Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 11:22 PM
Study NCT ID:
NCT05049993
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-10-23
First Post:
2021-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pyrocarbon Clinical Follow-up Study
Sponsor:
Stryker Trauma and Extremities
Organization:
Study Overview
Official Title:
Pyrocarbon Clinical Follow-up Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-10
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:
PYC CFS
Brief Summary:
The objective of this multi-center study is to collect medium and long-term data on the related clinical complications and functional outcomes of the Pyrocarbon Humeral Head to demonstrate safety and performance, in subjects from the Pyrocarbon IDE Study cohort.
Data collected from this study will support post-market surveillance and MDR requirements as well provide the basis for peer-reviewed publications on mid- and long-term product performance and safety (five to ten years post-op).
Data collected from this study will support post-market surveillance and MDR requirements as well provide the basis for peer-reviewed publications on mid- and long-term product performance and safety (five to ten years post-op).
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?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: