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.
Brief Title
The MOTION Study - Treatment of LSS With the MILD Procedure
Detailed Description
The study will follow participants treated in the MILD plus CMM group and crossover participants for up to 5 years on annual bases.
Completion Date
Completion Date Type
Estimated
Conditions
Spinal Stenosis, Lumbar Region, With Neurogenic Claudication
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.
* 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.
Inclusion 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.
* 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.
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
80 Years
Minimum Age
50 Years
NCT Id
NCT03610737
Org Class
Industry
Org Full Name
Vertos Medical, Inc.
Org Study Id
Motion
Overall Status
Active, not recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
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.
Primary Outcomes
Outcome Description
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).
Outcome Measure
Mean Change in Oswestry Disability Index (ODI)
Outcome Time Frame
Mean Change in Oswestry Disability Index (ODI) baseline to 12 month
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
80
Minimum Age Number (converted to Years and rounded down)
50
Investigators
Investigator Type
Principal Investigator
Investigator Name
Sayed Wahezi
Investigator Email
swahezi@montefiore.org