Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00485173
Status:
COMPLETED
Last Update Posted:
2013-03-19
First Post:
2007-06-08
Brief Title:
INFUSE Bone Graft PEEK Interbody Spacer Anterior Cervical Plate Pivotal Clinical Trial
Sponsor:
Medtronic Spinal and Biologics
Organization:
Medtronic Spinal and Biologics
Study Overview
Official Title:
A Pivotal Clinical Investigation of INFUSE Bone Graft With a PEEK Interbody Spacer and an Anterior Cervical Plate in Patients With Cervical Degenerative Disc Disease at a Single Level
Status:
COMPLETED
Status Verified Date:
2012-12
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:
ACDF
Brief Summary:
The purpose of this study is to evaluate the safety and effectiveness of the investigational implant INFUSE Bone GraftPEEK Interbody SpacerAnterior Cervical Plate as a method of facilitating spinal fusion at a single level from C3-C7 in patients with symptomatic cervical degenerative disc disease
Detailed Description:
This pivotal clinical trial is being conducted to evaluate the safety and effectiveness of INFUSE Bone Graft with the PEEK Interbody Spacer and Anterior Cervical Plate in patients with symptomatic cervical degenerative disc disease DDD The implant under investigation in this clinical trial is INFUSE Bone Graft the PEEK Interbody Spacer and Anterior Cervical Plate The device will be implanted using an anterior surgical approach Safety and effectiveness data for patients in this study will be compared to that of historical controls Historical control data will be taken from the control arms of the following Medtronic studies 1 the Artificial Cervical Disc also known as PRESTIGE Cervical Disc System pivotal IDE trial NCT00642876 and 2 the BRYAN Cervical Disc System pivotal IDE trial NCT00437190
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