Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06285981
Status:
RECRUITING
Last Update Posted:
2024-04-12
First Post:
2024-02-22
Brief Title:
Retrospective Study Chimaera Long Nail in Adult Patient
Sponsor:
Orthofix srl
Organization:
Orthofix srl
Study Overview
Official Title:
Observational Retrospective Study to Assess the Clinical Benefit and Safety Profile of the Intramedullary Nail CHIMAERA in Adult Patient Who Have Suffered Pertrochanteric Intertrochanteric and Subtrochanteric Fractures of the Femur in Daily Practice CHIMAERA Study
Status:
RECRUITING
Status Verified Date:
2024-02
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 CHIMERA study intends to evaluate the clinical benefits of the study medical device in the standard clinical practice
Detailed Description:
The CHIMERA study intends to evaluate the clinical benefits of the study medicalinvestigational device in the standard clinical practice The study will be conducted in two sites located in Italy both considered reference sites for the treatment of adult patients with pertrochanteric intertrochanteric and subtrochanteric fractures of the femur where the usage of Orthofix Chimaera Hip Fracture SystemTM from now on CHIMAERA was part of the normal clinical practice The CHIMAERA is an internal fixation system intended for insertion into the medullary canal of a femur in individuals suffering from stable and unstable pertrochanteric intertrochanteric and subtrochanteric fractures of the femur alone or when these fractures occur in combination with shaft fractures extending distally to a point approximately 10cm proximal to the intercondylar notch The participant investigators will retrospectively include a maximum of 44 patients meeting inclusion and exclusion criteria considering an imprecision of 5 that will contribute for approximately 44 patients in which CHIMAERA was used
The study is designed to analyze medical records of adult patients who underwent CHIMAERA implantation from 2018 to 2023 in the standard clinical practice setting
The study is designed to analyze medical records of adult patients who underwent CHIMAERA implantation from 2018 to 2023 in the standard clinical practice setting
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?:
False
Is an FDA AA801 Violation?:
None