This trial is active, not recruiting.

Condition spinal stenosis, lumbar region, with neurogenic claudication
Treatments minimally invasive lumbar decompression, epidural steroid injection
Sponsor Vertos Medical, Inc.
Start date May 2014
End date April 2017
Trial size 302 participants
Trial identifier NCT02093520, MiDAS ENCORE


Study Objective: To compare patient outcomes following treatment with either the MILD procedure or epidural steroid injections (ESIs) in patients with painful lumbar spinal stenosis exhibiting neurogenic claudication and having verified ligamentum flavum hypertrophy as a contributing factor.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
Image guided minimally-invasive lumbar decompression
minimally invasive lumbar decompression MILD lumbar decompression
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.
(Active Comparator)
An epidural steroid injection (ESI) is a combination of a corticosteroid with a local anesthetic pain relief medicine.
epidural steroid injection ESI
Injection of epidural steroids into the lumbar spine

Primary Outcomes

Oswestry Disability Index (ODI)
time frame: 12 months

Secondary Outcomes

Numeric Pain Rating Scale (NPRS)
time frame: 12 months

Eligibility Criteria

Male or female participants at least 65 years old.

Inclusion Criteria: 1. 65 years or older and a Medicare beneficiary. 2. Patients experiencing neurogenic claudication symptoms for at least 3 months duration which has failed to respond or poorly responded to physical therapy, home exercise programs, and oral analgesics. 3. LSS with neurogenic claudication diagnosed via: 1. Symptomatic diagnosis and 2. 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. 4. Patients with comorbid conditions commonly associated with spinal stenosis, such as osteophytes, facet hypertrophy, minor spondylolisthesis, foraminal stenosis, and/or disk protrusion may be included unless the treating physician has determined that the condition is too advanced. 5. Available to complete 6 month and one year follow-up visits. Exclusion Criteria: 1. ODI Score < 31 (0-100 ODI Scale). 2. NPRS Score < 5 (0-10 NPRS Scale). 3. Prior surgery at any treatment level. 4. History of recent spinal fractures with current related pain symptoms. 5. Patients with Grade III or higher spondylolisthesis. 6. 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.). 7. 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. 8. Patients previously randomized and/or treated in this clinical study. 9. Patients that have previously received the MILD procedure. 10. ESI during eight weeks prior to study enrollment. 11. Epidural lipomatosis (if it is deemed to be a significant contributor of canal narrowing by the physician). 12. On (or pending) Workman's Compensation or known to be considering litigation associated with back pain.

Additional Information

Official title MILD® Percutaneous Image-Guided Lumbar Decompression Versus Epidural Steroid Injections in Patients With Lumbar Spinal Stenosis Exhibiting Neurogenic Claudication
Principal investigator Ramsin Benyamin, MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Vertos Medical, Inc..