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

Vertos Medical

Status: Enrolling

Conditions: Lumbar Spinal Stenosis

Treatments: Device: MILD; Device: Interspinous Process Decompression

Study type: Observational

Funder types: Industry

Identifiers

NCT03072927

MILD Medicare Claims

Details and patient eligibility

About

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.

Full description

In this study the treatment group will include all patients receiving MILD, and the control group will include all patients receiving IPD for the treatment of LSS during the enrollment period. Reoperation and harms data will be studied for the MILD and IPD procedures for a 24-month follow-up period after the index procedure using Medicare claims data. This study is exempt from IRB oversight (Department of Health and Human Services regulations 45 CFR 46) and does not require prior enrollment nor patient consent. The inclusion of the study's NCT number on MILD Medicare claims is required and results in enrollment.

Enrollment: 8,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

8,000 participants in 2 patient groups

MILD

Description:

All Medicare patients treated with MILD as reported via CPT® Code 0275T (or successor code(s)).

Treatment:

Device: MILD

Interspinous Process Decompression

Description:

All Medicare patients treated with interspinous process decompression (CPT Code 22869 or 22870, or successor code(s)) for the treatment of LSS with NC.

Treatment:

Device: Interspinous Process Decompression