Mild procedure: single-site prospective IRB study.

OBJECTIVE: The mild lumbar decompression procedure is a minimally invasive therapy for the treatment of symptomatic lumbar spinal stenosis (LSS). Mild offers LSS patients an early alternative after failed conservative therapy and before open surgery. This report describes 6-month safety and efficacy of mild patients treated at a single center.
METHODS: From November 2009 through June 2010, 27 consecutive patients were enrolled in a prospective Study at a single center. Efficacy of the mild procedure was evaluated by comparing the Visual Analog Scale, Oswestry Disability Index, and Zurich Claudication Questionnaire (ZCQ) at baseline and 6-month follow-up. Significant mild device or procedure-related adverse events were tracked and patient outcomes reported.
RESULTS: There were no significant mild device or procedure-related adverse events observed or reported. No patients required more than 24 hours postoperative observation. At 6-months, Visual Analog Scale showed a statistically significant improvement of 5.2 points. Oswestry Disability Index also showed statistically significant improvement of 24.0 points. Improvement in all ZCQ domains was statistically significant, and the average ZCQ Patient Satisfaction score was 1.86 at 6-month follow-up indicating that patients were "satisfied" to "very satisfied" with the treatment. DISCUSSION: The safety profile of mild, combined with the significant improvement in quality of life for these patients at 6-months is remarkable. Having failed conservative therapy, the high level of effectiveness of the mild procedure is particularly important in this patient population. In this series, mild has been shown to be a safe, effective, and cost-effective treatment for LSS patients with neurogenic claudication.