Ignite Creation Date:
2025-12-24 @ 3:59 PM
Ignite Modification Date:
2026-02-02 @ 8:19 PM
Study NCT ID:
NCT05415592
Status:
WITHDRAWN
Last Update Posted:
2023-02-16
First Post:
2022-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
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:
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WITHDRAWN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:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| DST202002 | OTHER | DePuy Synthes Products, Inc. | View |