Clinical Trial

Post Market Follow-Up Study of the EVOLUTION® Total Knee Arthroplasty System With Cruciate Sacrificing Inserts

Study acronym: AMETHYST
Active, Not Recruiting
View on ClinicalTrials.gov →
Summary
MPO is conducting this PMCF study to evaluate the safety and efficacy of its EVOLUTION® Total Knee Arthroplasty (TKA) components marketed in the EU. These types of studies are required by regulatory authorities for all devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the EU. This study has been designed in accordance with MEDDEV 2.12/2 rev 2.
Protocol Amendment History 15 amendments
This ClinicalTrials.gov record has been amended 15 times since 2015-01-27; most recent amendment 2022-10-12.
Status change: Enrolling by Invitation → Active, Not Recruiting 2019-05-18
Status change: Recruiting → Enrolling by Invitation 2017-11-30
Status change: Not Yet Recruiting → Recruiting 2015-07-07
Trial Details
NCT Number NCT02351414
Lead Sponsor MicroPort Orthopedics Inc.
Conditions Joint Disease
Enrollment 150 participants
Start Date 2015-06-15
Primary Completion 2027-06 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2022-10-13