Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06180525
Status:
RECRUITING
Last Update Posted:
2024-03-22
First Post:
2023-12-12
Brief Title:
Radiological Evaluation of 3D Printed Porous Collars in Hip and Knee Resection Prostheses Pilot Study
Sponsor:
Regina Elena Cancer Institute
Organization:
Regina Elena Cancer Institute
Study Overview
Official Title:
Radiological Evaluation of 3D Printed Porous Collars in Resection Prostheses Hip and Knee Pilot Study
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:
COLLARS
Brief Summary:
This study aims to evaluate the osseointegration of 3D printed porous collars in hip and knee resection prostheses in order to eliminate one of the causes of diaphyseal osteolysis which often lead to loosening of the implants and therefore to guarantee a further improvement in fixation of the implants in terms of both primary and secondary stability
Detailed Description:
Non-interventional retro-prospective non-pharmacological multicenter pilot study
The objective of the study is the radiological and clinical evaluation of collar osteointegration porous 3D printed in hip and knee resection prostheses
Aims to enroll patients undergoing resection prosthesis surgery hip and knee with the use of 3D printed porous collars performed according to normal practice clinic at the institutions participating in the study
It is structured in a retrospective part which will evaluate the patients for whom follow-up data is available at the time of the start of the study up to at least 1 year after the operation And a prospective part both with regard to patients not yet subjected to intervention at the start of the study according to the inclusion criteria both regarding those in follow-up for whom data are not available according to the time of observation required 1 year which will begin once all the necessary authorizations have been obtained administrative requests
The objective of the study is the radiological and clinical evaluation of collar osteointegration porous 3D printed in hip and knee resection prostheses
Aims to enroll patients undergoing resection prosthesis surgery hip and knee with the use of 3D printed porous collars performed according to normal practice clinic at the institutions participating in the study
It is structured in a retrospective part which will evaluate the patients for whom follow-up data is available at the time of the start of the study up to at least 1 year after the operation And a prospective part both with regard to patients not yet subjected to intervention at the start of the study according to the inclusion criteria both regarding those in follow-up for whom data are not available according to the time of observation required 1 year which will begin once all the necessary authorizations have been obtained administrative requests
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