Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Diego, California and other locations
Dates
study started
estimated completion

Description

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.

Details

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).

Keywords

Lumbar Spinal Stenosis Interspinous process decompression MILD Medicare Medicare Advantage Spinal Stenosis

Eligibility

You can join if…

Open to people ages 18 years and up

  • Medicare beneficiaries receiving MILD or interspinous process decompression
  • Diagnosis of LSS with NC

You CAN'T join if...

  • 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

Locations

  • UCSD Medical Center accepting new patients
    San Diego California 92103 United States
  • Scripps La Jolla Hospital accepting new patients
    La Jolla California 92037 United States
  • Pacific Surgical Institute accepting new patients
    San Diego California 92108 United States
  • Scripps Mercy Surgery Pavilion accepting new patients
    San Diego California 92103 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Vertos Medical, Inc.
ID
NCT03072927
Study Type
Observational
Last Updated