Archus Orthopedics

FAQs :: Frequently Asked Questions about the TFAS Clinical Trial

:: What is the purpose of the TFAS® clinical trial?

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

:: What is Spinal Stenosis?

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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 the 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 ability to walk and to perform other everyday activities. Back pain can also be an element of spinal stenosis but it in not usually a primary symptom of this condition.

:: What are facet joints?

The facet joints are small, stabilizing bony structures located between and behind the vertebrae (spinal column segments) at all the levels of the spine.

:: What is lumbar decompression spinal surgery?

Lumbar decompression surgery is the surgical removal of bony spinal structures, tissue and/or disc material that is causing compression of the spinal nerves. The lumbar decompression procedure may be performed in conjunction with an instrumented spinal fusion surgery particularly if the facet joints are removed because the complete excision of the facet joints can result in spinal column instability.

:: Am I a candidate for the TFAS clinical study?

Click Here to find out if you may be a candidate...

:: How does the clinical study work?

Patients who meet the eligibility requirements and are enrolled in the TFAS Clinical Study will be randomly assigned to either the investigational TFAS group or the instrumented spinal fusion surgery group which is the current standard of care. Two-thirds of the patients enrolled in the TFAS Clinical Study will be assigned to the investigational TFAS group and one-third will be assigned to the spinal fusion group. TFAS Clinical Study participants will be followed for a minimum of 24 months at 1, 3, 6, 12 and 24 month intervals.

:: Where are the TFAS clinical study sites?

Click here to view the growing list by location of TFAS® clinical sites...

:: Who is the study sponsor?

Archus Orthopedics, Inc. is the study sponsor. Archus Orthopedics, Inc. is a medical device developer focused on pioneering new solutions for diseases that require the complete removal and replacement of the lumbar spinal facet joints. Visit www.archususa.com for more information about the company and TFAS.

:: How long before I am back on my feet after surgery?

You should be back on your feet shortly after the surgery, however, full recovery will take anywhere from 2 to 6 months for most patients. Post-surgical recovery time can also be heavily impacted by the existence of other pre-existing conditions and your overall state of health.

:: When should I expect relief from the pain I have been experiencing?

Pre-operative symptoms could potentially diminish shortly after surgery.

:: How do I rehabilitate after surgery?

Physical therapy is typically recommended. Your rehabilitation program will vary depending on your physical condition and your surgeonâ€™s preferences.

:: Is TFAS my best treatment option?

TFAS is an option for patients who fit the criteria and are willing to participate in a clinical study. Pre-existing conditions and your overall state of health may affect the selection of the treatment option that is best for you. You should discuss these various treatment options with your spine surgeon.