NCT03072927 MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study
| NCT ID | NCT03072927 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Stryker Instruments |
| Condition | Lumbar Spinal Stenosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 8,000 participants |
| Start Date | 2017-03-10 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 8,000 participants in total. It began in 2017-03-10 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03072927 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lumbar Spinal Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03072927 currently recruiting?
Yes, NCT03072927 is actively recruiting participants. Contact the research team at angie.lee@stryker.com for enrollment information.
Where is the NCT03072927 trial being conducted?
This trial is being conducted at Athens, United States, Bay Minette, United States, Birmingham, United States, Birmingham, United States and 11 additional locations.
Who is sponsoring the NCT03072927 clinical trial?
NCT03072927 is sponsored by Stryker Instruments. The trial plans to enroll 8,000 participants.