The MiDAS ENCORE Study

MILD® Percutaneous Image-Guided Lumbar Decompression Versus Epidural Steroid Injections in Patients With Lumbar Spinal Stenosis Exhibiting Neurogenic Claudication

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.

Study Overview

• Status: Completed
• Conditions: Spinal Stenosis, Lumbar Region, With Neurogenic Claudication
• Intervention / Treatment: Procedure: MILD Procedure; Drug: Epidural Steroid Injection

• Study Type: Interventional
• Enrollment (Actual): 302
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Chula Vista, California, United States, 91914
      • Synovation Medical Group
    • Fresno, California, United States, 93710
      • Spine Intervention Medical Group/Fresno Surgical Hospital
    • Murrieta, California, United States, 92563
      • The Spine Institute
    • Newport Beach, California, United States, 92660
      • Newport Beach Headache and Pain
  • Illinois
    • Bloomington, Illinois, United States, 61701
      • Millennium Pain Center
  • Kentucky
    • Frankfort, Kentucky, United States, 40601
      • Frankfort Pain Clinic
  • Michigan
    • Brownstown Charter Township, Michigan, United States, 48183
      • MI Interventional Pain Center
    • Ypsilanti, Michigan, United States, 48198
      • Michigan Pain Specialist
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Pain Management
  • New Jersey
    • Shrewsbury, New Jersey, United States, 07702
      • Premier Pain
  • South Carolina
    • Mount Pleasant, South Carolina, United States, 29464
      • Southern Spine Institute
    • Myrtle Beach, South Carolina, United States, 29572
      • SC Spine and Pain Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: MILD; The MILD procedure is an image-guided minimally-invasive lumbar decompression	Procedure: 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 Names: MILD lumbar decompression
Active Comparator: Epidural Steroid Injection (ESI); An epidural steroid injection (ESI) is a combination of a corticosteroid with a local anesthetic pain relief medicine.	Drug: Epidural Steroid Injection; Injection of epidural steroids into the lumbar spine; Other Names: ESI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Achieved a Clinically Significant Improvement in the Oswestry Disability Index at 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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Acheived a Clinical Significant Improvement in the Numeric Pain Rating Scale (NPRS) at 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.	12 months
Number of Participants Who Achieved a Clinically Significant Improvement in the Zurich Claudication Questionnaire (ZCQ) at 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.	12 months

Collaborators and Investigators

• Sponsor: Vertos Medical, Inc.
• Investigators: Principal Investigator: Ramsin Benyamin, MD, AAPM; ASIPP; ISIS; ASA; Principal Investigator: Peter Staats, MD, AAPM; ASIPP; ASA

Publications and helpful links

General Publications

• Staats PS, Chafin TB, Golovac S, Kim CK, Li S, Richardson WB, Vallejo R, Wahezi SE, Washabaugh EP 3rd, Benyamin RM; MiDAS ENCORE Investigators. Long-Term Safety and Efficacy of Minimally Invasive Lumbar Decompression Procedure for the Treatment of Lumbar Spinal Stenosis With Neurogenic Claudication: 2-Year Results of MiDAS ENCORE. Reg Anesth Pain Med. 2018 Oct;43(7):789-794. doi: 10.1097/AAP.0000000000000868.
• Benyamin RM, Staats PS, MiDAS Encore I. MILD(R) Is an Effective Treatment for Lumbar Spinal Stenosis with Neurogenic Claudication: MiDAS ENCORE Randomized Controlled Trial. Pain Physician. 2016 May;19(4):229-42.
• Staats PS, Benyamin RM; MiDAS ENCORE Investigators. MiDAS ENCORE: Randomized Controlled Clinical Trial Report of 6-Month Results. Pain Physician. 2016 Feb;19(2):25-38.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: March 18, 2014
• First Submitted That Met QC Criteria: March 20, 2014
• First Posted (Estimate): March 21, 2014

Study Record Updates

• Last Update Posted (Actual): December 6, 2017
• Last Update Submitted That Met QC Criteria: October 31, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Spinal Stenosis; Lumbar Spinal Stenosis; Neurogenic Claudication
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Intermittent Claudication; Constriction, Pathologic; Spinal Stenosis
• Other Study ID Numbers: MiDAS ENCORE