The MOTION Study - Treatment of LSS With the MILD Procedure

• Sponsor: Vertos Medical, Inc. (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03610737
• Collaborator: (none)
• Enrollment: 150
• Locations: 18
• Arms: 2
• Anticipated Duration (Months): 80.9
• Patients Per Site: 8.3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Stenosis, Lumbar Region, With Neurogenic Claudication	Device: MILD Procedure; Other: Conventional Medical Management (CMM)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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.
• Actual Study Start Date: Aug 2, 2018
• Actual Primary Completion Date: May 30, 2021
• Anticipated Study Completion Date: Apr 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: MILD with CMM The MILD procedure is an image-guided minimally-invasive lumbar decompression with conventional medical managment	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.
Active Comparator: CMM alone 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); CMM can include physical therapy, home exercise, pain medication, epidural steroid injections, nerve blocks, and other lumbar steroid injections.

Outcome Measures

Primary Outcome Measures

1. Mean Change in Oswestry Disability Index (ODI) [12 month]

   Mean change in ODI for patients without a disallowed procedure/imputation of no improvement for patients receiving a disallowed procedure.

Secondary Outcome Measures

1. Mean Change in Numeric Pain Rating Scale (NPRS) [12 Month]

   NPRS measures pain intensity on scale of 0 to 10. Zero (0) represents 'no pain' and '10' represents the "worst pain imaginable".

2. Mean Change in Zurich Claudication Questionaire (ZCQ) [12month]

   ZCQ quantifies severity of symptoms, physical function characteristics, and patient's satisfaction after treatment. Symptom severity scale (1-5), Physical function scale (1-4), Patient's satisfaction (1-4). The lower the score the better.

3. Walking Tolerance Test [12 month]

   Subjects will walk at their own desired pace, and time to symptoms will be recorded.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Newport Heache & Pain	Newport Beach	California	United States	92660
2	Centura Spine Center	Colorado Springs	Colorado	United States	80923
3	Spine & Pain Institute of Florida	Lakeland	Florida	United States	33602
4	SIMED	Ocala	Florida	United States	34474
5	The Pain Management and Rehabilitation Center	Seymour	Indiana	United States	47274
6	Kansas Pain Management	Overland Park	Kansas	United States	66201
7	Interventional Pain Management Specialists	Overland Park	Kansas	United States	66209
8	University of Kentucky	Lexington	Kentucky	United States	40508
9	MI Interventional Pain Center	Brownstown	Michigan	United States	48183
10	Michigan Pain Specialists	Ypsilanti	Michigan	United States	63376
11	Center for Pain Management	Hackensack	New Jersey	United States	07601
12	Montefiore Medical Center	Bronx	New York	United States	10467
13	Roanoke-Chowan Pain Management	Ahoskie	North Carolina	United States	27910
14	Cleveland Clinic	Cleveland	Ohio	United States	44195
15	UH St. John Pain Management Center	Westlake	Ohio	United States	44145
16	Pennsylvania Pain & Spine Institute	Chalfont	Pennsylvania	United States	18914
17	Precision Spin Care	Tyler	Texas	United States	75701
18	The Center for Pain Relief	Charleston	West Virginia	United States	25301

Sponsors and Collaborators

• Vertos Medical, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vertos Medical, Inc.
• ClinicalTrials.gov Identifier: NCT03610737
• Other Study ID Numbers: Motion
• First Posted: Aug 1, 2018
• Last Update Posted: Oct 13, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Spinal Stenosis; Constriction, Pathologic

Study Results

No Results Posted as of Oct 13, 2021