Ignite Creation Date:
2024-05-05 @ 7:24 PM
Last Modification Date:
2024-10-26 @ 9:48 AM
Study NCT ID:
NCT00667459
Status:
COMPLETED
Last Update Posted:
2023-06-06
First Post:
2008-04-24
Brief Title:
Study of Safety Effectiveness of PRESTIGE LP Cervical Disc vs Anterior Cervical Fusion in Cervical DDD
Sponsor:
Medtronic Spinal and Biologics
Organization:
Medtronic Spinal and Biologics
Study Overview
Official Title:
A Prospective Multicenter Controlled Clinical Trial of an Artificial Cervical Disc LP at a Single Level for Symptomatic Cervical Disc Disease
Status:
COMPLETED
Status Verified Date:
2023-05
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 clinical trial is to evaluate the safety and effectiveness of the PRESTIGE LP Cervical Disc as a method of treating patients with symptoms of cervical degenerative disc disease at a single level from C3-C4 to C6-C7
Detailed Description:
This pivotal clinical trial was conducted to compare treatment data of the investigational implant devicethe PRESTIGE LP Cervical Disc with a control patient group receiving a plate The PRESTIGE LP Cervical Disc devices were implanted using an anterior surgical approach Data from control patients receiving anterior cervical discectomy and fusion with an ATLANTIS Anterior Cervical Plate from the initial Artificial Cervical Disc study NCT00642876 were compared as both treatment groups receive single-level surgical treatment from C3-C4 to C6-C7 for symptomatic cervical degenerative disc disease
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