Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06511856
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-08
Brief Title:
FH ORTHO Shoulder Observatory
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Observational Study of Shoulder Surgery Using FH ORTHO Medical Devices
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a real-life observatory designed to collect long-term clinical data on patients who have undergone shoulder joint replacement or repair following shoulder trauma
In this type of intervention one or more medical devices distributed by FH ORTHO SAS may be used by surgeons
This study meets the requirement for post-market clinical follow-up PMCF as defined in the European Medical Device Regulation MDR 2017745
It therefore involves collecting in real life ie under the usual conditions of surgery and short and long-term patient follow-up minimal clinical data that will make it possible to document the continued benefitrisk of the medical devices concerned
This study is designed as a permanent long-term observatory of a non-interventional nature with the objective of having long-term follow-up data 5 to 10 years depending on the devices concerned for a maximum number of patients included
In this type of intervention one or more medical devices distributed by FH ORTHO SAS may be used by surgeons
This study meets the requirement for post-market clinical follow-up PMCF as defined in the European Medical Device Regulation MDR 2017745
It therefore involves collecting in real life ie under the usual conditions of surgery and short and long-term patient follow-up minimal clinical data that will make it possible to document the continued benefitrisk of the medical devices concerned
This study is designed as a permanent long-term observatory of a non-interventional nature with the objective of having long-term follow-up data 5 to 10 years depending on the devices concerned for a maximum number of patients included
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None