NCT03610737

The MOTION Study - Treatment of LSS With the MILD Procedure

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 155 (actual)
• Sponsor: Vertos Medical, Inc. · Industry
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

• Spinal Stenosis, Lumbar Region, With Neurogenic Claudication

Interventions

Type	Name	Description
DEVICE	MILD Procedure	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
OTHER	Conventional Medical Management (CMM)	CMM can include physical therapy, home exercise, pain medication, epidural steroid injections, nerve blocks, and other lumbar steroid injections.

Timeline

• Start date: 2018-08-02
• Primary completion: 2021-05-30
• Completion: 2025-04-30
• First posted: 2018-08-01
• Last updated: 2024-10-02
• Results posted: 2023-05-01

Locations

18 sites across 1 country: United States

Regulatory

• FDA-regulated device study