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Comparing MILD procedure outcomes for lumbar spinal stenosis patients

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

Stryker Instruments · NCT03072927

This study looks at how well the MILD procedure works for people with lumbar spinal stenosis compared to another treatment, to see which one leads to better outcomes and fewer complications.

Quick facts

Study typeObservational
Enrollment8000 (estimated)
Ages18 Years and up
SexAll
SponsorStryker Instruments (industry)
Locations2263 sites (Athens, Alabama and 2262 other locations)
Trial IDNCT03072927 on ClinicalTrials.gov

What this trial studies

This observational study aims to compare the incidence rates of surgical and minimally invasive interventions among Medicare beneficiaries who have undergone the MILD procedure for lumbar spinal stenosis. It will track outcomes and potential harms associated with the MILD procedure over a 24-month period, using Medicare claims data. The study will include a treatment group of patients receiving MILD and a control group of patients undergoing interspinous process decompression, allowing for a comprehensive analysis of both approaches. Enrollment will continue until the sponsor decides to stop the study.

Who should consider this trial

Good fit: Ideal candidates for this study are Medicare beneficiaries diagnosed with lumbar spinal stenosis who are receiving either the MILD procedure or interspinous process decompression.

Not a fit: Patients who have undergone prior lumbar surgeries such as laminectomy, laminotomy, fusion, or MILD within the last 12 months will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the effectiveness and safety of the MILD procedure compared to traditional surgical options for patients with lumbar spinal stenosis.

How similar studies have performed: Other studies have explored similar minimally invasive techniques, but this specific comparison of MILD against interspinous process decompression in a Medicare population is relatively novel.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Athens, Alabama and 2262 other locations

+2213 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Lumbar Spinal Stenosis, Interspinous process decompression, MILD, Medicare, Medicare Advantage

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.