Presented at the 2012 AAPM Annual Meeting « Back

Mild® Procedure Metadata Demonstrate Safety, Positive Long-Term Patient Outcomes Following Lumbar Decompression

Lora L. Brown, MD, painmedicinedoctor@hotmail.com, Coastal Orthopedics & Sports Medicine, Bradenton, Florida

Introduction: Lumbar Spinal Stenosis (LSS) patients typically present with painful symptoms of neurogenic claudication. While conservative management is adequate for those with less severe symptoms, surgical decompression is often indicated as this degenerative condition progresses. Less invasive options, including the mild procedure, are now available for these patients. Mild is performed through a 5.1mm port resulting in minimal bone and tissue disruption. Unlike lengthy recovery times from open surgery, mild patients typically experience a less painful, more rapid recuperation. Objectives: This metaanalysis reports 1-year safety and effectiveness data for patients treated with the mild procedure. Materials and Methods: One-year follow-up for a total of 179 patients is reported in this metaanalysis. Patient Reported Outcomes include Visual Analog Score (VAS) and Oswestry Disability Index (ODI). Significant adverse events were documented throughout the studies. All studies were approved by an Institutional Review Board for each participating site, and were registered on the U.S. Clinical Trial Registry. Results: No serious device or procedure-related adverse events were reported through Year 1. VAS improved more than two points on average. Patient mobility was significantly improved and above the clinical minimally important difference threshold as measured by ODI. Conclusion: Review of multiple studies having comparable protocols demonstrated an excellent safety profile for mild. Serious adverse events were absent in these studies, indicating that this procedure is safe. Outcome measures demonstrated durable, significant improvement in patient mobility and significant reduction in pain 1 year post-mild treatment.

Funding: Financial support was provided by Vertos Medical for all referenced studies. I was a paid investigator in one of the studies.