Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2026-01-02 @ 12:12 AM
Study NCT ID:
NCT00887835
Status:
WITHDRAWN
Last Update Posted:
2012-04-27
First Post:
2009-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Post-Market Study of Transfacet Lumbar Spine Fixation and Fusion Utilizing the PERPOS™ PLS System
Sponsor:
Interventional Spine, Inc.
Organization:
Study Overview
Official Title:
A Post-Market Study of Transfacet Lumbar Spine Fixation and Fusion Utilizing the PERPOS™ PLS System
Status:
WITHDRAWN
Status Verified Date:
2009-04
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 utilize the PERPOS™ PLS System for transfacet lumbar spine fixation to evaluate its effect on patients' level of pain, procedural complications and functional status.
Detailed Description:
The PERPOS™ PLS System involves a minimally invasive, percutaneous implant procedure via a small incision.
The PERPOS™ PLS is intended for lumbar bilateral facet fixation, with or without bone graft, at single or multiple levels from L1 to S1.
The PERPOS™ PLS is intended for lumbar bilateral facet fixation, with or without bone graft, at single or multiple levels from L1 to S1.
Study Oversight
Has Oversight DMC:
False
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?: