The MOTION Study - Treatment of LSS With the MILD Procedure

• ClinicalTrials.gov Identifier: NCT03610737
• Recruitment Status: Active, not recruiting
• First Posted: August 1, 2018
• Last Update Posted: November 12, 2020
• Sponsor: Vertos Medical, Inc.
• Information provided by (Responsible Party): Vertos Medical, Inc.

Tracking Information

• First Submitted Date: June 28, 2018
• First Posted Date: August 1, 2018
• Last Update Posted Date: November 12, 2020
• Actual Study Start Date: August 2, 2018
• Estimated Primary Completion Date: March 30, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 24, 2018)

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).

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 24, 2018)

• 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".
• 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.
• Steps/Walking Distance [ Time Frame: 6 month ]
  Steps and walking distance will be measured by Fitbit device
• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The MOTION Study - Treatment of LSS With the MILD Procedure
• 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.
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: 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.

Study Arms

• Active Comparator: MILD with CMM
  The MILD procedure is an image-guided minimally-invasive lumbar decompression with conventional medical managment
  Interventions:

  • Device: MILD Procedure
  • Other: Conventional Medical Management (CMM)
• 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.
  Intervention: Other: Conventional Medical Management (CMM)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: July 24, 2018): 150
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 30, 2022
• Estimated Primary Completion Date: March 30, 2021 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03610737
• Other Study ID Numbers: Motion
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Vertos Medical, Inc.
• Study Sponsor: Vertos Medical, Inc.
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Vertos Medical, Inc.
• Verification Date: November 2019