Clinical trial NCT00956631: MiDAS I (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study
Official title: MiDAS I (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lumbar Spinal Stenosis
Keywords: Spinal Stenosis
Lumbar Spinal Stenosis
Lead sponsor: Vertos Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2009-08-11
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multi-center, prospective, clinical study to assess the clinical application and outcomes of MILD® Interlaminar Decompression in patients with symptomatic lumbar spinal stenosis.


Eligibility criteria: Inclusion Criteria:

* Symptomatic Lumbar Spinal Stenosis (LSS) primarily caused by dorsal element hypertrophy.
* 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:

* Prior surgery at intended treatment level.
* 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.

Primary outcomes:
measure: Mean Change in Back Pain as Measured by a 10-point Visual Analog Scale (VAS).
timeFrame: Baseline and Six Months
Secondary outcomes:
Other outcomes:
measure: Function Measure Oswestry Disability Index (ODI). Measures Permanent Functional Disability Through Questions Which Characterize Disturbance of Activities of Daily Living (ADL) Resulting From Chronic Back Pain. Higher Scores Indicate Greater Disability.
timeFrame: Baseline and Six months
measure: Quality of Life Physical Component Score (PCS) as Measured by the 12-question Short Form Survey Version 2 (SF-12v2). Change From Baseline Mean to Six Month Mean is Reported Below. A Positive Value Represents the 6 Month Value Minus the Baseline Value.
timeFrame: Baseline and Six Months
Locations:
city: Jonesboro
country: United States
facility: NEA Clinic
state: Arkansas
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Napa
country: United States
facility: Napa Pain Institute
state: California
city: San Diego
country: United States
facility: Scripps, Division of Orthopedic Surgery
state: California
city: San Diego
country: United States
facility: UCSD
state: California
city: Temecula
country: United States
facility: Your Pain Care
state: California
city: Bradenton
country: United States
facility: Coastal Orthopedics & Sports Medicine
state: Florida
city: Miami Beach
country: United States
facility: South Florida Spine Institute
state: Florida
city: Baltimore
country: United States
facility: The Spine Center
state: Maryland
city: Henderson
country: United States
facility: Rainer Vogel, MD LTD
state: Nevada
city: Las Vegas
country: United States
facility: Lab2Marche, LLC
state: Nevada
city: Mansfield
country: United States
facility: MedCentral Health System
state: Ohio
city: Easton
country: United States
facility: Orthopedic Associates of the Greater Lehigh Valley
state: Pennsylvania
Study officials:
affiliation: The Center for Pain Relief Tri-State, PLLC
name: David Caraway, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MedCentral Health System
name: Bohdan W Chopko, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.