The MiDAS ENCORE Study

Not Applicable

Completed

• Conditions: Spinal Stenosis, Lumbar Region, With Neurogenic Claudication
• Interventions: Procedure: MILD Procedure; Drug: Epidural Steroid Injection

• Registration Number: NCT02093520
• Lead Sponsor: Vertos Medical, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-18
• Study First Submitted QC: 2014-03-20
• Study First Posted: 2014-03-21
• Study Start: 2014-05
• Primary Completion: 2016-05
• Status Verified: 2017-05
• Results First Submitted: 2017-05-23
• Results First Submitted QC: 2017-06-15
• Results First Posted: 2017-07-17
• Study Completion: 2017-10
• Last Update Submitted: 2017-10-31
• Last Update Posted: 2017-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 302

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MILD	MILD Procedure	The MILD procedure is an image-guided minimally-invasive lumbar decompression
Epidural Steroid Injection (ESI)	Epidural Steroid Injection	An epidural steroid injection (ESI) is a combination of a corticosteroid with a local anesthetic pain relief medicine.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Achieved a Clinically Significant Improvement in the Oswestry Disability Index at 12 Months	12 months	Proportion of ODI Responders from baseline to one year follow-up in the treatment group versus the proportion of ODI Responders from baseline to one year follow-up in the control group. ODI Responders are defined as those patients achieving the validated Minimal Important Change in ODI score from baseline to follow-up as a clinically significant efficacy threshold.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Acheived a Clinical Significant Improvement in the Numeric Pain Rating Scale (NPRS) at 12 Months	12 months	Proportion of NPRS Responders from baseline to one year follow-up in each of the two treatment groups using validated Minimal Important Change value as the clinically significant efficacy threshold.
Number of Participants Who Achieved a Clinically Significant Improvement in the Zurich Claudication Questionnaire (ZCQ) at 12 Months	12 months	Proportion of ZCQ Responders from baseline to one year follow-up in each of the two treatment groups using validated Minimal Important Change value as the clinically significant efficacy threshold.

Trial Locations

Locations (12)

Spine Intervention Medical Group/Fresno Surgical Hospital; 🇺🇸 Fresno, California, United States

Synovation Medical Group; 🇺🇸 Chula Vista, California, United States

Southern Spine Institute; 🇺🇸 Mount Pleasant, South Carolina, United States

Newport Beach Headache and Pain; 🇺🇸 Newport Beach, California, United States

The Spine Institute; 🇺🇸 Murrieta, California, United States

Michigan Pain Specialist; 🇺🇸 Ypsilanti, Michigan, United States

MI Interventional Pain Center; 🇺🇸 Brownstown Charter Township, Michigan, United States

SC Spine and Pain Specialists; 🇺🇸 Myrtle Beach, South Carolina, United States

Mayo Clinic Pain Management; 🇺🇸 Rochester, Minnesota, United States

Frankfort Pain Clinic; 🇺🇸 Frankfort, Kentucky, United States

Premier Pain; 🇺🇸 Shrewsbury, New Jersey, United States

Millennium Pain Center; 🇺🇸 Bloomington, Illinois, United States