MiDAS I (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study
NCT ID: NCT00956631
Last Updated: 2013-04-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
78 participants
INTERVENTIONAL
2008-07-31
2012-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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interlaminar decompression
Commercially available product (mild® Device Kit) used to perform interlaminar decompression
Interlaminar Decompression
The MILD® devices used in this study are specialized surgical instruments intended to be used to perform percutaneous lumbar decompression.
Interventions
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Interlaminar Decompression
The MILD® devices used in this study are specialized surgical instruments intended to be used to perform percutaneous lumbar decompression.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Prior failure of conservative therapy.
* Radiologic evidence of LSS (L3-L5), Ligamentum flavum \> 2.5mm, confirmed by pre-op MRI and/or CT.
* Central canal cross sectional area ≤ 100 square mm.
* Anterior listhesis ≤ 5.0mm.
* Able to walk at least 10 feet unaided before being limited by pain.
* Available to complete 12 weeks of follow-up.
* Consistent with the intended labeling statement for use.
* Able to use all package components to perform the procedure.
* A signed Informed Consent Form is obtained from the patient.
Exclusion Criteria
* History of recent spinal fractures with concurrent pain symptoms.
* Disabling back or leg pain from causes other than LSS (e.g. acute compression fracture, metabolic neuropathy, or vascular claudication symptoms, etc.).
* Significant / symptomatic disk protrusion or osteophyte formation.
* Excessive / symptomatic facet hypertrophy.
* 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 steroids within prior three weeks.
* Inability of the patient to lie prone for any reason with anesthesia support (e.g. chronic obstructive pulmonary disease (COPD), obesity, etc.).
* Any potential wound healing pathologies that may compromise outcomes, including diabetes, excessive smoking history, cancer, connective tissue diseases, recent spine radiation and severe COPD.
* Dementia and/or inability to give informed consent.
* Pregnancy.
* Intended treatment that is defined by the product labeling contraindications.
* On Workman's Compensation or considering litigation associated with back pain.
18 Years
ALL
No
Sponsors
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Vertos Medical, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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David Caraway, MD
Role: PRINCIPAL_INVESTIGATOR
The Center for Pain Relief Tri-State, PLLC
Bohdan W Chopko, MD
Role: PRINCIPAL_INVESTIGATOR
MedCentral Health System
Locations
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NEA Clinic
Jonesboro, Arkansas, United States
UCLA
Los Angeles, California, United States
Napa Pain Institute
Napa, California, United States
Scripps, Division of Orthopedic Surgery
San Diego, California, United States
UCSD
San Diego, California, United States
Your Pain Care
Temecula, California, United States
Coastal Orthopedics & Sports Medicine
Bradenton, Florida, United States
South Florida Spine Institute
Miami Beach, Florida, United States
The Spine Center
Baltimore, Maryland, United States
Rainer Vogel, MD LTD
Henderson, Nevada, United States
Lab2Marche, LLC
Las Vegas, Nevada, United States
MedCentral Health System
Mansfield, Ohio, United States
Orthopedic Associates of the Greater Lehigh Valley
Easton, Pennsylvania, United States
Countries
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References
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Chopko B, Caraway DL. MiDAS I (mild Decompression Alternative to Open Surgery): a preliminary report of a prospective, multi-center clinical study. Pain Physician. 2010 Jul-Aug;13(4):369-78.
Other Identifiers
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MiDAS I
Identifier Type: -
Identifier Source: org_study_id
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