Facet Replacement System to Treat Spinal Stenosis
Who May Be a Candidate
Men and women ages 21- to 85-years who have been diagnosed with lateral, lateral recess, and / or central canal stenosis in the lumbar spine may be candidates. Patients must be skeletally mature and have undergone at least 6 months of nonoperative treatment prior to a surgical recommendation.
Product Being Studied
The ACADIA™ Facet Replacement System allows for anatomic reconstruction of the facet joint after decompression and removal of the degenerated facet. Like the original facet joint, the replacement implant is designed to reproduce facet motion while also restoring normal stability.
 ACADIA™ Facet Replacement System |
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Lateral (side) postoperative x-ray shows the
implanted ACADIA™ Facet Replacement System |
Clinical Trial Sponsor
This clinical trial is sponsored by Globus Medical, Inc. The ACADIA™ Facet Replacement System is an investigational device designed to treat lumbar spinal stenosis.
Purpose and Objective
The purpose of this study is to determine if the ACADIA™ Facet Replacement System is effective for the treatment of lumbar spinal stenosis. The primary objective of the study is to evaluate the overall success rate of the ACADIA™ Facet Replacement System in patients with lumbar spinal stenosis as compared to the posterolateral spinal fusion control
The ACADIA™ Facet Replacement System has been designed on the principles that have allowed other total joint replacement procedures to provide significant patient benefits. These guiding principles include:
- Anatomically based implant design
- Reproducible surgical technique
- Elimination of pain
Recruiting Locations
California
Institute for Spinal Disorders
Beverly Hills, CA 90212
(310) 385-8888
The Anand Spine Group
Los Angeles, CA 90048
(310) 423-9779
Desert Orthopedic Center
Rancho Mirage, CA 92270
(760) 766-1207
Colorado
The Spine Institute
Loveland, CO 80538
(970) 669-8881
Spine Colorado
Durango, CO 81301
(970) 375-3696
Florida
Florida Spine Institute
Clearwater, FL 33765
(727) 797-7463
Florida Orthopaedic Institute
Tampa, FL 33607
(813) 978-9700
Indiana
Fort Wayne Orthopaedics
Ft. Wayne, IN 46804
(260) 436-6589 ext 4278
Maryland
Greater Baltimore Spine Center
Baltimore, MD 21204
(410) 683-7260
Massachusetts
UMass Memorial Group Physicians
Worcester, MA 01605
(888) 244-6094
Missouri
Springfield Neurological & Spine Institute
Springfield, MO 65804
(417) 885-3888 ext 1214
Spine Midwest
Jefferson City, MO 65101
(573) 636-9000 ext 321
New York
AMC Neurosurgery Group
Albany, NY 12208
(518) 262-5088
North Carolina
OrthoCarolina
Charlotte, NC 28207
(704) 323-2264
Ohio
Central Ohio Neurosurgical Surgeons
Westerville, OH 43081
(614) 261-0402
South Carolina
Marzluff Tyler and Highsmith MDs
Charleston, SC 29406
(843) 553-7615
Tennessee
Neuro-Spine Solutions
Bristol, TN 37620
(423) 844-0501
Center for Sports Medicine and Orthopaedics
Chattanooga, TN 37404
(423) 624-2696
Texas
Central Texas Spine Institute
Austin, TX 78731
(512) 795-2225
Eligibility, Inclusion and Exclusion Criteria
Men and women ages 21- to 85-years who meet the following criteria are eligible to participate in this clinical trial.
ClinicalTrials.gov Identifier: NCT00401518
Study ID Numbers: 1020-9052
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety / Efficacy Study
Official Title: The Investigational Plan for the Evaluation of the ACADIA™ Facet Replacement System
