Ignite Creation Date:
2024-05-06 @ 5:45 PM
Last Modification Date:
2024-10-26 @ 2:34 PM
Study NCT ID:
NCT05415592
Status:
WITHDRAWN
Last Update Posted:
2023-02-16
First Post:
2022-06-09
Brief Title:
A Study of Participants Undergoing Radial Head Replacement Using the DePuy Synthes Radial Head Replacement System for Partial Replacement of the Elbow Joint
Sponsor:
DePuy Synthes Products Inc
Organization:
DePuy Synthes Products Inc
Study Overview
Official Title:
A Multi-Center Post-Market Single-Arm Observational Clinical Follow-Up Study of Patients Undergoing Radial Head Replacement Using the DePuy Synthes Radial Head Replacement System for Partial Replacement of the Elbow Joint
Status:
WITHDRAWN
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This was a business decision made due to competing regulatory commitments Please note that this was not related to the safety or performance of the device
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 survivorship defined by the cumulative incidence of revision over the first 6 months post-implantation
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DST202002 | OTHER | DePuy Synthes Products Inc | None |