Lawrence Poree

Objective This prospective longitudinal study compares outcomes between Medicare beneficiaries receiving percutaneous image‐guided lumbar decompression (PILD) using the mild ® procedure and a control group of patients receiving interspinous spacers for the treatment of lumbar spinal stenosis (LSS) with neurogenic claudication (NC). Methods Patients diagnosed with LSS with NC and treated with either the mild procedure or a spacer were identified in the Medicare claims database. The incidence of harms, the rate of subsequent interventions, and the overall combined rate of harms and subsequent interventions during 2‐year follow‐up after the index procedure were compared between the two groups and assessed for statistical significance with p = 0.05. Results The study included 2229 patients in the mild group and 3401 patients who were implanted with interspinous spacers. The rate of harms for those treated with the mild procedure was less than half that of patients implanted with a spacer (5.6% vs. 12.1%, respectively; p < 0.0001) during 2‐year follow‐up. The rate of subsequent interventions was not significantly different between the two groups (24.9% and 26.1% for the mild and spacer groups, respectively; p = 0.7679). The total rate of harms and subsequent interventions for mild was found to be noninferior to spacers ( p < 0.0001). Conclusions This comprehensive study of real‐world Medicare claims data demonstrated a significantly lower rate of harms for the mild procedure compared to interspinous spacers for patients diagnosed with LSS with NC, and a similar rate of subsequent interventions during 2‐year follow‐up.