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

STUDY OVERVIEW

This prospective longitudinal study is sponsored by Vertos Medical Inc. and aims to compare the incidence rates of surgical and minimally invasive interventions and associated harms in Medicare beneficiaries undergoing the MILD procedure versus a control group over a 24-month follow-up period, starting from January 1, 2017, using Medicare claims data, with enrollment continuing until halted by the sponsor.

STUDY GOALS

The goal of this study is to assess the efficacy and safety of the MILD procedure in Medicare beneficiaries by comparing post-treatment incidence rates of surgical and minimally invasive interventions and associated harms with a control group undergoing a comparable procedure over a 24-month follow-up period, using Medicare claims data, with enrollment ongoing until stopped by the sponsor.

LOCATION

El Paso, Texas: El Paso Center for GI; El Paso Specialty Hospital, Sierra Medical Center; Gateway Surgical Center

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 Population: Study participants will include Medicare beneficiaries for whom claims have been submitted to the Medicare Claims database and who have been enrolled in Medicare fee-for-service or Medicare Advantage for one year prior to their index procedure and two years post-index procedure.

For more information, visit ClinicalTrials.gov.