2013
Sponsor
Vertos Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01082159
Brief Title
MiDAS II (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study
Official Title
MiDAS II (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
February 2010 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
January 2013 (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, patient outcomes assessment of Minimally Invasive Lumbar Decompression with the Mild® devices in patients with symptomatic central canal 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
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lumbar decompression
Arm Type
Other
Arm Description
Percutaneous lumbar decompression with mild® Device Kit.
Intervention Type
Procedure
Intervention Name(s)
lumbar decompression
Other Intervention Name(s)
The mild® Device Kit
Intervention Description
The mild® devices used in this study are specialized surgical instruments intended to be used to perform percutaneous lumbar decompressive procedures for the treatment of various spinal conditions.
Primary Outcome Measure Information:
Title
Changes in Back Pain as Measured by a 10-point Visual Analog Scale (VAS).
Description
The 10-point Visual Analog Scale (VAS)rates 'no pain' as zero and 'worst pain imaginable' as ten. VAS mean improvement greater than or equal to 2 points is considered clinically relevant. The change from baseline to Month 6 is presented below where a positive value represents the baseline value minus the 6 month value.
Time Frame
Baseline and Month 6
Title
Function as Measured Subjectively by the Oswestry Disability Index Questionnaire
Description
Oswestry Disability Index (ODI) measures permanent functional disability using questions regarding activities of daily living (ADL), specifically disturbance of ADL related to chronic back pain. Higher scores indicate a 'more limited' life. The ten topics of the ODI are rated from zero (no pain/limitation) to five (high pain/very limited physically). The worst possible score is 50 (100% disability) with the best score being zero (0% disability).Change from baseline to 6 months is presented below, where a positive value represents the baseline value minus the 6 month value.
Time Frame
Baseline and Month 6
Title
Quality of Life Changes as Determined by Short Form 12-question (SF-12) Survey Specifically Related to Physical Component Score (PCS).
Description
The SF-12 is a validated norm-based scoring tool used to determine treatment outcomes. The PCS summary measure shows the impact of the treatment on the patients abilities to conduct their usual physical activities. Clinical relevance of PCS is established by baseline to post-treatment improvement of 2 to 3 points. Norm-based scoring is used so that each scale has the same mean (50 points) and the same standard deviation (10 points) as the general US population in 1998. Scores below 50 indicate a decline in health status, with lower scores representing worse health status. Minimally Important Difference (MID) is a measure of true clinical relevance of a difference, with suggested MID for the Physical Component Summary (PCS) being 2 to 3 points. Change from baseline to 6 months is presented, where a positive value represents the 6 month value minus the baseline value.
Time Frame
Baseline and Month 6

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 and Oswestry Disability Index (ODI) score > 20%. Radiologic evidence of lumbar spinal stenosis (LSS), ligamentum flavum hypertrophy (typically > 2.5 mm), confirmed by pre-op MRI and/or CT. Central canal cross sectional area clearly reduced per MRI/CT report. If present, anterior listhesis preferred ≤ 5.0mm and deemed stable by Investigator. Able to walk at least 10 feet unaided before being limited by pain. Available to complete 26 weeks of follow-up. A signed Informed Consent Form is obtained from the patient. Adults at least 18 years of age. Exclusion Criteria: Prior surgery at intended treatment level. Compound fracture with interspinal retropulsion contributing to spinal stenosis. Disabling back or leg pain from causes other than LSS (e.g. acute compression fracture, metabolic neuropathy, or vascular claudication symptoms, etc.). Disc protrusion or osteophyte formation severe enough to confound study outcome. Facet hypertrophy severe enough to confound study outcome. 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 steroid administration within prior three weeks (of procedure). Inability of the patient to lie prone for any reason with anesthesia support (e.g.chronic obstructive pulmonary disease (COPD), obesity, etc.). Metabolic wound healing pathologies deemed by Investigator to compromise study outcomes. Dementia and/or inability to give informed consent. Pregnant and/or breastfeeding. On Workman's Compensation or considering litigation associated with back pain.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David L Caraway, MD, PhD
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
Space Coast Pain Institute
City
Merritt Island
State/Province
Florida
ZIP/Postal Code
32953
Country
United States
Facility Name
The Spine Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21211
Country
United States
Facility Name
Occupational and Pain Management Professionals
City
Festus
State/Province
Missouri
ZIP/Postal Code
63028
Country
United States
Facility Name
Lab2Marche, LLC
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89149
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
MedCentral Health System
City
Mansfield
State/Province
Ohio
ZIP/Postal Code
44903
Country
United States
Facility Name
Kenneth Alo, MD, PA-TX
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
The Center for Pain Relief Tri-State, PLLC
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25702
Country
United States

12. IPD Sharing Statement

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

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