Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 10:55 PM
Study NCT ID:
NCT00698867
Status:
COMPLETED
Last Update Posted:
2017-08-07
First Post:
2008-06-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Clinical Investigation of the Discovery™ Elbow System
Sponsor:
Biomet Orthopedics, LLC
Organization:
Study Overview
Official Title:
A Prospective, Non-controlled, Clinical Investigation of the Discovery™ Elbow System
Status:
COMPLETED
Status Verified Date:
2017-04
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 this study is to perform a five-year, multi-center prospective evaluation of the Discovery™ Elbow System for outcome and durability. Relief of pain and restoration of function will determine long-term clinical outcome while durability will be measured by the absence of revisions.
Detailed Description:
Patient follow-up outcomes measured by the ASES score, radiographs and adverse events/revisions.
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?: