TFAS™ Total Facet Arthroplasty System™ Clinical Trial

Introduction
Spinal stenosis is a progressive degenerative condition, typically first manifesting in the 5th or 6th decade of life, marked by a predominance of painful leg symptoms, including burning, tingling, numbness and weakness. It occurs when the articulating spinal joints, called "the facets", become arthritic and no longer provide necessary stability to the spine.

As with any joint in the body, the arthritic facets often become inflamed and osteophytic (produce bony spurs), resulting in irritation and impingement of nearby nerves leading to clinical symptoms. As the disease progresses, symptoms escalate, and the ability to walk and carry out basic activities of daily living becomes increasingly difficult due to clinical symptoms.

While patients are treated with conservative therapy during the early phases of the disease, many patients ultimately require surgical removal of the arthritic spinal elements and placement of spinal instrumentation to achieve spinal stability and symptom relief.

The Total Facet Arthroplasty System™ (TFAS™) is a non-fusion spinal implant indicated for treatment of patients with moderate to severe spinal stenosis. TFAS™ replaces the diseased facets (and lamina, if necessary, to attain adequate decompression) following surgical removal. TFAS™ offers the surgeon new options for treating spinal stenosis, enabling a more comprehensive decompression via complete removal of the facets. TFAS™ also offers an alternative to rigid spinal fusion fixation enabling intervertebral motion and restoration of stability and sagittal balance to the spine. TFAS™ eliminates the need for painful bone graft harvest from the patient's hip, typically required with fusion procedures.

The Total Facet Arthroplasty System™ is a new device currently limited by United States law to investigational use within the U.S. The TFAS™ clinical trial is a multi-center, prospective, randomized controlled clinical trial comparing the safety and effectiveness of the TFAS™ to spinal fusion surgery in the treatment of moderate to severe degenerative lumbar spinal stenosis.

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

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

Study Objective
The objective of this clinical investigation is to demonstrate the safety and effectiveness of the Total Facet Arthroplasty System™ (TFAS™) for the treatment of moderate to severe degenerative lumbar spinal stenosis.

Study Overview
Approximately 20 investigative sites will enroll patients satisfying the inclusion/exclusion criteria into the TFAS™ clinical trial. At a high level, the study is designed for patients with moderate to severe lumbar spinal stenosis requiring neural decompression with facetectomy at L3-L4 or L4-L5 at a single level to treat central or lateral stenosis, Grade I degenerative spondylolisthesis with objective evidence of neurologic impairment, and degenerative disease of the facets, with or without instability.

Study participants will be placed into one of two groups: 1) treatment with the investigational artificial facet replacement device (TFAS™) or 2) treatment with posterior instrumented fusion, considered the current standard of care for stenosis patients and likely the treatment that would be carried out on these patients, regardless of their participation in the trial. Patient enrollment in the trial will be randomized such that two thirds will receive the TFAS™ and one third will receive the standard instrumented fusion treatment.

Study Sponsor
Archus Orthopedics, Inc. is a medical device developer focused on pioneering novel solutions for diseases requiring complete removal and replacement of the facets of the lumbar spine.

Status
Patients are currently being enrolled and treated at Phase One investigative sites. Archus Orthopedics is currently recruiting clinical investigators for Phase Two of the 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

Questions? Please email Archus Orthopaedics.

• Clinical Trial Sites and Other Information: TFAS™ Total Facet Arthroplasty System™
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• Spinal Stenosis: Lumbar and Cervical
• TFAS™ Total Facet Arthroplasty System™ Clinical Trial FAQS
• Spondylolisthesis: Back Condition and Treatment
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