Ignite Creation Date:
2024-05-06 @ 7:36 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06077942
Status:
RECRUITING
Last Update Posted:
2023-10-12
First Post:
2023-09-26
Brief Title:
FX Shoulder Solutions Retrospective Prospective Clinical Study
Sponsor:
FX Shoulder Solutions
Organization:
FX Shoulder Solutions
Study Overview
Official Title:
FX Shoulder Solutions Retrospective Prospective Clinical Study
Status:
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:
None
Brief Summary:
Subjects implanted with the shoulder replacement medical devices manufactured by FX Shoulder Solutions and distributed by FX Shoulder Solutions
Detailed Description:
To evaluate patient outcomes following shoulder replacement with FX Shoulder Solutions medical devices To demonstrate effectiveness safety and survivorship of FX Shoulder Solutions medical devices To provide data and analysis to FX Shoulder Solutions to meet regulatory requirements
To provide data and analysis for presentations abstracts publications and other public release of results
Clinical data in the Investigators clinic notes and patient files regarding demographics baseline medical and shoulder status surgical procedure and implant components and any completed postoperative clinical data will be collected retrospectively as data for the Study following signed patient consent and enrollment into the study
Each patient will be evaluated prospectively and clinical data collected at the first baseline clinical evaluation using the protocol specified evaluations following study enrollment with successive postoperative evaluations in accordance with the postoperative intervals
To provide data and analysis for presentations abstracts publications and other public release of results
Clinical data in the Investigators clinic notes and patient files regarding demographics baseline medical and shoulder status surgical procedure and implant components and any completed postoperative clinical data will be collected retrospectively as data for the Study following signed patient consent and enrollment into the study
Each patient will be evaluated prospectively and clinical data collected at the first baseline clinical evaluation using the protocol specified evaluations following study enrollment with successive postoperative evaluations in accordance with the postoperative intervals
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