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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 Stenosis Interspinous process decompression MILD Medicare Spinal 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 Center accepting new patients
    San Francisco, California, 94115, United States
  • Ky Advanced Surgical Center, Inc. accepting new patients
    Fresno, California, 93726, United States
  • Fresno Surgical Hospital accepting new patients
    Fresno, California, 93710, United States
  • Kaiser Permanente Richmond Medical Center accepting new patients
    Richmond, California, 94801, United States
  • Delta Bay Surgery Center, LLC accepting new patients
    Benicia, California, 94510, United States
  • Silicon Valley ASC accepting new patients
    Los Gatos, California, 95032, United States
  • Pacific Restorative Center accepting new patients
    Santa Rosa, California, 95401, United States
  • Sutter Auburn Surgery Center accepting new patients
    Auburn, California, 95603, United States
  • Galileo Surgery Center accepting new patients
    San Luis Obispo, California, 93405, United States
  • Pain Management Specialists accepting new patients
    San Luis Obispo, California, 93405, United States
  • Cypress Ambulatory Surgery Center accepting new patients
    Santa Maria, California, 93454, United States
  • Spanish Hills Surgery Center accepting new patients
    Camarillo, California, 93010, United States
  • Avalon Surgery and Robotic Center accepting new patients
    Glendale, California, 91204, United States
  • Surgery Center of the Pacific accepting new patients
    Santa Monica, California, 90403, United States
  • Pacific Ambulatory Surgery Center accepting new patients
    Alhambra, California, 91801, United States
  • Desert Valley Hospital accepting new patients
    Victorville, California, 92395, United States
  • St Mary Medical Center accepting new patients
    Apple Valley, California, 92307, United States
  • Coast Surgery Center accepting new patients
    Torrance, California, 90505, United States
  • Newport Coast Surgery Center accepting new patients
    Newport Beach, California, 92660, United States
  • VA Medical Center Pecos MSPV accepting new patients
    Las Vegas, Nevada, 89086, United States
  • University Surgery Center accepting new patients
    Murrieta, California, 92562, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Vertos Medical, Inc.
ID
NCT03072927
Study Type
Observational
Last Updated
November 29, 2017
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