The MOTION Study - Treatment of LSS With the MILD Procedure

Spinal Stenosis, Lumbar Region, With Neurogenic Claudication Clinical Trial

Official title: 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.

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

The study will follow participants treated in the MILD plus CMM group and crossover participants for up to 5 years on annual bases. ;

Related Conditions & MeSH terms

• Constriction, Pathologic
• Spinal Stenosis
• Spinal Stenosis, Lumbar Region, With Neurogenic Claudication

• NCT number: NCT03610737
• Study type: Interventional
• Source: Vertos Medical, Inc.
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 2, 2018
• Completion date: April 30, 2025