The MOTION Study - Treatment of LSS With the MILD Procedure

NCT03610737 | Active Not Recruiting Results FDA Device

• 1 other identifier: Motion
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 18

Brief 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.

Conditions

Spinal Stenosis, Lumbar Region, With Neurogenic Claudication

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

MILD with CMM

ACTIVE COMPARATOR

The MILD procedure is an image-guided minimally-invasive lumbar decompression with conventional medical managment

Device: MILD Procedure; Other: Conventional Medical Management (CMM)

CMM alone

ACTIVE COMPARATOR

Patient in the CMM alone group can have physical therapy, home exercise, pain medication, epidural steroid injections, nerve blocks, and other lumbar steroid injections.

Other: Conventional Medical Management (CMM)

Interventions

MILD Procedure DEVICE

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

MILD with CMM

Conventional Medical Management (CMM) OTHER

CMM can include physical therapy, home exercise, pain medication, epidural steroid injections, nerve blocks, and other lumbar steroid injections.

CMM alone; MILD with CMM

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vertos Medical, Inc.: lead

Study Sites (18)

Newport Heache & Pain

Newport Beach, California, 92660, United States

Location

Centura Spine Center

Colorado Springs, Colorado, 80923, United States

Location

Spine & Pain Institute of Florida

Lakeland, Florida, 33602, United States

Location

SIMED

Ocala, Florida, 34474, United States

Location

The Pain Management and Rehabilitation Center

Seymour, Indiana, 47274, United States

Location

Kansas Pain Management

Overland Park, Kansas, 66201, United States

Location

Interventional Pain Management Specialists

Overland Park, Kansas, 66209, United States

Location

University of Kentucky

Lexington, Kentucky, 40508, United States

Location

MI Interventional Pain Center

Brownstown, Michigan, 48183, United States

Location

Michigan Pain Specialists

Ypsilanti, Michigan, 63376, United States

Location

Center for Pain Management

Hackensack, New Jersey, 07601, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Roanoke-Chowan Pain Management

Ahoskie, North Carolina, 27910, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

UH St. John Pain Management Center

Westlake, Ohio, 44145, United States

Location

Pennsylvania Pain & Spine Institute

Chalfont, Pennsylvania, 18914, United States

Location

Precision Spin Care

Tyler, Texas, 75701, United States

Location

The Center for Pain Relief

Charleston, West Virginia, 25301, United States

Location

Related Publications (2)

• 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):109-119. doi: 10.1111/papr.13293. Epub 2023 Sep 3.

  PMID: 37661347 RESULT

• Deer TR, Costandi SJ, Washabaugh E, Chafin TB, Wahezi SE, Jassal N, Sayed D. The MOTION Study: A Randomized Controlled Trial with Objective Real-World Outcomes for Lumbar Spinal Stenosis Patients Treated with the mild(R) Procedure: One-Year Results. Pain Med. 2022 Apr 8;23(4):625-634. doi: 10.1093/pm/pnac028.

  PMID: 35167700 DERIVED

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Results Point of Contact

• Title: Angie Lee
• Organization: Vertos Medical

alee@vertosmed.com

949-349-0008

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2018
• First Posted: August 1, 2018
• Study Start: August 2, 2018
• Primary Completion: May 30, 2021
• Study Completion: April 30, 2025
• Last Updated: October 2, 2024
• Results First Posted: May 1, 2023

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (18)