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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
78
The MILD® devices used in this study are specialized surgical instruments intended to be used to perform percutaneous lumbar decompression.
NEA Clinic
Jonesboro, Arkansas, United States
UCLA
Los Angeles, California, United States
Napa Pain Institute
Napa, California, United States
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.
Time frame: Baseline and Six Months
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Scripps, Division of Orthopedic Surgery
San Diego, California, United States
UCSD
San Diego, California, United States
Your Pain Care
Temecula, California, United States
Coastal Orthopedics & Sports Medicine
Bradenton, Florida, United States
South Florida Spine Institute
Miami Beach, Florida, United States
The Spine Center
Baltimore, Maryland, United States
Rainer Vogel, MD LTD
Henderson, Nevada, United States
...and 3 more locations