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

This study is looking at people who have undergone MILD (Percutaneous Image-Guided Lumbar Decompression) or Interspinous Process Decompression for Lumbar Spinal Stenosis (LSS), a condition where the spinal canal narrows and presses on nerves. Researchers want to compare the rates of additional surgeries or minimally invasive procedures, as well as any problems that might occur, within 24 months after the initial MILD procedure. They will compare these results to a similar group of patients who received Interspinous Process Decompression. You may be eligible if you are a Medicare beneficiary who has received MILD or Interspinous Process Decompression for LSS and have not had certain spinal surgeries in the past 12 months. This study is currently enrolling patients.

Study design
This is an observational study comparing 8,000 Medicare beneficiaries who received MILD or Interspinous Process Decompression for Lumbar Spinal Stenosis.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants are followed for 24 months after their initial procedure to track reoperations and harms.

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NCT03072927

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

Recruiting
Not specifiedAges 18+Observational
Stryker Instruments
~8,000 participants
Updated 2026-09-01 on ClinicalTrials.gov
What's tested:MILDInterspinous Process Decompression

At a glance

Recruiting sites
2365 of 2370 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of participants with harms associated with the index procedure
Measured over 24 months
+1 more outcome measured
Lumbar Spinal Stenosis
2370 sites across 51 states
Florida224
California217
Texas209
New York121
New Jersey110
Ohio108
Illinois104
Maryland101

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Eligibility criteria

Inclusion

Medicare beneficiaries receiving MILD or interspinous process decompression
Diagnosis of LSS with NC

Exclusion

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
  • Rate of participants with harms associated with the index procedure24 months

    Rate of participants with harms associated with the index procedure including, but not limited to, revisions, displacement, mechanical complications, and death. Complications will be counted if they are recorded during the index hospitalization, or any rehospitalization within 30 days of discharge.

  • Rate of surgical, minimally invasive intervention.24 months

    Measure the rate of Medicare beneficiary surgical and minimally invasive intervention for LSS with NC post index procedure.