Ignite Creation Date:
2024-05-06 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 12:22 PM
Study NCT ID:
NCT03123549
Status:
COMPLETED
Last Update Posted:
2023-01-06
First Post:
2017-03-29
Brief Title:
Investigation of the Two Level Simplify Cervical Artificial Disc
Sponsor:
NuVasive
Organization:
NuVasive
Study Overview
Official Title:
Clinical Study Protocol for the Investigation Of The Two Level Simplify Cervical Artificial Disc
Status:
COMPLETED
Status Verified Date:
2022-12
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:
None
Brief Summary:
This study is intended to demonstrate that the Simplify Cervical Artificial Disc Simplify Disc is at least as safe and effective as conventional anterior cervical discectomy and fusion ACDF when used to treat two contiguous discs from C3 to C7 following discectomy at two contiguous levels for intractable radiculopathy arm pain andor a neurological deficit with neck pain or myelopathy due to abnormalities localized to the levels of the two contiguous disc spaces in subjects who are unresponsive to conservative management
Detailed Description:
The objective of this clinical study is to evaluate the safety and effectiveness of the two-level Simplify Disc compared to conventional two-level ACDF in skeletally mature patients for reconstruction of two contiguous discs from C3 to C7 following discectomy at two contiguous levels for intractable radiculopathy arm pain andor a neurological deficit with neck pain or myelopathy due to abnormalities localized to the levels of the two contiguous disc spaces that are unresponsive to conservative management
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None