Fluid composition impacts standardized testing protocols in ultrahigh molecular weight polyethylene knee wear testing

Wear of total knee replacements is determined gravimetrically in simulator studies. A mix of bovine serum, distilled water, and additives is intended to replicate the lubrication conditions in vivo. Weight gain due to fluid absorption during testing is corrected using a load soak station. In this study, three sets of ultrahigh molecular weight polyethylene tibial plateau were tested against highly polished titanium condyles. Test 1 was performed in two different institutions on the same simulator according to the standard ISO 14243-1, using two testing lubricants. Test 2 and test 3 repeated both previous test sections. The wear and load soak rates changed significantly with the lubricant. The wear rate decreased from 16.9 to 7.9 mg weight loss per million cycles when switching from fluid A to fluid B. The weight gain of the load soak specimen submersed in fluid A was 6.1 mg after 5 x 10(6) cycles, compared with 31.6 mg for the implant in fluid B after the same time period. Both lubricants were mixed in accordance with ISO 14243 (Implants for surgery - wear of total knee-joint prostheses), suggesting that calf serum should be diluted to 25 +/- 2 per cent with deionized water and a protein mass concentration of not less than 17 g/l. The main differences were the type and amount of additives that chemically stabilize the lubricant throughout the test. The results suggest that wear rates can only be compared if exactly the same testing conditions are applied. An agreement on detailed lubricant specifications is desirable.     

Relative movements between Kinemax Plus tibial inserts and the tibial base-plates

Tests were performed on six large Kinemax Plus knee bearings (snap-fit design) to evaluate the amount of movement between 10- and 15-mm-thick tibial inserts and the tibial base plates. The knee bearings were tested up to 1 x 10(6) cycles on the Durham six-station knee wear simulator which subjected the bearings to similar motion and loading profiles that would be experienced by the natural knee during walking. Although passive internal/external (I/E) rotation was allowed, no active I/E rotation was applied. The movement of the tibial inserts was measured with dial gauges (accuracy +/-0.01 mm) before and after the bearings were tested on the simulator, when unloaded, and throughout the tests while the bearings were being dynamically loaded in the simulator. Movement occurred between the tibial insert and the tibial base plate after initial assembly due to the snap-fit mechanism used to locate the tibial insert within the tibial base plate. However this decreased appreciably when the bearings were loaded in the simulator. The amount of movement did not change with time when the bearings were continuously loaded in the simulator. However, after each test the amount of movement of the tibial inserts, when unloaded, was only 65 per cent (anterior-posterior) and 46 per cent (medial-lateral) of the values before the test. This was thought to be due to creep of the ultra-high molecular weight polyethylene (UHMWPE) inserts. The movement between the tibial insert and tibial base plate in situ is likely to be much less than that observed by a surgeon at the time of assembly due to loading of the knee bearing in the body. However, the amount of movement when the tibial inserts are loaded may still be great enough to produce a second interface where wear of the tibial insert may take place.     

Demonstration of a New Technique Using Radioisotope Tracers to Measure the Backside Wear Rate on Tibial Inserts

Local backside wear measurements on ultra-high molecular weight polyethylene (UHMWPE) tibial inserts in LCS mobile bearing knee prostheses have been performed using a new radioisotope tracing technique. The radioisotope tracers ⁹⁷Ru and ^101mRh were synthesized via a fusion evaporation reaction and recoil-implanted into cylindrical plugs of UHMWPE. The labelled plugs were carefully fitted into tibial inserts at two relevant locations. With bovine serum acting as a lubricant, the tibial inserts were then worn in vitro for 500,000 and 780,000 cycles, respectively, in a pneumatic knee motion simulator. Results reflect the non-linear change of wear during the wear-in phase and its evolution to a long-term steady-state rate. This new technique shows potential for extracting localized wear rates across the backside of a tibial insert in order to develop a comprehensive backside wear model.     

Quantification of Wear Rates and Plastic Deformation on Mobile Unicompartmental UHMWPE Tibial Knee Inserts

Experimental wear testing is an essential step in the evaluation of unicompartmental knee prostheses; the major mechanisms that dominate the wear of conventional ultra high molecular weight polyethylene tibial knee menisci are the sub-surface cracking and delamination that induce particle release by abrasion/adhesion and subsequently periprosthetic osteolysis. The aim of this study was to determine whether plastic deformation affects the wear of the polymer and to measure the magnitude of these effects. Wear test was performed using a displacement-control knee wear simulator with “three-plus-one” stations, in accordance with the ISO 14243-3/2. A state-of-the-art coordinate measuring machine was used to quantify the volumetric mass loss of the mobile knee polyethylene menisci as well as creep/plastic deformations. The volumetric wear measured by this method was compared to that measured by the gravimetric method. Raman spectroscopy showed morphology changes induced by mechanical stress in both the upper and lower surfaces of the menisci. The amorphous content increased at expenses of the crystalline orthorhombic content, which generally decreased in all menisci. A slight orthorhombic → monoclinic phase transformation occurred upon mechanical stress. Plastic deformation appeared as the main factor affecting the trend of the spectroscopic markers and thus the morphology degradation.     

Effect of stair descent loading on ultra-high molecular weight polyethylene wear in a force-controlled knee simulator

A loading protocol approximating forces, torques and motions at the knee during stair descent was developed from previously published data for input into a force-controlled knee simulator. A set of total knee replacements (TKRs) was subjected to standard walking cycles and stair descent cycles at a ratio of 70: 1 for 5 million cycles. Another set of implants with similar articular geometry and the same ultra-high molecular weight polyethylene (UHMWPE) resin (GUR 415), sterilization and packaging was tested with standard walking cycles only. Implant kinematics, gravimetric wear and surface roughness of the UHMWPE inserts were analysed for both sets of implants. Contact stresses were calculated for both loading protocols using a Hertzian line contact model. Significantly greater weight loss (p < 0.05) and more severe surface damage of UHMWPE inserts resulted with the walking + stair descent loading protocol compared to walking cycles only. Anterior-posterior (AP) tibiofemoral contact point displacements were lower during stair descent than walking, but not significantly different (p = 0.05). Contact stresses were significantly higher during stair descent than walking, owing to higher axial loads and the smaller radius of curvature of the femoral components at higher flexion angles. High contact stresses on UHMWPE components are likely to accelerate the fatigue of the material, resulting in more severe wear, similar to what is observed in retrieved implants. Thus the inclusion of loading protocols for activities of daily living in addition to walking is warranted for more realistic in vitro testing of TKRs.     

Validation of ion level analysis as method to assess in vitro total hip replacement wear

Abstract

Currently in vitro hip simulator wear of metal on metal hip replacements is carried out by gravimetric means. However, this is time consuming and cannot be used to assess wear between measurement intervals. Measuring ion levels (Co and Cr) by inductively coupled plasma mass spectroscopy has been proposed as an alternative method. A standard hip simulator test was conducted using clinically available parts and wear assessed by gravimetric means; additionally, the serum lubricant was assessed for Co and Cr ion levels. A strong correlation in the ion levels and gravimetric was observed, indicating that this method would provide an appropriate alternative wear measurement technique in hip simulator testing.     

The influence of femoral condylar lift-off on the wear of artificial knee joints

In vivo fluoroscopic studies of patients with total knee replacements (TKRs) have shown lift-off of the femoral condyles from the tibial insert. This study investigated the influence of femoral condylar lift-off on the ultra-high molecular weight polyethylene (UHMWPE) wear of fixed bearing (FB) and rotating platform mobile bearing (RP MB) total knee replacements, using a physiological knee joint simulator. In the absence of lift-off, the RP MB knees exhibited a lower wear rate of 5.2 +/- 2.2 mm3 per million cycles (mm3/MC) compared with 8.8 +/- 4.8 mm3/MC for the FB knees. The presence of femoral condylar lift-off was found to accelerate the wear of the FB and RP MB knees tested in this study to 16.4 +/- 2.9 and 16.9 +/- 2.9 mm3/MC respectively. For the RP MB knees the increase in wear rate was more marked, resulting in a similar wear rate for both designs of knee under lift-off conditions. In both cases the medial condyle displayed more wear damage. This study has shown that a small amount of abduction/adduction lift-off and medial-lateral shift increases wear and that the increase in wear is design dependent. In this simulator test, lift-off was simulated on every cycle, whereas the amount of wear and effect of lift-off clinically would depend on the frequency of occurrence of lift-off in vivo.     

The effect of minimum load on the fluid uptake and wear of highly crosslinked UHMWPE total hip acetabular components

Thirteen total hip replacement acetabular components of the same design (32 mm diameter, cup liners made of highly crosslinked ultra-high molecular weight polyethylene (UHMWPE)) were tested in an AMTI hip simulator (six in wear stations and seven in load-soak stations). Two additional liners were immersed in undiluted bovine calf serum but not loaded. The test conditions were otherwise similar for all wear and load-soak samples, with the following exceptions: (a) no motion was applied onto load-soak liners; (b) the minimum load during the swing phase was set at 40 N for three of the wear liners and four of the load-soak liners (group A: low minimum load), and 230 N for the remaining three wear liners and three load-soak liners (group B: high minimum load). It was found that: (a) load-soak liners gained about 10 times more weight than no-load soak liners; (b) load-soak liners in the low minimum load group gained twice as much weight as those in the high minimum load group, and (c) the observed wear rates were low for both groups; surprisingly, however, the wear rates of the low minimum load liners were also higher than those of the high minimum load liners. This study showed for the first time that the fluid uptake and wear rates of highly crosslinked UHMWPE are sensitive to small differences in the loading pattern.     

Effect of Water and Serum Absorption on Wear of Unirradiated and Crosslinked UHMWPE Orthopedic Bearing Materials

Abstract

In addition to confounding mass-based wear measurements in serum-lubricated hip simulator experiments, fluid absorption by the acetabular cups may simultaneously modify the wear resistance of the ultra-high molecular weight polyethylene (UHMWPE) from which they are composed. To decouple the fluid absorption and wear processes enabling clearer investigation of this effect, absorption was first imposed during an initial stage where UHMWPE was exposed to pressurized (10 MPa) fluid. This was followed by a second stage, where resultant wear behavior was assessed by a multidirectional pin-on-flat technique that, though still providing a serum-lubricating environment, does not promote the simultaneous fluid absorption occurring in hip simulator testing. Both unirradiated and highly crosslinked UHMWPE were investigated, each with both bovine calf serum and water soaking exposures of duration to 129 days. The pressurized soaking of a highly crosslinked UHMWPE decreased its wear resistance, causing an increase in wear rate by approximately 50% during subsequent serum-lubricated multidirectional pin-on-flat sliding tests as compared to non-soaked material. The magnitude of this effect did not appear to depend on whether the soaking fluid was water or serum, nor did it appear to depend on soak time provided it was at least of a 14-day duration, during which more rapid transient fluid absorption occurs. Such soaking did not produce as pronounced an effect on unirradiated UHMWPE, as its lack of wear resistance likely causes the absorption-affected surface region to be removed within the earliest stages of sliding contact.     

Investigation of wear of knee prostheses in a new displacement/force-controlled simulator

The performance of two knee simulators designed by ProSim (Manchester, UK) was evaluated by comparison of the wear seen in the press-fit condylar (PFC) Sigma (DePuy) knee prosthesis. Twelve specimens of the same design and manufacturing specification, were subjected to a wear test of 2 x 10(6) cycles duration using bovine serum as a lubricant. The anterior/posterior displacement and internal/external rotation inputs were based on the kinematics of the natural knee. International Standards Organization (ISO) standards were used for the flexion and axial load. The wear rates and wear scar areas were compared across all stations. The mean wear rates found were 17.6+/-5 mm3/10(6) cycles for stations 1 to 6 and 19.6+/-4 mm3/10(6) cycles for stations 7 to 12, resulting in an overall mean wear rate of 18.1+/-3 mm3/10(6) cycles. The differences between the two simulators were not significant. The average wear scar area seen on inserts from stations I to 6 was calculated at 32.4+/-1 per cent of the intended articulating surface. Similarly on stations 7 to 12 the average wear scar area was 30.7+/-3 per cent. The wear scars seen were a good physiological representation of those found from clinical explant data. This study has shown good repeatability from the simulator, both within and between the simulators.     

Semi-quantitative assessment methods for backside polyethylene damage in modular total knee replacements

Two semi-quantitative grading methods (referred to as the Hood/Wasielewski-method and the Modified-method) were described and then applied to 52 retrieved tibial polyethylene inserts from modular total knee replacements. Their ability to assess backside surface damage was compared. The damage score correlation with the implantation period greater than 24 months was better using the Modified-method (R=0.524, p=0.006) than using the Hood/Wasielewski-method (R=0.328, p=0.102). Also, the Modified-method gave significantly higher damage scores for males with gamma-in-air irradiated polyethylene inserts whereas the Hood/Wasielewski-method did not. Thus, the damage score obtained using the Modified-method seemed to provide a better representation of clinical surface damage and possibly PE wear.     

Improvement in the assessment of wear of total knee replacements using coordinate-measuring machine techniques

Total joint replacement is one of the most common elective surgical procedures performed worldwide, with an estimate of 1.5x 10(6) operations performed annually. Currently joint replacements are expected to function for 10-15 years; however, with an increase in life expectancy, and a greater call for knee replacement due to increased activity levels, there is a requirement to improve their function to offer longer-term improved quality of life for patients. Wear analysis of total joint replacements has long been an important means in determining failure mechanisms and improving longevity of these devices. The effectiveness of the coordinate-measuring machine (CMM) technique for assessing volumetric material loss during simulated life testing of a replacement knee joint has been proved previously by the present authors. The purpose of the current work is to present an improvement to this method for situations where no pre-wear data are available. To validate the method, simulator tests were run and gravimetric measurements taken throughout the test, such that the components measured had a known wear value. The implications of the results are then discussed in terms of assessment of joint functionality and development of standardized CMM-based product standards. The method was then expanded to allow assessment of clinically retrieved bearings so as to ascertain a measure of true clinical wear.     

A five-station hip joint simulator

A five-station hip joint wear simulator was designed and built which featured simplified motion and loading. An elliptical wear path was produced using approximately sinusoidal motion in the flexion/extension and internal/external rotation axes and the dynamic loading approximated to a square wave. Five 28 mm diameter zirconia femoral heads articulated against ultra-high molecular weight polyethylene acetabular cups in 25 per cent bovine serum for 5 x 10(6) cycles. Gravimetric wear measurement was used with moisture absorption compensation using a dynamically loaded soak control. With motion of physiological magnitude, the mean acetabular cup wear rate was 52.2 mm3/10(6) cycles which is comparable with a number of clinical studies.     

A hip simulator study of metal-on-metal hip joint device using acetabular cups with different fixation surface conditions

In vitro wear data for hip joint devices reported in the literature vary in a wide range from one simulator study to another sometimes for the same type of device tested under identical physiological testing conditions. We hypothesized that non-bearing surface condition of the testing components could be an important factor affecting the simulator wear results. To confirm this hypothesis, fifteen 50 mm metal-on-metal hip resurfacing devices with identical bearing specifications were tested in a ProSim hip wear simulator for 5 million cycles. The heads were standard Birmingham Hip Resurfacing (BHR) heads; whilst the pairing acetabular cups were identical to the standard BHR cup except their different back surface conditions, including: (a) off-the-shelf products after removing the hydroxyapatite (HA) coating; (b) semi-finished products without HA coating; and (c) purposely-made cups without cast-in beads and HA coating. Results showed that the different back surfaces of the cups used indeed caused significantly large variations in the gravimetrically measured wear loss. We postulated that materials loss from the non-bearing surface of the testing components could contribute to the gravimetrically measured wear loss during a wear simulator test both directly and indirectly. The results presented in this paper pertain to In vitro wear simulator study and have little clinical relevance to the performance of any implant in vivo.     

The effect of 'running-in' on the tribology and surface morphology of metal-on-metal Birmingham hip resurfacing device in simulator studies

It is well documented that hard bearing combinations show a running-in phenomenon in vitro and there is also some evidence of this from retrieval studies. In order to investigate this phenomenon, five Birmingham hip resurfacing devices were tested in a hip wear simulator. One of these (joint 1) was also tested in a friction simulator before, during, and after the wear test and surface analysis was conducted throughout portions of the testing. The wear showed the classical running in with the wear rate falling from 1.84 mm3 per 10(6) cycles for the first 10(6) cycles of testing to 0.24 mm3 per 10(6) cycles over the final 2 x 10(6) cycles of testing. The friction tests suggested boundary lubrication initially, but at 1 x 10(6) cycles a mixed lubrication regime was evident. By 2 x 10(6) cycles the classical Stribeck curve had formed, indicating a considerable contribution from the fluid film at higher viscosities. This continued to be evident at both 3 x 10(6) and 5 x 10(6) cycles. The surface study complements these findings.     

A machine for the preliminary investigation of design features influencing the wear behaviour of knee prostheses

Degradation of tibial inserts in vivo has been found to be multifactorial in nature, resulting in a complex interaction of many variables. A range of kinematic conditions occurs at the tibio-femoral interface, giving rise to various degrees of rolling and sliding at this interface. The movement of the tibio-femoral contact point may be an influential factor in the overall wear of ultra-high molecular weight polyethylene (UHMWPE) tibial components. As part of this study a three-station wear-test machine was designed and built to investigate the influence of rolling and sliding on the wear behaviour of specific design aspects of contemporary knee prostheses. Using the machine, it is possible to monitor the effect of various slide roll ratios on the performance of contemporary bearing designs from a geometrical and materials perspective.     

Prediction of backside micromotion in total knee replacements by finite element simulation

The micromotion at the interface between the polyethylene tibial insert and metal tibial tray [corrected] in modular total knee replacements [corrected] has been shown to contribute to wear particle-induced osteolysis and may [corrected] cause implant failure. Therefore, studying the design parameters that are involved in the backside wear process is an important task that may lead to improvement in new total knee replacements. In the present study, a finite element model was developed to predict the backside micromotion along the entire modular interface. Both the linear elastic constitutive model and non-linear J2-plasticity constitutive model were considered in the finite element model for polyethylene and were corroborated against published results obtained from displacement controlled knee simulator wear tests. The finite element simulation with the non-linear J2-plasticity constitutive model was able to predict backside micromotion [corrected] more accurately than the simulation with the linear elastic constitutive model. [corrected] The developed finite element model (including the non-linear J2-plasticity constitutive model) was then applied to assess the effects of the tibial tray locking mechanism design (dovetails versus fullperipheral [corrected] design) and different levels of interference fit on insert micromotion. The developed finite element model, implementing the non-linear J2-plasticity constitutive model, was shown to successfully predict clinical amounts of backside micromotion and could be used for the design and development of total knee replacements for the reduction of backside micromotion and polyethylene [corrected] wear.     

Commissioning of a displacement-controlled knee wear simulator and exploration of some issues related to the lubricant

A six-station displacement-controlled knee simulator with separately controlled left (L) and right (R) banks (three wear implants per bank) was commissioned for a total of three million cycles (Mc) following ISO 14243-3. A commissioning protocol was applied to compare the polyethylene wear among the six wear stations by exchanging the implants between wear stations. Changes in lubricant characteristics during wear testing, such as polypeptide degradation, low-molecular-weight polypeptide concentration, and possible microbial contamination were also assessed. The total mean wear rate for the implants was 23.60 +/- 1.96 mm3/Mc and this was of a similar magnitude to the mean wear rate for the same implant tested under similar conditions by DePuy Orthopaedics Inc. (Warsaw, IN). Repeated run-in wear was observed when the implants were exchanged between wear stations, suggesting that implants should be subjected to the same wear station throughout the duration of a wear test. The total polypeptide degradation for the implants measured 30.53 +/- 3.96 percent; the low-molecular-weight polypeptide concentration of the "used" lubricant for implants (0.131 +/- 0.012 g/L) was 3.3 times greater than the mean polypeptide concentration of the fresh, "unused" lubricant (0.039 +/- 0.004 g/L). This increase in low-molecular weight polypeptide concentration was suggested to be attributable to protein shear in the articulation of the implant, the circulation of the lubricant, and some proteolytic activity. Sodium azide was ineffective in maintaining a sterile environment for wear testing as a single, highly motile Gram-negative micro-organism was identified in the lubricant from wear tests.     

Increased total knee arthroplasty ultra-high molecular weight polyethylene wear using a clinically relevant hyaluronic acid simulator lubricant

In this study, osteoarthritic and periprosthetic synovial fluid samples were rheologically and biochemically compared to develop a hyaluronic acid (HA) supplemented bovine serum (BS) lubricant that mimicked the properties of human joint synovial fluid. The effect of this BS + HA lubricant (50 per cent bovine calf serum + 1.5 g/l HA) on the wear rate of ultra-high molecular weight polyethylene (UHMWPE) during a total knee replacement wear test was then investigated. In conjunction with biochemical similarities, the rheological analysis showed that the BS + HA lubricant viscosity was not statistically different to aspirated total knee arthroplasty (TKA) revision joint fluid viscosity over a range of physiologic shear rates. Gravimetric results at 5 million wear testing cycles showed that the BS + HA lubricant produced an average of 6.88 times more UHMWPE wear than 50 per cent bovine serum lubricant alone. The BS + HA lubricated CoCr femoral component surfaces revealed pitting and surface roughening that was not observed using standard bovine serum only lubricants, but that was similar to the metallic surface corrosion observed on in vivo CoCr femoral component retrievals. These findings support the hypothesis that the addition of HA to simulator lubricant is capable of producing CoCr femoral component surface damage similar to that observed in vivo.     

Validation of the soft tissue restraints in a force-controlled knee simulator

In vitro testing of total knee replacements (TKRs) is important both at the design stage and after the production of the final components. It can predict long-term in vivo wear of TKRs. The two philosophies for knee testing are to drive the motion by displacement or to drive the motion by force. Both methods have advantages and disadvantages. For force control an accurate simulation of soft tissue restraints is required. This study was devised to assess the accuracy of the soft tissue restraints of the force-controlled Stanmore knee simulator in simulating the restraining forces of the anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL). In order to do this, human cadaver knee joints were subjected to the ISO Standard Walking Cycle. The resulting kinematics were monitored when the soft tissue structures were intact, when the ACL and PCL were resected, and when they were simulated by springs positioned anteriorly and posteriorly. The stiffness of the springs was determined from the literature. Two different stiffnesses of springs were used which were 7.24 N/mm (designated as soft springs) and 33.8 N/mm (designated as hard springs). All the intact knees showed displacements that were within the range of the machine. Cutting the ACL and PCL resulted in anterior and posterior motion and internal external rotation that were significantly greater than the intact knee. Results showed that when the ACL and PCL were cut hard springs positioned anterior and posterior to the knee returned the knee to near normal anterior-posterior (AP) motion. Using hard springs in the posterior position in any condition reduced rotational displacements. Therefore using springs in a force-controlled simulator is a compromise. More accuracy may be obtained using springs that are of intermediate stiffness.