Abstract
BACKGROUND: Minimally invasive lumbar decompression (mild(®) ) has been shown to be safe and effective for the treatment of lumbar spinal stenosis patients with hypertrophic ligamentum flavum as a contributing factor. This study examines the long-term durability of the mild procedure through 5-year follow-up. Pain relief and opioid medications utilization during 12-month follow-up were also assessed. METHODS: All patients diagnosed with lumbar spinal stenosis secondary to ligamentum flavum hypertrophy who underwent mild from 2010 through 2015 at the Cleveland Clinic Department of Pain Management were included in this retrospective longitudinal observational cohort study. The primary outcome measure was the incidence of open lumbar decompression surgery at the same level(s) as the mild intervention during 5-year follow-up. Secondary outcome measures were the change in pain levels using the Numeric Rating Scale and opioid medications utilization using Morphine Milligram Equivalent dose per day from baseline to 3, 6, and 12 months post-mild procedure. Postprocedural complications (minor or major) were also collected. RESULTS: Seventy-five patients received mild during the protocol-defined time period and were included in the study. Only 9 out of 75 patients required lumbar surgical decompression during the 5-year follow-up period. Subjects experienced statistically significant pain relief and reduction of opioid medications utilization at 3, 6, and 12 months compared to baseline. CONCLUSION: Based on our analysis, the mild procedure is durable over 5 years and may allow elderly patients with symptomatic lumbar spinal stenosis to avoid lumbar decompression surgery while providing significant symptomatic relief.