Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00401518
Status:
COMPLETED
Last Update Posted:
2020-09-10
First Post:
2006-11-17
Brief Title:
A Pivotal Study of a Facet Replacement System to Treat Spinal Stenosis
Sponsor:
Globus Medical Inc
Organization:
Globus Medical Inc
Study Overview
Official Title:
The Investigational Plan for the Evaluation of the ACADIA Facet Replacement System
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
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 purpose of this study is to determine if the ACADIA Facet Replacement System is effective in the treatment of spinal stenosis The primary objective of the study is to evaluate the overall success rate of the Anatomic Facet Replacement System in patients with spinal stenosis when compared to a posterior spinal fusion control
Detailed Description:
Spinal Stenosis continues to be a major cause of back and leg pain The condition is attributed to narrowing of the space around the nerves in the lumbar spine This is often caused by the degenerative process in the spine and the facet joints The current treatment calls for removal of bone around the affected nerve including the facet joints and fusing the posterior of the spine to ensure the segments remain stable
The ACADIA Facet Replacement System AFRS allows for an anatomic reconstruction of the facet joint after decompression and removal of the degenerated facet Like the original facet joint the replacement implant is designed to reproduce facet motion while restoring normal stability and motion
The ACADIA Facet Replacement System AFRS has been designed on the principals that have allowed other total joint replacement procedures to provide significant patient benefits These guiding principals include
Anatomically based implant design
Reproducible surgical technique
Elimination of pain
The ACADIA Facet Replacement System allows the surgeon to remove the offending bone while preserving the motion of the facet joint
This study will evaluate the outcomes of patients using the AFRS investigation compared to those receiving instrumented posterior fusion procedure Patients will be required to complete study visits before the procedure and at 6 weeks 3 6 12 24 months post procedure and annually thereafter as required by FDA Follow up visits consist of administration of questionnaires radiographs and neurological assessment
The ACADIA Facet Replacement System AFRS allows for an anatomic reconstruction of the facet joint after decompression and removal of the degenerated facet Like the original facet joint the replacement implant is designed to reproduce facet motion while restoring normal stability and motion
The ACADIA Facet Replacement System AFRS has been designed on the principals that have allowed other total joint replacement procedures to provide significant patient benefits These guiding principals include
Anatomically based implant design
Reproducible surgical technique
Elimination of pain
The ACADIA Facet Replacement System allows the surgeon to remove the offending bone while preserving the motion of the facet joint
This study will evaluate the outcomes of patients using the AFRS investigation compared to those receiving instrumented posterior fusion procedure Patients will be required to complete study visits before the procedure and at 6 weeks 3 6 12 24 months post procedure and annually thereafter as required by FDA Follow up visits consist of administration of questionnaires radiographs and neurological assessment
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