Ignite Creation Date:
2024-05-06 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 2:22 PM
Study NCT ID:
NCT05197335
Status:
UNKNOWN
Last Update Posted:
2022-03-03
First Post:
2021-12-23
Brief Title:
Observational Clinical Study on Elderly Patients With Fracture of the Proximal Femur Treated With the Chimaera Nail
Sponsor:
Orthofix srl
Organization:
Orthofix srl
Study Overview
Official Title:
Observational Prospective and Multicentre Clinical Study for the Evaluation of Clinical Parameters of Elderly Patients With Fractures of the Proximal Femur Treated by the Intramedullary Nail Chimaera Orthofix Srl Italian on Documents Indagine Clinica Osservazionale Prospettica e Multicentrica Per la Valutazione di Parametri Clinici di Pazienti Anziani Con Frattura Del Femore Prossimale Trattata Mediante il Chiodo Intramidollare Chimaera Orthofix Srl
Status:
UNKNOWN
Status Verified Date:
2022-02
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
Chimaera
Brief Summary:
This is an observational prospective and multicenter clinical investigation that is part of the active materiovigilance plan that Orthofix Srl in agreement with its Notified Body The sponsor has planned to actively collect clinical data relating to the use of Chimaera Intramedullary Nail in a representative number of users and elderly patients with fractures of the proximal femur The data obtained from this clinical investigation will be used to complete the pre-market clinical evaluation carried out on the Chimaera with post-market clinical data from the use of the device in normal clinical practice
Detailed Description:
Orthofix Srl has developed and placed on the European market the Chimaera Intramedullary Nail after having evaluated the clinical performance and safety of the medical device based on biomechanical tests and clinical data obtained from scientific publications on equivalent products The outcome of this pre-market assessment established that Chimaera possesses the requirements for CE marking in particular it possesses an acceptable riskbenefit ratio if used according to the manufacturers directions for use
The enrolled patients as would happen even if they did not decide to participate in this study will proceed by undergoing the surgery necessary for the application of the medical device under observation Chimaera which coincides with the start of the treatment period
After the surgery and the hospital discharge the patient will undergo subsequent follow-up visits The follow-up visits carried out respectively at 1 month and 3 months after the date of surgery conclude the treatment period which barring complications is expected within 8 - 12 weeks from the date of surgery with the consolidation of the fracture of the proximal femur treated Healing will be verified by the Investigator based on an X-ray check through which heshe will make a qualitative assessment of the bone density at the fracture site and the positioning of the bone stumps Starting from the 3-month visit and up to 1-year visit the Investigator will compile the Bowers Parker functional score a measure of effectiveness for the evaluation of the patients functional recovery The score obtained at the follow-up visits will be compared to the score compiled during the discharge visit representative of the pre-fracture patients status
For patients that undergo this treatment the removal of the device is not planned except for serious adverse events that require a second surgery to complete the treatment of the fracture safety measure Once the treatment period has ended the control period begins during which 2 visits will be made respectively 6 months and 1 year after the date of the surgery During these visits clinical data will be collected to follow the evolution of the fracture consolidation and the functional recovery of the patient and the occurrence of any adverse events in the medium term
The enrolled patients as would happen even if they did not decide to participate in this study will proceed by undergoing the surgery necessary for the application of the medical device under observation Chimaera which coincides with the start of the treatment period
After the surgery and the hospital discharge the patient will undergo subsequent follow-up visits The follow-up visits carried out respectively at 1 month and 3 months after the date of surgery conclude the treatment period which barring complications is expected within 8 - 12 weeks from the date of surgery with the consolidation of the fracture of the proximal femur treated Healing will be verified by the Investigator based on an X-ray check through which heshe will make a qualitative assessment of the bone density at the fracture site and the positioning of the bone stumps Starting from the 3-month visit and up to 1-year visit the Investigator will compile the Bowers Parker functional score a measure of effectiveness for the evaluation of the patients functional recovery The score obtained at the follow-up visits will be compared to the score compiled during the discharge visit representative of the pre-fracture patients status
For patients that undergo this treatment the removal of the device is not planned except for serious adverse events that require a second surgery to complete the treatment of the fracture safety measure Once the treatment period has ended the control period begins during which 2 visits will be made respectively 6 months and 1 year after the date of the surgery During these visits clinical data will be collected to follow the evolution of the fracture consolidation and the functional recovery of the patient and the occurrence of any adverse events in the medium term
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