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

Lumbar Spinal Stenosis Clinical Trial

— MiDAS I  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00956631
• Other study ID #: MiDAS I
• Status: Completed
• Phase: Phase 4
• First received: August 7, 2009
• Last updated: February 21, 2013
• Start date: July 2008
• Est. completion date: April 2012

Study information

• Verified date: February 2013
• Source: Vertos Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lumbar Spinal Stenosis
• Spinal Stenosis

Intervention

Procedure:
• Interlaminar Decompression
The MILD® devices used in this study are specialized surgical instruments intended to be used to perform percutaneous lumbar decompression.

Locations

Country	Name	City	State
United States	The Spine Center	Baltimore	Maryland
United States	Coastal Orthopedics & Sports Medicine	Bradenton	Florida
United States	Orthopedic Associates of the Greater Lehigh Valley	Easton	Pennsylvania
United States	Rainer Vogel, MD LTD	Henderson	Nevada
United States	NEA Clinic	Jonesboro	Arkansas
United States	Lab2Marche, LLC	Las Vegas	Nevada
United States	UCLA	Los Angeles	California
United States	MedCentral Health System	Mansfield	Ohio
United States	South Florida Spine Institute	Miami Beach	Florida
United States	Napa Pain Institute	Napa	California
United States	Scripps, Division of Orthopedic Surgery	San Diego	California
United States	UCSD	San Diego	California
United States	Your Pain Care	Temecula	California

Sponsors (1)

Lead Sponsor	Collaborator
Vertos Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	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	No
Primary	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	No