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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorStryker Instruments

About this trial

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

Qualifiers

Medicare beneficiaries receiving MILD or interspinous process decompression

Diagnosis of LSS with NC

Disqualifiers

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

Trial design

Treatments tested in this trial

  • MILD
  • Interspinous Process Decompression

Treatment groups

8,000 Participants
are divided into 2 treatment groups

Locations

2,326
Alabama
Athens-Limestone Hospital35611, Athens United States
North Baldwin Infirmary36507, Bay Minette United States
Alabama Ortho Spine and Sports35235, Birmingham United States
Birmingham Surgery Center35233, Birmingham United States

Sponsors and collaborators

Stryker Instruments

Lead sponsor