Summary

for people ages 66 years and up (full criteria)
at San Francisco, California and other locations
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.

Details

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).

Keywords

Lumbar Spinal StenosisInterspinous process decompressionMILDMedicareSpinal Stenosis

Eligibility

You can join if…

Open to people ages 66 years and up

  • Medicare beneficiaries receiving MILD or interspinous process decompression
  • Diagnosis of LSS with NC
  • ≥66 years old

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

  • UCSF Medical Centeraccepting new patients
    San FranciscoCalifornia94115United States
  • Ky Advanced Surgical Center, Inc.accepting new patients
    FresnoCalifornia93726United States
  • Fresno Surgical Hospitalaccepting new patients
    FresnoCalifornia93710United States
  • Herndon Surgery Centeraccepting new patients
    FresnoCalifornia93720United States
  • Summit Surgicalaccepting new patients
    FresnoCalifornia93720United States

Details

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