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

Recruiting in Palo Alto (17 mi)

+1869 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Vertos Medical, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

Inclusion Criteria

Medicare beneficiaries receiving MILD or interspinous process decompression

Diagnosis of LSS with NC

Treatment Details

Interventions

MILD (Procedure)

Participant Groups

2Treatment groups

Experimental Treatment

Group I: MILDExperimental Treatment1 Intervention

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

Group II: Interspinous Process DecompressionExperimental Treatment1 Intervention

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