MiDAS II (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||MiDAS II (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study|
- Changes in Back Pain as Measured by a 10-point Visual Analog Scale (VAS). [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]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). [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]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.
|Study Start Date:||February 2010|
|Study Completion Date:||January 2013|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Percutaneous lumbar decompression with mild® Device Kit.
Procedure: lumbar decompression
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.
Other Name: The mild® Device Kit
|United States, Florida|
|Space Coast Pain Institute|
|Merritt Island, Florida, United States, 32953|
|United States, Maryland|
|The Spine Center|
|Baltimore, Maryland, United States, 21211|
|United States, Missouri|
|Occupational and Pain Management Professionals|
|Festus, Missouri, United States, 63028|
|United States, Nevada|
|Las Vegas, Nevada, United States, 89149|
|United States, Ohio|
|The Cleveland Clinic Foundation|
|Cleveland, Ohio, United States, 44195|
|MedCentral Health System|
|Mansfield, Ohio, United States, 44903|
|United States, Texas|
|Kenneth Alo, MD, PA-TX|
|Houston, Texas, United States, 77090|
|United States, West Virginia|
|The Center for Pain Relief Tri-State, PLLC|
|Huntington, West Virginia, United States, 25702|
|Principal Investigator:||David L Caraway, MD, PhD||The Center for Pain Relief Tri-State, PLLC|
|Principal Investigator:||Bohdan W Chopko, MD||MedCentral Health System|