Ignite Creation Date:
2024-05-05 @ 9:41 PM
Last Modification Date:
2024-10-26 @ 10:08 AM
Study NCT ID:
NCT00945243
Status:
TERMINATED
Last Update Posted:
2017-11-06
First Post:
2009-07-22
Brief Title:
Clinical Outcomes Study Evaluating the Zero-P PEEK
Sponsor:
Synthes USA HQ Inc
Organization:
Synthes USA HQ Inc
Study Overview
Official Title:
Prospective Multi-Center Clinical Outcomes Study Evaluating the Zero-P PEEK for Anterior Cervical Interbody Fusion in the Treatment of Cervical Degenerative Disc Disease
Status:
TERMINATED
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This study was terminated early due to lower than expected enrollment rates
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multi-center prospective outcomes study In this study the Zero-P PEEK implant will be used in patients undergoing ACDF for treatment of SCDD at a single level between C3 and C7 The cohort will be followed over time to twenty-four 24 months after surgery Up to fifteen 15 sites will participate in this study This is not a controlled study
Detailed Description:
This was a post-market study
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