Purpose

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

Eligibility

Eligible Ages
Between 50 Years and 80 Years
Eligible Genders
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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

Montefiore Medical Center
Bronx, New York 10467
Contact:
718-920-7246

More Details

NCT ID
NCT03610737
Status
Recruiting
Sponsor
Vertos Medical, Inc.

Study Contact

Karen L Davis
877-958-6227
kdavis@vertosmed.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.