19.03.2024
Evidence-based success
– Mathys’ legacy of clinical data
Seit jeher spielen klinische Daten bei Mathys eine wichtige Rolle – oft weit über die regulatorischen Vorgaben hinaus. Auch Implantat-Register sowie Bewertungen von klinischen Daten (Ratings) werden aktiv unterstützt.
For example, an important part of this is recording clinical data after products have been authorised and placed on the market. These are known as post-market clinical follow-up (PMCF) studies. PMCF studies have been and are being carried out for the vast majority of Mathys products.
The aim is to collect empirical data on the implants under everyday conditions and, in this way, be able to better assess their long-term effectiveness, safety and service life. Furthermore, additional questions were answered for the most important implants in investigator initiated trials (IIT).
Arthroplasty registries are also very important to Mathys. The registries are important for quality control and provide the opportunity to observe how Mathys prostheses are handled in practice and compare them to other similar implant systems. Find out more here in an interview with Peter Münger, Head of Medical Affairs at Mathys.
There are also evaluations (ratings) for clinical data in some countries, the most important being the ODEP rating from the UK. ODEP is short for Orthopaedic Data Evaluation Panel and is an independent panel of experts.
The ODEP rating in short
It consists of a NUMBER and a LETTER. The ASTERISK (*) in a rating is optional.
- The numbers indicate the number of years of clinical evidence.
(Ratings of 3, 5, 7, 10, 13 and 15 years)
- The letter represents the level of clinical evidence of the data provided by the manufacturer.
A = Strong evidence, generally higher number of patients/number of treatments.
B = Acceptable evidence, lower number of patients/number of treatments than A-rating.
- The asterisk was introduced in February 2014 in accordance with revised guidelines.
The A* rating is the highest rating that can be achieved and is based on very strong clinical evidence including low revision rates.
Many of Mathys implants have a very good ODEP rating
Here is a short overview of the five core products:
Bonepreservation
(consisting of optimys stem, ceramic head and RM Pressfit cup)
- Optimys: 7A*
- RM Pressfit vitamys: 10A*
- Affinis Short: 7A*
- Affinis Inverse cementless: 7A
- Affinis Inverse cemented: 7B
- balanSys BICONDYLAR CR: 7A*
- balanSys BICONDYLAR PS: 7A
- balanSys BICONDYLAR RP: 7A
- balanSys BICONDYLAR UC: 7B
- balanSys UNI: 10A
If you would like to know more
All of the clinical data for these implant systems are presented in a concise brochure. Click on the product heading above to download the clinical brochure. You will find the latest and most important results from the literature, registries and evaluations.
By the way:
all of the key products mentioned here and many others are already EU MDR certified. Find out more in this interview with Armand Linge, Head of Regulatory Affairs at Mathys.
Winglet Journal Club
We would like to let you know about our upcoming Winglet Journal Club on the subject of ‘Short stem prostheses after femoral neck fractures’. Professor Karl Philipp Kutzner from Mainz will introduce you to the topic. Together with two other experts in hip prosthetics, he’s looking forward to discussing the findings of his study with you. Prof. Kutzner has been working intensively on the subject of hip short stem prostheses for 15 years and prefers to adopt this implant philosophy whenever possible.
The Journal Club will take place on Monday, 17 June 2024 between 7 pm and 8 pm (CET).
Registration is free and takes place via the Winglet website.