Ignite Creation Date:
2024-05-05 @ 9:26 PM
Last Modification Date:
2024-10-26 @ 10:04 AM
Study NCT ID:
NCT00887835
Status:
WITHDRAWN
Last Update Posted:
2012-04-27
First Post:
2009-04-23
Brief Title:
A Post-Market Study of Transfacet Lumbar Spine Fixation and Fusion Utilizing the PERPOS PLS System
Sponsor:
Interventional Spine Inc
Organization:
Interventional Spine Inc
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WITHDRAWN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:
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