Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00374413
Status:
TERMINATED
Last Update Posted:
2013-09-13
First Post:
2006-09-07
Brief Title:
KineflexC Artificial Disc System to Treat Cervical Degenerative Disc Disease DDD
Sponsor:
SpinalMotion
Organization:
SpinalMotion
Study Overview
Official Title:
Clinical Study Protocol for the Investigation of the KineflexC Spinal System - a Pivotal Study in Continued Access Stage
Status:
TERMINATED
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Economic and business factors
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 show that the KineflexC Spinal System is no worse than conventional Anterior Cervical Diskectomy with Fusion ACDF in patients with single level degenerative disc disease at any cervical level from C3 to C7
Detailed Description:
The KineflexC disc is a 3-piece modular design consisting of two cobalt chrome molybdenum CCM end-plates and a fully articulating CCM core The system is available in two foot print sizes
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