NCT03072927

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 8,000 (estimated)
• Sponsor: Stryker Instruments · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Lumbar Spinal Stenosis

Interventions

Type	Name	Description
DEVICE	MILD	MILD is performed under fluoroscopic image guidance through an ipsilateral interlaminar dorsal approach to the spine. Partial decompression is performed through the removal of tissue and bone at the symptomatic level confirmed with correlated MRI and clinical findings.
DEVICE	Interspinous Process Decompression	Interspinous Process Decompression

Timeline

• Start date: 2017-03-10
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2017-03-07
• Last updated: 2026-04-16

Locations

2,241 sites across 1 country: United States

Regulatory

• FDA-regulated device study