Project AMETHYST
Research type
Research Study
Full title
Post Market Clinical Follow-Up Study of the EVOLUTION® Total Knee Arthroplasty System with Cruciate Sacrificing Inserts (Project AMETHYST)
IRAS ID
180952
Contact name
Rhys Williams
Contact email
Sponsor organisation
MicroPort Orthopedics, Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
12 years, 0 months, 1 days
Research summary
Research Summary
MicroPort Orthopedics is conducting this Post-Market Clinical Follow-Up study to evaluate the safety and efficacy of its EVOLUTION® Total Knee Arthroplasty (TKA) components marketed in the EU within a 10-year follow-up period. 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.
Summary of Results
MicroPort Orthopedics (MPO), a US based medical device company, started this clinical trial with Mr. Rhys Williams in August 2016. This trial aimed to collect safety and performance data on a medical device called, Evolution Primary Total Knee System. This device is used to replace the natural knee that is affected by osteoarthritis and cannot be treated by other non-surgical treatment options, with a goal of reviving normal knee functionality.
The study enrolled 30 patients between 2016 and 2019, who were followed up at (2-5) years and (5-7) years, after surgery. The study ended in September 2023, by which 24 patients had completed their (5-7) years follow-up. During the course of the study, none of the patients had any medical problems related to the device or the surgical procedure, none died, and none were lost to follow up.
The performance of the device was evaluated by asking the patients to answer two questionnaires on their quality of life and knee functionality, post-surgery. At an average follow up of 6 years, majority of the patients were satisfied with their knee function and had a good quality of life.
Outcomes of this study have enabled MPO to determine that this device is safe for treating patients with severe knee arthritis, which in turn can help them lead a good quality life with normal knee function.REC name
Wales REC 3
REC reference
15/WA/0258
Date of REC Opinion
18 Dec 2015
REC opinion
Further Information Favourable Opinion