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RecruitingNCT03072927

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

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Trial Parameters

ConditionLumbar Spinal Stenosis
SponsorStryker Instruments
Study TypeOBSERVATIONAL
PhaseN/A
Enrollment8,000
SexALL
Min Age18 Years
Max AgeN/A
Start Date2017-03-10
Completion2026-12
Interventions
MILDInterspinous Process Decompression

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Brief 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.

Eligibility Criteria

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

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