NCT04145401

Post Market Clinical Follow-Up Study- EVOLUTION® Revision CCK

Post Market Clinical Follow-Up Study for EVOLUTION® Revision Tibial System and EVOLUTION® Revision Constrained Condylar Knee (CCK) Femur With the EVOLUTION® CCK Tibial Insert

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

Summary

Sponsor is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its EVOLUTION® Revision CCK Tibia and EVOLUTION® Revision CCK Femur with EVOLUTION® CCK Tibial inserts. These type of studies are required by regulatory authorities for all devices that have been approved in Europe (EU) to evaluate the medium and long term clinical evidence. This study has been designed in accordance with MEDDEV2.12/2 rev 2 (European Medical Device Vigilance System) and ISO (International Organization for Standardization) 14155:2011 guidelines.

Detailed description

The objectives of this study are: 1. To estimate the individual component survivorship of EVOLUTION® Revision Tibia, EVOLUTION® Revision CCK Femur, and EVOLUTION® CCK Tibial Insert. 2. To find out the cumulative incidence of component revision of each component in this combination. 3. To find out the functional outcome scores at early, midterm, and long-term follow-up.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DEVICE	Revision Knee implants	Primary knee arthroplasty or a revision knee that requires a revision procedure.

Timeline

• Start date: 2020-09-30
• Primary completion: 2033-05-01
• Completion: 2033-11-01
• First posted: 2019-10-30
• Last updated: 2024-03-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study