Proceedings of the Institution of Mechanical Engineers,Part H: Journal of Engineering in Medicine

One of the most important mandates of physical joint simulators is to provide test results that allow the implant manufacturer to anticipate and perhaps avoid clinical wear problems with their new products. This is best done before market release. This study gives four steps to follow in conducting such wear simulator testing. Two major examples involving hip wear simulators are discussed in which attempts had been made to predict clinical wear performance prior to market release. The second one, involving the DePuy ASR implant systems, is chosen for more extensive treatment by making it an illustrative example to explore whether wear simulator testing can anticipate clinical wear problems. It is concluded that hip wear simulator testing did provide data in the academic literature that indicated some risk of clinical wear problems prior to market release of the ASR implant systems. This supports the idea that physical joint simulators have an important role in the pre-market testing of new joint replacement implants.

The measurement of friction in artificial hip joints can lead to the knowledge of the lubrication mechanisms occurring in the joints. However, the measurement of friction, particularly in spherical contacts, is not always straightforward. The important loading and kinematic features must be appropriate and the friction must be measured in the correct plane. Even defining a coefficient of friction is difficult with spherical contacts as friction acts at different moment arms throughout the contact area. Thus, the generated frictional torques depend on the pressure distribution of the contact and the moment arms at which this pressure acts. The pressure distribution depends on the material properties, the surface entraining velocities, the joint diameters, and the clearance between the two surfaces of the ball and socket joint. Equally measuring friction is very taxing for machines which are applying very high loads. Slight misalignments of the application of these loads can produce torques which are very much greater than the frictional torques that we are trying to measure. This article attempts to share the thoughts behind over 40 years of measuring friction in artificial joints using the Durham Friction Simulators. This has led to accrued consistency of measurement and a robust scientific design rationale to understand the nature of friction in these spherical contacts. It also impacts on how to obtain accurate measurements as well as on the understanding of where the difficult issues lie and how to overcome them.

A torque measurement system was added to a widely used hip wear simulator, the biaxial rocking motion device. With the rotary transducer, the frictional torque about the drive axis of the biaxial rocking motion mechanism was measured. The principle of measuring the torque about the vertical axis above the prosthetic joint, used earlier in commercial biaxial rocking motion simulators, was shown to sense only a minor part of the total frictional torque. With the present method, the total frictional torque of the prosthetic hip was measured. This was shown to consist of the torques about the vertical axis above the joint and about the leaning axis. Femoral heads made from different materials were run against conventional and crosslinked polyethylene acetabular cups in serum lubrication. Regarding the femoral head material and the type of polyethylene, there were no categorical differences in frictional torque with the exception of zirconia heads, with which the lowest values were obtained. Diamond-like carbon coating of the CoCr femoral head did not reduce friction. The friction factor was found to always decrease with increasing load. High wear could increase the frictional torque by 75%. With the present system, friction can be continuously recorded during long wear tests, so the effect of wear on friction with different prosthetic hips can be evaluated.

We propose and have evaluated a method to measure hip friction during wear testing on a popular multi-station hip simulator. A 6-degree-of-freedom load cell underneath the specimen sensed forces and torques during implant wear testing of simulated walking. This included internal–external and adduction–abduction rotations which are often neglected during friction testing on pendulum-type machines. Robust mathematical analysis and data processing provided friction estimates in three simultaneous orthogonal rotations, over extended multi-million cycle wear tests. We tested various bearing couples including metal-on-plastic, ceramic-on-plastic, and metal-on-metal material couples. In one test series, new and intentionally scratched CoCrMo 40-mm-diameter femoral heads were tested against conventional ultrahigh-molecular-weight polyethylene, highly cross-linked, and highly cross-linked with vitamin E versions. The scratching significantly increased friction and doubled the wear of all groups. Before scratching, friction levels for the aforementioned plastic groups were 0.056 ± 0.0060, 0.062 ± 0.0080, and 0.070 ± 0.0045, respectively, but after scratching increased to 0.088 ± 0.018, 0.076 ± 0.0066, and 0.082 ± 0.0049, respectively, all statistically significant increases (p = 0.00059, 0.00005, 0.0115, respectively). In another test series of 44-mm femoral head diameter hips, metal-on-plastic hips with conventional ultrahigh-molecular-weight polyethylene showed the lowest friction at 0.045 ± 0.0085, followed by highly cross-linked with 0.046 ± 0.0035 (not significantly different). In a ceramic-on-plastic design with conventional ultrahigh-molecular-weight polyethylene, higher friction 0.079 ± 0.0070 was measured likely due to that ceramic surface being rougher than usual. Metal-on-metal hips were compared without and with a TiN coating, resulting in 0.049 ± 0.014 and 0.097 ± 0.020 friction factors, respectively (statistically significant, p < 0.001), and the coating wore away on all coated hips eventually. Higher friction mostly correlated with higher wear or damage to femoral heads or implant coatings, except for the highly cross-linked wear resistant ultrahigh-molecular-weight polyethylene which had slightly higher friction, confirming the same finding in other independent studies. This type of friction measurements can help screen for clamping and elevated wear of metal-on-metal and resurfacing total hip replacements, surgical malpositioning, and abraded and otherwise damaged surfaces.

Hip joint simulators are used extensively for preclinical testing of hip replacements. The variation in simulator design and test conditions used worldwide can affect the tribological performance of polyethylene. The aim of this study was to assess the effects of simulator mechanics and design on the wear and creep of ultra-high-molecular-weight polyethylene. In the first part of this study, an electromechanical simulator and pneumatic simulator were used to compare the wear and creep of metal-on-polyethylene components under the same standard gait conditions. In the second part of the study, the same electromechanical hip joint simulator was used to investigate the influence of kinematics on wear. Higher wear rates and penetration depths were observed from the electromechanical simulator compared with the pneumatic simulator. When adduction/abduction was introduced to the gait cycle, there was no significant difference in wear with that obtained under the gait cycle condition without adduction/abduction. This study confirmed the influence of hip simulator design and loading conditions on the wear of polyethylene, and therefore direct comparisons of absolute wear rates between different hip joint simulators should be avoided. This study also confirmed that the resulting wear path was the governing factor in obtaining clinically relevant wear rates, and this can be achieved with either two axes or three axes of rotations. However, three axes of rotation (with the inclusion of adduction/abduction) more closely replicate clinical conditions and should therefore be the design approach for newly developed hip joint simulators used for preclinical testing.

Simulation of wear in total hip replacements has been recognised as an important factor in determining the likelihood of clinical success. However, accurate measurement of wear can be problematic with factors such as number and morphology of wear particles produced as well as ion release proving more important in the biological response to hip replacements than wear volume or wear rate alone. In this study, hard-on-hard (CoCr alloy, AgCrN coating) and hard-on-soft (CoCr alloy and CrN coating on vitamin E blended highly cross-linked polyethylene) bearing combinations were tested in an orbital hip simulator under standard and some adverse conditions. Gravimetric wear rates were determined for all bearings, with cobalt and where applicable, silver release determined throughout testing. Isolation of wear particles from the lubricating fluid was used to determine the influence of different bearing combinations and wear conditions on particle morphology. It was found that cobalt and silver could be measured in the lubricating fluid even when volumetric wear was not detectable. In hard-on-hard bearings, Pearson’s correlation of 0.98 was established between metal release into the lubricating fluid and wear volume. In hard-on-soft bearings, coating the head did not influence the polyethylene wear rates measured under standard conditions but did influence the cobalt release; the diameter influenced both polyethylene wear and cobalt release, and the introduction of adverse testing generated smaller polyethylene particles. While hip simulators can be useful to assess the wear performance of a new material or design, measurement of other outcomes may yield greater insight into the clinical behaviour of the bearings in vivo.

Corrosion is not routinely considered in the assessment of the degradation or the lifetime of total hip replacement bearing surfaces. Biomechanical simulations are becoming ever more complex and are taking into account motion cycles that represent activities beyond a simple walking gait at 1 Hz, marking a departure from the standard ISO BS 14242. However, the degradation is still very often referred to as wear, even though the material loss occurs due to a combination of tribological and corrosion processes and their interactions. This article evaluates how, by incorporating real-time corrosion measurements in total hip replacement simulations, pre-clinical evaluations and research studies can both yield much more information and accelerate the process towards improved implants.

Mechanical evaluation of total knees is frequently required for aspects such as wear, strength, kinematics, contact areas, and force transmission. In order to carry out such tests, we developed a crouching simulator, based on the Oxford-type machine, with novel features including a synthetic knee including ligaments. The instrumentation and data processing methods enabled the determination of contact area locations and interface forces and moments, for a full flexion–extension cycle. To demonstrate the use of the simulator, we carried out a comparison of two different total knee designs, cruciate retaining and substituting. The first part of the study describes the simulator design and the methodology for testing the knees without requiring cadaveric knee specimens. The degrees of freedom of the anatomic hip and ankle joints were reproduced. Flexion–extension was obtained by changing quadriceps length, while variable hamstring forces were applied using springs. The knee joint was represented by three-dimensional printed blocks on to which the total knee components were fixed. Pretensioned elastomeric bands of realistic stiffnesses passed through holes in the block at anatomical locations to represent ligaments. Motion capture of the knees during flexion, together with laser scanning and computer modeling, was used to reconstruct contact areas on the bearing surfaces. A method was also developed for measuring tibial component interface forces and moments as a comparative assessment of fixation. The method involved interposing Tekscan pads at locations on the interface. Overall, the crouching machine and the methodology could be used for many different mechanical measurements of total knee designs, adapted especially for comparative or parametric studies.

Advancements in knee replacement design, material and sterilisation processes have provided improved clinical results. However, surface wear of the polyethylene leading to osteolysis is still considered the longer-term risk factor. Experimental wear simulation is an established method for evaluating the wear performance of total joint replacements. The aim of this study was to investigate the influence of simulation input conditions, specifically input kinematic magnitudes, waveforms and directions of motion and position of the femoral centre of rotation, on the wear performance of a fixed-bearing total knee replacement through a combined experimental and computational approach. Studies were completed using conventional and moderately cross-linked polyethylene to determine whether the influence of these simulation input conditions varied with material. The position of the femoral centre of rotation and the input kinematics were shown to have a significant influence on the wear rates. Similar trends were shown for both the conventional and moderately cross-linked polyethylene materials, although lower wear rates were found for the moderately cross-linked polyethylene due to the higher level of cross-linking. The most important factor influencing the wear was the position of the relative contact point at the femoral component and tibial insert interface. This was dependent on the combination of input displacement magnitudes, waveforms, direction of motion and femoral centre of rotation. This study provides further evidence that in order to study variables such as design and material in total knee replacement, it is important to carefully control knee simulation conditions. This can be more effectively achieved through the use of displacement control simulation.

In vitro gait simulations have been available to researchers for more than two decades and have become an invaluable tool for understanding fundamental foot–ankle biomechanics. This has been realised through several incremental technological and methodological developments, such as the actuation of muscle tendons, the increase in controlled degrees of freedom and the use of advanced control schemes. Furthermore, in vitro experimentation enabled performing highly repeatable and controllable simulations of gait during simultaneous measurement of several biomechanical signals (e.g. bone kinematics, intra-articular pressure distribution, bone strain). Such signals cannot always be captured in detail using in vivo techniques, and the importance of in vitro experimentation is therefore highlighted. The information provided by in vitro gait simulations enabled researchers to answer numerous clinical questions related to pathology, injury and surgery. In this article, first an overview of the developments in design and methodology of the various foot–ankle simulators is presented. Furthermore, an overview of the conducted studies is outlined and an example of a study aiming at understanding the differences in kinematics of the hindfoot, ankle and subtalar joints after total ankle arthroplasty is presented. Finally, the limitations and future perspectives of in vitro experimentation and in particular of foot–ankle gait simulators are discussed. It is expected that the biofidelic nature of the controllers will be improved in order to make them more subject-specific and to link foot motion to the simulated behaviour of the entire missing body, providing additional information for understanding the complex anatomical structure of the foot.

Artificial finger joints lack the long-term clinical success seen with hip and knee prostheses. In part, this can be explained by the challenges of rheumatoid arthritis, a progressive disease which attacks surrounding tissues as well as the joint itself. Therefore, the natural finger joints’ biomechanics are adversely affected, and consequently, this imbalance due to subluxing forces further challenges any prosthesis. Many different designs of finger prosthesis have been offered over a period of greater than 50 years. Most of these designs have failed, and it is likely that many of these failures could have been identified had the prostheses been appropriately tested prior to implantation into patients. While finger joint simulators have been designed, arguably only those from a single centre have been able to reproduce clinical-type failures of the finger prostheses tested in them. This article describes the design and development of a finger simulator at Durham University, UK. It explains and justifies the engineering decisions made and thus the evolution of the finger simulator. In vitro results and their linkage to clinical-type failures are outlined to help to show the effectiveness of the simulator. Failures of finger implants in vivo continue to occur, and the need for appropriate in vitro testing of finger prostheses remains strong.

Reverse total shoulder arthroplasty is a clinically accepted surgical procedure; however, its long-term wear performance is not known. The purpose of this work is to review wear simulator testing of reverse total shoulder arthroplasty, to develop a wear simulator protocol for reverse total shoulder arthroplasty, and to test it by performing a pilot study. The review of wear simulator testing in the literature revealed considerable variation in protocols. A combination of our own cadaveric testing and those of other research groups helped in determining the magnitude and direction of joint loading for the development of the present protocol. A MATCO orbital-bearing simulator was adapted using custom fixtures to simulate a circumduction motion of the shoulder under mildly adverse conditions, and a pilot study gave wear rates within the wide range found in the literature. Arguments were presented in support of the currently developed protocol, but it was also suggested that, rather than rely on one protocol, a series of simulator wear protocols should be developed to fully test the implant wear performance in reverse total shoulder arthroplasty.

This work aimed to engineer a multi-station shoulder simulator in order to wear test shoulder prostheses using recognized shoulder activities of daily living. A bespoke simulator was designed, built and subject to commissioning trials before a first wear test was conducted. Five JRI Orthopaedics Reverse Shoulder VAIOS 42 mm prostheses were tested for 2.0 million cycles and a mean wear rate and standard deviation of 14.2 ± 2.1 mm³/10⁶ cycles measured for the polymeric glenoid components. This result when adjusted for prostheses diameters and test conditions showed excellent agreement with results from hip simulator studies of similar materials in a lubricant of bovine serum. The Newcastle Shoulder Simulator is the first multi-station shoulder simulator capable of applying physiological motion and loading for typical activities of daily living.

Metal-on-polyethylene total disc replacements have been an alternative to spinal fusion in the lumbar spine under certain indications for more than a decade. Recently, cervical total disc replacement has also become an alternative to cervical fusion. Knowledge acquired from years of in vitro simulator studies on other joint replacements has highlighted the risks associated with premature wear due to unforeseen adverse clinical conditions and the effect of particulate debris on surrounding natural tissues. Having no evidence of the type and composition of the lubricating fluid that will result after spinal arthroplasty, a study on the effects of lubricant serum concentration was undertaken. The wear rate was shown to be inversely proportional to protein content of the serum over a range of 50%–3% bovine serum to water concentration.