Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06546345
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
Post Market Clinical Follow-Up KeriFlex
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effectiveness and Safety of the Silicone Joint Implant KeriFlex and of Its Associated Instruments in the Treatment of MCP and PIP Arthritis Post Market Clinical Follow up
Status:
RECRUITING
Status Verified Date:
2024-08
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:
The general objective of this study is to assess the performance and safety of the KeriFlex silicone joint implant and its associated instruments used in accordance with the labeling and instructions in force
The performance and safety of the KeriFlex joint implant will be established in the short and long term with regard to the life cycle of the implant
The performance and safety of the KeriFlex joint implant will be established in the short and long term with regard to the life cycle of the implant
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