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

  • STATUS
    Recruiting
  • End date
    Dec 18, 2024
  • participants needed
    4000
  • sponsor
    Vertos Medical, Inc.
Updated on 20 June 2021
Investigator
Angie Lee
Primary Contact
VA Medical Center - Little Rock (2.0 mi away) Contact
+844 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

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).

Details
Condition Lumbar Spinal Stenosis
Treatment MILD
Clinical Study IdentifierNCT03072927
SponsorVertos Medical, Inc.
Last Modified on20 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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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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