Ignite Creation Date:
2024-05-06 @ 7:29 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06028971
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2023-09-01
Brief Title:
Safety and Performance of the Biphasic Plate Distal Femur A Multicenter Case Series
Sponsor:
41medical AG
Organization:
41medical AG
Study Overview
Official Title:
Safety and Performance of the Biphasic Plate Distal Femur A Multicenter Case Series
Status:
RECRUITING
Status Verified Date:
2024-03
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:
The goal of this observational multicenter case series is to assess the safety and performance of the CE-marked Biphasic Plate Distal Femur during standard of care
Detailed Description:
The goal of this observational study is to assess the safety and performance of the CE-marked Biphasic Plate Distal Femur during standard of care The study is conducted as a retrospective and prospective multicenter case series Eligible patients are those with fractures of the distal femur who are treated with the Biphasic Plate DF according to the Instruction for Use IFU The patient will be followed-up until healing or up to 12 months whichever comes first
To assess the safety and performance following data is collected
incidents of AEsSAEs occurring in the affected lower extremityextremities
Bone healing assessed by a surgeon
Weightbearing and function
Patients quality of life and pain level
To assess the safety and performance following data is collected
incidents of AEsSAEs occurring in the affected lower extremityextremities
Bone healing assessed by a surgeon
Weightbearing and function
Patients quality of life and pain level
Study Oversight
Has Oversight DMC:
None
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?:
None