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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.

Tracking Information
First Submitted Date  ICMJE March 18, 2014
First Posted Date  ICMJE March 21, 2014
Results First Submitted Date  ICMJE May 23, 2017
Results First Posted Date  ICMJE July 17, 2017
Last Update Posted Date December 6, 2017
Study Start Date  ICMJE May 2014
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 15, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 20, 2014)
Oswestry Disability Index (ODI) [ Time Frame: 12 months ]
The primary efficacy endpoint for this study will be superiority of ODI improvement of the treatment group versus the control group
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 15, 2017)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2014)
Numeric Pain Rating Scale (NPRS) [ Time Frame: 12 months ]
Mean improvement from baseline for each group using validated Minimal Important Change values as clinically significant efficacy thresholds.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: March 20, 2014)
Zurich Claudication Questionnaire (ZCQ) [ Time Frame: 12 months ]
Mean improvement from baseline for each group using validated Minimal Important Change values as clinically significant efficacy thresholds.
 
Descriptive Information
Brief Title  ICMJE The MiDAS ENCORE Study
Official Title  ICMJE MILD® Percutaneous Image-Guided Lumbar Decompression Versus Epidural Steroid Injections in Patients With Lumbar Spinal Stenosis Exhibiting Neurogenic Claudication
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Spinal Stenosis, Lumbar Region, With Neurogenic Claudication
Intervention  ICMJE
  • 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
  • Drug: Epidural Steroid Injection
    Injection of epidural steroids into the lumbar spine
    Other Name: ESI
Study Arms  ICMJE
  • Active Comparator: MILD
    The MILD procedure is an image-guided minimally-invasive lumbar decompression
    Intervention: Procedure: MILD Procedure
  • Active Comparator: Epidural Steroid Injection (ESI)
    An epidural steroid injection (ESI) is a combination of a corticosteroid with a local anesthetic pain relief medicine.
    Intervention: Drug: Epidural Steroid Injection
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 20, 2015)
302
Original Estimated Enrollment  ICMJE
 (submitted: March 20, 2014)
300
Actual Study Completion Date  ICMJE October 2017
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02093520
Other Study ID Numbers  ICMJE MiDAS ENCORE
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Vertos Medical, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Vertos Medical, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ramsin Benyamin, MD AAPM; ASIPP; ISIS; ASA
Principal Investigator: Peter Staats, MD AAPM; ASIPP; ASA
PRS Account Vertos Medical, Inc.
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP