The MiDAS ENCORE Study

NCT02093520 | Completed Results

• 1 other identifier: MiDAS ENCORE
• Study Type: interventional
• Target: 302
• Locations: 1 country
• Sites: 12

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.

Conditions

Spinal Stenosis, Lumbar Region, With Neurogenic Claudication

Keywords

Lumbar Spinal Stenosis; Spinal Stenosis; Neurogenic Claudication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Participants Who Acheived a Clinical Significant Improvement in the Numeric Pain Rating Scale (NPRS) at 12 Months

  12 months

• Number of Participants Who Achieved a Clinically Significant Improvement in the Zurich Claudication Questionnaire (ZCQ) at 12 Months

  12 months

Study Arms (2)

MILD

ACTIVE COMPARATOR

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

Procedure: MILD Procedure

Epidural Steroid Injection (ESI)

ACTIVE COMPARATOR

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

Drug: Epidural Steroid Injection

Interventions

MILD Procedure 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.

Also known as: MILD lumbar decompression

MILD

Epidural Steroid Injection DRUG

Injection of epidural steroids into the lumbar spine

Also known as: ESI

Epidural Steroid Injection (ESI)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Vertos Medical, Inc.: lead

Study Sites (12)

Synovation Medical Group

Chula Vista, California, 91914, United States

Location

Spine Intervention Medical Group/Fresno Surgical Hospital

Fresno, California, 93710, United States

Location

The Spine Institute

Murrieta, California, 92563, United States

Location

Newport Beach Headache and Pain

Newport Beach, California, 92660, United States

Location

Millennium Pain Center

Bloomington, Illinois, 61701, United States

Location

Frankfort Pain Clinic

Frankfort, Kentucky, 40601, United States

Location

MI Interventional Pain Center

Cherry Island, Michigan, 48183, United States

Location

Michigan Pain Specialist

Ypsilanti, Michigan, 48198, United States

Location

Mayo Clinic Pain Management

Rochester, Minnesota, 55905, United States

Location

Premier Pain

Shrewsbury, New Jersey, 07702, United States

Location

Southern Spine Institute

Mt. Pleasant, South Carolina, 29464, United States

Location

SC Spine and Pain Specialists

Myrtle Beach, South Carolina, 29572, United States

Location

Related Publications (3)

• 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.

  PMID: 30199512 DERIVED

• 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.

  PMID: 27228511 DERIVED

• 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.

  PMID: 26815247 DERIVED

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Results Point of Contact

• Title: VP of Clinical Affairs
• Organization: Vertos Medical

kdavis@vertosmed.com

9493490008

Study Officials

• Ramsin Benyamin, MD

  AAPM; ASIPP; ISIS; ASA

  PRINCIPAL INVESTIGATOR

• Peter Staats, MD

  AAPM; ASIPP; ASA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2014
• First Posted: March 21, 2014
• Study Start: May 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: October 1, 2017
• Last Updated: December 6, 2017
• Results First Posted: July 17, 2017

Record last verified: 2017-05

Locations

US (12)