Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT05703958
Status:
RECRUITING
Last Update Posted:
2024-10-24
First Post:
2023-01-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exactech Proximal Humerus Fracture Plate System Post Market Clinical Follow-up
Sponsor:
Exactech
Organization:
Study Overview
Official Title:
An Open Label, Multi-Center, Retrospective and Prospective Evaluation of Equinoxe Proximal Humerus Fracture Plates Clinical and Radiographic Outcomes
Status:
RECRUITING
Status Verified Date:
2024-10
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 objective of this study is to collect and evaluate long-term clinical outcomes data in order to better understand the safety and performance of the Equinoxe Proximal Humerus Fracture Plates over time. This study will follow subjects for a period of up to 10 years post-surgery.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: