Ignite Creation Date:
2024-05-05 @ 7:14 PM
Last Modification Date:
2024-10-26 @ 9:46 AM
Study NCT ID:
NCT00637312
Status:
TERMINATED
Last Update Posted:
2014-03-27
First Post:
2008-03-10
Brief Title:
Advent Cervical Disc Versus ACDF for Treatment of One Level Degenerative Disc Disease IDE Study
Sponsor:
Orthofix Inc
Organization:
Orthofix Inc
Study Overview
Official Title:
Clinical Trial Comparing the Blackstone Advent Cervical Disc to Anterior Cervical Discectomy and Fusion ACDF for the Treatment of One Level Degenerative Disc Disease
Status:
TERMINATED
Status Verified Date:
2014-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Greater-than-anticipated rate of revisions
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 Advent Cervical Disc compared to Anterior Cervical Discectomy and Fusion ACDF in treating degenerative disc disease at a single-level in the cervical spine from C3 to C7 following cervical discectomy in skeletally mature patients at least 18 years of age
Detailed Description:
Following surgery study subjects will be evaluated at the following intervals 6 wks 2wks 3 Months 2 wks 6 Month 1 months 12 and 24 Month 2 months and annually until the last subject enrolled completes their 24 Month follow-up
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