Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

The MOTION Study - Treatment of LSS With the MILD Procedure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03610737
Recruitment Status : Recruiting
First Posted : August 1, 2018
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
Vertos Medical, Inc.

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 will be allowed to crossover and receive MILD after completion of 12-month follow-up.

Condition or disease Intervention/treatment Phase
Spinal Stenosis, Lumbar Region, With Neurogenic Claudication Device: MILD Procedure Other: Conventional Medical Management (CMM) Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : August 2, 2018
Estimated Primary Completion Date : July 30, 2020
Estimated Study Completion Date : February 22, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spinal Stenosis

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.




Primary Outcome Measures :
  1. Mean Change in ODI [ Time Frame: 6 month ]

    Oswestry Disability Index (ODI) measures permanent functional disability using questions regarding activities of daily living (ADL), specifically disturbance in ADL related to chronic back pain. Higher score indicate a 'more limited' life.

    The ten topics of the ODI are rated from zero (no pain/limitation) to five (high pain/very limited physically). Calculated values range from zero (0% disability) to 100 (100% disability).



Secondary Outcome Measures :
  1. Mean Change in NPRS [ Time Frame: 6 month ]
    Numeric Pain Rating Scale (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 ZCQ [ Time Frame: 6 month ]
    Zurich Claudication Questionaire (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. Steps/Walking Distance [ Time Frame: 6 month ]
    Steps and walking distance will be measured by Fitbit device

  4. Walking Time [ Time Frame: 6 month ]
    Subjects will walk at their own desired pace, and time to first symptoms and time to severe symptoms will be recorded.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03610737


Contacts
Layout table for location contacts
Contact: Karen L Davis 877-958-6227 kdavis@vertosmed.com
Contact: Angie Lee alee@vertosmed.com

Locations
Layout table for location information
United States, Florida
Florida Pain Medicine Recruiting
Wesley Chapel, Florida, United States, 33544
Contact    813-388-2948      
United States, Indiana
The Pain Management and Rehabilitation Center Recruiting
Seymour, Indiana, United States, 47274
Contact    812-523-3700      
United States, Kansas
Kansas Pain Management Recruiting
Overland Park, Kansas, United States, 66201
Contact    913-339-9437      
Interventional Pain Management Specialists Recruiting
Overland Park, Kansas, United States, 66209
Contact    913-498-7240      
United States, Michigan
MI Interventional Pain Center Recruiting
Brownstown, Michigan, United States, 48183
Contact    734-479-7246      
Michigan Pain Specialists Recruiting
Ypsilanti, Michigan, United States, 63376
Contact    734-547-4860      
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact    718-920-7246      
United States, North Carolina
Roanoke-Chowan Pain Management Recruiting
Ahoskie, North Carolina, United States, 27910
Contact    252-209-3360      
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact    440-695-4000      
United States, Pennsylvania
Pennsylvania Pain & Spine Institute Recruiting
Chalfont, Pennsylvania, United States, 18914
Contact    215-608-0126      
United States, Texas
Precision Spin Care Recruiting
Tyler, Texas, United States, 75701
Contact    903-592-6000      
United States, West Virginia
The Center for Pain Relief Recruiting
Charleston, West Virginia, United States, 25301
Contact    304-347-6120      
Sponsors and Collaborators
Vertos Medical, Inc.

Layout table for additonal information
Responsible Party: Vertos Medical, Inc.
ClinicalTrials.gov Identifier: NCT03610737     History of Changes
Other Study ID Numbers: Motion
First Posted: August 1, 2018    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Constriction, Pathologic
Intermittent Claudication
Spinal Stenosis
Pathological Conditions, Anatomical
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases