Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2025-12-25 @ 8:43 PM
Study NCT ID:
NCT06142669
Status:
RECRUITING
Last Update Posted:
2024-01-22
First Post:
2023-05-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
EVOLUTION® Revision STEMMED CS Post Market Clinical Follow-up Study Protocol
Sponsor:
MicroPort Orthopedics Inc.
Organization:
Study Overview
Official Title:
Post Market Clinical Follow-Up Study for EVOLUTION® Revision Tibial System and EVOLUTION® Stemmed CS Femur With the EVOLUTION® MP CS Tibial Insert
Status:
RECRUITING
Status Verified Date:
2023-11
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:
MicroPort (MPO) is conducting this PMCF study to evaluate the safety and effectiveness of its EVOLUTION® Revision Tibial System and EVOLUTION® Revision STEMMED CS Femur with the EVOLUTION® MP CS Tibial Insert. This type of study is required by regulatory authorities for all devices that have been approved in Europe to evaluate the medium and long-term clinical evidence.
Detailed Description:
The primary objective of this study is to estimate individual component survivorship for tibial base, femoral component, and tibial insert at specified intervals out to 10 years follow-up.
The secondary objectives include:
* Determine the cumulative incidence of individual component revision at specified intervals out to 10 years follow-up;
* Characterize functional scores for subjects, as assessed by KOOS Scores and EQ-5D-5L Scores, out to 10 years follow-up;
* To assess subject satisfaction with their TKA procedure using the Forgotten Joint Score and a Satisfaction Survey;
* To assess the presence, zone, and the size of radiolucencies surrounding implanted components out to 10 years follow-up;
* To assess safety and characterize protocol defined adverse events and adverse device effects.
The secondary objectives include:
* Determine the cumulative incidence of individual component revision at specified intervals out to 10 years follow-up;
* Characterize functional scores for subjects, as assessed by KOOS Scores and EQ-5D-5L Scores, out to 10 years follow-up;
* To assess subject satisfaction with their TKA procedure using the Forgotten Joint Score and a Satisfaction Survey;
* To assess the presence, zone, and the size of radiolucencies surrounding implanted components out to 10 years follow-up;
* To assess safety and characterize protocol defined adverse events and adverse device effects.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: