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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vertos Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01082159
First received: March 4, 2010
Last updated: February 21, 2013
Last verified: February 2013
  Purpose

This is a multi-center, prospective, patient outcomes assessment of Minimally Invasive Lumbar Decompression with the Mild® devices in patients with symptomatic central canal spinal stenosis.


Condition Intervention Phase
Lumbar Spinal Stenosis
Procedure: lumbar decompression
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: MiDAS II (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:
  • Changes in Back Pain as Measured by a 10-point Visual Analog Scale (VAS). [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]

    The 10-point Visual Analog Scale (VAS)rates 'no pain' as zero and 'worst pain imaginable' as ten. VAS mean improvement greater than or equal to 2 points is considered clinically relevant.

    The change from baseline to Month 6 is presented below where a positive value represents the baseline value minus the 6 month value.


  • Function as Measured Subjectively by the Oswestry Disability Index Questionnaire [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
    Oswestry Disability Index (ODI) measures permanent functional disability using questions regarding activities of daily living (ADL), specifically disturbance of ADL related to chronic back pain. Higher scores indicate a 'more limited' life. The ten topics of the ODI are rated from zero (no pain/limitation) to five (high pain/very limited physically). The worst possible score is 50 (100% disability) with the best score being zero (0% disability).Change from baseline to 6 months is presented below, where a positive value represents the baseline value minus the 6 month value.

  • Quality of Life Changes as Determined by Short Form 12-question (SF-12) Survey Specifically Related to Physical Component Score (PCS). [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
    The SF-12 is a validated norm-based scoring tool used to determine treatment outcomes. The PCS summary measure shows the impact of the treatment on the patients abilities to conduct their usual physical activities. Clinical relevance of PCS is established by baseline to post-treatment improvement of 2 to 3 points. Norm-based scoring is used so that each scale has the same mean (50 points) and the same standard deviation (10 points) as the general US population in 1998. Scores below 50 indicate a decline in health status, with lower scores representing worse health status. Minimally Important Difference (MID) is a measure of true clinical relevance of a difference, with suggested MID for the Physical Component Summary (PCS) being 2 to 3 points. Change from baseline to 6 months is presented, where a positive value represents the 6 month value minus the baseline value.


Enrollment: 55
Study Start Date: February 2010
Study Completion Date: January 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
lumbar decompression
Percutaneous lumbar decompression with mild® Device Kit.
Procedure: lumbar decompression
The mild® devices used in this study are specialized surgical instruments intended to be used to perform percutaneous lumbar decompressive procedures for the treatment of various spinal conditions.
Other Name: The mild® Device Kit

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Symptomatic lumbar spinal stenosis (LSS) primarily caused by dorsal element hypertrophy.
  • Prior failure of conservative therapy and Oswestry Disability Index (ODI) score > 20%.
  • Radiologic evidence of lumbar spinal stenosis (LSS), ligamentum flavum hypertrophy (typically > 2.5 mm), confirmed by pre-op MRI and/or CT.
  • Central canal cross sectional area clearly reduced per MRI/CT report.
  • If present, anterior listhesis preferred ≤ 5.0mm and deemed stable by Investigator.
  • Able to walk at least 10 feet unaided before being limited by pain.
  • Available to complete 26 weeks of follow-up.
  • A signed Informed Consent Form is obtained from the patient.
  • Adults at least 18 years of age.

Exclusion Criteria:

  • Prior surgery at intended treatment level.
  • Compound fracture with interspinal retropulsion contributing to spinal stenosis.
  • Disabling back or leg pain from causes other than LSS (e.g. acute compression fracture, metabolic neuropathy, or vascular claudication symptoms, etc.).
  • Disc protrusion or osteophyte formation severe enough to confound study outcome.
  • Facet hypertrophy severe enough to confound study outcome.
  • Bleeding disorders and/or current use of anti-coagulants.
  • Use of acetylsalicylic acid (ASA) and/or non-steroidal anti-inflammatory drug (NSAID) within 5 days of treatment.
  • Epidural steroid administration within prior three weeks (of procedure).
  • Inability of the patient to lie prone for any reason with anesthesia support (e.g.chronic obstructive pulmonary disease (COPD), obesity, etc.).
  • Metabolic wound healing pathologies deemed by Investigator to compromise study outcomes.
  • Dementia and/or inability to give informed consent.
  • Pregnant and/or breastfeeding.
  • On Workman's Compensation or considering litigation associated with back pain.
  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: NCT01082159

Locations
United States, Florida
Space Coast Pain Institute
Merritt Island, Florida, United States, 32953
United States, Maryland
The Spine Center
Baltimore, Maryland, United States, 21211
United States, Missouri
Occupational and Pain Management Professionals
Festus, Missouri, United States, 63028
United States, Nevada
Lab2Marche, LLC
Las Vegas, Nevada, United States, 89149
United States, Ohio
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
MedCentral Health System
Mansfield, Ohio, United States, 44903
United States, Texas
Kenneth Alo, MD, PA-TX
Houston, Texas, United States, 77090
United States, West Virginia
The Center for Pain Relief Tri-State, PLLC
Huntington, West Virginia, United States, 25702
Sponsors and Collaborators
Vertos Medical, Inc.
Investigators
Principal Investigator: David L Caraway, MD, PhD The Center for Pain Relief Tri-State, PLLC
Principal Investigator: Bohdan W Chopko, MD MedCentral Health System
  More Information

No publications provided

Responsible Party: Vertos Medical, Inc.
ClinicalTrials.gov Identifier: NCT01082159     History of Changes
Other Study ID Numbers: MiDAS II
Study First Received: March 4, 2010
Results First Received: February 15, 2013
Last Updated: February 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Vertos Medical, Inc.:
Spinal Stenosis
Lumbar Spinal Stenosis

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

ClinicalTrials.gov processed this record on September 22, 2014