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
- Medicare beneficiaries receiving MILD or interspinous process decompression
- Diagnosis of LSS with NC
- 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 Type
- Observational Model
- Time Perspective
|MILD||All Medicare patients treated with MILD as reported via CPT® Code 0275T (or successor code(s)).||
|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.||
- Vertos Medical, Inc.
Study ContactAngie Lee
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).