Introduction of innovations in joint arthroplasty: Recommendations from the 'EFORT implant and patient safety initiative'.

With the implementation of the new MDR 2017/745 by the European Parliament, more robust clinical and pre-clinical data will be required due to a more stringent approval process. The EFORT Implant and Patient Safety Initiative WG1 'Introduction of Innovation', combined knowledge of orthopaedic surgeons, research institutes, orthopaedic device manufacturers, patient representatives and regulatory authorities to develop a comprehensive set of recommendations for the introduction of innovations in joint arthroplasty within the boundaries of MDR 2017/745. Recommendations have been developed to address key questions about pre-clinical and clinical requirements for the introduction of new implants and implant-related instrumentation with the participation of a steering group, invited by the EFORT Board in dialogue with representatives from European National Societies and Speciality Societies. Different degrees of novelty and innovation were described and agreed on in relation to when surgeons can start, using implants and implant-related instrumentation routinely. Before any clinical phase of a new implant, following the pre-market clinical investigation or the equivalent device PMCF pathway, it is a common understanding that all appropriate pre-clinical testing (regulatory mandatory and evident state of the art) - which has to be considered for a specific device - has been successfully completed. Once manufacturers receive the CE mark for a medical device, it can be used in patients routinely when a clinical investigation has been conducted to demonstrate the conformity of devices according to MDR Article 62 or full equivalence for the technical, biological and clinical characteristics has been demonstrated (MDR, Annex XIV, Part A, 3.) and a PMCF study has been initiated.

Toward A Regulatory Pathway for the Use of in Silico Trials in the CE Marking of Medical Devices.

In Silico Trials methodologies will play a growing and fundamental role in the development and de-risking of new medical devices in the future. While the regulatory pathway for Digital Patient and Personal Health Forecasting solutions is clear, it is more complex for In Silico Trials solutions, and therefore deserves a deeper analysis. In this position paper, we investigate the current state of the art towards the regulatory system for in silico trials applied to medical devices while exploring the European regulatory system toward this topic. We suggest that the European regulatory system should start a process of innovation: in principle to limit distorted quality by different internal processes within notified bodies, hence avoiding that the more innovative and competitive companies focus their attention on the needs of other large markets, like the USA, where the use of such radical innovations is already rapidly developing.

Experimental validation of the abrasive wear stage of the gross taper failure mechanism in total hip arthroplasty.

BACKGROUND: Gross taper failure (GTF) is a rare but catastrophic failure mode of the head-stem-taper junction of hip prostheses, facilitated by massive material loss. GTF is a two stage process initiated by corrosion leading to head bottoming out, followed by abrasive wear due to the head rotating on the stem. The purpose of this study was to reproduce the clinical failure patterns and to determine the material loss during simulated gait. METHODS: Six cobalt-chromium alloy heads (36 mm, 12/14 taper) with three different head lengths (short / medium / extra long) were combined with stem taper replicas made from titanium alloy sized to achieve bottoming out. A hip simulator was used to simulate gait loading after (ISO 14242-1 for 2 million cycles). RESULTS: Wear patterns from in-vitro testing match the clinical failure patterns. Stem taper wear increased linearly with time (p< 0.001). After two million cycles the material loss of short / medium / extra long heads was (M+-STD) 1168±242 mg / 400±23 mg / 94±12 mg on the stem side and 46±36 mg / 46±24 mg / 70±8 mg on the head side. Stem taper wear decreased with increasing head length (p=0.01), whereas clinical failures are mostly seen for long and extra long heads.

Bone plate-screw constructs for osteosynthesis - recommendations for standardized mechanical torsion and bending tests.

This paper follows up on a recent systematic review of test methods and parameters for biomechanical testing of bone plates and it is the first study that contains recommendations for standardized mechanical testing of bone plate-screw constructs for osteosynthesis. Following the testing philosophy of ASTM F382 and ISO 9585, we have developed standardized quasi-static and dynamic testing methods for straight linear and anatomically shaped plates, including locked type and conventional systems. The test specification comprises torsion and bending tests along the implant axis and therefore modifies and extends the methods proposed by ASTM F382. We present specific test setups in order to determine product-specific characteristics of the mechanical construct, consisting of the bone plate with corresponding screws (such as construct stiffness, yield strength, ultimate strength and fatigue properties) under the condition that it is rigidly fixed to "healthy bone". We also address specific testing requirements that are important for the purpose of standardization, such as the positioning of the construct for testing or the number of screws in the diaphysis and metaphysis. Finally, we define the outcome parameters and associated failure criteria related to quasi-static and dynamic testing for comparative purposes. This paper does not intend to replace biomechanical testing of those devices under physiological loading conditions.

Evaluation of impingement behaviour in lumbar spinal disc arthroplasty.

INTRODUCTION: The objective of our in vitro study was to introduce a test method to evaluate impingement in lumbar spinal disc arthroplasty in terms of wear, contact pattern, metal ion concentration and particle release. MATERIAL AND METHOD: Impingement wear simulation was performed on a 6-station spinal wear simulator (Endolab, Germany) on a lumbar spinal disc system (activ L Aesculap AG, Germany) using four different protocols specific to impingement in flexion, in extension, in lateral bending and in combined flexion bending. Impingement contact stress is intentionally created by applying an angular displacement of +2° in addition to the intended range of motion in the impingement direction, whereas a bending moment of 8 Nm remains constant during the impingement phase (plateau). RESULTS: An average volumetric wear rate of 0.67 mm(3)/million cycles was measured by impingement under flexion, of 0.21 mm(3)/million cycles under extension, of 0.06 mm(3)/million cycles under lateral bending and of 1.44 mm(3)/million cycles under combined flexion bending. The particle size distribution of the cobalt-chromium wear particles released by impingement in flexion (anterior), extension (posterior), lateral bending (lateral) and combined flexion bending (antero-lateral) revealed that most of the detected cobalt-chromium particles were in a size range between 0.2 and 2 µm. CONCLUSION: The impingement wear simulation introduced here proved to be suitable to predict in vivo impingement behaviour in regard to contact pattern seen on retrieved devices of the activ L lumbar disc arthroplasty design in a pre-clinical test.

Definition and evaluation of testing scenarios for knee wear simulation under conditions of highly demanding daily activities.

The objective of our study was the definition of testing scenarios for knee wear simulation under various highly demanding daily activities of patients after total knee arthroplasty. This was mainly based on a review of published data on knee kinematics and kinetics followed by the evaluation of the accuracy and precision of a new experimental setup. We combined tibio-femoral load and kinematic data reported in the literature to develop deep squatting loading profiles for simulator input. A servo-hydraulic knee wear simulator was customised with a capability of a maximum flexion of 120°, a tibio-femoral load of 5000N, an anterior-posterior (AP) shear force of ±1000N and an internal-external (IE) rotational torque of ±50Nm to simulate highly demanding patient activities. During the evaluation of the newly configurated simulator the ability of the test machine to apply the required load and torque profiles and the flexion kinematics in a precise manner was examined by nominal-actual profile comparisons monitored periodically during subsequent knee wear simulation. For the flexion kinematics under displacement control a delayed actuator response of approximately 0.05s was inevitable due to the inertia of masses in movement of the coupled knee wear stations 1-3 during all applied activities. The axial load and IE torque is applied in an effective manner without substantial deviations between nominal and actual load and torque profiles. During the first third of the motion cycle a marked deviation between nominal and actual AP shear load profiles has to be noticed but without any expected measurable effect on the latter wear simulation due to the fact that the load values are well within the peak magnitude of the nominal load amplitude. In conclusion the described testing method will be an important tool to have more realistic knee wear simulations based on load conditions of the knee joint during activities of daily living.

Effect of anterior-posterior and internal-external motion restraint during knee wear simulation on a posterior stabilised knee design.

The objective of our study was to examine the effect of biphaseal AP translation and IE rotation restraint, using a system defined specifically for posterior stabilised knee designs, on wear, kinematics and particle release in comparison to linear motion restraint as required by the established ISO 14243-1:2002(E) protocol. In the ISOlinear groups, an AP motion restraint of 30 N/mm and an IE rotation restraint of 0.6 Nm/° were applied in the knee wear simulation. In the ISOgap biphaseal groups with PCL sacrificing implants, the restraining AP force was zero in a ±2.5mm range with, externally, a constant of 9.3N/mm applied proportionally to the AP translation of the tibia plateau, whereas the restraining IE torque was zero in a ±6° range with, externally, a constant of 0.13 Nm/° applied proportionally to the IE rotation of the tibia plateau. Using the ISOgap biphaseal protocol on a posterior stabilised knee design, we found an increase of 41% in AP translation and of 131% in IE rotation, resulting in a 3.2-fold higher wear rate compared to the results obtained using the ISOlinear protocol. Changes in AP translation and IE rotation ligament motion restraints have a high impact on knee joint kinematics and wear behaviour of a fixed bearing posterior stabilised knee design.

Fixed bearing knee congruency -- influence on contact mechanics, abrasive wear and kinematics.

The objective of our study was to evaluate the in vitro wear behavior of fixed bearing designs for total knee arthroplasty in relation to contact mechanics and resultant kinematics for different degrees of congruency. a finite element model was created for three knee articulations with increasing degrees of tibio-femoral congruency (flat, curved, and dished design). For the three different knee design configurations, in vitro wear simulation was performed according to iso 14243-1. Contact areas increased with increasing knee congruency, whereas the peak surface contact stresses decreased. The wear rates for the knee design configurations differed substantially between the three test groups (flat, curved, and dished). our observations demonstrate that increased congruency in conjunction with decreased surface contact stresses significantly contributes to reducing wear in fixed bearing knee articulations.