Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06628050
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-05-07
Brief Title:
ORIGIN PS Modular Associated Instruments
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Post-market Observational Study of the ORIGIN PS Modular Total Knee Prosthesis and Associated Instruments
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study objective is to evaluate safety and performance of the ORIGIN PS postero-stabilized Modular devices and associated instruments more precisely to evaluate safety by the proportion of patients requiring a revision ie revision rate at 2-6 months 1y and 2y post-procedure and to evaluate performance by means of a Knee Society Score KSS Score at 2-6 months 1y and 2y post procedure
The hypothesis raised for this study regarding the scoring is that patients will experience a marked improvement in the natural feel of the prosthesis during the first year after the surgery and slightly significant improvement at the following interval of 2 years The overall patient satisfaction is expected to be improved after 2 years follow-up with ORIGIN PS Modular
The hypothesis raised for this study regarding the scoring is that patients will experience a marked improvement in the natural feel of the prosthesis during the first year after the surgery and slightly significant improvement at the following interval of 2 years The overall patient satisfaction is expected to be improved after 2 years follow-up with ORIGIN PS Modular
Detailed Description:
The study is ambispective post market non-comparative non-randomized multicentric and observational in which 200 patients will be enrolled to evaluate the safety and performance of the ORIGIN PS Modular devices and associated instruments
Patients will be included in the study during 18 months inclusion window and followed-up for 24 months
Patients will be included in the study during 18 months inclusion window and followed-up for 24 months
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