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Recruiting NCT03072927

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

Conditions: Lumbar Spinal Stenosis

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 8000
Sponsor: Stryker Instruments

Location: Athens-Limestone Hospital Athens Alabama

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT03072927). StuddyBuddy aggregates publicly available trial information.