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

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ClinicalTrials.gov Identifier: NCT00956631
Recruitment Status : Completed
First Posted : August 11, 2009
Results First Posted : April 4, 2013
Last Update Posted : April 4, 2013
Sponsor:
Information provided by (Responsible Party):
Vertos Medical, Inc.

Tracking Information
First Submitted Date  ICMJE August 7, 2009
First Posted Date  ICMJE August 11, 2009
Results First Submitted Date  ICMJE January 4, 2013
Results First Posted Date  ICMJE April 4, 2013
Last Update Posted Date April 4, 2013
Study Start Date  ICMJE July 2008
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 21, 2013)
Mean Change in Back Pain as Measured by a 10-point Visual Analog Scale (VAS). [ Time Frame: Baseline and Six Months ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 7, 2009)
  • Changes in back pain as measured by a 10-point visual analog scale (VAS) and pain medication requirements. [ Time Frame: 1 wk, 6 wks, 12 wks, 26 wks, 1 yr, 2 yrs ]
  • Function as measured subjectively by the Oswestry Disability, Zurich Claudication Questionnaire (ZCQ), and Work Production Index patient questionnaires [ Time Frame: 1 wk, 6 wks, 12 wks, 26 wks, 1 yr, 2 yrs ]
  • Quality of Life Physical Component Score (PCS) as measured by the SF-12 short-form survey. [ Time Frame: 1 wk, 6 wks, 12 wks, 26 wks, 1 yr, 2 yrs ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: February 21, 2013)
  • 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 ]
    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 ]
    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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MiDAS I (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study
Official Title  ICMJE MiDAS I (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lumbar Spinal Stenosis
Intervention  ICMJE 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
Study Arms  ICMJE interlaminar decompression
Commercially available product (mild® Device Kit) used to perform interlaminar decompression
Intervention: Procedure: Interlaminar Decompression
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 16, 2010)
78
Original Estimated Enrollment  ICMJE
 (submitted: August 7, 2009)
75
Actual Study Completion Date  ICMJE April 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00956631
Other Study ID Numbers  ICMJE MiDAS I
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vertos Medical, Inc.
Study Sponsor  ICMJE Vertos Medical, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Caraway, MD The Center for Pain Relief Tri-State, PLLC
Principal Investigator: Bohdan W Chopko, MD MedCentral Health System
PRS Account Vertos Medical, Inc.
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP