MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study
ConditionLumbar Spinal Stenosis
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 groupsSponsors and collaborators
Source ClinicalTrials.gov