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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03610737
• Other study ID #: Motion
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 2, 2018
• Est. completion date: April 30, 2025

Study information

• Verified date: February 2024
• Source: Vertos Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 155
• Est. completion date: April 30, 2025
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients experiencing neurogenic claudication symptoms for at least 3 months duration.
• LSS with neurogenic claudication
• Radiologic evidence of LSS with unilateral or bilateral ligamentum flavum = 2.5mm confirmed by pre-op MRI or CT performed within 12 months of baseline visit.
• Patients with comorbid conditions commonly associated with spinal stenosis, such as osteophytes, facet hypertrophy, minor spondylolisthesis (Grade I without instability), foraminal stenosis, and/or disk protrusion may be included unless the treating physician has determined that the condition is too advanced.
• Stable opioid intake with no change during 30 days prior to enrollment.
• Available to complete all follow-up visits.

Exclusion Criteria:

• ODI Score < 31 (0-100 ODI Scale).
• NPRS Score < 5 (0-10 NPRS Scale).
• Lumbar epidural injections during eight weeks prior to study enrollment.
• Baseline analgesic medication greater than 90 milligram morphine equivalent (MME).
• Prior surgery at the same treatment level.
• Previously received interspinous spacer at the same treatment level.
• Previously received intradiscal procedure at the same treatment level.
• Previously received vertebral augmentation procedure at the same treatment level.
• Previously received the MILD procedure at the same treatment level.
• Received radiofrequency ablation at the same or the adjacent levels within 6 months prior to study enrollment.
• History of spinal fractures with current related pain symptoms.
• Grade II or higher spondylolisthesis.
• Motor deficit or disabling back and/or leg pain from causes other than LSS neurogenic claudication (e.g. acute compression fracture, metabolic neuropathy, or vascular claudication symptoms, etc.).
• Unable to walk = 10 feet unaided before being limited by pain. In this context, 'unaided' means without the use of a cane, walker, railing, wall, another person or any other means of walking assistance.
• Previously randomized and/or treated in this clinical study.
• Epidural lipomatosis (if it is deemed to be a significant contributor of canal narrowing by the physician).
• On (or pending) Workman's Compensation or known to be considering litigation associated with back pain.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Roanoke-Chowan Pain Management	Ahoskie	North Carolina
United States	Montefiore Medical Center	Bronx	New York
United States	MI Interventional Pain Center	Brownstown	Michigan
United States	Pennsylvania Pain & Spine Institute	Chalfont	Pennsylvania
United States	The Center for Pain Relief	Charleston	West Virginia
United States	Cleveland Clinic	Cleveland	Ohio
United States	Centura Spine Center	Colorado Springs	Colorado
United States	Center for Pain Management	Hackensack	New Jersey
United States	Spine & Pain Institute of Florida	Lakeland	Florida
United States	University of Kentucky	Lexington	Kentucky
United States	Newport Heache & Pain	Newport Beach	California
United States	SIMED	Ocala	Florida
United States	Interventional Pain Management Specialists	Overland Park	Kansas
United States	Kansas Pain Management	Overland Park	Kansas
United States	The Pain Management and Rehabilitation Center	Seymour	Indiana
United States	Precision Spin Care	Tyler	Texas
United States	UH St. John Pain Management Center	Westlake	Ohio
United States	Michigan Pain Specialists	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Vertos Medical, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Deer TR, Chafin TB, Costandi SJ, Qu H, Kim C, Jassal N, Patel K, Calodney A. The MOTION study: Two-year results of a real-world randomized controlled trial of the mild(R) procedure for treatment of lumbar spinal stenosis. Pain Pract. 2024 Jan;24(1):109-11 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change in Oswestry Disability Index (ODI)	Oswestry Disability Index (ODI) is a widely-used validated questionnaire use to measure a patient's functional disability. The total score ranges from 0 (no disability) - 100 (complete disability). Score categories: 0-20 (minimal disability), 21-40 (moderate disability), 41-60 (severe disability), 61-80 (crippling back pain), 81-100 (bed bound or have an exaggerating).	Mean Change in Oswestry Disability Index (ODI) baseline to 12 month