Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2026-03-03 @ 6:45 PM
Study NCT ID:
NCT02139527
Status:
TERMINATED
Last Update Posted:
2014-05-15
First Post:
2014-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CARES Lumbar Artificial Disc Registry
Sponsor:
DePuy Spine
Organization:
Study Overview
Official Title:
The Centers for Arthroplasty Research and Education in Spine (CARES) Lumbar Artificial Disc Registry Protocol
Status:
TERMINATED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low enrollment and follow-up data on enrolled patients.
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 registry is to assess outcomes following treatment with lumbar total disc replacement (TDR) in patients outside the clinical trial setting.
Detailed Description:
The purpose of this study is to capture outcomes associated with use of total disc replacement (TDR) in patients treated with either the CHARITE™ Artificial Disc or the PRODISC®-L Total Disc Replacement may be included in the registry.
Study Oversight
Has Oversight DMC:
False
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?: