Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00437190
Status:
COMPLETED
Last Update Posted:
2016-05-13
First Post:
2007-02-16
Brief Title:
Pivotal IDE Study of the BRYANR Cervical Disc Prosthesis in the Treatment of DDD Versus ACDF
Sponsor:
Medtronic Spinal and Biologics
Organization:
Medtronic Spinal and Biologics
Study Overview
Official Title:
Pivotal IDE Study of the BRYANR Cervical Disc Prosthesis in the Treatment of Degenerative Disc Disease
Status:
COMPLETED
Status Verified Date:
2016-05
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 study is to establish the safety and effectiveness of the BRYANR Cervical Disc Prosthesis in treating single-level degenerative disc disease of the cervical spine
Detailed Description:
BryanR Cervical Disc Prosthesis is indicated in skeletally mature patients for reconstruction of the disc from C3 to C7 following single level discectomy for intractable radiculopathy andor myelopathy
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