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The MiDAS ENCORE Study

Primary Purpose

Spinal Stenosis, Lumbar Region, With Neurogenic Claudication

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MILD Procedure
Epidural Steroid Injection
Sponsored by
Vertos Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Stenosis, Lumbar Region, With Neurogenic Claudication focused on measuring Lumbar Spinal Stenosis, Spinal Stenosis, Neurogenic Claudication

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Synovation Medical Group
  • Spine Intervention Medical Group/Fresno Surgical Hospital
  • The Spine Institute
  • Newport Beach Headache and Pain
  • Millennium Pain Center
  • Frankfort Pain Clinic
  • MI Interventional Pain Center
  • Michigan Pain Specialist
  • Mayo Clinic Pain Management
  • Premier Pain
  • Southern Spine Institute
  • SC Spine and Pain Specialists

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

MILD

Epidural Steroid Injection (ESI)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
March 18, 2014
Last Updated
October 31, 2017
Sponsor
Vertos Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02093520
Brief Title
The MiDAS ENCORE Study
Official Title
MILD® Percutaneous Image-Guided Lumbar Decompression Versus Epidural Steroid Injections in Patients With Lumbar Spinal Stenosis Exhibiting Neurogenic Claudication
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vertos Medical, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Stenosis, Lumbar Region, With Neurogenic Claudication
Keywords
Lumbar Spinal Stenosis, Spinal Stenosis, Neurogenic Claudication

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
302 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MILD
Arm Type
Active Comparator
Arm Description
The MILD procedure is an image-guided minimally-invasive lumbar decompression
Arm Title
Epidural Steroid Injection (ESI)
Arm Type
Active Comparator
Arm Description
An epidural steroid injection (ESI) is a combination of a corticosteroid with a local anesthetic pain relief medicine.
Intervention Type
Procedure
Intervention Name(s)
MILD Procedure
Other Intervention Name(s)
MILD lumbar decompression
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Epidural Steroid Injection
Other Intervention Name(s)
ESI
Intervention Description
Injection of epidural steroids into the lumbar spine
Primary Outcome Measure Information:
Title
Number of Participants Who Achieved a Clinically Significant Improvement in the Oswestry Disability Index at 12 Months
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Number of Participants Who Acheived a Clinical Significant Improvement in the Numeric Pain Rating Scale (NPRS) at 12 Months
Description
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.
Time Frame
12 months
Title
Number of Participants Who Achieved a Clinically Significant Improvement in the Zurich Claudication Questionnaire (ZCQ) at 12 Months
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ramsin Benyamin, MD
Organizational Affiliation
AAPM; ASIPP; ISIS; ASA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Staats, MD
Organizational Affiliation
AAPM; ASIPP; ASA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Synovation Medical Group
City
Chula Vista
State/Province
California
ZIP/Postal Code
91914
Country
United States
Facility Name
Spine Intervention Medical Group/Fresno Surgical Hospital
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Facility Name
The Spine Institute
City
Murrieta
State/Province
California
ZIP/Postal Code
92563
Country
United States
Facility Name
Newport Beach Headache and Pain
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
Millennium Pain Center
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61701
Country
United States
Facility Name
Frankfort Pain Clinic
City
Frankfort
State/Province
Kentucky
ZIP/Postal Code
40601
Country
United States
Facility Name
MI Interventional Pain Center
City
Brownstown Charter Township
State/Province
Michigan
ZIP/Postal Code
48183
Country
United States
Facility Name
Michigan Pain Specialist
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48198
Country
United States
Facility Name
Mayo Clinic Pain Management
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Premier Pain
City
Shrewsbury
State/Province
New Jersey
ZIP/Postal Code
07702
Country
United States
Facility Name
Southern Spine Institute
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
SC Spine and Pain Specialists
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30199512
Citation
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.
Results Reference
derived
PubMed Identifier
27228511
Citation
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.
Results Reference
derived
PubMed Identifier
26815247
Citation
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.
Results Reference
derived

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The MiDAS ENCORE Study

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