Growing requirements lead to uncertainty in clinical practice
The EU MDR is in full swing. The landmark piece of legislation envisages sharpened requirements for safety and efficacy data for a breadth of medical device classes in Europe. Particularly affected are high-risk and implantable devices, including those employed in common joint arthroplasty procedures such as total hip arthroplasty (THA) and total knee arthroplasty (TKA).
While the MDR’s requirements are clear cut on paper, their practical implications for clinical research and daily practice remain nebulous. This is especially true given rapid innovation in implant designs and materials.
As EFORT describes, “Understanding and clarity are of the utmost importance for the introduction of new implants and implant-related instrumentation in combination with surgical technique to ensure a safe use of implants and treatment of patients.”1
The first EFORT consensus
Recognizing the disparity between politics and practice, EFORT – a scientific platform linking all of Europe’s national orthopedic associations – initiated the formation of a pan-European consensus regarding implant performance and safety requirements as well as the clinical evaluation methodologies necessary to demonstrate these in accordance with the EU MDR.
EFORT consists of 41 national member societies hailing from 39 countries. Together with 13 associate scientific organizations, they cooperate to identify and disseminate scientific, clinical, and educational knowledge in the field of orthopedics and musculoskeletal traumatology.
With a focus on promoting the highest standard of patient and implant safety, the consensus book compiles guidelines from these associations and leading healthcare, research, and industry experts on the state-of-the-art surgical techniques and evaluation technologies in the field.
Left: The 1st EFORT European Consensus on Medical & Scientific Research Requirements for the Clinical Introduction of Artificial Joint Arthroplaty Devices compiles guidelines sourced from Europe’s leading experts in orthopedics and traumatology to define and standardize research requirements for joint arthroplasty under the EU MDR.
Right: Dr. Marcel Dreischarf contributes to a research topic highlighting analysis techniques for implant wear in TKA and THA.
Internationally accepted medical image analysis techniques
Among the participating experts was RAYLYTIC Chief Scientific Officer Dr. Marcel Dreischarf. A leader in the development of automated medical image analysis techniques, Dr. Dreischarf made contributions to several of the research topics, which consensus committee members from across Europe identified and voted on based on relevance to the arthroplasty community in times of shifting regulatory requirements.
Specifically, he was involved in developing an overview of methodologies to evaluate linear penetration and volumetric wear in THA and TKA clinical studies using standard clinical X-rays as well as radiologic methods and parameters to estimate primarily stability of implant fixation to bone.
RAYLYTIC’s automated CAD-based 2D-3D registration technique, which objectively determines rates of THA wear in vivo of modern implants with extremely low wear rates, was among the recommended methods:
“The use of the 3D-information through the CAD models in an iterative optimization process leads to improved accuracy and precision in the determination of implant wear. While Burckhardt et al. [2] still requires the user to manually select a region of interest, the CAD 2D-3D-registration according to the RayMatch method is fully automated and therefore does not rely on subjective user input resulting in full objectivity. Compared to other methods, it does not depend on additional implanted beads, complex setups or manual interaction. This approach resulted in the lowest mean error and standard deviation (0.003 mm ± 0.014 mm for hip joint images), as shown in Figure 1. Furthermore, it was shown that in vitro determined wear rates [21] were precisely confirmed in vivo using the CAD 2D-3D-registration method [22].”2
We are immensely proud that Dr. Dreischarf was invited to contribute to the development of this consensus. It is our goal and a true honor for us to support physicians, device manufacturers, and patients in the realm of joint arthroplasty by utilizing robust and internationally accepted image analysis methods, meticulously developed using high-quality data.
1. European Federation of National Associations of Orthopedics and Traumatology: 1st European Consensus. Medical & Scientific Research Requirements for the Clinical Introduction of Artificial Joint Arthroplasty Devices. 2023. Chairs: Grupp T., Overgaard, S. Pg.: 6.
2. Research Topic 9: Methodologies to Evlauate Linear Wear in Clinical Studies – Imaging Techniques for the Evlauation of Articulations in THA, TKA to Assess Wear and Function of the Joint Throughout the Expected Implant Lifetime. Jäger, M., Dreischarf, M., Grupp, T., Rieker C. In: European Federation of National Associations of Orthopedics and Traumatology: 1st European Consensus. Medical & Scientific Research Requirements for the Clinical Introduction of Artificial Joint Arthroplasty Devices. 2023. Chairs: Grupp T., Overgaard, S. Pg.: 81 – 84.