Loyola University Medical Center

Gottlieb Memorial Hospital

MacNeal Hospital

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NCT03072927

MILD® Percutaneous Image-Guided Lumbar Decompression: a Medicare Claims Study

Official Title:

MILD® Percutaneous Image-Guided Lumbar Decompression: a Medicare Claims Study

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.

Eligibility

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

Disease(s) and\or Condition(s)

Lumbar Spinal Stenosis

Primary Purpose
Intervention/Treatment
    • Type: DEVICE
    • Name: MILD
    • Description: MILD is performed under fluoroscopic image guidance through an ipsilateral interlaminar dorsal approach to the spine. Following epidurography, partial decompression is performed through the removal of tissue and bone at the symptomatic level confirmed with correlated MRI and clinical findings.
    • Arm Group Labels: MILD
    • Type: DEVICE
    • Name: Interspinous Process Decompression
    • Description: Interspinous Process Decompression
    • Arm Group Labels: Interspinous Process Decompression
Sponsor
  • Vertos Medical, Inc.