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

  • STATUS
    Recruiting
  • End date
    Dec 26, 2024
  • participants needed
    4000
  • sponsor
    Vertos Medical, Inc.
Updated on 26 November 2020
Investigator
Angie Lee
Primary Contact
National Spine and Pain Centers (3.2 mi away) Contact
+677 other location

Summary

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.

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).

Details
Treatment MILD
Clinical Study IdentifierNCT03072927
SponsorVertos Medical, Inc.
Last Modified on26 November 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Lumbar Spinal Stenosis?
Do you have any of these conditions: Do you have Lumbar Spinal Stenosis??
Do you have any of these conditions: Do you have Lumbar Spinal Stenosis??
Medicare beneficiaries receiving MILD or interspinous process decompression
Diagnosis of LSS with NC

Exclusion Criteria

Patients that have received a laminectomy, laminotomy, fusion, interspinous process decompression, or MILD in the lumbar region during the 12 months prior to the index date
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Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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