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The MiDAS ENCORE Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02093520
Recruitment Status : Completed
First Posted : March 21, 2014
Results First Posted : July 17, 2017
Last Update Posted : December 6, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Spinal Stenosis, Lumbar Region, With Neurogenic Claudication Procedure: MILD Procedure Drug: Epidural Steroid Injection Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 302 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: MILD® Percutaneous Image-Guided Lumbar Decompression Versus Epidural Steroid Injections in Patients With Lumbar Spinal Stenosis Exhibiting Neurogenic Claudication
Study Start Date : May 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spinal Stenosis

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 Name: 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 Name: ESI




Primary Outcome Measures :
  1. Number of Participants Who Achieved a Clinically Significant Improvement in the Oswestry Disability Index at 12 Months [ Time Frame: 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 :
  1. Number of Participants Who Acheived a Clinical Significant Improvement in the Numeric Pain Rating Scale (NPRS) at 12 Months [ Time Frame: 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.

  2. Number of Participants Who Achieved a Clinically Significant Improvement in the Zurich Claudication Questionnaire (ZCQ) at 12 Months [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02093520


Locations
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United States, California
Synovation Medical Group
Chula Vista, California, United States, 91914
Spine Intervention Medical Group/Fresno Surgical Hospital
Fresno, California, United States, 93710
The Spine Institute
Murrieta, California, United States, 92563
Newport Beach Headache and Pain
Newport Beach, California, United States, 92660
United States, Illinois
Millennium Pain Center
Bloomington, Illinois, United States, 61701
United States, Kentucky
Frankfort Pain Clinic
Frankfort, Kentucky, United States, 40601
United States, Michigan
MI Interventional Pain Center
Brownstown Charter Township, Michigan, United States, 48183
Michigan Pain Specialist
Ypsilanti, Michigan, United States, 48198
United States, Minnesota
Mayo Clinic Pain Management
Rochester, Minnesota, United States, 55905
United States, New Jersey
Premier Pain
Shrewsbury, New Jersey, United States, 07702
United States, South Carolina
Southern Spine Institute
Mount Pleasant, South Carolina, United States, 29464
SC Spine and Pain Specialists
Myrtle Beach, South Carolina, United States, 29572
Sponsors and Collaborators
Vertos Medical, Inc.
Investigators
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Principal Investigator: Ramsin Benyamin, MD AAPM; ASIPP; ISIS; ASA
Principal Investigator: Peter Staats, MD AAPM; ASIPP; ASA
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Vertos Medical, Inc.
ClinicalTrials.gov Identifier: NCT02093520    
Other Study ID Numbers: MiDAS ENCORE
First Posted: March 21, 2014    Key Record Dates
Results First Posted: July 17, 2017
Last Update Posted: December 6, 2017
Last Verified: May 2017
Keywords provided by Vertos Medical, Inc.:
Lumbar Spinal Stenosis
Spinal Stenosis
Neurogenic Claudication
Additional relevant MeSH terms:
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Spinal Stenosis
Intermittent Claudication
Constriction, Pathologic
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases