LAUSR

OBJECTIVE The purpose of this study is to provide Level-1 objective, real-world outcome data for patients with lumbar spinal stenosis suffering from neurogenic claudication secondary to hypertrophic ligamentum flavum(HLF). DESIGN The MOTION Study is a prospective, multi-center, randomized controlled trial comparing the mild® Procedure as a first-line therapy in combination with non-surgical conventional medical management (CMM) to CMM alone as the active control. METHODS Patients in the test group received the mild Procedure at baseline. Both the mild+CMM and the control group were allowed unrestricted access to conventional real-world therapies. Patient reported outcomes included Oswestry Disability Index, Zurich Claudication Questionnaire, and Numeric Pain Rating Scale. A validated Walking Tolerance Test, incidence of subsequent lumbar spine interventions, and occurrence of adverse events were used to measure objective outcomes. RESULTS Sixty-nine patients in each group were analyzed at 1-year follow-up. No device or procedure-related adverse events were reported in either group. Results from all primary and secondary outcome measures showed statistical significance in favor of mild+CMM. CONCLUSIONS One-year results of this Level-1 study demonstrated superiority of mild+CMM over the use of CMM-Alone for LSS patients suffering from neurogenic claudication secondary to HLF. Use of the validated Walking Tolerance Test to objectively measure increased ability to walk without severe symptoms provided evidence of statistically-significantly better outcomes for mild+CMM versus CMM-Alone. With no reported device or procedure-related adverse events, the long-standing safety profile of the mild Procedure was reaffirmed. mild is a safe, durable, minimally-invasive procedure that has been shown to be effective as an early interventional therapy for patients suffering from symptomatic LSS.