Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis UC Irvine UCLA UCSD UCSF
Dates
study started
study ends around

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) 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.

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

  • UC Davis Medical Cetner-Lawrence Ellison Ambulatory Care Building accepting new patients
    Sacramento 5389489 California 5332921 95817 United States
  • Ucsd Med Ctr Hillcrest accepting new patients
    San Diego 5391811 California 5332921 92103 United States
  • UCSD Medical Center accepting new patients
    San Diego 5391811 California 5332921 92103 United States
  • UCSF Medical Center accepting new patients
    San Francisco 5391959 California 5332921 94115 United States
  • UCI Medical Center- Central Distribution Warehouse - Dyer accepting new patients
    Santa Ana 5392900 California 5332921 92705 United States
  • UCLA Medical Center Santa Monica accepting new patients
    Santa Monica 5393212 California 5332921 90404 United States
  • UCLA-Thousand Oaks accepting new patients
    Thousand Oaks 5402405 California 5332921 91360 United States
  • VA Medical Center - San Diego accepting new patients
    San Diego 5391811 California 5332921 92161 United States
  • Source Healthcare accepting new patients
    Santa Monica 5393212 California 5332921 90403 United States
  • Source Surgery Center accepting new patients
    Santa Monica 5393212 California 5332921 90403 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Stryker Instruments
ID
NCT03072927
Study Type
Observational
Participants
Expecting 8000 study participants
Last Updated