The MiDAS ENCORE Study

Completed · Not applicable

Conditions studied: Spinal Stenosis, Lumbar Region, With Neurogenic Claudication

In brief

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.

Key facts

Study ID

NCT02093520

Run by

Vertos Medical, Inc.

People needed

302

Starts

2014-05-01

Expected to finish

2017-10-01

Last updated by the study team

2017-12-06

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 65 years or older and a Medicare beneficiary.
• 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.
• LSS with neurogenic claudication diagnosed via:
• Symptomatic diagnosis and
• 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, foraminal stenosis, and/or disk protrusion may be included unless the treating physician has determined that the condition is too advanced.
• Available to complete 6 month and one year follow-up visits.

You may not qualify if…

• ODI Score < 31 (0-100 ODI Scale).
• NPRS Score < 5 (0-10 NPRS Scale).
• Prior surgery at any treatment level.
• History of recent spinal fractures with current related pain symptoms.
• Patients with Grade III 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.
• Patients previously randomized and/or treated in this clinical study.
• Patients that have previously received the MILD procedure.
• ESI during eight weeks prior to study enrollment.
• 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.

Where it is running

• Synovation Medical Group — Chula Vista, California, United States
• Spine Intervention Medical Group/Fresno Surgical Hospital — Fresno, California, United States
• The Spine Institute — Murrieta, California, United States
• Newport Beach Headache and Pain — Newport Beach, California, United States
• Millennium Pain Center — Bloomington, Illinois, United States
• Frankfort Pain Clinic — Frankfort, Kentucky, United States
• MI Interventional Pain Center — Cherry Island, Michigan, United States
• Michigan Pain Specialist — Ypsilanti, Michigan, United States
• Mayo Clinic Pain Management — Rochester, Minnesota, United States
• Premier Pain — Shrewsbury, New Jersey, United States
• Southern Spine Institute — Mt. Pleasant, South Carolina, United States
• SC Spine and Pain Specialists — Myrtle Beach, South Carolina, United States

Full record on ClinicalTrials.gov

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