Abstract
OBJECTIVE: The MOTION prospective, multicenter randomized controlled trial compares the outcomes of percutaneous image-guided lumbar decompression in combination with conventional medical management (CMM) to the use of CMM alone for the treatment of lumbar spinal stenosis with neurogenic claudication secondary to hypertrophic ligamentum flavum. The study includes extended follow-up for patients in both the treatment group and for those who crossed over from the control group to the treatment group. METHODS: The treatment group received the mild® Procedure (Vertos Medical, Aliso Viejo, CA, USA) in combination with nonsurgical CMM, while the active control group received CMM alone. There were no restrictions for either group regarding access to real-world CMM therapies. Patients reported outcomes using the Oswestry Disability Index (ODI), Zurich Claudication Questionnaire (ZCQ), and Numeric Pain Rating Scale (NPRS). Objective outcomes were measured using a validated Walking Tolerance Test (WTT), the incidence of subsequent lumbar spine interventions, and the occurrence of adverse events. RESULTS: Forty-eight patients initially receiving mild + CMM consented to extended follow-up and were available for 3-year follow-up. All outcomes for this group were significantly improved over baseline (p-values ranging from <0.0001 to 0.0001). At 3-year, ODI, NPRS back and leg, ZCQ symptom severity, and physical function improved by 16.9, 3.0, 4.3, 0.8, and 0.6, respectively. Walking tolerance test demonstrated 274 % improvement from baseline, and only 4 (5.6 %) patients had received surgical intervention. No device- or procedure-related adverse events were reported. CONCLUSIONS: MOTION 3-year follow-up results continue to demonstrate the safety and durability of the mild Procedure combined with CMM for early interventional treatment of symptomatic LSS. The absence of device or procedure-related adverse events further underscores the robust safety profile of the mild Procedure. Significant and substantial improvements in all the outcomes were observed from baseline to follow-up for patients treated with the mild Procedure. These results support the mild Procedure as an effective approach for early intervention in LSS treatment.