Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00418197
Status:
UNKNOWN
Last Update Posted:
2009-02-05
First Post:
2007-01-02
Brief Title:
Total Facet Arthroplasty SystemTFAS Clinical Trial
Sponsor:
Archus Orthopedics Inc
Organization:
Archus Orthopedics Inc
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2009-02
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 patients hip which may be required with fusion procedures
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None