Clinical Trial

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

Enrolling by Invitation
View on ClinicalTrials.gov →
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.
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2019-10-28; most recent amendment 2024-03-19.
Status change: Not Yet Recruiting → Enrolling by Invitation 2020-07-24
Trial Details
NCT Number NCT04145401
Lead Sponsor MicroPort Orthopedics Inc.
Conditions Knee Osteoarthritis
Enrollment 45 participants
Start Date 2020-09-30
Primary Completion 2033-05-01 (estimated)
Study Completion 2033-11-01 (estimated)
Updated on ClinicalTrials.gov 2024-03-20