NCT06142669

EVOLUTION® Revision STEMMED CS Post Market Clinical Follow-up Study Protocol

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
• Phase: —
• Study type: Observational
• Enrollment: 45 (estimated)
• Sponsor: MicroPort Orthopedics Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Joint Diseases

Interventions

Type	Name	Description
DEVICE	EVOLUTION® Revision Tibial System and EVOLUTION® Stemmed CS Femur with the EVOLUTION® MP CS Tibial Insert	Primary knee arthroplasty or a revision knee that requires a revision procedure.

Timeline

• Start date: 2023-10-31
• Primary completion: 2036-06-01
• Completion: 2036-12-01
• First posted: 2023-11-21
• Last updated: 2024-01-22

Locations

1 site across 1 country: Italy

Regulatory

• FDA-regulated device study