Total Facet Arthroplasty System (TFAS) US Clinical Trial
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| TFAS posterior view (larger view) |
Spinal Stenosis
Spinal stenosis is a condition that commonly affects people over the age of 50 where the joints of the spine (facets) can enlarge due to arthritic degeneration. This increase in the size of the facets is often combined with an age-related reduction in the height of the discs between the vertebrae resulting in the compression and irritation of the nerve roots and/or spinal cord. Leg pain is a frequent symptom of spinal stenosis and is often described by patients as numbness or as a tingling sensation. As spinal stenosis progresses these symptoms may worsen resulting in severe leg weakness that can impact the patient’s ability to walk and to perform other everyday activities.
Traditional Treatment Options: Decompression and Spinal Fusion Surgery
Patients who are unresponsive to non-surgical pain management treatments such as physical therapy and pain medications may be offered a surgical option called decompression which can involve the surgical removal of the facet joints and other spinal structures to relieve pressure on the affected nerve roots. This initial surgical intervention is often followed by the placement of instrumentation designed to facilitate the fusion of the patient’s vertebrae to stabilize the spine after the decompression is complete.
The Total Facet Arthroplasty System® (TFAS®)
The TFAS® offers spinal stenosis patients an alternative to traditional spinal fusion surgery by removing the facet joints and replacing them with a motion preserving implant. The TFAS® surgical technique eliminates the need to harvest bone from the patient’s hip to fuse the spine, may allow for a more comprehensive decompression of the affected nerves and can potentially restore stability and motion to the degenerated spinal column.
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| TFAS lateral view (larger view) |
Total Facet Arthroplasty System® (TFAS®) Study Objective and Overview
The Total Facet Arthroplasty System® is a new device currently limited by United States law to investigational use within the U.S. The primary objective of this total facet replacement clinical investigation is to demonstrate the safety and effectiveness of TFAS® for the treatment of moderate to severe lumbar (lower back) spinal stenosis.Approximately 20 investigative sites will enroll patients into TFAS® Clinical Study after determining if a patient qualifies for the study based on the established inclusion/exclusion criteria. Those patients who are evaluated to be TFAS® study participants will be placed into one of these two groups: 1) treatment with the investigational facet replacement device (TFAS®) or 2) treatment with posterior instrumented spinal fusion which is considered to be the current standard of surgical intervention for stenosis patients. Patient enrollment in the TFAS® Clinical Study will be randomized such that two-thirds of the patients will receive the TFAS® and one-third will receive the instrumented spinal fusion. For more detailed information about the TFAS® Clinical Study please visit and look in the Clinical Trial section.
Study Sponsor
Archus Orthopedics Inc. is a medical device developer focused on pioneering novel solutions for diseases requiring the complete removal and replacement of the facets of the lumbar spine. Please visit www.archususa.com for more information about the company and the Total Facet Arthroplasty System® (TFAS®).
Current Participating TFAS®Clinical Study Sites:
- Scott Webb, D.O. - Clearwater, Florida
More on this physician - Antonio Castellvi, M.D. - Tampa, Florida
- Charles Wingo, M.D. - Tallahassee, Florida
- Courtney Brown, M.D. - Denver, Colorado More on this physician
- Bart Sachs, M.D. - Plano, Texas
- Michael Halperin, M.D. - Norwich, Connecticut
- Paul Schwaegler, M.D. - Seattle, Washington
- Wayne Cheng, M.D. - San Bernardino, California
- Bruce Frankel, M.D. - Charleston, South Carolina
- David Wiles, M.D. - Johnson City, Tennessee
- Noam Stadlan, M.D. - Chicago, Illinois
- Kenneth Paonessa, M.D. - Norwich, Connecticut
- Saeed Bajwa, M.D. - Johnson City, New York
- Khalid Sethi, M.D. - Johnson City, New York
- Robert Replogle, M.D. - Billings, Montana
- Jamal Taha, M.D. - Kettering, Ohio
- Christopher Bono, M.D. - Boston, MA
- John Hsiang, M.D. - Seattle, Washington
- John Demakas, M.D. - Spokane, Washington
- Thomas C. Chen, M.D., Ph.D. - Los Angeles, California
- Charles Liu, M.D. - Los Angeles, California
- Roger Frankel, M.D. - Atlanta, Georgia
- John R. Barker, M.D. - Lone Tree, Colorado
- Philip Schneider, M.D. - Kensington, Maryland
Additional sites will be added to this list as they begin enrollment.
| Name of center: | Loma Linda University Medical Center |
| Primary investigator: | Wayne K. Cheng, MD |
| Location: | 250 East Caroline Street, Suite A San Bernadino, CA 92408 |
| Contact name: | Elisabeth Clarke |
| Phone number: | 909-835-1779 |
| Fax number: | 909-835-1705 |
| E-mail: | eaclarke@llu.edu |
| Name of center: | University of Southern California |
| Primary investigator: | Charles Liu, MD |
| Co-investigator: | Thomas Chen, MD, PhD |
| Location: | 1520 San Pablo Street, Suite 3800 Los Angeles, CA 90033 |
| Contact name: | Kelly Vecchiarelli |
| Phone number: | 323-442-7434 |
| Website | www.uscneurosurgery.com |
| Name of center: | Skyridge Medical Center |
| Primary investigator: | John R. Barker, MD |
| Location: | 10103 RidgeGate Parkway, Suite 306 Lone Tree, CO 80124 |
| Contact name: | Stephanie Moore |
| Phone number: | 303-225-8120 |
| E-mail: | smoore@spineclinic.com |
| Website | www.spineclinic.com |
| Name of center: | William Backus Hospital |
| Primary investigator: | Michael Halperin, MD Kenneth Paonessa, MD |
| Location: | 82 New Park Avenue North Franklin, CT 06254 |
| Contact name: | Judy Bedard, CMA |
| Email: | JBedard@NorwichOrthopedic.com |
| Phone number: | 860-889-7345 X159 |
| Name of center: | Florida Orthopaedic Institute |
| Primary investigator: | Antonio E. Castellvi, MD |
| Location: | 2727 W. Martin Luther King Jr. Blvd. Suite 630 Tampa, FL 33607 |
| Contact name: | Deborah H. Clabeaux, RN |
| Phone number: | 813-876-6885, #4 |
| Fax number: | 813-876-9845 |
| E-mail: | dclabeaux@floridaortho.com |
| Website: | www.floridaortho.com |
| Name of center: | Piedmont Hospital |
| Primary investigator: | Roger Frankel, MD |
| Location: | 35 Collier Road Suite 115 Atlanta, GA 30309 |
| Contact name: | Alison Paolino |
| Phone number: | 404-605-2890 |
| Fax number: | 404-605-9535 |
| E-mail: | alison.paolino@piedmont.org |
| Website: | www.piedmont.org |
| Name of center: | Chicago Institute of Neurosurgery and Neuroresearch |
| Primary investigator: | Noam Y. Stadlan, MD |
| Location: | 4501 North Winchester Ave Third Floor Chicago, IL 60640 |
| Contact name: | Michelle M. Catalano |
| Phone number: | 773-250-0500 |
| Fax number: | 773-250-0497 |
| E-mail: | mcatalano@cinn.org |
| Website: | www.cinn.org |
| Name of center: | Holy Cross Hospital |
| Primary investigator: | Philip Schneider, MD More on this physician |
| Location: | 10400 Connecticut Ave. Concourse Level Kensington, MD 20895 |
| Contact name: | Karen Frangione |
| Phone number: | 301-949-8100 |
| Fax number: | 301-962-7450 |
| Website: | www.montgomeryorthopaedics.org |
| Name of center: | Brigham and Women's Hospital |
| Primary investigator: | Christopher Bono, MD |
| Location: | 75 Francis Street Dept. of Orthopedics Boston, MA 02115 |
| Contact name: | Natalie Warholic |
| Phone number: | 617-525-8761 |
| Fax number: | 617-732-6937 |
| E-mail: | nwarholic@partners.org |
| Name of center: | Southern New York Neurosurgical Group, PC |
| Primary investigator: | Khalid Sethi , MD Saeed Ahmed Bajwa, MD |
| Location: | 46 Harrison Street Johnson City, NY 13790 |
| Contact name: | Genevieve Romano |
| Fax number: | 607-729-7516 |
| E-mail: | gromano@rcresearchinc.com |
| Name of center: | Kettering Medical Center |
| Primary investigator: | Jamal Taha , MD |
| Location: | Advanced Neurosurgery, Inc. 3533 Southern Blvd, Suite 300 Kettering, OH 45429 |
| Contact name: | Judi DeSimio |
| Phone number: | 937-395-8411 |
| Fax number: | 937-395-8413 |
| E-mail: | judi.desimio@khnetwork.org |
| Name of center: | Medical University of South Carolina |
| Primary investigator: | Bruce Frankel, MD |
| Location: | Dept. of Neurosurgery 96 Jonathan Lucas St, Rm 428CSB Charleston, SC 29425 |
| Contact name: | Bonnie Muntz-Pope, BSN, RN, CNRN |
| Phone number: | 843-792-8967 |
| Fax number: | 843-792-7263 |
| E-mail: | muntzpob@musc.edu |
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| Name of center: | East Tennessee Brain and Spine Center |
| Primary investigator: | David Wiles, M.D. |
| Location: | East Tennessee Brain and Spine Center 701 Med Tech Parkway, Suite 300 Johnson City, TN 37604 |
| Clinical Coordinator: | Susan Maye, RN |
| Phone number: | 423-232-8301 |
| Fax number: | 423-232-8304 |
| E-mail: | etbswebsite@aol.com |
| Website: | www.etbscenter.com |
| Name of center: | Texas Back Institute |
| Primary investigator: | Barton L. Sachs, MD |
| Location: | 6020 West Parker Road Suite 200 Plano, TX 75093 |
| Contact name: | Research Coordinator |
| Phone number: | 972-403-5544 |
| Fax number: | 972-403-5566 |
| E-mail: | ddelacy@spinemarkcro.com |
| Website: | www.texasback.com |
| Name of center: | Orthopedic International |
| Primary investigator: | Paul Schwaegler, MD |
| Location: | 1600 East Jefferson #400 Seattle, WA 98122 |
| Contact name: | Eileen Uson |
| Phone number: | 206-302-0702 |
| Fax number: | 206-302-0207 |
| E-mail: | eileenf@orthopedics-intl.net |
| Website: | www.oispine.com |
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| Name of center: | Swedish Medical Center |
| Primary investigator: | John Hsiang, MD |
| Location: | 550 17th Ave, Suite 500 Seattle, WA 98122 |
| Contact name: | Hazel Ball |
| Phone number: | 206-320-2244 |
| Fax number: | 206-320-2827 |
| E-mail: | hazel.ball@swedish.org |
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| Name of center: | Spokane Brain and Spine |
| Primary investigator: | John Demakas, MD |
| Location: | 801 West 5th Ave, Suite 210 Spokane, WA 99204 |
| Contact name: | Liza Carlson, RN |
| Phone number: | 509-744-3490 |
| E-mail: | lcarlson@spokanebrainandspine.com |
Spine Patients
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 either (1) contacting the investigating sites directly, if their detailed contact information is provided above, or (2) sending an email to clinicaltrialdept@archususa.com. 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 clinicaltrialdept@archususa.com. Please include your name, address and contact information, including an email address where you can be reached.
Caution: TFAS® is an investigational device in the United States. It is limited by Federal (United States) Law to investigational use.
The information provided by Spine-Health in this Clinical Trials listing section is designed to help patients find clinical trials that are ongoing in the field of spine medicine, and to provide information to help patients contact the centers conducting the research. Spine-Health is not involved in conducting any of these trials and is not promoting the trials or research. This is a listing of industry-sponsored clinical trials. These clinical trial listings are not peer-reviewed by Spine-health.com.
