Am I a Candidate for the Total Facet Arthroplasty System™ (TFAS ™) Clinical Trial?

If you are spine patient who has been diagnosed with moderate to severe lumbar spinal stenosis and meet the following criteria, you may be a candidate for participation in the TFAS ™ clinical trial.

Inclusion Criteria:

• Degenerative spinal stenosis, central or lateral, at spinal levels L3-L4 or L4-L5
• Skeletally mature male or female between the ages of 50 and 85 years of age inclusive
• No greater than Grade I degenerative spondylolisthesis at the index level
• Persistent leg symptoms, including pain, numbness, burning or tingling for a minimum duration of six months
• Operative candidates with no more than three levels of degenerative lumbar spinal stenosis requiring decompression
• Failed to respond to non-operative treatment modalities for a minimum duration of six months

Exclusion Criteria:

• Male or female less than 50, or greater than 85 years old
• Grade 2 or higher spondylolisthesis, or any retrolisthesis at the index level
• More than 3 vertebral levels of degenerative spinal stenosis requiring decompression
• More than 1 vertebral level of degenerative spinal stenosis requiring instrumentation
• Not available for long term follow-up and interval visits
• Prior, or concurrently planned lumbar fusion or disc replacement at any level of the lumbar spine
• Two or more previous surgeries to the lumbar spine at the same level to be implanted
• Is being treated with other devices for the same disorder (e.g. pain control devices)
• Active systemic infection or infection at the operating site "
• Osteoporosis
• Known sensitivity to device materials
• Has an immunosuppressive disorder
• Has a medical condition that may interfere with clinical evaluations
• Is obese defined by a patient body mass index greater than 40
• Has significant scoliosis (Cobb >25°)
• Is pregnant or planning to become pregnant within the proposed three year investigation

Participating Sites and Contact Information
Sites that are currently participating are located in the following cities and states:

United States, California
Loma Linda University Healthcare
Wayne Cheng, M.D., Principal Investigator
Contact: Elisabeth A. Clarke 909-835-1779 eaclark@ahs.llumc.edu

University of Southern California
Charles Liu, M.D., Principal Investigator
Thomas Chen, M.D., Ph.D., Sub-Investigator
Contact: Kelly Vecchiarelli, 323-442-7434

United States, Colorado
Courtney Brown, M.D., Principal Investigator

Skyridge Medical Center, Lone Tree, Colorado, 80124, United States, Recruiting
John R. Barker, M.D., Principal Investigator
Contact: Stephanie Moore 303-225-8120 smoore@spineclinic.com

United States, Connecticut
William W. Backus Hospital, Norfolk, Connecticut, 06254, United States; Recruiting
Michael Halperin, M.D., Principal Investigator
Kenneth Paonessa, M.D., Sub-Investigator
Contact: Judy Bedard, CMA 860-889-7345 jbedard@norwichorthopedic.com

United States, Florida
Florida Spine Institute, Clearwater, Florida, 33765, United States; Recruiting
Scott Webb, D.O., Principal Investigator
Contact: Rose Bingham 727-432-7145 rbingham@floridaspineinstitute.com

Florida Orthopaedic Institute, Tampa, Florida, 33607, United States; Recruiting
Anthony E. Castellvi, M.D., Principal Investigator
Contact: Deborah H. Clabeaux, RN 813-876-6885 Ext. 4 dclabeaux@floridaortho.com

Tallahassee Orthopedic Clinic, Tallahassee, Florida, 32308, United States; Recruiting
Charles Wingo, M.D., Principal Investigator
Contact: Debra McGarey 850-219-1957 Debra.McGarey@tlhoc.com

United States, Georgia
Piedmont Hospital, Atlanta, Georgia, 30309, United States; Recruiting
Roger Frankel, M.D., Principal Investigator
Contact: Alison Paolino 404-605-2890 alison.paolino@piedmont.org

United States, Illinois
Chicago Institute of Neurosurgery & Neuroresearch, Chicago, Illinois, 60640, United States; Recruiting
Noam Stadlan, M.D., Principal Investigator
Contact: Michelle Catalano 773-250-0500 mcatalano@cinn.org

United States, Indiana
Indiana Spine Group, Indianapolis, Indiana, 46260, United States; Recruiting
Kenneth L. Renkens, Jr., M.D., Principal Investigator
Contact: Amber Walker 317-715-5875 awalker@indianaspinegroup.com

United States, Maryland
Holy Cross Hospital, Kensington, Maryland, 20895, United States: Recruiting
Philip Schneider, M.D., Principal Investigator
Contact: Karen Frangione 301-949-8100

United States, Massachusetts
Brigham and Women's Hospital, Boston, Massachusetts, 02115, United States; Recruiting
Christopher Bono, M.D., Principal Investigator
Mitchel Harris, M.D., Sub-Investigator
Contact: Natalie Warholic 617-525-8761 nwarholic@partners.org

United States, Montana
Robert Replogle, M.D., Principal Investigator

United States, New York
Southern New York NeuroSurgical Group, Johnson City, New York, 13790, United States: Recruiting
Khalid Sethi, M.D., Principle Investigator
Saeed Bajwa, M.D., Sub-Investigator
Contact: Genevieve Romano gromano@rcresearchinc.com

United States, Ohio
Kettering Medical Center, Kettering, Ohio, 45429, United States: Recruiting
Jamal Taha, M.D., Principal Investigator
Contact: Judy DeSimio 937-395-8411 judi.desimio@khnetwork.org

United States, South Carolina
Medical University of South Carolina, Charleston, South Carolina, 29425, United States; Recruiting
Bruce Frankel, M.D., Principal Investigator
Contact: Bonnie Muntz-Pope, BSN, RN, CNRN 843-792-8967 muntzpob@musc.edu

United States, Tennessee
East Tennessee Brain & Spine Center, Johnson City, Tennessee, 37604, United States; Recruiting
David Wiles, M.D., Principal Investigator
Contact: Susan Maye, RN 423-232-8301 etbswebsite@aol.com

United States, Texas
Texas Back Institute, Plano, Texas, 75093, United States; Recruiting
Barton L Sachs, M.D., Principal Investigator
Contact: Dawn Delacy 972-403-5544 ddelacy@spinemarkcro.com

United States, Washington
Orthopedics International, Seattle, Washington, 98122, United States; Recruiting
Paul Schwaegler, M.D., Principal Investigator
Contact: Eileen Uson 206-302-0702 eileenf@orthopedics-intl.net

John Demakas, M.D., Principal Investigator

Swedish Medical Center, Seattle, Washington,98122, United States; Recruiting
John Hsiang, M.D., Principal Investigator
Contact: Hazel Ball 206-320-2244 hazel.ball@swedish.org

Additional sites will be added to this list as they begin enrollment.

To learn more about Archus Orthopedics, please access our website at www.archususa.com.

Spine Patients
To determine if you may be a potential candidate for the TFAS™ clinical trial, please access our website at www.archususa.com and click on "Clinical Trial" and "Am I a Candidate?" If you are a spine patient who has been diagnosed with moderate to severe lumbar spinal stenosis, you feel that you may meet the study criteria and you live within 50 miles of the cities listed above, please contact us by sending an email to our Clinical Trial Department. Please include your name, address and contact information, including an email address where you can be reached.

Physicians
If you are a spine surgeon who treats patients meeting the inclusion/exclusion criteria and may be interested in participating as a clinical investigator in the TFAS™ clinical study, please contact us by sending an email to our Clinical Trial Department. Please include your name, address and contact information, including an email address where you can be reached.

Questions? Please email Archus Orthopaedics.

• TFAS™ Total Facet Arthroplasty System™ Clinical Trial
• Clinical Trials from A to Z - Key Questions
• Lumbar Spinal Stenosis
• Spinal Stenosis: Lumbar and Cervical
• Spondylolisthesis: Back Condition and Treatment
• Archus Orthopedics