An observational study in Lumbar Spinal Stenosis, sponsored by Stryker Instruments. Recruiting at 2,394 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Stryker Instruments (part of Stryker) · Observational
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.
In this study the treatment group will include all patients receiving MILD, and the control group will include all patients receiving IPD for the treatment of LSS during the enrollment period. Reoperation and harms data will be studied for the MILD and IPD procedures for a 24-month follow-up period after the index procedure using Medicare claims data. This study is exempt from IRB oversight (Department of Health and Human Services regulations 45 CFR 46) and does not require prior enrollment nor patient consent. The inclusion of the study's NCT number on MILD Medicare claims is required and results in enrollment.
458 studies on the registry are indexed under Spinal Stenosis; 105 are open to participants now.
This study's planned enrollment of 8,000 is above the median of 120 across 154 observational studies indexed under Spinal Stenosis.
Browse Spinal Stenosis studies →Stryker Instruments is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Study participants will include Medicare beneficiaries for whom claims have been submitted to the Medicare Claims database and who have been enrolled in Medicare fee-for-service or Medicare Advantage for one year prior to their index procedure and two years post index procedure.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
All Medicare patients treated with MILD as reported via CPT® Code 0275T or successor codes (62330/62331).
Device: MILD
All Medicare patients treated with interspinous process decompression (CPT Code 22869 or 22870, or successor code(s)) for the treatment of LSS with NC.
Device: Interspinous Process Decompression
MILD is performed under fluoroscopic image guidance through an ipsilateral interlaminar dorsal approach to the spine. Partial decompression is performed through the removal of tissue and bone at the symptomatic level confirmed with correlated MRI and clinical findings.
Interspinous Process Decompression
Rate of participants with harms associated with the index procedure
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.
Time frame: 24 months
Rate of surgical, minimally invasive intervention.
Measure the rate of Medicare beneficiary surgical and minimally invasive intervention for LSS with NC post index procedure.
Time frame: 24 months
Showing the first 100 of 2,394 sites. Choose a country and city above to see the rest.
Plan to share: No
Started Mar 2017 (actual). Primary completion is estimated for Dec 2026, 117 months after the start.
Of 78 observational studies under Spinal Stenosis, half reached primary completion within 51 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 84. This study's planned 117 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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