Last updated on July 2019

MILD Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study


Brief description of 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.

Detailed Study Description

Using the Centers for Medicare and Medicaid (CMS) Medicare Research Identifiable Files (RIFs) containing all medical claims for 100% of Medicare beneficiaries enrolled in the Medicare fee-for-service program, claims-based patient history and demographics will be combined with longitudinal analyses. In this study, the control group will include all patients receiving interspinous process decompression (IPD) for the treatment of lumbar spinal stenosis (LSS) with neurogenic claudication (NC). The treatment group will include all patients receiving MILD during the enrollment period. The date of the MILD and IPD procedure will serve as the index procedure date for 24-month follow-up. This study is exempt from IRB oversight (Department of Health and Human Services regulations 45 CFR 46).

Clinical Study Identifier: NCT03072927

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Morehead City, NC United States
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Pinehurst, NC United States
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Cleveland, OH United States
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Cuyahoga Falls, OH United States
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Huntingdon Valley, PA United States
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King Of Prussia, PA United States
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Pottstown, PA United States
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Chattanooga, TN United States
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Sulphur Springs, TX United States
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Recruitment Status: Open


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