Bi-unicondylar knee prosthesis functional assessment utilizing force-control wear testing.

Recent in vivo studies have identified variations in knee prosthesis function depending on prosthesis geometry, kinematic conditions, and the absence/presence of soft-tissue constraints after knee replacement surgery. In particular, unicondylar knee replacements (UKR) are highly sensitive to such variations. However, rigorous descriptions of UKR function through experimental simulation studies, performed under physiological force-controlled conditions, are lacking. The current study evaluated the long-term functional performance of a widely used fixed-bearing unicompartmental knee replacement, mounted in a bi-unicondylar configuration (Bi-UKR), utilizing a force-controlled knee simulator during a simulated (ISO 14243) walking cycle. The wear behaviour, the femoral-tibial kinematics, and the incurred damage scars were analysed. The wear rates for the medial and the lateral compartments were 10.27 +/- 1.83 mg/million cycles and 4.49 +/- 0.53 mg/million cycles, respectively. Although constant-input force-controlled loading conditions were maintained throughout the simulation, femoral-tibial contact point kinematics decreased by 65 to 68 per cent for average anterior/posterior travel and by 58 to 74 per cent for average medial/lateral travel with increasing cycling time up to 2 million cycles. There were no significant differences in damage area or damage extent between the medial and the lateral compartments. Focal damage scars representing the working region of the femoral component on the articular surface extended over a range of 16-21 mm in the anterior-posterior direction. Kinematics on the shear plane showed slight variations with increasing cycling time, and the platform exhibited medial pivoting over the entire test. These measures provide valuable experimental insight into the effect of the prosthesis design on wear, kinematics, and working area. These functional assessments of Bi-UKR under force-controlled knee joint wear simulation show that accumulated changes in the UKR articular conformity manifested as altered kinematics both for anterior/posterior translations and internal/external rotations.

Integrated friction measurements in hip wear simulations: short-term results.

Hip joint wear simulators are used extensively to simulate the dynamic behaviour of the human hip joint and, through the wear rate, gain a concrete indicator about the overall wear performance of different coupled bearings. Present knowledge of the dynamic behaviour of important concurrent indicators, such as the coefficient of friction, could prove helpful for the continuing improvement in applied biomaterials. A limited number of commercial or custom-made simulators have been designed specifically for friction studies but always separately from wear tests; thus, analysis of these two important parameters has remained unconnected. As a result, a new friction sensor has been designed, built, and integrated in a commercial biaxial rocking motion hip simulator. The aim of this study is to verify the feasibility of an experimental set-up in which the dynamic measurement of the friction factor could effectively be implemented in a standard wear test without compromising its general accuracy and repeatability. A short wear test was run with the new set-up for 1 x 10(6) cycles. In particular, three soft-bearings (metal-on-polyethylene, phi = 28 mm) were tested; during the whole test, axial load and frictional torque about the vertical loading axis were synchronously recorded in order to calculate the friction factor. Additional analyses were performed on the specimens, before and after the test, in order to verify the accuracy of the wear test. The average friction factor was 0.110 +/- 0.025. The friction sensors showed good accuracy and repeatability throughout. This innovative set-up was able to reproduce stable and reliable measurements. The results obtained encourage further investigations of this set-up for long-term assessment and using different combinations of materials.

Polyethylene insert damage in unicondylar knee replacement: a comparison of in vivo function and in vitro simulation.

Modification of knee joint wear simulation methods has included 'anatomic attachment' of unicondylar knee replacements (UKR) onto synthetic femurs with material properties and morphology similar to human femurs. The present study assesses the effect of such modification by comparing the damage patterns on UKR polyethylene inserts after in vitro simulation using standard and modified simulation methods with those on inserts retrieved after in vivo function. Three groups of UKR inserts were evaluated after retrieval (Explant Group, n = 17) or after knee joint wear simulation with the components attached to standard metal blocks (Standard Group, n = 6) or synthetic femurs (Anatomic Group, n = 6). All UKR had similar non-conforming articular surfaces. Articular damage patterns (mode, frequency, and area) were quantified using digital image photogrammetry. Although some common damage modes were noted, knee joint wear simulation with standard or 'anatomic' attachment did not generate damage pattern sizes similar to the explanted UKR. A focal damage pattern consistent with contact between the metal femoral articular surface and the polyethylene inserts was evident on all inserts, but only the Explant Group had evidence of dispersed damage dominated by abrasive modes. Synthetic femurs added complexity to the wear simulation without generating wear patterns substantially more similar to those observed on retrieved inserts.

Does the addition of vitamin E to conventional UHMWPE improve the wear performance of hip acetabular cups? Micro-Raman characterization of differently processed polyethylene acetabular cups worn on a hip joint simulator.

In knee replacements, vitamin E-doped ultra-high molecular weight polyethylene (UHMWPE) shows a better wear behavior than standard UHMWPE. Therefore, different sets of polyethylene (PE) acetabular cups, i.e. standard UHMWPE and cross-linked polyethylene irradiated with 50 kGy and 75 kGy, were compared, at a molecular level, with vitamin E-doped UHMWPE to evaluate their wear performance after being tested on a hip joint simulator for five million cycles. Unworn control and worn acetabular cups were analyzed by micro-Raman spectroscopy to gain insight into the effects of wear on the microstructure and phase composition of PE. Macroscopic wear was evaluated through mass loss measurements. The data showed that the samples could be divided into two groups: 1) standard and vitamin E-doped cups (mass loss of about 100 mg) and 2) the cross-linked cups (mass loss of about 30-40 mg). Micro-Raman spectroscopy disclosed different wear mechanisms in the four sets of acetabular cups, which were related to surface topography data. The vitamin E-doped samples did not show a better wear behavior than the cross-linked ones in terms of either mass loss or morphology changes. However, they showed lower variation at the morphological level (lower changes in phase composition) than the UHMWPE cups, thus confirming a certain protecting role of vitamin E against microstructural changes induced by wear testing.

Unicompartmental knee prostheses: in vitro wear assessment of the menisci tibial insert after two different fixation methods.

Knee osteoarthritis is a complex clinical scenario where many biological and mechanical factors influence the severity of articular degenerative changes. Minimally invasive knee prosthetic surgery, with only a compartment replacement (unicompartmental knee replacement), might be a good compromise between osteotomy and total knee prosthesis. The focus of this study was to develop and validate a protocol to assess the fixation method of the femoral components in mechanical simulation, for pre-clinical validation; the wear behaviour of two different fixation frames was quantified and compared. In particular, two different wear tests were conducted using the same knee simulator, the same load profiles and the same kinematics; two different fixation methods were applied to the femoral sleds (synthetic femur and metal block). Surface characterization on both articulating bearings was performed by a roughness measuring machine and coordinate measuring machine. The wear produced by the tibial inserts using the synthetic femur was considerably higher than the wear registered by the metal-block holder. Roughness measurements on femoral sleds showed a limited number of scratches with high R(t) values for the metal-block set-up; the damaged surface broadened in the case of femoral condyles and tibial inserts mounted on composite bone, but lower R(t) and linear penetration values were measured. The two holding frames showed different wear activities as a consequence of dissimilar dynamic performance. Further observations should be made in vivo to prove the actual importance of synthetic bone simulations and specific material behaviour.

Tribology and total hip joint replacement: current concepts in mechanical simulation.

Interest in the rheology and effects of interacting surfaces is as ancient as man. This subject can be represented by a recently coined word: tribology. This term is derived from the Greek word "tribos" and means the "science of rubbing". Friction, lubrication, and wear mechanism in the common English language means the precise field of interest of tribology. Wear of total hip prosthesis is a significant clinical problem that involves, nowadays, a too high a number of patients. In order to acquire further knowledge on the tribological phenomena that involve hip prosthesis wear tests are conducted on employed materials to extend lifetime of orthopaedic implants. The most basic type of test device is the material wear machine, however, a more advanced one may more accurately reproduce some of the in vivo conditions. Typically, these apparatus are called simulators, and, while there is no absolute definition of a joint simulator, its description as a mechanical rig used to test a joint replacement, under conditions approximating those occurring in the human body, is acceptable. Simulator tests, moreover, can be used to conduct accelerated protocols that replicate/simulate particularly extreme conditions, thus establishing the limits of performance for the material. Simulators vary in their level of sophistication and the international literature reveals many interpretations of the design of machines used for joint replacement testing. This paper aims to review the current state of the art of the hip joint simulators worldwide. This is specified through a schematic overview by describing, in particular, constructive solutions adopted to reproduce in vivo conditions. An exhaustive commentary on the evolution and actually existing simulation standards is proposed by the authors. The need of a shared protocol among research laboratories all over the world could lead to a consensus conference.

Long-term implant-bone fixation of the femoral component in total knee replacement.

Success of total knee replacement (TKR) depends on the prosthetic design. Aseptic loosening of the femoral component is a significant failure mode that has received little attention. Despite the clinical relevance of failures, no protocol is available to test long-term implant-bone fixation of TKR in vitro. The scope of this work was to develop and validate a protocol to assess pre-clinically the fixation of TKR femoral components. An in vitro protocol was designed to apply a simplified but relevant loading profile using a 6-degrees-of-freedom knee simulator for 1,000000 cycles. Implant-bone inducible micromotions and permanent migrations were measured at three locations throughout the test. After test completion, fatigue damage in the cement was quantified. The developed protocol was successfully applied to a commercial TKR. Additional tests were performed to exclude artefacts due to swelling or creep of the composite femur models. The components migrated distally; they tilted towards valgus in the frontal plane and in extension in the sagittal plane. The migration patterns were consistent with clinical roentgen-stereophotogrammetric recordings with TKR. Additional indicators were proposed that could quantify the tendency to loosen/stabilize. The type and amount of damage found in the cement, as well as the migration patterns, were consistent with clinical experience with the specific TKR investigated. The proposed pre-clinical test yielded repeatable results, which were consistent with the clinical literature. Therefore, its relevance and reliability was proved.

Predictive role of the lambda ratio in the evaluation of metal-on-metal total hip replacement.

The wear of metal-on-metal bearings is affected by various design parameters, such as the clearance or surface roughness. It would be very useful to have a significant indicator of wear according to these design parameters, such as the lambda ratio. Three different batches of cast high- and low-carbon cobalt-chromium hip implants (28 mm, 32 mm, and 36 mm diameters) were tested in a hip joint simulator for 2 x 10(6) cycles. Bovine calf serum was used as lubricant, and the samples were weighed at regular intervals during the test. The predictive role of the lambda ratio on the wear behaviour was investigated. Three different configurations were tested to explore the wear rate for a broad range of lambda ratios. The results of these studies clearly showed that the femoral heads of 36 mm diameter had the best wear behaviour with respect to the other two smaller configurations tested. From a predictive point of view, the lambda ratios associated with the configurations tested could clearly indicate that the femoral heads of 36 mm diameter worked in the mixed-lubrication regime (lambda > 1); all the smallest configurations (28mm size) had lambda < 1, thus showing their aptitude to work in the boundary lubrication regime, with substantially higher volume depletion due to wear. The lambda values associated with the 32 mm size varied in a range around 1 (0.95 < lambda < 1.16), suggesting the possibility of operating in the mixed-lubrication regime.

Meniscal wear at a three-component total ankle prosthesis by a knee joint simulator.

Despite the fundamental value of wear simulation studies to assess wear resistance of total joint replacements, neither specialised simulators nor established external conditions are available for the human ankle joint. The aim of the present study was to verify the suitability of a knee wear simulator to assess wear rates in ankle prostheses, and to report preliminary this rate for a novel three-component total ankle replacement design. Four intact 'small' size specimens of the Box ankle were analysed in a four-station knee wear simulator. Special component-to-actuator holders were manufactured and starting spatial alignment of the three-components was sought. Consistent load and motion cycles representing conditions at the ankle joint replaced exactly with the prosthesis design under analysis were taken from a corresponding mechanical model of the stance phase of walking. The weight loss for the three specimens, after two million cycles, was 32.68, 14.78, and 62.28mg which correspond to a linear penetration of 0.018, 0.008, and 0.034mm per million-cycle, respectively for the specimens #1, #2, and #3. The knee wear simulator was able to reproduce load-motion patterns typical of a replaced ankle. Motion of the meniscal bearing in between the tibial and talar components was smooth, this component remaining in place and in complete congruence with the metal components throughout the test.

Thermomechanical analysis of ultra-high molecular weight polyethylene-metal hip prostheses.

In order to predict the frictional heating and the contact stresses between the polyethylene cup and the metallic ball-head forming the articulation of a hip prosthesis a three-dimensional finite element model was developed and calculated. The non-linear model includes a fully coupled thermomechanical formulation of the mechanical properties of the ultra-high-molecular-weight polyethylene, and a large-sliding Coulomb frictional contact between the two components. The model predicts the temperature of the polyethylene with an accuracy that was tested by comparing the model predictions with the temperature measurements. The temperature measurements were taken by thermocouples placed on the cup surface, the head surface and the inside of the thermostatic bath, during a complete test within a hip joint wear simulator. The model was found to be very accurate, predicting the measured temperatures with an accuracy better than 2 per cent. The temperature peak (51 degrees C) was predicted at the contact surface. The model results indicate that frictional heat is mostly dissipated through the metallic ball-head. The full coupling between the thermal and the mechanical conditions used in this study appears to be necessary if accurate predictions of the polyethylene deformation are required.

Advanced nanocomposite materials for orthopaedic applications. I. A long-term in vitro wear study of zirconia-toughened alumina.

The use of ceramic-on-ceramic (alumina- and zirconia-based) couplings in hip joint prostheses has been reported to produce lower wear rates than other combinations (i.e., metal-on-polyethylene and ceramic-on-polyethylene). The addition of zirconia into an alumina matrix (zirconia-toughened alumina, ZTA) has been reported to result in an enhancement of flexural strength, fracture toughness, and fatigue resistance. The development of new processing routes in nonaqueous media has allowed to obtain high-density ZTA nanocomposites with a very homogeneous microstructure and a significantly smaller and narrower particle-size distribution of zirconia than conventional powder mixing methods. The aim of the present study was to set up and validate a new ZTA nanocomposite by testing its biocompatibility and wear behavior in a hip-joint simulator in comparison with commercial alumina and experimental alumina specimens. The primary osteoblast proliferation onto ZTA nanocomposite samples was found to be not significantly different from that onto commercial alumina samples. After 7 million cycles, no significant differences were observed between the wear behaviors of the three sets of cups. In this light, it can be affirmed that ZTA nanocomposite materials can offer the option of improving the lifetime and reliability of ceramic joint prostheses.

The predictive power of surface profile parameters on the amount of wear measured in vitro on metal-on-polyethylene artificial hip joints.

Various studies report a weak correlation between the average surface roughness R(a) of metallic ballheads and the observed wear rate of the polyethylene cups coupled to them. The aim of this study is to verify, with controlled in vitro experiments, whether other parameters such as the total roughness R(t), and the skewness R(sk) are better predictors of the polyethylene wear when the metallic heads present a surface conditioning that varies substantially from specimen to specimen, as is usually the case with retrieved specimens. Twelve CoCrMo (cobalt-chromium-molybdenum) ballheads were intentionally damaged in order to reproduce a wide spectrum of surface conditioning and were then subjected to the standard wear test against polyethylene cups, using a hip joint wear simulator. After 2 x 10(6) cycles the weight lost by the cups was assessed with a gravimetric procedure, and the surface roughness of the metallic ballheads was qualified in terms of R(a), R(t), and R(sk). The various parameters were correlated to the weight loss using a linear regression analysis. The skewness R(sk) showed a coefficient linear regression R2 = 0.80, while the average roughness R(a), used in most previous studies, presented an R2 = 0.56. It was concluded that when specimens with substantially different surface conditioning are compared, as in retrievals analysis, it is also important to report the skewness R(sk) so that qualify the surface roughness of the specimens can be qualified.

Does the addition of vitamin E to conventional UHMWPE improve the wear performance of hip acetabular cups? Micro-Raman characterization of differently processed polyethylene acetabular cups worn on a hip joint simulator

In knee replacements, vitamin E-doped ultra-high molecular weight polyethylene (UHMWPE) shows a better wear behavior than standard UHMWPE. Therefore, different sets of polyethylene (PE) acetabular cups, i.e. standard UHMWPE and cross-linked polyethylene irradiated with 50 kGy and 75 kGy, were compared, at a molecular level, with vitamin E-doped UHMWPE to evaluate their wear performance after being tested on a hip joint simulator for five million cycles. Unworn control and worn acetabular cups were analyzed by micro-Raman spectroscopy to gain insight into the effects of wear on the microstructure and phase composition of PE. Macroscopic wear was evaluated through mass loss measurements. The data showed that the samples could be divided into two groups: 1) standard and vitamin E-doped cups (mass loss of about 100 mg) and 2) the cross-linked cups (mass loss of about 30-40 mg). Micro-Raman spectroscopy disclosed different wear mechanisms in the four sets of acetabular cups, which were related to surface topography data. The vitamin E-doped samples did not show a better wear behavior than the cross-linked ones in terms of either mass loss or morphology changes. However, they showed lower variation at the morphological level (lower changes in phase composition) than the UHMWPE cups, thus confirming a certain protecting role of vitamin E against microstructural changes induced by wear testing.

Mixed oxides prosthetic ceramic ball heads. Part 3: effect of the ZrO2 fraction on the wear of ceramic on ceramic hip joint prostheses. A long-term in vitro wear study.

Using ceramic materials it is possible to obtain a number of beneficial mechanical properties such as considerable hardness, good chemical resistance, high tensile strength, and a good fracture toughness. The use of ceramic-on-ceramic as bearing surfaces for hip joint prostheses has been reported to produce a lower wear rate than other combinations (i.e. metal-on-polyethylene and ceramic-on-polyethylene) in total hip artroplasty. These advantages may increase the life expectancy of hip implants and improve the life of patients. Two new types of mixed-oxide ceramics (alumina and yttria-stabilised zirconia) femoral heads and acetabular cups containing different ratios of alumina and zirconia were compared with pure commercial alumina in terms of wear behaviour in a hip joint simulator. Hip joint wear simulator studies were carried out with a full-peak load of 2030 N and a frequency of 1 Hz in bovine calf serum. After 10 million cycles the measured weight loss of all specimens was very low. However, the experimental results did not show any significant difference between the new experimental mixed-oxide ceramics prototype and the commercial ceramic material couplings.

Sodium-azide versus ProClin 300: influence on the morphology of UHMWPE particles generated in laboratory tests.

Ultra-high molecular-weight polyethylene (UHMWPE) has been used in total joint replacement for the last three decades and is currently the best polymer available for this use. Nevertheless, the wear of UHMWPE remains a serious clinical problem. Polyethylene wear debris has been identified as a cause of osteolysis and a major factor reducing the life of the total hip arthroplasty. Debris generated at the articular surfaces enters the periprostethic tissue where it is phagocyted by macrophages. Studies have shown that particles in the 0.1-10microm size range are particularly important in causing adverse cellular reactions resulting in osteolysis. The morphology, size, mass, and number of wear particles produced in a hip joint simulator are influenced by the tribological conditions used during the experiment. This paper shows that the morphology of the UHMWPE particles generated in vitro is influenced by the type of lubricant used. This study compared, quantitatively and qualitatively, particles generated in vitro using bovine calf serum as lubricant with two different preservatives: sodium azide and ProClin 300. No significant difference was observed with regards to wear between the two types of lubricant used. Quantitative analysis of the wear particles showed that particles generated in serum with sodium azide were not [corrected] morphologically different from those produced in serum with ProClin 300 [corrected]

Mixed oxides prosthetic ceramic ball heads. Part 1: effect of the ZrO2 fraction on the wear of ceramic on polythylene joints.

Although mixed oxides ceramics have been indicated in the literature as a promising compromise between strength and wear, to the authors' knowledge no reports are available on the influence of the percentage of zirconia in ceramic femoral heads when sliding against polyethylene cups. Two types of mixed oxides ceramic ball heads (alumina plus, respectively, 60 and 80% of zirconia) were compared to pure zirconia and pure alumina heads in terms of wear behaviour against UHMWPE in a hip joint simulator. Polyethylene cups and ceramic femoral heads were fixed on a simulator apparatus with a sinusoidal movement and load in presence of bovine calf serum. The experimental results did not show significant difference between the two experimental ceramic materials or in comparison with pure materials. Considering that all specimens, regardless of the material, had the same level of surface roughness, this roughness factor seems to have a more relevant role than the mix of oxides used to manufacture the ceramic head. Wear tests are conducted on materials used in prosthetic hip implants in order to obtain quality control and to acquire further knowledge of the tribological processes that involve joint prostheses, therefore reducing the risk of implant failure of innovative prostheses.

Isolation and morphological characterisation of UHMWPE wear debris generated in vitro.

Wear tests are generally carried out on materials used in prosthetic hip implants, in order to obtain a better understanding of the tribological processes involved and improve the quality control of joint prostheses, directed towards reducing the risk of implant failure of innovative prostheses. Ceramic femoral heads of mixed alumina-zirconia oxides as well as zirconia and alumina single oxide heads were tested against UHMWPE acetabular cups in a hip joint simulator. Polyethylene cups and ceramic femoral heads were mounted in a simulator apparatus moving according to a sinusoidal function, under load and in the presence of bovine calf serum as lubricant. Wear particles were isolated from the bovine calf serum collected during the wear tests. An easy to follow method was used to separate the wear particles from the lubricant. Chemical digestive methods were used to separate the wear particles from the lubricant and the isolated particles were studied using scanning electron microscopy. The morphologies of the polyethylene debris showed considerable differences, both in size and shape of the particles, as a function of the coupled head material.

Mixed-oxides prosthetic ceramic ball heads. Part 2: effect of the ZrO2 fraction on the wear of ceramic on ceramic joints.

Three different types of mixed-oxides ceramic ball heads have been investigated for their wear behaviour against acetabular cups of the same materials in a hip joint simulator. Mixed-oxides ceramics have been indicated in literature as a promising compromise between strength and wear but no reports are available on the influence of a percentage of zirconia in a ceramic femoral head when sliding against itself. Mixed-oxides ceramic acetabular cups and femoral heads were tested on a simulator apparatus with a sinusoidal load in presence of bovine calf serum. The experimental results did not show any significant difference between the experimental and commercial ceramic material couplings. These results were found to be in accord with those developed in Part 1.

The performance of gamma- and EtO-sterilised UHWMPE acetabular cups tested under severe simulator conditions. Part 1: role of the third-body wear process.

Due to its excellent combination of properties, ultra-high-molecular-weight-polyethylene has been used for the last 30 years in the replacement of damaged articulating cartilage for total joint replacement surgery. However, in some cases, wear, failure and delamination have been observed. Polyethylene performance may be affected by oxidation during consolidation of the resin, sterilisation of the finished specimens and post-irradiation storage. In order to evaluate the influence of the sterilisation method (gamma-irradiation and ethylene oxide(EtO)-treatment) and third-body particles on the ultra-high-molecular-weight-polyethylene wear behaviour, gamma- and EtO-sterilised ultra-high-molecular-weight-polyethylene acetabular cups were tested against CoCrMo femoral heads in a hip joint simulator run for 2.5 million cycles in bovine calf serum in the presence of third-body PMMA particles. Weight loss measurements revealed that the gamma-sterilised acetabular cups exhibited a significantly lower wear rate than those EtO-sterilised. Moreover, significant differences were found for each type of sterilisation between the gravimetric wear trends obtained until 2.5 million cycles in the presence and in the absence of PMMA particles.

The performance of gamma- and EtO-sterilised UHMWPE acetabular cups tested under severe simulator conditions. Part 2: wear particle characteristics with isolation protocols.

Ultra-high molecular-weight polyethylene (UHMWPE) has been used in total joint replacement for the last three decades. Despite the recent advancements in prosthesis design, the wear of UHMWPE remains a serious clinical problem; the release of wear debris may induce osteolysis and implant loosening. Controlling the quality of the polyethylene is essential to improve its wear resistance and any potential adverse effect caused by processing, manufacturing or sterilisation should be avoided. To evaluate the influence of the sterilisation method (gamma-irradiation and ethylene oxide (EtO)-treatment) and third-body particles, gamma- and EtO-sterilised UHMWPE acetabular cups were tested against CoCrMo femoral heads in a hip joint simulator run for 2.5million cycles in bovine calf serum in the presence of third-body polymethylmethacrylate (PMMA) particles. A method not requiring ultra-centrifugation has been proposed for the isolation of polyethylene wear debris from the serum lubricant. SEM analysis allowed debris shape and morphology to be determined, and the wear mechanism operating in this study to be hypothesised. The morphological features of the wear debris were in agreement with clinical findings, enabling the hip simulator function to be validated. Micro-Raman spectroscopy coupled to PLS analysis showed that the mechanical friction during in vitro tests induced significant crystallinity changes in all the cups. The most significant changes were observed for the EtO-sterilised cups, which showed the highest weight loss.