Ignite Creation Date:
2024-05-06 @ 12:32 AM
Last Modification Date:
2024-10-26 @ 10:51 AM
Study NCT ID:
NCT01599221
Status:
UNKNOWN
Last Update Posted:
2012-09-11
First Post:
2012-05-09
Brief Title:
Observational Retrospective and Prospective Study on the Treatment of Femoral Fractures With EBA2
Sponsor:
Citieffe Srl
Organization:
Citieffe Srl
Study Overview
Official Title:
Observational Retrospective and Prospective Study on the Treatment of Lateral Proximal Femoral Fractures With Medical Device EBA2
Status:
UNKNOWN
Status Verified Date:
2012-05
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:
None
Brief Summary:
This is an observational retrospective and prospective study where subjects who have undergone surgery with EBA2 medical device for lateral proximal femoral fractures will be followed for data collection since the day before their surgery retrospectively until day 180 after surgery retrospectively and prospectively
This study is aimed at collecting data from patients who have already been treated with EBA2 nail Data collection will cover the details of the fracture and surgery from which the retrospective nature of the study as well as details of follow up visits after surgery that patients routinely carry out up to 6 months from which the prospective nature of the study
The study will be conducted in three clinical sites in Italy
This study is aimed at collecting data from patients who have already been treated with EBA2 nail Data collection will cover the details of the fracture and surgery from which the retrospective nature of the study as well as details of follow up visits after surgery that patients routinely carry out up to 6 months from which the prospective nature of the study
The study will be conducted in three clinical sites in Italy
Detailed Description:
EBA2 the technological evolution of Endovis BA is now available The device was developed in conformity with Regulations 9342CE and 200747CE it has the CE trademark and it is registered in the Italian National Registry of Medical Devices EBA2 has the unique features described below
it is undersized compared to other nails in commerce both proximal and distal to further facilitate the insertion into the bone The undersizing is aimed to reduce the stiffness of the stem In particular the biological nail-bone interaction will be improved as a consequence of lower shear stresses on the frontal plane
it is made entirely of titanium The choice of such a material is aimed to create a flexible means of synthesis that minimizes the differences with the healthy bone mechanical properties and reduces complications in the process of fracture healing
it is a dual-lag screw system that provides appropriate guidance to the sliding of the fractured extremities and an improved stability It is effective to limit torsional instability of the femoral head both during the intervention by the action of tightening of the screw itself and during the healing period due to improved bearing capacity towards multidirectional loads
the associated surgical instruments are simple the low number of pieces and their ease of use made the success even of the previous version
The aim of the present observational study is to collect data that confirm for EBA2 the technological evolution of Endovis BA the performance and tolerability proved in the previous trial In addition given the increasing importance that good quality of life represents in elderly objective of this observational study is to verify the general satisfaction of the patient with lateral proximal femoral fractures treated with EBA2
In order to evaluate subjects walking ability after the surgical insertion of EBA2 only subjects who could walk independently before of the fracture will be included in this observational study
it is undersized compared to other nails in commerce both proximal and distal to further facilitate the insertion into the bone The undersizing is aimed to reduce the stiffness of the stem In particular the biological nail-bone interaction will be improved as a consequence of lower shear stresses on the frontal plane
it is made entirely of titanium The choice of such a material is aimed to create a flexible means of synthesis that minimizes the differences with the healthy bone mechanical properties and reduces complications in the process of fracture healing
it is a dual-lag screw system that provides appropriate guidance to the sliding of the fractured extremities and an improved stability It is effective to limit torsional instability of the femoral head both during the intervention by the action of tightening of the screw itself and during the healing period due to improved bearing capacity towards multidirectional loads
the associated surgical instruments are simple the low number of pieces and their ease of use made the success even of the previous version
The aim of the present observational study is to collect data that confirm for EBA2 the technological evolution of Endovis BA the performance and tolerability proved in the previous trial In addition given the increasing importance that good quality of life represents in elderly objective of this observational study is to verify the general satisfaction of the patient with lateral proximal femoral fractures treated with EBA2
In order to evaluate subjects walking ability after the surgical insertion of EBA2 only subjects who could walk independently before of the fracture will be included in this observational study
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