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