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

Lumbar Spinal Stenosis Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03072927
Study type Observational
Source Vertos Medical, Inc.
Contact Angie Lee
Phone 877-958-6227
Email alee@vertosmed.com
Status Recruiting
Phase
Start date March 10, 2017
Completion date December 2026
View Details
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