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MiDAS III (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study (MiDAS III)

This study has been completed.
Information provided by (Responsible Party):
Vertos Medical, Inc. Identifier:
First received: March 11, 2011
Last updated: August 19, 2015
Last verified: August 2015
This is a multi-center, prospective, observational clinical study to compare patient outcomes following treatment with either the mild® procedure or epidural steroid injection in patients with moderate to severe lumbar spinal stenosis exhibiting neurogenic claudication.

Condition Intervention
Lumbar Spinal Stenosis
Procedure: Percutaneous Lumbar Decompression
Drug: Epidural Steroid Injection

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: MiDAS III (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study

Resource links provided by NLM:

Further study details as provided by Vertos Medical, Inc.:

Primary Outcome Measures:
  • Percentage of Participants With a 2-point Improvement in Visual Analogue Scale [ Time Frame: 16 weeks ]
    The primary endpoint for evaluating effectiveness will be the proportion of subjects in each group achieving at least a 2-point improvement from baseline in the Visual Analog Scale.

Enrollment: 138
Study Start Date: March 2011
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Percutaneous Lumbar Decompression
Patients receiving percutaneous decompression using the mild® Device Kit.
Procedure: Percutaneous Lumbar Decompression
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 procedure
  • mild lumbar decompression
Active Comparator: Lumbar Epidural Steroid Injection
Injection of epidural steroids into the lumbar spine
Drug: Epidural Steroid Injection
Injection of epidural steroids into the lumbar spine
Other Name: ESI

Detailed Description:
The study was initially designed as a randomized trial. Due to difficulty of enrollment, the study was amended and converted to an observational comparative study with study arm being self-selected by the patient.

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Lumbar spinal stenosis (LSS) with neurogenic claudication where the Visual Analog Scale (VAS) of back and leg pain average is ≥ 5.
  • Prior failure of conservative therapy.
  • Oswestry Disability Index (ODI) score of ≥ 31%.
  • Radiologic evidence of LSS, with unilateral or bilateral ligamentum flavum ≥ 4.1mm confirmed by pre-op MRI performed within 6-12 months of baseline visit.
  • Able to walk ≥ 10 feet before being limited by pain.
  • Available to complete 24-months of follow-up.
  • Adults ≥ 50 years of age.

Exclusion Criteria:

  • Prior surgery at intended treatment level.
  • History of spinal fractures with current related pain symptoms.
  • Motor deficit or disabling back and/or leg pain from causes other than LSS neurogenic claudication (e.g. acute compression fracture, metabolic neuropathy, vascular claudication symptoms, etc.).
  • Significant/symptomatic disc protrusion or osteophyte formation judged by the Investigator as possible confounding factor to study results.
  • Excessive facet hypertrophy judged by the Investigator as possible confounding factor to study results.
  • Significant symptomatic foraminal stenosis.
  • Confirmed anterior or retro-listhesis ≥ 3mm.
  • Bleeding disorders and/or current use of anti-coagulants with the inability to withhold anticoagulants for required time prior to procedure.
  • Able to walk ≥ 200 yards unaided in erect non-flexed position before being limited by pain.
  • Able to stand ≥ 15 minutes in erect, non-flexed position before being limited by pain.
  • Use of acetylsalicylic acid (ASA) and/or non-steroidal anti-inflammatory drug (NSAID) within 7 days of treatment.
  • Pregnant and/or breastfeeding.
  • Body mass index (BMI) ≥ 32 as calculated using the patient's weight multiplied by 703 then divided by height in inches squared.
  • Epidural steroid, systemic steroid or any spine interventional procedure within prior six weeks of study procedure.
  • Dementia and/or inability to give informed consent and to understand and complete follow-up patient reported outcomes forms.
  • Inability of the patient to lie prone for any reason with anesthesia support (e.g. chronic obstructive pulmonary disease (COPD), obesity, etc.).
  • On (or pending) Workman's Compensation or known to be considering litigation associated with back pain.
  • Unable to tolerate MRI (pacemaker, spinal cord stimulator, etc.).
  • Intrathecal pump.
  • Any medical condition determined by the Investigator that would not allow subject to fulfill trial requirements or safely tolerate procedures in this study.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01315145

  Show 27 Study Locations
Sponsors and Collaborators
Vertos Medical, Inc.
Principal Investigator: Nagy Mekhail, MD The Cleveland Clinic
  More Information

Responsible Party: Vertos Medical, Inc. Identifier: NCT01315145     History of Changes
Other Study ID Numbers: MiDAS III
Study First Received: March 11, 2011
Results First Received: June 1, 2015
Last Updated: August 19, 2015

Additional relevant MeSH terms:
Spinal Stenosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases processed this record on April 27, 2017