The MiDAS ENCORE Study

October 31, 2017 updated by: Vertos Medical, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
302

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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.
12 months
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vertos Medical, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ramsin Benyamin, MD, AAPM; ASIPP; ISIS; ASA
  • Principal Investigator: Peter Staats, MD, AAPM; ASIPP; ASA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 18, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 21, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 6, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MiDAS ENCORE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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