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The Investigational Plan for the Evaluation of the ACADIA? Facet Replacement System

This study is currently Recruiting

March 2010 By Facet Solutions, Inc.

First Recieved on November 17, 2006

Last Updated on March 24, 2010

Sponsor: Facet Solutions, Inc.
Collaborators:
Information provided by: Facet Solutions, Inc.
Identifier: NCT00401518

Purpose

The purpose of this study is to determine if the ACADIA? Facet Replacement System is effective in the treatment of spinal stenosis. The primary objective of the study is to evaluate the overall success rate of the Anatomic Facet Replacement System in patients with spinal stenosis when compared to a posterior spinal fusion control.

Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Eligibility

Ages Eligible for Study:21 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:Accepts Healthy Volunteers
Criteria

Inclusion Criteria: - 21-85 years of age and skeletally mature; - Have undergone 6 months of non-operative treatment prior to surgery; - Lateral, lateral recess and/or central canal stenosis; - Disc height measuring ? 4 mm at the operative level; - Persistent leg, thigh and/or buttock symptoms,including pain,numbness, burning or tingling with a minimum leg pain score of 40mm as measured with the Visual Analogue Scale (VAS) Index; - A score greater than 2 on a scale of 1-5 on the Zurich Claudication Questionnaire (ZCQ) Symptom Severity (SS) Score-Candidate; - A score greater than or equal to 2 on a scale of 1-4 on the ZCQ Physical Function (PF) Score; - A candidate for a decompression with full facetectomy at the operative level - Candidate for a posterior lumbar fusion; - Physically and mentally willing and able to comply evaluations; - Lives in the immediate area and has no plans to relocate; Exclusion Criteria: - Previous surgical procedure at the operative or adjacent level except for one of the following: Micro-discectomy, laminectomy, lamino/foraminotomy, rhizotomy, IDET, and/or interspinous spacer; - Previous lumbar fusion or disc replacement procedure; - Osteoporosis; - greater than Grade I spondylolisthesis or retrolithesis; - Spondylolisthesis at levels other than at the operative level; - Scoliosis of the lumbar spine (defined as more than 11 deg sagittal deformity); - Primary diagnosis of discogenic back pain due to torn, herniated, inflamed or irritated disc or other pathology where the patient exhibits axial back pain from degenerative disc disease; - Acute traumatic pars fracture at the operative/adjacent level vertebral body; - Spinal stenosis at more than three lumbar segments; - Acute trauma to the lumbar spine within the last 24 months; - Active infection at the operative level, or a systemic infection; - Physically / mentally compromised; - Systemic disease that would affect the patient's welfare or the research study. - Immunologically suppressed or immunocompromised; - Insulin-Dependent Diabetes Mellitus (Type I Diabetes); - Currently undergoing long-term steroid therapy; - Metabolic bone disease; - Active malignancy: (except non-melanoma skin cancer), unless treated with no clinical signs or symptoms of the malignancy for at least 5 years; - Known allergy to cobalt chromium or titanium; - Used any investigational drug or device within the past 30 days; - Pending litigation or receiving Workers Compensation related to back pain or injury; - Is a prisoner.

Investigators

Locations

  • DISC

    Beverly Hills, California 90211 United States

  • Cedars-Sinai Spine Center

    Los Angeles, California 90048 United States

  • Desert Orhtpaedic Center

    Rancho Mirage, California 92270 United States

  • The Spine Institute

    Santa Monica, California 90404 United States

  • Spine Colorado

    Durango, Colorado 81301 United States

  • Rocky Mountain Associates (RMA) in Orthopedic Medicine

    Loveland, Colorado 80538 United States

  • Midwest Orthopaedics at Rush

    Chicago, Illinois 60612 United States

  • Fort Wayne Orthopaedics

    Ft. Wayne, Indiana 46804 United States

  • Greater Baltimore Spine Center

    Baltimore, Maryland 21204 United States

  • UMASS Memorial Medical Center

    Worcester, Massachusetts 01605 United States

  • Spine Midwest, Inc.

    Jefferson City, Missouri 65101 United States

  • Springfield Neurological & Spine Institute

    Springfield, Missouri 65804 United States

  • Albany Medical Center

    Albany, New York 12208 United States

  • Charleston Brain & Spine

    Charleston, North Carolina 29406 United States

  • OrthoCarolina Spine Center

    Charlotte, North Carolina 28207 United States

  • Central Ohio Neurological Surgeons, Inc

    Westerville, Ohio 43081 United States

  • Neuro-Spine Solutions

    Bristol, Tennessee 37620 United States

  • The Center for Sports Medicine & Orthopedics

    Chattanooga, Tennessee 37404 United States

  • Central Texas Spine Institute

    Austin, Texas 78731 United States

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