1st EFORT European Consensus: Medical & Scientific Research Requirements for the Clinical Introduction of Artificial Joint Arthroplasty Devices

Innovations in Orthopaedics and Traumatology have contributed to the achievement of a high-quality level of care in musculoskeletal disorders and injuries over the past decades. The applications of new implants as well as diagnostic and therapeutic techniques in addition to implementation of clinical research, have significantly improved patient outcomes, reduced complication rates and length of hospital stay in many areas. However, the regulatory framework is extensive, and there is a lack of understanding and clarity in daily practice what the meaning of clinical & pre‐clinical evidence as required by the MDR is. Thus, understanding and clarity are of utmost importance for introduction of new implants and implant-related instrumentation in combination with surgical technique to ensure a safe use of implants and treatment of patients. Therefore EFORT launched IPSI, The Implant and Patient Safety Initiative, which starting from an inaugural workshop in 2021 issued a set of recommendations, notably through a subsequent Delphi Process involving the National Member Societies of EFORT, European Specialty Societies as well as International Experts. These recommendations provide surgeons, researchers, implant manufacturers as well as patients and health authorities with a consensus of the development, implementation, and dissemination of innovation in the field of arthroplasty. The intended key outcomes of this 1st EFORT European Consensus on “Medical & Scientific Research Requirements for the Clinical Introduction of Artificial Joint Arthroplasty Devices”are consented, practical pathways to maintain innovation and optimisation of orthopaedic products and workflows within the boundaries of MDR 2017/745. Open Access practical guidelines based on adequate, state of the art pre-clinical and clinical evaluation methodologies for the introduction of joint replacements and implant-related instrumentation shall provide hands-on orientation for orthopaedic surgeons, research institutes and laboratories, orthopaedic device manufacturers, Notified Bodies but also for National Institutes and authorities, patient representatives and further stakeholders. We would like to acknowledge and thank the Scientific Committee members, all International Expert Delegates, the Delegates from European National & Specialty Societies and the Editorial Team for their outstanding contributions and support during this EFORT European Consensus

Biomechanical Behaviour of Bone-Implant Interface: A Review

International audienceIn recent decades, cementless implants have been widely used in clinical practice to replace missing organs, to replace damaged or missing bone tissue or to restore joint functionality. However, there remain risks of failure which may have dramatic consequences. The success of an implant depends on its stability, which is determined by the biomechanical properties of the bone–implant interface (BII). The aim of this review article is to provide more insight on the current state of the art concerning the evolution of the biomechanical properties of the BII as a function of the implant's environment. The main characteristics of the BII and the determinants of implant stability are first introduced. Then, the different mechanical methods that have been employed to derive the macroscopic properties of the BII will be described. The experimental multi-modality approaches used to determine the microscopic biomechanical properties of periprosthetic newly formed bone tissue are also reviewed. Eventually, the influence of the implant's properties, in terms of both surface properties and biomaterials, is investigated. A better understanding of the phenomena occurring at the BII will lead to (i) medical devices that help surgeons to determine an implant's stability and (ii) an improvement in the quality of implants

Development of Optimal Total Hip Joint Replacement

Total hip replacement (THR) is a surgical process in which the hip joint is replaced by a hip prosthesis. It is one of the most popular and cost effective surgery. In particular in 2014, 83,125 primary procedures were recorded. Some of these operations need to be carried out again for different reasons after sometime. These are called revision (replacement of the prosthesis) procedures. Important studies and statistics suggest that the number of THR procedures is projected to increase by almost 175% by 2030. Aseptic loosening appears to be the most significant cause of failure in THR. Aseptic loosening might lead to revision surgery and in turn can be avoided by enhancing the stability and durability of the hip replacement. Primary stability attained after surgery is a determinant issue for the long-term stability of cementless hip arthroplasty. Primary stability is the level of relative micromotion between the femur and the prosthesis induced via the physiological joint forces following the surgery. The hip prosthesis is also exposed to dynamic loadings and activities of daily living, which can induce the stress distribution on the prosthesis of the hip joint model and affect the durability of the implant. The aim of this study is to develop an optimal total hip replacement (THR) implant with new and improved design features to achieve stability and durability. The micromotion between bone and implant interface and the stress distribution on the prosthesis and femur assembly has been reviewed and investigated. The laboratory testing were carried out on the femur including the compression, torsion and Brinell hardness testing. A compression testing using strain gauge technique done on the hip implant. Finite element analysis software used to simulate all compression and torsion testing assuming the same boundary and loading conditions and subsequently the computational results were compared with the earlier experimental data to verify the experiments and models used. 7 The comparative micromotion studies and findings of other researchers were used beside the clinical follow-up reports on success or failure rates of related hip designs, to justify the best solutions for design factors. In this computational approach researchers usually use finite element methodology to calculate micromotion of elements, sometimes known as migration. The elements exceeding the threshold limit would simulate the migration and subsequently eliminated from the assembly. This procedure recurs until reaching the convergence that derives a stable mechanical equilibrium. One of the restrictions of micromotion analysis was the inability to divide the final results into axial and rotational components. Therefore it would have been inappropriate to eventually conclude the best femoral stem, without considering the sustaining torsional loadings. Another limitation was that the micromotion analysis would not reflect the stress distribution on the hip prosthesis and consequently would ignore the potential high stress concentration that is associated with post operative pain as well as low durability and long-term stability. For these reasons stress analysis was carried out under dynamic loadings of nine different activities to examine the von Mises stress, shear stress and principal stress distribution of a cementless hip implant. In each activity realistic boundary and loading conditions of a complete assembly of femur and hip implant were investigated which includes defining of many variables including different geometry, material properties, boundary conditions, forces and moments of varying magnitude and orientation over specific time intervals. The critical points and areas that were developed in the entire 3D model were evaluated and explained. The finite element analysis which verified by experimental testing and hold the clinical relevance were used to decide the best optimal hip stem design amongst different presented design concepts. This was accompanied and improved with further stress analysis of different design factors to get the final optimal model. High offset stem option is a unique feature that helps tightening the abductor and boosts the hip implant stability with the ability to adjust neck and offset. It gives a surgeon more options to fix the most accurate offset and do the operation more effectively. The final optimal design and its advantages were presented in the last chapter

Book of Abstracts 15th International Symposium on Computer Methods in Biomechanics and Biomedical Engineering and 3rd Conference on Imaging and Visualization

In this edition, the two events will run together as a single conference, highlighting the strong connection with the Taylor & Francis journals: Computer Methods in Biomechanics and Biomedical Engineering (John Middleton and Christopher Jacobs, Eds.) and Computer Methods in Biomechanics and Biomedical Engineering: Imaging and Visualization (JoãoManuel R.S. Tavares, Ed.). The conference has become a major international meeting on computational biomechanics, imaging andvisualization. In this edition, the main program includes 212 presentations. In addition, sixteen renowned researchers will give plenary keynotes, addressing current challenges in computational biomechanics and biomedical imaging. In Lisbon, for the first time, a session dedicated to award the winner of the Best Paper in CMBBE Journal will take place. We believe that CMBBE2018 will have a strong impact on the development of computational biomechanics and biomedical imaging and visualization, identifying emerging areas of research and promoting the collaboration and networking between participants. This impact is evidenced through the well-known research groups, commercial companies and scientific organizations, who continue to support and sponsor the CMBBE meeting series. In fact, the conference is enriched with five workshops on specific scientific topics and commercial software.info:eu-repo/semantics/draf

Failure Analysis of Biometals

Metallic biomaterials (biometals) are widely used for the manufacture of medical implants, ranging from load-bearing orthopaedic prostheses to dental and cardiovascular implants, because of their favourable combination of properties, including high strength, fracture toughness, biocompatibility, and wear and corrosion resistance. Owing to the significant consequences of implant material failure/degradation, in terms of both personal and financial burden, failure analysis of biometals has always been of paramount importance in order to understand the failure mechanisms and implement suitable solutions with the aim to improve the longevity of implants in the body. Failure Analysis of Biometals presents some of the latest developments and findings in this area. This includes a great range of common metallic biomaterials (Ti alloys, CoCrMo alloys, Mg alloys, and NiTi alloys) and their associated failure mechanisms (corrosion, fatigue, fracture, and fretting wear) that commonly occur in medical implants and surgical instruments