TFAS™ Total Facet Arthroplasty System™ Clinical Trial FAQS

What is the purpose of the TFAS™ clinical trial?
The purpose of the TFAS™ Total Facet Arthroplasty System™ (TFAS™) clinical trial is to compare the safety and effectiveness of TFAS™ to spinal fusion surgery for the treatment of lower leg and back pain caused by moderate to severe degenerative lumbar spinal stenosis.

What is spinal stenosis?
Spinal stenosis is a progressive degenerative condition commonly affecting people in their 50s and 60s. Leg pain is the predominant symptom and is often described by patients as a burning, tingling or numb sensation. Leg weakness and loss of function can be additional symptoms of spinal stenosis.

What causes spinal stenosis?
The joints of the spine (the facets) can become inflamed due to age-related degeneration resulting in irritation, impingement of nearby nerves and spinal instability. As spinal stenosis progresses the symptoms may worsen impacting the patient's ability to walk and to perform everyday activities.

How is TFAS™ different from spinal fusion?
The surgical removal of the arthritic facets and other spinal structures to relieve pressure of the impinged nerves (decompression) may include the instrumentation and fusion of the vertebrae to stabilize the spine. The TFAS™ System offers an alternative to the spinal fusion procedure by:

1. Removing the diseased facets and enabling a more comprehensive decompression by replacing the facets with a motion preserving implant.

2. Offering an alternative to rigid spinal fusion by facilitating motion and potentially restoring spinal stability.

3. Eliminating the need to harvest bone from the patient's hip used to fuse the spine.

Side View (Lateral) TFAS™ Total Facet Arthroplasty System™

Rear View (Posterior) TFAS™ Total Facet Arthroplasty System™

Where are the TFAS™ clinical trial sites?
Sites currently participating are found in the following cities and states. Additional sites will be added to this list as they begin enrollment.

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, 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.

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