At a glance
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A Multi-center, Randomized Controlled Study of the Vertos MILD Procedure With Conventional Medical Management Versus Conventional Medical Management Alone in the Treatment of Lumbar Spinal Stenosis.
In Brief
A clinical study evaluating MILD Procedure and Conventional Medical Management (CMM) for Spinal Stenosis, Lumbar Region, With Neurogenic Claudication. Active but no longer recruiting, targeting 155 participants across 18 sites.
Detailed Summary
Prospective, multicenter, randomized controlled clinical study examining functional improvement in lumbar spinal stenosis (LSS) patients with neurogenic claudication who are treated with the MILD procedure plus conventional medical management (CMM) compared to those treated with CMM alone, as the control. Subjects in the control group are able to crossover and receive MILD after completion of 12-month follow-up. The study will provide objective functional improvement data for patients treated with the mild Procedure as first-line therapy in a real-world setting.
Study Details
Timeline
Interventions
The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue. Other Name: MILD lumbar decompression
CMM can include physical therapy, home exercise, pain medication, epidural steroid injections, nerve blocks, and other lumbar steroid injections.