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


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.


  • Lumbar Spinal Stenosis


Eligible Ages
Over 18 Years
Eligible Genders
Accepts Healthy Volunteers

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

Study Design

Study Type
Observational Model
Time Perspective

Arm Groups

ArmDescriptionAssigned Intervention
MILD All Medicare patients treated with MILD as reported via CPT® Code 0275T (or successor code(s)).
  • Device: MILD
    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.
Interspinous Process Decompression All Medicare patients treated with interspinous process decompression (CPT Code 22869 or 22870, or successor code(s)) for the treatment of LSS with NC.

Recruiting Locations

Montefiore Medical Center
Bronx, New York 10467

More Details

Vertos Medical, Inc.

Study Contact

Angie Lee

Detailed Description

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).