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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Vertos Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01315145
First received: March 11, 2011
Last updated: December 19, 2013
Last verified: December 2013
  Purpose

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:
  • Visual Analog Scale [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Oswestry Disability Index [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    Measure of degree of mobility

  • Zurich Claudication Questionnaire [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    Measure of satisfaction

  • Standing time [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    Measures length of standing time before repositioning is required to relieve discomfort.


Enrollment: 138
Study Start Date: March 2011
Estimated Study Completion Date: May 2014
Estimated 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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01315145

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

No publications provided

Responsible Party: Vertos Medical, Inc.
ClinicalTrials.gov Identifier: NCT01315145     History of Changes
Other Study ID Numbers: MiDAS III
Study First Received: March 11, 2011
Last Updated: December 19, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Spinal Stenosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 22, 2014