Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 10:05 PM
Study NCT ID:
NCT06234358
Status:
COMPLETED
Last Update Posted:
2024-01-31
First Post:
2024-01-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Study Carried Out in Patients Operated With Calcanail®
Sponsor:
FH ORTHO
Organization:
Study Overview
Official Title:
A Retrospective Observational Clinical Study Carried Out in Patients Operated With Calcanail® in Order to Evaluate the Safety and Performance of the Device
Status:
COMPLETED
Status Verified Date:
2024-01
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:
This study is part of the Post-Market Clinical Follow-up process for the Calcanail medical device; the objective of which is to collect data on the safety and performance of the device after it has been placed on the market.
The primary objective of this study is to evaluate the safety of the device. The secondary objectives are to evaluate the clinical performance and safety of the device.
This is a research not involving the human person: observational study, retrospective, monocentric, non-comparative and national.
84 patients will be included in the study.
The primary objective of this study is to evaluate the safety of the device. The secondary objectives are to evaluate the clinical performance and safety of the device.
This is a research not involving the human person: observational study, retrospective, monocentric, non-comparative and national.
84 patients will be included in the study.
Detailed Description:
The CALCANAIL nail is an osteosynthesis nail intended for the repair of articular fractures of the calcaneus, deformities of the hindfoot and arthrosis of the hindfoot. This study aims to answer specific questions about the clinical performance, efficacy or safety of the medical device when used in accordance with its instructions for use. It will also enable us to better detect rare adverse events if necessary, as well as medium-term results.
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?: