MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study
Recruiting
Observational Study
Lumbar Spinal Stenosis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
8,000 (estimated)
Sponsor
Stryker Instruments · Industry
Who this trial is looking for
This trial is looking for Medicare beneficiaries who have been diagnosed with lumbar spinal stenosis and are receiving a specific treatment called MILD. Participants will be compared to others who have had similar procedures to understand the effects over two years.
Are You a Good Fit for This Trial?
You may be able to join if
I am a Medicare beneficiary
I have been diagnosed with lumbar spinal stenosis
You may not be able to join if
I have had a laminectomy in the past 12 months
I have had a laminotomy in the past 12 months
I have had a fusion in the past 12 months
I have had an interspinous process decompression in the past 12 months
I have had a MILD procedure in the past 12 months
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 proced…
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.
Trial Locations
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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 p…
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
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