MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study
MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study
This prospective longitudinal study will compare incidence rates of Medicare beneficiary surgical and minimally invasive intervention post index procedure, as well as harms associated with the MILD procedure, at 24 months post-treatment with MILD, tested against a control group of similar patients that have had a comparable procedure. This study will start with patients treated with a study procedure having an index date on or after January 1, 2017, and enrollment will continue until stopped by the sponsor.
In this study the treatment group will include all patients receiving MILD, and the control group will include all patients receiving IPD for the treatment of LSS during the enrollment period. Reoperation and harms data will be studied for the MILD and IPD procedures for a 24-month follow-up period after the index procedure using Medicare claims data. This study is exempt from IRB oversight (Department of Health and Human Services regulations 45 CFR 46) and does not require prior enrollment nor patient consent. The inclusion of the study's NCT number on MILD Medicare claims is required and results in enrollment.
Inclusion Criteria:
Exclusion Criteria:
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Phoenix, Arizona 85012, United States
Fayetteville, Arkansas 72703, United States
Redwood City, California 94063, United States
Sacramento, California 95817, United States
San Pedro, California 90732, United States
Santa Ana, California 92705, United States
Thousand Oaks, California 91360, United States
Greenwood Village, Colorado 80111, United States
Cheshire, Connecticut 06410, United States
Washington D.C., District of Columbia 20007, United States
Washington D.C., District of Columbia 20010, United States
Washington D.C., District of Columbia 20036, United States
Bradenton, Florida 34211, United States
Fort Myers, Florida 33901, United States
Ocala, Florida 34471, United States
West Palm Beach, Florida 33407, United States
Chicago, Illinois 60612, United States
Evanston, Illinois 60201, United States
Highland Park, Illinois 60035, United States
Hoffman Estates, Illinois 60169, United States
Morton Grove, Illinois 60053, United States
Naperville, Illinois 60561, United States
Oakbrook Terrace, Illinois 60181, United States
Peoria, Illinois 61602, United States
Saint Charles, Illinois 60175, United States
630-584-9800
Bethesda, Maryland 20817, United States
Attleboro, Massachusetts 02703, United States
Foxborough, Massachusetts 02035, United States
Framingham, Massachusetts 01702, United States
Newton, Massachusetts 02459, United States
Royal Oak, Michigan 48073, United States
Alexandria, Minnesota 56308, United States
Sartell, Minnesota 56377, United States
Chesterfield, Missouri 63017, United States
Jefferson City, Missouri 65109, United States
Lake Saint Louis, Missouri 63367, United States
Bedford, New Hampshire 03110, United States
Portsmouth, New Hampshire 03801, United States
Bridgewater, New Jersey 08801, United States
New Brunswick, New Jersey 08901, United States
North Brunswick, New Jersey 08902, United States
New York, New York 10010, United States
Rochester, New York 14642, United States
Ahoskie, North Carolina 27910, United States
Chapel Hill, North Carolina 27517, United States
Charlotte, North Carolina 28207, United States
High Point, North Carolina 27265, United States
Raleigh, North Carolina 27609, United States
Twinsburg, Ohio 44087, United States
Westlake, Ohio 44145, United States
Pottsville, Pennsylvania 17901, United States
Wilkes-Barre, Pennsylvania 18702, United States
Wilkes-Barre Township, Pennsylvania 18702, United States
Mt. Pleasant, South Carolina 29466, United States
Simpsonville, South Carolina 29681, United States
Chattanooga, Tennessee 37404, United States
Cookeville, Tennessee 38501, United States
Amarillo, Texas 79124, United States
Austin, Texas 78731, United States
Fort Worth, Texas 76110, United States
Houston, Texas 77090, United States
Marble Falls, Texas 78654, United States
Charleston, West Virginia 25301, United States
Appleton, Wisconsin 54911, United States
Lake Geneva, Wisconsin 53147, United States