Clinical trial NCT01082159: MiDAS II (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study
Official title: MiDAS II (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: 2010-03-08
Enrollment: 55
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, patient outcomes assessment of Minimally Invasive Lumbar Decompression with the Mild® devices in patients with symptomatic central canal spinal stenosis.


Eligibility 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.

Primary outcomes:
measure: Changes in Back Pain as Measured by a 10-point Visual Analog Scale (VAS).
timeFrame: Baseline and Month 6
measure: Function as Measured Subjectively by the Oswestry Disability Index Questionnaire
timeFrame: Baseline and Month 6
measure: Quality of Life Changes as Determined by Short Form 12-question (SF-12) Survey Specifically Related to Physical Component Score (PCS).
timeFrame: Baseline and Month 6
Secondary outcomes:
Other outcomes:
Locations:
city: Merritt Island
country: United States
facility: Space Coast Pain Institute
state: Florida
city: Baltimore
country: United States
facility: The Spine Center
state: Maryland
city: Festus
country: United States
facility: Occupational and Pain Management Professionals
state: Missouri
city: Las Vegas
country: United States
facility: Lab2Marche, LLC
state: Nevada
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Mansfield
country: United States
facility: MedCentral Health System
state: Ohio
city: Houston
country: United States
facility: Kenneth Alo, MD, PA-TX
state: Texas
city: Huntington
country: United States
facility: The Center for Pain Relief Tri-State, PLLC
state: West Virginia
Study officials:
affiliation: The Center for Pain Relief Tri-State, PLLC
name: David L Caraway, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: MedCentral Health System
name: Bohdan W Chopko, MD
role: PRINCIPAL_INVESTIGATOR
References: