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

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.

Study Overview

• Status: Completed
• Conditions: Lumbar Spinal Stenosis
• Intervention / Treatment: Procedure: Interlaminar Decompression

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • NEA Clinic
  • California
    • Los Angeles, California, United States, 90095
      • UCLA
    • Napa, California, United States, 94558
      • Napa Pain Institute
    • San Diego, California, United States, 92037
      • UCSD
    • San Diego, California, United States, 92037
      • Scripps, Division of Orthopedic Surgery
    • Temecula, California, United States, 92591
      • Your Pain Care
  • Florida
    • Bradenton, Florida, United States, 34209
      • Coastal Orthopedics & Sports Medicine
    • Miami Beach, Florida, United States, 33140
      • South Florida Spine Institute
  • Maryland
    • Baltimore, Maryland, United States, 21211
      • The Spine Center
  • Nevada
    • Henderson, Nevada, United States, 89074
      • Rainer Vogel, MD LTD
    • Las Vegas, Nevada, United States, 89149
      • Lab2Marche, LLC
  • Ohio
    • Mansfield, Ohio, United States, 44903
      • MedCentral Health System
  • Pennsylvania
    • Easton, Pennsylvania, United States, 18045
      • Orthopedic Associates of the Greater Lehigh Valley

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and Six Months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	Baseline and Six months
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.	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.	Baseline and Six Months

Collaborators and Investigators

• Sponsor: Vertos Medical, Inc.
• Investigators: Principal Investigator: Bohdan W Chopko, MD, MedCentral Health System; Principal Investigator: David Caraway, MD, The Center for Pain Relief Tri-State, PLLC

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: August 7, 2009
• First Submitted That Met QC Criteria: August 7, 2009
• First Posted (Estimate): August 11, 2009

Study Record Updates

• Last Update Posted (Estimate): April 4, 2013
• Last Update Submitted That Met QC Criteria: February 21, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Spinal Stenosis; Lumbar Spinal Stenosis
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Constriction, Pathologic; Spinal Stenosis
• Other Study ID Numbers: MiDAS I