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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vertos Medical, Inc.
ClinicalTrials.gov Identifier:
NCT00956631
First received: August 7, 2009
Last updated: February 21, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Lumbar Spinal Stenosis
Procedure: Interlaminar Decompression
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: MiDAS I (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study

Resource links provided by NLM:


Further study details as provided by Vertos Medical, Inc.:

Primary Outcome Measures:
  • Mean Change in Back Pain as Measured by a 10-point Visual Analog Scale (VAS). [ Time Frame: Baseline and Six Months ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • 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. [ Time Frame: Baseline and Six months ] [ Designated as safety issue: No ]
    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).

  • 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. [ Time Frame: Baseline and Six Months ] [ Designated as safety issue: No ]
    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.


Enrollment: 78
Study Start Date: July 2008
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
interlaminar decompression
Commercially available product (mild® Device Kit) used to perform interlaminar decompression
Procedure: Interlaminar Decompression
The MILD® devices used in this study are specialized surgical instruments intended to be used to perform percutaneous lumbar decompression.
Other Names:
  • mild® Device Kit
  • percutaneous decompression

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00956631

Locations
United States, Arkansas
NEA Clinic
Jonesboro, Arkansas, United States, 72401
United States, California
UCLA
Los Angeles, California, United States, 90095
Napa Pain Institute
Napa, California, United States, 94558
Scripps, Division of Orthopedic Surgery
San Diego, California, United States, 92037
UCSD
San Diego, California, United States, 92037
Your Pain Care
Temecula, California, United States, 92591
United States, Florida
Coastal Orthopedics & Sports Medicine
Bradenton, Florida, United States, 34209
South Florida Spine Institute
Miami Beach, Florida, United States, 33140
United States, Maryland
The Spine Center
Baltimore, Maryland, United States, 21211
United States, Nevada
Rainer Vogel, MD LTD
Henderson, Nevada, United States, 89074
Lab2Marche, LLC
Las Vegas, Nevada, United States, 89149
United States, Ohio
MedCentral Health System
Mansfield, Ohio, United States, 44903
United States, Pennsylvania
Orthopedic Associates of the Greater Lehigh Valley
Easton, Pennsylvania, United States, 18045
Sponsors and Collaborators
Vertos Medical, Inc.
Investigators
Principal Investigator: David Caraway, MD The Center for Pain Relief Tri-State, PLLC
Principal Investigator: Bohdan W Chopko, MD MedCentral Health System
  More Information

No publications provided by Vertos Medical, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Vertos Medical, Inc.
ClinicalTrials.gov Identifier: NCT00956631     History of Changes
Other Study ID Numbers: MiDAS I
Study First Received: August 7, 2009
Results First Received: January 4, 2013
Last Updated: February 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Vertos Medical, Inc.:
Spinal Stenosis
Lumbar Spinal Stenosis

Additional relevant MeSH terms:
Spinal Stenosis
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases

ClinicalTrials.gov processed this record on November 25, 2014