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.     

Long-term results for Kinemax and Kinematic knee bearings on a six-station knee wear simulator

A long-term wear test was performed on Kinemax and Kinematic (Howmedica Inc.) knee bearings on the Durham six-station knee wear simulator. The bearings were subjected to flexion/extension of 65-0 degrees, anterior-posterior translation of between 4.5 and 8.5 mm and a maximum axial load of 3 kN. Passive abduction/adduction and internal/external rotation were also permitted, however, two of the stations had a linkage system which produced +/- 5 degrees active internal/external rotation. The bearings were tested at 37 degrees C in a 30 per cent bovine serum solution and the test was run to 5.6 x 10(6) cycles. The bearings from stations 2 and 3, and stations 4 and 5 were swapped during the test to investigate the effects of interstation variability. The average wear rate and standard error was 3.00 +/- 0.98 mg/10(6) cycles (range 1.33-4.72 mg/10(6) cycles) for the Kinemax bearings and 3.78 +/- 1.04 mg/10(6) cycles (range 1.87-4.89 mg/10(6) cycles) for the Kinematic bearings. There were no significant differences in wear rates between the different bearing designs, the addition of active internal/external rotation or a change of stations. However, the wear tracks were different for the two types of bearings and with active internal/external rotation. The wear rates and factors were generally lower than previously published in vitro wear results; however, this may have been due to a difference in the axial loads and lubricants used. The appearance of the wear tracks with active internal/external rotation was comparable with those seen on explanted knee bearings.     

An in vitro wear study of alumina-alumina total hip prostheses.

Four 28 mm diameter alumina-alumina hip prostheses were tested in the Mkll Durham hip simulator for 5 x 10(6) cycles using 25 per cent bovine serum as lubricant. Wear of the heads and cups was measured gravimetrically. The mean and standard deviation of the wear rate for the alumina cups was 0.097 +/- 0.039 mm3/10(6) cycles. The femoral heads produced such low wear that it could not be measured by weighing but could be detected byincreased surface roughness measurements. Such low wear rates represent about one-five-hundredthof the wear of ultra-high molecular weight polyethylene (UHMWPE) against ceramic in a similar test and supports work which indicates that fluid film lubrication exists in these joints.     

The wear of fixed and mobile bearing unicompartmental knee replacements

Unicompartmental knee replacements (UKR) are an option for surgical intervention for the treatment of single-compartment osteoarthritis. The aim of this study was to compare the wear of a low-conformity fixed-bearing UKR with a conforming mobile bearing UKR under two kinematic conditions, to investigate the effect of implant design and kinematics on wear performance in a physiological knee wear simulator. Under both sets of kinematic conditions, the relatively low-conforming fixed UKR showed lower wear, compared with the more conforming anterior-posterior sliding mobile bearing. However, it should be noted that differences in materials between the two designs also contribute to the relative wear performance of the bearings. The combined wear of the medial and lateral bearings of the fixed-bearing UKR as a 'total knee' were significantly reduced compared with a fixed-bearing total knee replacement studied under the same kinematic conditions.     

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.     

Mass gain behaviour of tibial polyethylene inserts during soak testing

Fluid adsorption and the associated mass gain behaviour in tibial inserts of total knee replacements was investigated in polyethylene (PE) manufactured from extruded GUR 1050 resin. Repeatedly removing the PE inserts from the soak fluid for gravimetric assessment (including cleaning, desiccation, and weighing) increased the mass gain. Soaking PE inserts for 46 days or 92 days seemed to give about the same mass gain. PE inserts that were soaked at 37 degrees C gained more mass than PE inserts soaked at room-temperature. Gas-plasma sterilized PE inserts gained less mass than gamma-in-air sterilized PE inserts. No statistically significant differences were detected in mass gain between PE inserts that were of 10mm and 14mm thickness. The mass gain of PE inserts was higher in protein-rich soak fluid compared with low-ion distilled water. Prior to knee simulator wear testing, tibial PE inserts should be conditioned in the same medium and under the same test conditions (gravimetric assessment frequency, fluid protein content, and fluid temperature). This approach would help improve the accuracy and precision of the gravimetrically determined PE wear rate during knee simulator wear testing.     

Single flexion-axis selection influences femoral component alignment and kinematics during knee simulation

The objective of this paper is to investigate the effect of the implant geometry and alignment on its surface displacement, and to show that the proposed method of alignment can be used to improve the consistency of total knee replacement alignment for knee simulation. Poor femoral flexion-axis selection in the alignment process can possibly alter the intended design's functionality and introduce significant anterior/posterior (A/P), and proximal/distal (P/D) displacements. In the study, four multi-axis femoral components from each of two different manufacturers, NKII and 3DKnee, were used. A custom-built femoral alignment and surface measurement instrument was used to adjust and locate the single femoral axis position for each implant, which would optimally minimize their P/D displacements and A/P translations. The aligned NKII implants yielded a mean implant maximum P/D and A/P contact point shifts of 0.577 +/- 0.078 mm (+/- std. dev.) and of 2.325 +/- 0.243 mm between 0 and 60 degrees of flexion, which was significantly different from the aligned 3DKnee, 0.415 +/- 0.157 mm and 0.800 +/- 0.1512mm (p<0.0001, p<0.0001). Future work is needed to quantify the effect of femoral flexion axis selection on resulting long-term wear, damage areas, and soft tissue loading during simulation.     

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.     

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.     

Analysis of mixed lubrication mechanism in metal-on-metal hip joint replacements

A simple mixed lubrication model has been developed to predict the asperity contact and wear for the metal-on-metal bearing couple for total hip joint replacements. It has been shown that the femoral head radius has a large effect on the predicted asperity contact and wear depending on the lubrication regime. An increase in the femoral head radius can lead to an increase in wear under a predominantly boundary lubrication regime, but this trend can be reversed under a mixed lubrication regime towards fluid film lubrication. These observations are consistent with the recent experimental findings from hip simulator studies by Smith and co-workers.     

Evaluation of a hip joint simulator

To evaluate the functioning of the Durham hip joint wear simulator, the wear rates of ultra high molecular weight polyethylene (UHMWPE) and polytetrafluoroethylene (PTFE) acetabular cups articulating against 22 mm diameter cobalt-chromium-molybdenum (CoCrMo) femoral heads were studied. A wear test was conducted in a lubricant of distilled water at 37 degrees C for a duration of 4.8 million cycles. The average penetration rate for the CoCrMo femoral heads against UHMWPE acetabular cups was 0.03 mm/10(6) cycles, while penetration rate for PTFE cups was some twenty times greater. These results are of a similar order of magnitude to other simulator studies in distilled water and are in a similar ratio to clinical data.     

Design forms of total knee replacement

The starting point of this article is a general design criterion applicable to all types of total knee replacement. This criterion is then expanded upon to provide more specifics of the required kinematics, and the forces which the total knee must sustain. A characteristic which differentiates total knees is the amount of constraint which is required, and whether the constraint is translational or rotational. The different forms of total knee replacement are described in terms of these constraints, starting with the least constrained unicompartments to the almost fully constrained fixed and rotating hinges. Much attention is given to the range of designs in between these two extreme types, because they constitute by far the largest in usage. This category includes condylar replacements where the cruciate ligaments are preserved or resected, posterior cruciate substituting designs and mobile bearing knees. A new term, 'guided motion knees', is applied to the growing number of designs which control the kinematics by the use of intercondylar cams or specially shaped and even additional bearing surfaces. The final section deals with the selection of an appropriate design of total knee for specific indications based on the design characteristics.     

Wear and deformation of ceramic-on-polyethylene total hip replacements with joint laxity and swing phase microseparation

Wear of polyethylene and the resulting wear debris-induced osteolysis remains a major cause of long-term failure in artificial hip joints. There is interest in understanding engineering and clinical conditions that influence wear rates. Fluoroscopic studies have shown separation of the head and the cup during the swing phase of walking due to joint laxity. In ceramic-on-ceramic hips, joint laxity and microseparation, which leads to contact of the head on the superior rim of the cup, has led to localized damage and increased wear in vivo and in vitro. The aim of this study was to investigate the influence of joint laxity and microseparation on the wear of ceramic on polyethylene artificial hip joints in an in vitro simulator. Microseparation during the swing phase of the walking cycle produced contact of the ceramic head on the rim of the polyethylene acetabular cup that deformed the softer polyethylene cup. No damage to the alumina ceramic femoral head was found. Under standard simulator conditions the volume change of the moderately crosslinked polyethylene cups was 25.6 +/- 5.3 mm3/million cycles and this reduced to 5.6 +/- 4.2 mm3/million cycles under microseparation conditions. Testing under microseparation conditions caused the rim of the polyethylene cup to deform locally, possibly due to creep, and the volume change of the polyethylene cup when the head relocated was substantially reduced, possibly due to improved lubrication. Joint laxity may be caused by poor soft tissue tension or migration and subsidence of components. In ceramic-on-polyethylene acetabular cups wear was decreased with a small degree of joint laxity, while in contrast in hard-on-hard alumina bearings, microseparation accelerated wear. These findings may have significant implications for the choice of fixation systems to be used for different types of bearing couples.     

A comparative joint simulator study of the wear of metal-on-metal and alternative material combinations in hip replacements

While total hip replacement represents the major success story in orthopaedic surgery in the twentieth century, there is much interest in extending even further, early in the twenty first century, the life of implants. Osteolysis has been identified as a major factor limiting the life of prostheses, with indications that fine polyethylene wear debris, generated primarily at the interface between the femoral head and the acetabular cup, promotes the process. There is therefore considerable interest in the introduction of alternative wear resistant systems to limit the deleterious effects of wear. These alternatives include ceramic-on-ceramic and metal-on-metal configurations and the present paper is primarily concerned with the latter. Some six pairs of new metal-on-metal implants of 36 mm diameter and four pairs of existing metal-on-metal implants of 28 mm diameter were tested in a ten-station hip joint simulator in the presence of a 25 per cent bovine serum solution. The implants were tested in the anatomical position to 5 x 10(6) cycles. The new heads and cups were manufactured from CoCrMo alloy with careful attention being paid to sphericity and surface finish of both components. The wear performance of the new and existing metal-on-metal total hip replacements have been evaluated and compared. The overall wear rates have then been compared with previously reported wear rates for a zirconia-on-polyethylene prosthesis of 22 mm diameter tested on the same simulator. The comparison is taken further by recalling published penetration data for metal-on-polyethylene implants of 22 and 28 mm diameter and converting these to volumetric wear rates. It was found that the heads and cups in metal-on-metal joints wore by almost equal amounts and that the opposing surfaces converged to similar surface roughness as the testing time increased. Steady state wear rates were generally achieved after 1-2 x 10(6) cycles. The mean long-term wear rates for the metal-on-metal prostheses were very low, being 0.36 mm3/10(6) cycles and 0.45 mm3/10(6) cycles for the new implants of 36 mm diameter and established implants of 28 mm diameter respectively. These wear rates compare with 6.3 mm3/10(6) cycles for zirconia-on-ultra-high molecular weight polyethylene tested on the same simulator and representative clinical values for metal-on-polyethylene of 36 mm3/year for heads of 22 mm diameter and a reported range of 60-180 mm3/year for 28 mm heads. These values do not translate directly into numbers of particles, since the metallic debris from metal-on-metal joints is very fine. The number of metallic particles may exceed the number of polyethylene wear particles from an otherwise similar metal-on-polyethylene joint by a factor of 10(3). A detailed discussion of the size and morphology of wear debris and tissue reaction to various forms of debris is beyond the scope of this paper, but the biological response to polymeric, metallic and ceramic wear debris forms a major subject for further study. The present investigation nevertheless confirms the potential of carefully designed and manufactured metal-on-metal total replacement joints for the treatment of diseased and damaged hips.     

Computational development of a polyethylene wear model for the articular and backside surfaces in modular total knee replacements

A computational model to predict polyethylene wear in modular total knee replacements was developed. The results from knee simulator wear tests were implemented with finite element simulations to identify the wear factors of Archard's wear law. The calculated wear factor for the articular and backside surface was 1.03±0.22×10⁻⁷ mm³/Nm and 2.43±0.52×10⁻¹⁰ mm³/Nm, respectively. The difference in wear factors was attributed to differences in wear mode and wear mechanisms between the articular (mainly two-body rolling/sliding wear mode with an abrasive/adhesive wear mechanism) and the backside surfaces (mainly fretting wear mode with an adhesive wear mechanism).     

Effect of Radial Clearance on Wear and Contact Pressure of Hard-on-Hard Hip Prostheses Using Finite Element Concepts

Wear of the bearing surface increases the revision rate of artificial hip replacements and is influenced by the radial clearances between the acetabulum cup and the femoral head. The objective of this article is to determine the effect of various radial clearance values over the contact pressure and wear of the hard-on-hard—that is, polycrystalline diamond (PCD)—hip prostheses using finite element concepts for normal walking conditions. The wear of the hip bearing surface is determined by considering the contact pressures obtained from the hip gait instants of normal walking activity and sliding distance determined from the three-dimensional hip gait motions. The radial clearance value of 0.05 mm showed less volumetric wear rate when compared with other radial clearance values. Overall, it is recommended that the low radial clearance between the contacting pair is suitable for PCD-on-PCD hip prostheses.     

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.     

An in vitro study of the reduction in wear of metal-on-metal hip prostheses using surface-engineered femoral heads

Although the wear of existing metal-on-metal (MOM) hip prostheses (1 mm3/10(6) cycles) is much lower than the more widely used polyethylene-on-metal bearings, there are concerns about the toxicity of metal wear particles and elevated metal ion levels, both locally and systemically, in the human body. The aim of this study was to investigate the possibility of reducing the volume of wear, the concentration of metal debris and the level of metal ion release through using surface-engineered femoral heads. Three thick (8-12 microm) coatings (TiN, CrN and CrCN) and one thin (2 microm) coating (diamond-like carbon, DLC), were evaluated on the femoral heads when articulating against high carbon content cobalt-chromium alloy acetabular inserts (HC CoCrMo) and compared with a clinically used MOM cobalt-chromium alloy bearing couple using a physiological anatomical hip joint simulator (Leeds Mark II). This study showed that CrN, CrCN and DLC coatings produced substantially lower wear volumes for both the coated femoral heads and the HC CoCrMo inserts. The TiN coating itself had little wear, but it caused relatively high wear of the HC CoCrMo inserts compared with the other coatings. The majority of the wear debris for all half-coated couples comprised small, 30 nm or less, CoCrMo metal particles. The Co, Cr and Mo ion concentrations released from the bearing couples of CrN-, CrCN- and DLC-coated heads articulating against HC CoCrMo inserts were at least 7 times lower than those released from the clinical MOM prostheses. These surface-engineered femoral heads articulating on HC CoCrMo acetabular inserts produced significantly lower wear volumes and rates, and hence lower volumetric concentrations of wear particles, compared with the clinical MOM prosthesis. The substantially lower ion concentration released by these surface-engineered components provides important evidence to support the clinical application of this technology.     

Wear and creep of highly crosslinked polyethylene against cobalt chrome and ceramic femoral heads

The wear and creep characteristics of highly crosslinked ultrahigh-molecular-weight polyethylene (UHMWPE) articulating against large-diameter (36mm) ceramic and cobalt chrome femoral heads have been investigated in a physiological anatomical hip joint simulator for 10 million cycles. The crosslinked UHMWPE/ceramic combination showed higher volume deformation due to creep plus wear during the first 2 million cycles, and a steady-state wear rate 40 per cent lower than that of the crosslinked UHMWPE/cobalt chrome combination. Wear particles were isolated and characterized from the hip simulator lubricants. The wear particles were similar in size and morphology for both head materials. The particle isolation methodology used could not detect a statistically significant difference between the particles produced by the cobalt chrome and alumina ceramic femoral heads.     

Tribological assessment of a flexible carbon-fibre-reinforced poly(ether-ether-ketone) acetabular cup articulating against an alumina femoral head

New material combinations have been introduced as the bearing surfaces of hip prostheses in an attempt to prolong their life by overcoming the problems of failure due to wear-particle-induced osteolysis. This will hopefully reduce the need for revision surgery. The study detailed here used a hip simulator to assess the volumetric wear rates of large-diameter carbon-fibre-reinforced pitch-based poly(ether-ether-ketone) (CFR-PEEK) acetabular cups articulating against alumina femoral heads. The joints were tested for 25 x 10(6) cycles. Friction tests were also performed on these joints to determine the lubrication regime under which they operate. The average volumetric wear rate of the CFR-PEEK acetabular component of 54 mm diameter was 1.16 mm(3)/10(6) cycles, compared with 38.6 mm(3)/10(6) cycles for an ultra-high-molecular-weight polyethylene acetabular component of 28 mm diameter worn against a ceramic head. This extremely low wear rate was sustained over 25 x 10(6) cycles (the equivalent of up to approximately 25 years in vivo). The frictional studies showed that the joints worked under the mixed-boundary lubrication regime. The low wear produced by these joints showed that this novel joint couple offers low wear rates and therefore may be an alternative material choice for the reduction of osteolysis.