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

NCT03072927 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 8000

Last updated 2026-05-14

No results posted yet for this study

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.

Conditions

  • Lumbar Spinal Stenosis

Interventions

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

Sponsors & Collaborators

  • Stryker Instruments

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-10
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03072927 on ClinicalTrials.gov