TFAS posterior view (larger view)

Facet Replacement Clinical Study: Total Facet Arthroplasty System^® (TFAS^®) US Clinical Trial (Sponsored clinical trial listing)

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.

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. - California
• Charles Liu, M.D. - California

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
Location:	1520 San Pablo Street, Suite 3800 Los Angeles, CA 90033
Contact name:	Jana Evenhouse, RN
Phone number:	323-442-7536
Website:	www.uscneurosurgery.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:	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:	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:	Justine Magurno
Phone number:	607-798-0165
Fax number:	607-729-7516
E-mail:	jmagurno@rcresearchinc.com

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:	Laurie Yniesta, BHS
Phone number:	843-792-9172
Fax number:	843-792-7263
E-mail:	yniesta@musc.edu

Name of center:	East Tennessee Brain and Spine Center
Primary investigator:	David Wiles, M.D.
Location:	East Tennessee Brain and Spine Center 310 N State of Franklin Road, Suite 103 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@texasback.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
Name of center:	Swedish Medical Center
Primary investigator:	John Hsiang, MD
Location:	550 17th Ave, Suite 500 Seattle, WA 98122
Contact name:	Megan Alexander
Phone number:	206-320-2261
Fax number:	206-320-2827
E-mail:	megan.alexander@swedish.org
Name of center:	Inland Neurosurgery & Spine
Primary investigator:	John Demakas, MD
Location:	105 West 8th Avenue, Suite 200 Spokane, WA 99204
Contact name:	LeeAnn Hanke
Phone number:	509-624-9112 x152
Fax number:	509-624-1087

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.