Ignite Creation Date:
2024-05-05 @ 9:25 PM
Last Modification Date:
2024-10-26 @ 10:04 AM
Study NCT ID:
NCT00882661
Status:
COMPLETED
Last Update Posted:
2017-06-09
First Post:
2009-04-14
Brief Title:
SECURE-C Cervical Artificial Disc Clinical Study SECURE-C Cervical Artificial Disc Postmarket Approval Study
Sponsor:
Globus Medical Inc
Organization:
Globus Medical Inc
Study Overview
Official Title:
A Prospective Randomized Clinical Investigation of the SECURE-C Cervical Artificial Disc A Pivotal Study SECURE-C Cervical Artificial Disc Postmarket Approval Study
Status:
COMPLETED
Status Verified Date:
2017-06
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 the pivotal IDE clinical study was to evaluate the safety and effectiveness of the SECURE-C Cervical Artificial Disc for the treatment of symptomatic cervical disc disease at one level between C3 and C7 compared to anterior cervical discectomy and fusion
The purpose of the Postmarket Approval Study is to evaluate the long-term safety and efficacy associated with the use of the SECURE-C Cervical Artificial Disc
The purpose of the Postmarket Approval Study is to evaluate the long-term safety and efficacy associated with the use of the SECURE-C Cervical Artificial Disc
Detailed Description:
Ages Eligible for Study 18 to 60 years
Genders Eligible for Study Both
Accepts Healthy Volunteers No
Genders Eligible for Study Both
Accepts Healthy Volunteers No
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