Total Facet Arthroplasty System® (TFAS®) U.S. Clinical Trial

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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 ARCHUS Total Facet Arthroplasty System® (ARCHUS 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 patients, 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® also eliminates the need for painful bone graft harvest from the patient’s hip, typically required with fusion procedures.

The ARCHUS 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.

Inclusion Criteria
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 Overview
Approximately 20 investigative sites will enroll patients satisfying the inclusion/exclusion criteria into the TFAS® clinical trial.  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.

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.