The MiDAS ENCORE Study

Vertos Medical

Status: Completed

Conditions: Spinal Stenosis, Lumbar Region, With Neurogenic Claudication

Treatments: Procedure: MILD Procedure; Drug: Epidural Steroid Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT02093520

MiDAS ENCORE

Details and patient eligibility

About

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.

Enrollment: 302 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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302 participants in 2 patient groups

MILD

Active Comparator group

Description:

The MILD procedure is an image-guided minimally-invasive lumbar decompression

Treatment:

Procedure: MILD Procedure

Epidural Steroid Injection (ESI)

Active Comparator group

Description:

An epidural steroid injection (ESI) is a combination of a corticosteroid with a local anesthetic pain relief medicine.

Treatment:

Drug: Epidural Steroid Injection