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Sponsored by: |
Archus Orthopedics, Inc. |
Information provided by: | Archus Orthopedics, Inc. |
ClinicalTrials.gov Identifier: | NCT00418197 |
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 demostrate 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.
Condition | Intervention | Phase |
Spinal Stenosis Low Back Pain Spondylolisthesis Lumbar Spinal Stenosis Leg Pain Spinal Diseases |
Device: Total Facet Arthroplasty System® (TFAS®) |
Phase III |
MedlinePlus related topics: | Back Pain Spinal Diseases Spinal Stenosis |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Prospective and Randomized Controlled Trial to Evaluate the Safety and Effectiveness of Total Facet Arthroplasty in the Treatment of Degenerative Spinal Stenosis |
Estimated Enrollment: | 450 |
Study Start Date: | August 2005 |
Ages Eligible for Study: | 50 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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Show 22 Study Locations |
Archus Orthopedics, Inc. |
Study ID Numbers: | PR0051 |
First Received: | January 2, 2007 |
Last Updated: | July 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00418197 |
Health Authority: | United States: Food and Drug Administration |
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