NCT00418197

Total Facet Arthroplasty System®(TFAS®) Clinical Trial

A Prospective and Randomized Controlled Trial to Evaluate the Safety and Effectiveness of Total Facet Arthroplasty in the Treatment of Degenerative Spinal Stenosis

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Archus Orthopedics, Inc. · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The Archus 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 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. The clinical trial is intended to demonstrate restoration of stability and sagittal balance to the spine. TFAS® also eliminates the need for painful bone graft harvest from the patient's hip which may be required with fusion procedures.

Conditions

• Spinal Stenosis
• Low Back Pain
• Spondylolisthesis
• Lumbar Spinal Stenosis
• Leg Pain
• Spinal Diseases

Interventions

Type	Name	Description
DEVICE	Total Facet Arthroplasty System® (TFAS®)

Timeline

• Start date: 2005-08-01
• First posted: 2007-01-04
• Last updated: 2009-02-05