The MOTIONStudy: A Randomized Controlled Trial with Objective Real-World Outcomes for Lumbar Spinal Stenosis Patients Treated with the mild® Procedure: One-Year Results

Author:

Deer Timothy R1ORCID,Costandi Shrif J2,Washabaugh Edward3,Chafin Timothy B4,Wahezi Sayed E5,Jassal Navdeep6,Sayed Dawood7

Affiliation:

1. The Spine & Nerve Centers of the Virginias, Charleston, West Virginia

2. Department of Pain Management, Cleveland Clinic, Cleveland, Ohio

3. Michigan Pain Specialists, Ypsilanti, Michigan

4. Vidant Roanoke-Chowan Hospital, Ahoskie, North Carolina

5. Multidisciplinary Pain Program,Bronx, New York

6. Spine & Pain Institute of Florida, Lakeland, Florida

7. The University of Kansas Medical Center, Kansas City, Kansas, USA

Abstract

Abstract 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. Design The MOTION Study is a prospective, multicenter, randomized controlled trial comparing the mild® Procedure (minimally invasive lumbar decompression; Vertos Medical, Aliso Viejo, CA, USA) as a first-line therapy in combination with nonsurgical conventional medical management (CMM) vs CMM alone as the active control. Methods Patients in the test group received the mild Procedure at baseline. Both the mild+CMM group and the control group were allowed unrestricted access to conventional real-world therapies. Patient-reported outcomes included the Oswestry Disability Index, the Zurich Claudication Questionnaire, and the Numeric Pain Rating Scale. A validated Walking Tolerance Test, the incidence of subsequent lumbar spine interventions, and the 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 CMM alone for patients with lumbar spinal stenosis who were suffering from neurogenic claudication secondary to hypertrophic ligamentum flavum. 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 than for 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 lumbar spinal stenosis.

Funder

Vertos Medical, Inc

Publisher

Oxford University Press (OUP)

Subject

Anesthesiology and Pain Medicine,Neurology (clinical),General Medicine

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