Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00432159
Status:
COMPLETED
Last Update Posted:
2017-10-20
First Post:
2007-02-05
Brief Title:
Comparison of DISCOVER Artificial Cervical Disc and ACDF for Treatment of Cervical DDD IDE Study
Sponsor:
DePuy Spine
Organization:
DePuy Spine
Study Overview
Official Title:
A Multi-Center Prospective Randomized Controlled Trial Comparing Cervical Arthroplasty to Anterior Cervical Discectomy and Fusion for the Treatment of Cervical Degenerative Disc Disease
Status:
COMPLETED
Status Verified Date:
2017-09
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 treat patients with symptomatic degenerative disc disease at one level of the cervical spine The patients will be randomized to the DISCOVER Artificial Cervical Disc total disc replacement or SLIM-LOC cervical fusion to determine the safety and efficacy at 2 years post operative Follow-up on patients treated with total disc replacement will be continued to 5 years post operative
Detailed Description:
This study is designed as a multicenter prospective randomized controlled trial Subjects will be stratified by the number of levels to be treated then assigned treatment in a randomized 11 ratio Participants in the treatment group will undergo cervical total disc replacement with the DISCOVER Artificial Cervical Disc Participants in the control group will undergo anterior cervical discectomy and fusion with the SLIM-LOC Anterior Cervical Plate System with a cortical or cortico-cancellous allograft spacer Follow-up visits will occur at 2 weeks 3 and 6 months and 1 and 2 years for all randomized subjects Subjects that received the control treatment will complete their required study participation at 2 years post operative and subjects assigned the Discover treatment will complete their participation at 5 years post operative Follow-up for the Discover treatment group will be via a telephone administered questionnaire at 3 4 and 5 years post operative
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