Introduction. A tibial insert with choices in size, thickness, and posterior slope is proposed to improve ligament balancing in total knee arthroplasty. However, increasing posterior slope, or the angle between the distal and proximal insert surfaces, will redistribute ultra-high molecular weight polyethylene (UHMWPE) thickness in the sagittal plane, potentially affecting wear. This study used in-vitro testing to compare wear for a standard cruciate-retaining tibial insert (STD) and a corresponding 6° sloped insert (SLP), both manufactured from direct-compression molded (DCM) UHMWPE. Our hypothesis was slope variation would have no significant effect on wear. Methods. Two of each insert (STD and SLP) were tested on an Instron-Stanmore knee simulator with a force-control regime. The gait cycle and other settings followed ISO 14243-1 and -2, except for reference positions. The STD insert was tilted 6° more than the SLP insert to level the articular surfaces. Wear was gravimetrically measured at intervals according to strict protocol. Results. No statistical difference (p=0.36) in wear rates was found for the STD (9.5 ±1.8 mg/Mc)) and SLP (11.4 ±0.5 mg/Mc) inserts. Discussion. The overall wear rate measured was higher than previously published rates for implants similar to the STD inserts. This may result from increased shear loads due to the shift in reference position and 6° slope. This is the first time the effect of tibial insert slope on wear has been evaluated in-vitro. For inserts made from DCM UHMWPE with a slope limited to 6°, this test suggests altering tibial insert slope has an insignificant effect on wear

Osteolysis induced by UHMWPE debris has historically been one of the major causes of long term failure of TJR. An increase in concentration of polyethylene particles in the peri-prostheic tissue has been linked to an increased incidence of osteolysis. The dual mobility hip bearing concept mates a femoral head into a polyethylene liner which has an unconstrained articulation into a metal shell. The wear mechanism of the dual mobility hip bearing is distinct from a constrained single articulation design, which may result in a difference in wear debris particles. The aim of this study is to evaluate wear debris generated from a dual mobility hip and compare it to a conventional single articulation design when both are manufactured from sequentially crosslinked and annealed polyethylene. The dual mobility hip (Restoration ADM) incorporated a 28mm CoCr femoral head into a polyethylene liner that articulates against a metal shell (48mm ID). The conventional hip (Trident®) mated a 28mm CoCr femoral head against a polyethylene liner. The polyethylene for all liners was sequentially crosslinked and annealed (X3). A hip joint simulator was used for testing at a rate of 1 Hz with cyclic Paul curve physiologic loading. A serum sample from each testing group was collected. Serum samples were protein digested following the published process by Scott et al. The digested serum was then filtered through a series of polycarbonate filter papers of decreasing size and sputter coated with gold for analysis using SEM. Image fields were randomized and wear debris was compared in terms of its length, width, aspect ration, and equivalent circular diameter (ECD). A total of 149 conventional hip particles and 114 dual mobility hip particles were imaged. Results show a majority of particles are of spherical nature and images do not indicate the presence of fibrillar or larger elongated polyethylene debris. Particle length between designs is not statistically different, while all other comparisons show statistical significance (p<0.05). It is hypothesized that the dual mobility hip system reduces the total amount of cross-shear motion on any one articulation, which aids in the reduction in wear. This design feature may be responsible for the slight difference in morphology of dual mobility wear debris when compared to the constrained hip design. The length of the particles was similar, simply indicating a different shape rather than a marked reduction in overall size. The debris generated is this study was from highly crosslinked polyethylene in two different designs, which produced a very significant decrease in quantity of particles when compared to the quantity of debris from conventional polyethylene. The wear debris was of similar length in both designs and so we do not expect any difference in biological response to debris from either device. The dual mobility design has also shown no effect of cup abduction angle on wear demonstrating forgiveness to implant positioning. This advantage, combined with the low wear rate and similar length wear particles, should lead to good clinical performance of dual mobility cups with sequentially irradiated and annealed polyethylene

Introduction. Unicompartmental knee arthroplasty (UKA) in patients with isolated medial osteoarthritis of the knee is nowadays a standard procedure with good results, especially with the minimally-invasive approach. However, the survival rate of the unicompartmental knee prostheses is inferior to that of total knee prostheses. Therefore, further studying of UKA is still necessary. In most mobile bearing designs the femoral component has a spherical surface and therefore its positioning is not crucial. The role of the tibial slope in UKA has not been investigated so far. The manufacturers recommend tibial slopes with values between 10° positive slope and 5° negative slope. Most surgeons try to reconstruct the anatomical slope with a high failure by measuring the slope on x-rays. The aim of this study was to investigate the influence of the tibial slope on the wear rate of a medial UKA. Materials and methods. In vitro wear simulation of medial mobile bearing unicompartmental knee prosthesis with a spherical femoral surface (Univation ®) was performed with a customized four-station servo-hydraulic knee wear simulator (EndoLab GmbH, Thansau, Germany) reproducing exactly the walking cycle as specified in ISO 14243–1:2002(E). The tibial tray was inserted with 2 different medial tibial slopes: 0°, 8° (n=3 for each group). The lateral tibial slope of the space-holder was not changed (0° for every group). We performed a total of 5 million cycles for every different slope, the gravimetric wear rate was determined gravimetrically using an analytical balance every 500 000 cycles according to the ISO 14243–2. Results. The wear rate in the 0° slope group was 3.46±0.59 mg/million cycles, and in the 8° slope group it was 0.99±0.42 mg/million cycles. The difference between the 0° tibial slope group and the 8° tibial slope group was highly significant (p<0.01, alternate t-test). Discussion. An increase of the tibial slope leads to a reduced wear rate in a mobile bearing UKA. Therefore, a higher tibial slope should be recommended for mobile bearing UKA. However, the influence on the ligaments has to be considered as a higher tibial slope leads to an increased strain on the anterior cruciate ligament. This influences needs to be investigated in further studies before a definite optimal range for the tibial slope can be recommended

INTRODUCTION. Whilst there is a great deal of research on hip implants, few studies have looked at implant orientation and the subsequent effect upon the wear performance of a hip resurfacing. This study aimed to measure implantation angles through radiographic analysis and linear wear for retrieved acetabular cups in order to investigate possible causal links between wear and implant orientation. MATERIALS & METHODS. Seventy Birmingham Hip Resurfacing (Smith & Nephew, UK) cups with known time in vivo were analysed. Linear wear of retrieved cups were assessed using a Talyrond 290 roundness machine. Deviations from the characteristic manufactured profile, was identified as a region of wear. Polar measurements across the wear region were taken to determine wear. The linear wear rate (LWR) of a component was defined as the linear wear (μm) divided by the duration of the implant life in vivo (years). Cups which showed the wear crossing over the edge of the cup were classified as edge loaded (EL). For all non-edge loaded (NEL) cups, the wear area was within the bearing surface. Cup orientation angles were conducted for 31 cups. This was determined by superimposing BHR models of appropriate size, generated by CAD ProEngineer Wildfire 4, onto anterior-posterior x-rays. Anatomical landmarks and specific features of the BHR were used as points of reference to determine cup version and inclination angles. RESULTS. Forty two cups were classed as EL, showing regions of wear extending beyond the edge of the cup. Twenty eight were classed as NEL. The EL group had an average LWR of 25.4(±8.05 95% CL) μm/yr, whilst the NEL group generated an average LWR of 1.45 (±0.34 95% CL) μm/yr, a statistically significant difference (p<0.05).a Following radiographic analysis, 23 cups were classed as EL, showing regions of wear extending beyond the edge of the cup. Eight were classed as NEL. Cups in the EL group showed average inclination and version angles of 54.35° (±5.37° 95% CL) and 22.43° (±5.23° 95% CL). Average inclination and version angles of cups in the NEL group were 45° (±7.20° 95% CL), and 14.88° (±3.38° 95% CL) respectively. Inclination and version angles between the two groups were statistically significant (p<0.05). DISCUSSION. Through linear wear and radiographic analysis, the current study has shown that mal-positioned resurfacing devices classed as EL had higher linear wear than the NEL cups. Edge loaded cups examined in this study showed significantly higher inclination and anteversion (p<0.05) than the non-edge loaded devices. This indicates that component wear is closely associated with in vivo orientation. The success of any implant is dependent upon implant orientation both in version and inclination angles. The correct implant orientation will help to ensure that wear occurs within the bearing surfaces, maintaining an optimal lubrication regime and low wear

INTRODUCTION. Hip wear simulator test results could be affected by many non-bearing related factors such as fixation surface conditions, equipment calibration and component set-up. In an effort to improve the accuracy, reliability and repeatability of hip simulator test, a quality management system has been established at the IDC hip tribology laboratory, which has been accredited by UKAS (United Kingdom Accreditation Service) in accordance with the recognised international standard ISO17025. This study demonstrates that under well-controlled laboratory and testing conditions, satisfactory repeatability can be achieved during hip simulator studies. METHODS. Between 2008 to 2010, ten 50 mm Birmingham Hip Resurfacing (BHR) devices were tested by the IDC tribology laboratory using two ProSim hip wear simulators in three different tests (T1, T2 and T3). All tests were performed following the same IDC testing protocols at 1 Hz frequency for 5 million cycles (Mc) or until after a steady state was reached. Paul type stance phase loadings with a maximum load of 3 kN and a swing phase load of 0.3 kN was used. The flexion and extension angles were 30 and 15 degree. The internal/external rotation angel was ±10 degree. Wear was measured gravimetrically using an analytical balance (Mettler, Toledo xp504) with an accuracy of 0.1 mg. RESULTS. Results showed that wear of all the components tested followed the typical biphasic trend of wear for MoM hip joint device with a high “running-in” wear during the initial stage followed by a low “steady state” wear in the later stage. The data points scattered in a narrow range following the same trend line throughout the tests. The maximum difference in accumulated volume loss between any two tests at any given cycle was less in 0.2 mm3. The average running-in wear rates (±SD) were 0.72 ±0.17, 0.86 ±0.01 and 0.71 ±0.19 mm3/Mc respectively for test T1, T2 and T3. The running-in wear rates for test T1 and T3 were identical, whilst that for T2 was slightly higher. In spite of this, the wear rates for the bearings tested in T2 were still in the same range as those tested in T1 and T3 during the running-in stage. The steady state (>1.0Mc) wear rate of three different tests was practically the same, being 0.18 ±0.02, 0.18 ±0.06 and 0.16 ±0.04 mm3/Mc respectively for test T1, T2 and T3. Overall, the mean running-in wear rate was 0.74 ±0.16 mm3/Mc, and the steady state wear rate was 0.17 ±0.04 mm3/Mc for the 10 BHR devices tested in three different studies. DISCUSSIONS. This study shows that satisfactory repeatability can be achieved during hip simulator test of metal on metal hip joint devices. Well controlled test procedures including calibration of testing and measurement equipment, correct and consistence test set-up and attention to non-bearing surfaces are some of the most important prerequisites for reliable and accurate hip simulator test results

INTRODUCTION. Studies have suggested that there is a reduction in head-neck-ratio (HNR) associated with MoMHRA. A reduction in HNR at operation would decrease range of movement and increase impingement risk. Impingement could lead to 20 edge loading, increasing wear. Serum ion levels of Chromium (Cr) and Cobalt (Co) are surrogate markers of wear. Although acetabular component orientation has been shown to contribute to wear and PT development, the role of a decrease in HNR has only been highlighted in PT development. This study aimed to measure changes in HNR that occur at resurfacing and determine any gender- and component size-specific differences. In addition it aimed to determine whether changes in HNR could be associated with increased wear. METHODS. 84 patients (56M: 28F) with unilateral MoMHRA were included. The mean age at surgery was 57 years. The mean femoral component was 49mm. Components were considered small if <45mm, average if between 45–50mm and large if >50mm. Three designs were implanted; BHR, C+ and Recap. The average follow up was 4 years. All patients had Cr/Co levels measured at follow up. Patients were considered to have high ions if Cr and Co levels were 5.1ppb and 4.4ppb respectively. Pre-operative HNR (HNRpre) and the post-operative HNR (HNRpost) were made from the respective pelvic radiographs. Assuming a 2mm thick cartilage layer, the HNR based on the diameter of the articular cartilage pre-operatively (HNRart) was calculated. The immediate changes in HNR as a result of the operation were expressed relative to articular HNR pre-op:. HNRartpost=HNRpost–HNRart. RESULTS. The changes in HNR at operation were significantly negatively correlated with HNRpre, (p<0.001), (rho=−0.77). Females had greater ion levels (p=0.013) and smaller components (p<0.001). Females had bigger pre-operative HNRart and were downsized more (p<0.001). Similarly, patients with small components had higher ions (p=0.032). They had greater HNRart and were downsized more (p<0.001) Twelve patients comprised the high ion group. These patients had smaller components (p=0.004), greater HNRart and were down-sized significantly more at resurfacing (p<0.001). DISCUSSION. This study highlights HNR changes that occur in resurfaced hips. Females, patients with small components and patients in the high ion group had higher pre-operative HNR and were downsized more at operation. Femoral downsize, would probably increase impingement risk, lead to secondary edge loading and contribute to greater incidence of wear related problems

Introduction. Hip wear simulation is a widely used technique for the pre-clinical evaluation of new bearing designs. However, wear rates seen in vitro can often be significantly different to those seen clinically. This can be attributed to the difference between the optimal conditions in a simulator and wide ranging conditions in real patients. This study aimed to develop more clinically relevant simulator tests, looking specifically at the effects of cup inclination angle (in vivo) and stop-dwell-start (SDS) protocols on a clinically available product. Method. Five tests using a Paul type walking cycle (ISO 14242) were carried out on two ProSim hip simulators: . 28mm MoM, standard walking, cup inclination 45°, (n = 5). 36mm MoM, standard walking, cup 45°, (n = 4). 36mm MOM, SDS: 10 walking cycles and pause of 5s with stance load of 1250N cup 45°, (n = 5). 36mm MOM, SDS: 10 walking cycles and pause of 30s with stance load of 1250N, (n = 5) cup 45°. 36mm MOM, standard walking, cup 55°(n = 5), and 65°(n = 5). All samples had matched clearances, measured using a CMM (Prismo Navigator, Zeiss, Germany). Wear was measured gravimetrically (Sartorius ME235S: 0.01mg). Results and Discussion. Metal-on-metal hip bearings are known to exhibit a bi-phasic wear pattern in-vitro (1), with the majority of wear occurring over the first 1–1.5mc, followed by lower steady state wear as the components conform to each other. Therefore bedding in wear over the first 1 million cycles was compared for each of the sample groups in this study. Bedding in wear for 36mm bearings under standard angle (45 inclination) and walking conditions was 0.16±0.15mm3/mc, while for 28mm bearings, wear was 2.67±2.06mm3/mc. Positioning the acetabular cup at an increased angle led to increased wear. At 55bedding in wear was .25±0.29mm3/mc, while at 65wear was 0.65±0.32mm3/mc. When SDS conditions were applied, no significant increase in wear was observed under either the 5s or 30s pause conditions, with bedding in wear of 0.19±0.31mm3/mc and 0.14±0.13mm3/mc respectively. Conclusion. This study illustrates the robust performance of the 36mm MoM bearing under extreme test conditions when compared with 28mm MoM. No effect was observed with the application of stop-dwell-start conditions, and only a small increase in wear was observed when the cup was inclined to a greater angle. Despite the application of extreme test conditions, the 36mm MoM still demonstrates lower wear than 28mm under all conditions. In all but the 65 inclination conditions, this difference is statistically significant. This study replicates some of the more frequently observed extreme conditions measured in real patients with THRs (2,3). Even under these more aggressive scenarios, wear of the 36mm bearing is still relatively low when compared with a commercially available 28mm THR

Introduction. Patients suffering from finger joint pain or dysfunction due to arthritis and traumatic injury may require arthroplasty and joint replacement. Single-part silicone-based implants remain the material of choice and most widely used option, although reports on their long-term clinical performance are variable. For trauma indications, patients have a high expectation of functionality necessitating the use of materials with high wear resistance and mechanical performance. A new proximal inter phalangeal (PIP) joint designed by Zrinski AG (Wurmlingen, Germany), comprising a self-mating carbon fibre reinforced polyetheretherketone (CFR-PEEK) coupling, may provide a suitable alternative. Here we describe the wear performance of the CFR-PEEK components in a PIP joint wear simulator and subsequent characterisation of the wear particles. Methods. Four proximal and distal PIP components were milled (Zrinski AG) from CFR-PEEK (Invibio Ltd, UK) and subjected to wear testing (Endo Lab ® GmbH, Germany). The test was conducted at 37°C over 5 million cycles in 25% bovine serum (refreshed every 0.5 million cycles). The load was a static force of 63N applied at a frequency of 1Hz with a flexion/extension angle of ±40°. Wear rate was determined by mass loss from each component. Pooled serum samples from the wear simulator were subjected to protein digest and the remaining particulate debris isolated by serial filtration through 10μm, 1μm and 0.1μm filters. Particle size and morphology was subsequently determined by scanning electron microscopy (SEM) (Continuum Blue, UK). Results. Both components exhibited high resistance to wear, with the proximal component resulting in a wear rate of 0.09mg/million cycles, whilst that of the distal component was 0.07mg/million cycles. Particle analysis revealed that the majority of debris generated during the wearing in phase (0.5 million cycles) was <0.5μm in diameter. During the steady state phase (0.5–3 million cycles) a large peak in particle size was observed in the 2μm diameter range, whilst in the latter stage (3–5 million cycles) peaks in particle size were seen at 0.4μm and 2μm. During each stage, both the particle count and aspect ratio remained relatively unchanged. Conclusion. Under these test conditions the CFR-PEEK coupling demonstrated a linear and consistently low wear rate over the 5 million cycle test period, with the majority of particles generated being <2μm in diameter. The low wear rate and biocompatibility demonstrated by CFR-PEEK suggests it is a suitable alternative to silicone in PIP joint prostheses. Acknowledgements. The authors would like to thank Zrinski AG, Christian Kaddick at EndoLab GmbH for the wear simulator work and Mark Yeoman at Continuum Blue Ltd. for particle analysis

INTRODUCTION. Ceramic-on-metal hip replacements (COM, where the head is a Biolox Delta ceramic and liner is Co Cr alloy), have demonstrated reduced wear under standard conditions in vitro compared to metal-on-metal (MOM) [1]. Early clinical results are also encouraging [2]. Recently concerns have been raised regarding the poor clinical performance of MOM hip resurfacings [3], particularly when cups are steeply inclined. Laboratory hip simulator testing has been used to replicate edge loading, also demonstrating elevated wear [4]. Therefore, a range of conditions to replicate sub-optimal use clinically to better predict in vivo performance should be used. The aim of this study was to compare the wear rates of MOM and COM under adverse edge loading conditions in an in vitro hip simulator test. METHODS. Ceramic-on-metal (n=3) and metal-on-metal (n=3) 36mm hip prostheses (supplied by DePuy International Ltd, UK) were tested in the Leeds Physiological Anatomical Hip Joint Simulator. Liners were mounted to provide a clinical angle of 45o, and stems positioned anatomically. A simplified gait cycle and microseparation was applied as previously described [5] for two million cycles in 25% new born calf serum. Gravimetric analysis was completed every million cycles and wear volumes calculated. RESULTS. The overall mean volumetric wear rate of COM bearings was 0.36 ± 0.55mm3 per million cycles, this was significantly less than the MOM bearing wear (1.32 ± 0.91mm3 per million cycles). For both COM and MOM bearings wear under these edge loading conditions was significantly greater if compared to previously reported wear under standard conditions [1]. DISCUSSION. The reduced wear of COM has been attributed to the differential hardness decreasing adhesive wear and reduced corrosive wear [6]. Wear under the harsh edge-loading conditions in this study is also reported to be significantly less in COM bearings compared to MOM. In MOM bearings in edge contact conditions, the wear zone becomes starved of lubrication, this elevates wear and increases damage at the edge of the cup. In COM bearings the harder head does not become damaged when there is lubricant starvation and hence wear does not accelerate in the same way. In conclusion, COM bearings show reduced wear compared to MOM bearings under standard and adverse conditions and there is some early evidence to support this finding clinically. ACKNOWLEDGEMENTS. Supported by DePuy International Ltd. SW is supported by a Royal Academy of Engineering/EPSRC (UK) fellowship

Periprosthetic osteolysis depends on the biological activity of wear particles, but there is little known about the distribution of polyethylene wear particles (PE) in the surrounding joint tissue. The purpose of this study was to examine the localisation of wear particles of six different PEs, including four crosslinked polyethylenes (XPE), as well as their biological activity in the murine knee. Material and Methods. Wear particles of 4 XPE- and 2 UHMWPE-inserts were isolated (knee joint simulator). For all groups the particles were similar in size and shape (mean diameter 0.3–05μm; 20nm-nucleopore-filter; ISO; n = 100.000).56 female Balb/c mice were randomly assigned to six treatment groups and one control group: control (PBS), XPE1 (3×30 kGy Gamma, annealed/sequential irradiated), XPE2 (95 kGy E-beam, remelted), XPE3 (65 kGy E-beam, remelted), XPE 4 (50 kGy Gamma, remelted), UHMWPE 1, UHMWPE 2. 50 μl of each particle suspension [(0.1% vol/vol (particle volume/PBS volume) after removal of endotoxin] were injected into the left knee joint. After 1 week the mice were killed and a histological and immunhistochemical analysis of the knee joints was done (IL-1, TNF-, ICAM-1). For the immunhistochemistry the articular cartilage, the bone marrow and the synovial membrane were evaluated semiquantitatively (Kruskal-Wallis test; all pairwise multiple comparison procedure; Bonferoni correction; significance level: p<0.05). Results. All groups showed a thickened synovial layer with an increased cellular infiltration. The particles of XPE 1 and 2 were localised in the bone marrow as well as in the joint space. In contrast, the particles of XPE 3 and 4 were distributed in the synovial layer and in the bone marrow as well, but not in the joint space. The UHMWPE1 particles were mainly located in the bone marrow and joint space while the UHMWPE2 particles were mainly found in the bone marrow and the synovial layer. For all PE groups there was a higher cytokine expression compaired to control (p<0.0024) without any differences between the groups (bone marrow/synovial layer). The chondrocytes in the groups with XPE 1- and XPE 2-particles expressed more TNF- than in the control group and the other treatment groups (p = 0.000). Conclusion. XPEs lead to a similar inflammatory reaction in vivo compared to conventional polyethylenes. The high TNF- expression in the articular cartilage (groups XPE 1 and 2) might be explained by the localisation of the wear particles in the joint space in direct contact with the chondrocytes. Long-term studies are necessary to analyse the effects of different wear particle distributions in the joint surrounding tissue after knee and hip replacement. Furthermore it has to be investigated, whether their distribution in the joint space or their transport into the bone marrow is responsible for the level of the chronic inflammatory reaction

INTRODUCTION. One of the recent advances in the hard-on-hard hip arthroplasty is the development of a new material of diffusion hardened oxidised zirconium (DHOxZr). The DHOxZr material consists of a ceramic layer on the top surface which is supported by a thick oxygen diffusion hardened (DH) zone underneath. With the desired properties of metal substrate, ceramic surface and a gradient structure of the oxygen diffusion zone, the DHOxZr-on-DHOxZr bearing combination is expected to produce low wear and minimal metal ions. This can possibly address the concerns associated with metal hypersensitivity associated with metal on metal bearings and fracture risk associated with ceramics. The aim of this study was to evaluate the wear of DHOxZr-on-DHOxZr as a possible hard on hard bearing combination in hips. METHODS. Three pairs of 50 mm DHOxZr prototype hip joint devices, each consisting of a DHOxZr modular head and a DHOxZr liner were wear tested in a ProSim hip joint simulator under standard testing conditions used by the Implant Development Centre (IDC), Smith & Nephew, Leamington Spa for 5 million cycles (Mc). The flexion/extension was 30° and 15°. The internal/external rotation was ± 10°. The force was Paul-type stance phase loading, with a maximum load of 3 kN and a standard ISO swing phase load of 0.3 kN. The test frequency was 1 Hz. Gravimetric analysis was carried out at 0, 0.5, 1, 2, 3, 4 & 5 million cycles. The lubricant was new born calf serum with 2 g/l sodium azide concentration diluted with de-ionised water to achieve average protein concentration of 20 g/l. Lubricant was changed every 0.25Mc during the first million cycles of the test and at every 0.33 Mc from 1 to 5Mc. RESULTS. A biphasic wear pattern was observed for the DHOxZr on DHOxZr devices during the test, with a running in phase from 0–1 Mc and a steady state phase from 1–5 Mc. At a confidence level of 95%, the mean wear rate was 0.21 ±0.06 mm3/Mc during the running-in stage, and the wear rate was reduced to 0.01 ±0.03 mm3/Mc during the steady state for the device tested. The wear volume loss of the DHOxZr on DHOxZr devices was significantly lower than that generated by CoCrMo metal on metal (MoM) devices (p < 0.05) under identical simulator test conditions

The prevalent cause of implant failure after total joint replacement is aseptic loosening caused by wear debris. Improvement of the wear behaviour of the articulating bearing between the cup and femoral head is essential for increased survival rate of artificial hip joints. Cross-linking of the polyethylene (PE) material is one attempt to reduce wear particle release at the articulating surface. Various cross-linked polyethylenes (X-PE) are used in orthopaedics since several years. In total hip arthroplasty (THA) the use of larger femoral head sizes has specific reasons. Larger heads lead to a decreased risk of total hip dislocation and impingement as well as an improved range of motion in comparison to smaller head sizes like 28mm or less. However, the increasing diameter of femoral head can be associated with lower thickness of the PE liner and increased wear rate. Cross-linking of PE can improve the wear rate of the liner and hence supports the use of larger femoral heads. The aim of this experimental study was to evaluate the wear of standard vs. sequential X-PE (X3-PE) liner in combination with different ceramic femoral head sizes. Wear testing was performed for 5 million load cycles using standard UHMW-PE liners (N2Vac) and X3-PE liners (each Stryker GmbH & Co. KG, Duisburg, Germany) combined with 28mm ceramic ball heads and the Trident PSL acetabular cup (Stryker). Furthermore, X3-PE liners with an internal diameter of 36mm and 44mm and decreased wall thickness (5.9mm and 3.8mm) were combined with corresponding ceramic heads. An eight station hip wear simulator according to ISO 14242 (EndoLab GmbH, Rosenheim, Germany) was used to carry out the standard wear tests. The tests were realised in temperature-controlled chambers at 37°C containing calf serum (protein content 20g/l). The average gravimetrical wear rates of the standard UHMW-PE (N2Vac) liners combined with 28mm ceramic heads amounted to 12.6 ± 0.8mg/million cycles. Wear of X3-PE liners in combination with 28 mm ceramic heads was not detectable. The average gravimetrical wear rates of the X3-PE liners in combination with 36mm and 44mm ceramic heads amounted to 2.0 ± 0.5mg and 3.1 ± 0.3mg/million cycles, respectively. The purpose of this study was to evaluate the effect of femoral head size at THA on standard and sequential X-PE liner. The wear simulator tests showed that the wear rate of PE liners with small heads (28mm) decreased by cross-linking of the PE significantly. The amount of wear at X-PE increased slightly with larger head size (36mm and 44mm). However, by sequential cross-linking, the wear rate using thinner liners and larger femoral heads is reduced to a fractional amount of wear at conventional UHMW-PE. Hence, the above-mentioned advantages of larger femoral head diameters can be realised by improved wear behaviour of sequential X-PE

The Low Contact Stress (LCS) mobile-bearing total knee replacement (TKR) was designed to minimize polyethylene wear, aseptic loosening and osteolysis. However, registry data suggests there is a significantly greater revision rate associated with the LCS TKR. The primary aim of this study was to assess long-term survivorship of the LCS implant. Secondary aims were to assess survival according to mechanism of failure and identify predictors of revision. We retrospectively identified 1091 LCS TKRs that were performed between 1993 and 2006. There was incomplete data available 33 who were excluded. The mean age of the cohort was 69 (SD 9.2) years and there were 577 TKRs performed in females and 481 in males. Mean follow up was 14 years (SD 4.3). There were 59 revisions during the study period: 14 for infection, 18 for instability, and 27 for polyethylene wear. 392 patients died during follow up. All cause survival at 10-year was 95% (95%CI 91.7–98.3) and at 15-year was 93% (95%CI 88.6–97.8). Survival at 10-years according to mechanism of failure was: infection 99% (95%CI 94–100%), instability 98% (95%CI 94–100%), and polyethylene wear 98% (95%CI92–100). Of the 27 with polyethylene wear only 19 had associated osteolysis requiring component revision, the other 8 had simple polyethylene exchanges. Cox regression analysis, adjusting for confounding variables, identified younger age was the only predictor of revision (hazard ratio 0.96, 95%CI 0.94–0.99, p=0.003). The LCS TKR demonstrates excellent long-term survivorship with a low rate of revision for osteolysis, however the risk is increased in younger patients

INTRODUCTION. Femoral neck narrowing (NN) following Metal-on-Metal Hip Resurfacing Arthroplasty (MoMHRA) is a well-recognised clinical phenomenon. The incidence of resurfaced hips with NN > 10% is reported to be up to 27%. Its pathogenesis is thought to be multi-factorial secondary to stress shielding, impingement, osteolysis secondary to wear/ion particles and as a result of reduced vascularity and pressure effect on cancellous bone secondary to the presence of a soft-tissue mass around the resurfaced hip. Recognised risk factors for its development include: female gender and the presence of a pseudotumour. Serum Chromium (Cr) and Cobalt (Co) are recognised surrogate markers of in-vivo wear of MoMHRA. The aims of this study were to establish whether NN is associated with increased wear. METHODS. A cohort of 214 patients with unilateral MoMHRA (139M: 75F) was included in this study. Primary osteoarthritis was the diagnosis leading to surgery for the majority of patients (208). The average age at surgery was 54.1 years old (13–73). Six different implants were used; BHR (116), Conserve plus (92), Recap (2), ASR (2), Adept (1) and Cormet (1). The average femoral component size was 49.2mm (range: 38–59). The average follow up was 4.3 years (range: 2–10). Patients were subdivided into 3 groups as per implant size. Small size component group had implants <45mm, average size group had components 45–51mm and large component size group had components >51mm. All patients had Prosthesis-Junction-Ratio (PJR) measured from postoperative (PJRpost) and at latest follow up (PJRfollow) radiographs. Measurements were made using the method described by Lilikakis1. Metal ion levels (Cr/Co) were measured at last follow-up for all patients. Cr level >5.1g/ml and Co levels >4.4 g/ml were considered high2 and patients with such levels formed the high ion group. RESULTS. For the whole cohort, mean NN was 3.2% (range: 0–32%, SD:4.3). Females (4.7%, range: 0–32%, SD: 5.8) had significantly greater NN than males (2.4%, range: 0–23%, SD: 2.9) (p=0.001). Patients in the large component group had less NN (2.1%, SD: 2.3) in comparison to the average (3.2%, SD: 3.7%) (p=0.046) and the small (5.9%, SD: 7.9) (p=0.007) component size groups. There was no difference in NN between small and average sized components (p=0.1). Patients in the high ion group (25 patients) had significantly greater NN than patients with low ions (10.1%, range: 1%–32%, SD: 8.3 Vs 2.3%, range: 0–11, SD 2.3) (p<0.0001). NN >10% was seen in 16 hips (7.5%). The odds ratio of having high ions if NN >10% was 125 (p<0.001). DISCUSSION. The findings of this study showed that greater NN occurs in females and patients with small components and in patients with high ions. Furthermore, hips with NN >10% should be investigated further as they are more likely to have increased wear

INTRODUCTION. Although simulation studies have shown superior wear properties of metal-on-metal articulations, increased concern exists regarding the excess in-vivo wear of a small number of Metal-on-Metal-Hip-Resurfacing (MoMHRA) implants. Serum ion levels of Chromium (Cr) and Cobalt (Co) are surrogate markers of wear. Risk factors associated with increased wear include female gender, small components, dysplasia, cup orientation outside safe zone and femoral head downsize during surgery with an associated decrease in Head-Neck-Ratio (HNR). However, these factors are interlinked. This study aims to identify the factors that are most important for subsequent wear of MoMHRA, by performing a multivariate analysis. METHODS. 206 patients (124M: 82F) with unilateral MoMHRA were included in this study. The average follow up was 3.3 years. All patients had Cr/Co levels measured at follow up. Inclination and anteversion of each cup were measured using EBRA. Cups were analysed as being within or outside the previously defined optimum-zone. HNR measurements were made from pre-operative (HNRpre) and post-operative (HNRpost) radiographs. The immediate changes in HNR (downsize/upsize of femoral head) as a result of the operation were expressed as:. HNRprepost=HNRpost–HNRpre. Multivariate linear regression modelling was used to explore the association between measures of ions with the following predictor variables (gender, age, diagnosis, femoral component size, orientation of the acetabular component, head/neck ratio and position of femoral stem). Analyses were carried out separately for each outcome (Cr and Co). Classification and Regression Tree (CART) models were fitted as a complimentary approach to regression modelling. RESULTS. Articular surface downsize followed by cup orientation within/outside optimum zone, followed by cup anteversion followed by gender were the strongest predictors of ion levels. A percentage decrease in HNRartpost, predicted an increase in Cr ion level by 5% (and 6% for Co). If the cup was within the optimum zone this was associated with decreased levels of Cr and Co ions. As acetabular component anteversion increased, levels of ions increased. Gender had a strong effect on ion levels. Adjusting for other variables, the effect of gender was attenuated due to a confounding effect of component size and the amount of femoral head downsize. Predictors identified as important in regression analyses were similar to those produced in the CART model, where the highest levels of ions were seen in patients with a percentage decrease in pre-operative HNR −11.3. DISCUSSION. This analysis shows that (surgical) factors, such as amount of femoral head downsize at operation and whether the cup was orientated within the optimum zone, explained the majority of the variability in ion levels in MoMHRA

Introduction. Total hip replacements using highly cross-linked polyethylene show excellent clinical outcomes, low wear, and minimal lysis at 5 years follow-up. A recent RSA study reports a significant increase in femoral head penetration between 5 and 7 years. This study is a multi-center radiographic analysis to determine whether the RSA observation is present in a large patient cohort. Methods. Six centers were enrolled for radiographic analysis of primary total hip arthroplasty for standard head sizes (26mm, 28mm, or 32mm). Radiographic inclusion criteria required a minimum of four films per patient at the following time points: 1 year; 2–4.5 years; 4.5–5.5 years; and 5.5–11 years. The Martell Hip Analysis Suite was used to analyze pelvic radiographs resulting in head penetration values. Wear rates were determined in two ways: the longest follow-up radiograph compared to the 1 year film, and individual linear regressions for the early and late periods. For both methods, average wear rates from the early period (1 to 5.5 years) and late period (>5.5 years) were compared using t-tests. Results. We present the completed analysis of 235 of the 250 hips under active analysis with 3160 film comparisons. Average follow-up was 7.2±0.99 years (range 5.4–10.1). Based on latest follow-up, the average wear rate was not significantly different during the early and late periods (10.1±95μm/year and −3.8±235μm/year respectively, p=0.518). Based on the group regression, the average wear rate was not significantly different during the early and late periods (7.5μm/year and −36μm/year respectively, p=0.13). Conclusion. In this large multicenter radiographic study, we found no late increase in femoral head penetration into highly cross-linked polyethylene as suggested by the RSA report. Additional centers and patients are being recruited in order to reduce the variation in the late period

Due to increased life expectancy of human population, the amount of total knee replacements (TKR) is expected to increase. TKR reached a high grade of quality and safety, but most often it fail because of aseptic implant loosening caused by polyethylene (PE) wear debris. Wear is generated at the articulating surfaces, e.g. caused by three body particles, like bone fragments or bone cement particles. The aim of this experimental study was to compare the wear of tibial PE inserts combined with metallic and ceramic femoral components at three body wear situation induced by polymethylmethacrylate (PMMA) and zirconia (ZrO2) particles from the bone cement. Wear testing was performed for 5 Mio load cycles, using tibial standard PE inserts combined with the same CR femoral component, in two different materials, Cobalt Chromium (CoCrMo) and Biolox delta ® ceramic (Multigen Plus Knee System, Lima Corporate, Italy). A knee wear simulator, according to ISO 14243 (EndoLab GmbH, Rosenheim, Germany), was used to carry out the tests. The tests were performed in temperature-controlled test chambers at 37 °C, containing calf serum with a protein content of 30 g/l. Polymethylmethacrylate (PMMA) and zirconia (ZrO2) bone cement particles (Palacos R ®) were manufactured to a size of 30 μm. The three body particles were added at all stations onto the articulating surface of the tibial PE insert (7mg per condyle) at every 500,000 cycles. Wear was determined gravimetrically and the surfaces of tibial inserts were analysed by scanning electron microscope (SEM) after finishing the 5 million cycles. Furthermore, roughness of the PE insert surfaces and the articulating surfaces of the different femoral components were detected and the PE wear particles were analysed by SEM. The average gravimetrical wear rates of the tibial PE inserts in combination with CoCr and Biolox delta ® ceramic femoral components amounted to 6.4 ± 0.9 mg and 2.6 ± 0.4 mg per million cycles, respectively. Beside bone cement particles on the articulating surface of the PE inserts, polished surfaces and scratches were detected by SEM. In comparison to the untreated surfaces of the PE inserts at both material pairings the surface roughness at the articulating areas showed deep scratches and polished regions. Analyses of the metallic femoral components showed scratches at the articulating surfaces, none on ceramics. The present study pointed out the effect of femoral component material in an abrasive three body wear situation on the wear properties of TKR. The wear simulator tests showed that wear of PE inserts under three body wear conditions, in combination with ceramic femoral components, was significantly lower than with metallic femoral components. With regard to anti-allergic properties, ceramic femoral components are promising products for TKR

Introduction. Large wear rate reductions have been shown for crosslinked PE in simulators and short- to mid-term clinical wear studies. However, concerns persist about long-term in-vivo oxidation (especially with annealed PE), late accelerating wear and the possibly higher osteolytic potential of crosslinked PE particle debris. This is the first long-term study comparing conventional to crosslinked PE investigating whether the wear reduction is maintained in the long-term and if reduced osteolysis becomes evident. Materials & Methods. In a prospective study 48 primary THA patients (Stryker ABG-II, 28mm CoCr heads) were randomized to either receive a first generation crosslinked PE (Stryker Duration: 3MRad gamma irradiation in N2, annealed) or then conventional, now “historic” PE (3MRad gamma irradiation in air). Both groups were statistically non-different (p>0.1) regarding age (63.9 years), gender, BMI, stem and cup size, cup inclination, liner thickness or pre- and post-op HHS leaving the insert material as the only variable. Patients were followed-up annually using the Harris Hip score, AP and lateral radiographs and digital wear measurements using Roman V1.70 [1, 2]. Wear and radiographic signs of osteolysis were analysed at a mean follow-up of 12.9 years (12.0–13.3). Groups were compared using the t-test (means) or the Fisher Exact test (proportions). Results. Thirty-one patients (18 conventional, 13 Duration) were left for analysis (8 deaths, 9 lost to FU). At 13yrs the total linear head penetration was sign. lower with Duration (0.70 ±0.36mm, range: 0.3–1.2mm) than conventional PE (1.56 ±0.83, range: 0.4–3.3mm, p=0.015). Also the annual wear rate was sign. lower (p=0.005) for Duration (0.063 ±0.027mm/yr) than conventional PE (0.122 ±0.065mm/yr). This reduction (−48%) compared well to the original simulator prediction (−45%) and even increased with time (−30% at 5yrs, −38% at 8yrs, −42% at 10yrs). In the Duration group only 1 patient had a wear rate >0.1mm/yr (osteolysis threshold) compared to 10 in the Conventional group (p=0.007). Patients with radiographic signs of acetabular osteolysis (cysts) on the AP x-ray were less frequent in the Duration (4/13=31%) than in conventional group (13/18=72%, p=0.023). This difference became even more pronounced when also the lateral view was evaluated and the affected DeLee-Charnley zones were counted (7 vs 22, p=0.017). Only in the conventional group a revision was performed (cup for wear). Discussion & Conclusions. At long-term FU the absolute wear rate of Duration crosslinked PE did not increase but decrease and the wear relative reduction did not deteriorate but increased. The incidence of osteolysis was sign. less. Thus No clinical evidence of degradation or elevated osteolytic potential for this annealed first generation crosslinked PE debris was found

INTRODUCTION. Cementless Total Hip Replacement surgery is a well established procedure for relative young patients with severe hip disease. Excellent long term clinical results have been published on the performance of the femoral component. With growing clinical experience, our concern focused on excessive wear of the Ultra High Molecular Weight Polyethylene (UHMWPE) ringloc liner of the Mallory Head cementless Total Hip Prosthesis. After its introduction in our clinic in 1997, this implant is still in use without any modification. We were concerned that due to premature liner wear, the performance of this implant would not be compliant with the international guideline on implant survival (NICE guidelines: at 10 year follow up, 90% of all implants should still be in situ). Our objective was to establish the amount of liner wear in our first 200 MH implants. METHODS. Our first 200 patients consecutively treated with Mallory Head prostheses were followed up to obtain a recent digital image. Follow up was complete for 181 (90.5%) of our 200 patients. Ten had died and nine were not able or willing to come for follow up. The mean duration of follow up was 8.3 years (range: 8–13). The 181 recent digital images were classified as either excessive wear or no excessive wear by two independent orthopedic surgeons. Next, liner wear was measured in the 2D frontal plane using PolyWare Pro/3D Digital Version Rev 5.1 software (Draftware Developers, Conway, USA). A threshold for excessive liner wear was set at 0.2mm/year, according to literature. RESULTS. Using software for measuring PE wear, 46.7% of all patients had excessive UHMWPE wear (> 0.2mm/yr). There was no relation between the amount of wear and BMI, gender, component size or the acetabular inclination angle. Thirteen patients (6.5%) were revised. Nine of these revisions were for excessive liner wear or aseptic loosening (4.5%). For now, our series of cementless Mallory Head prostheses is compliant with the NICE guideline on implant survival. However, with the measured amount of wear we expect to see a significant increase in the number of revisions for liner wear in the near future. DISCUSSION. Our clinical observation of premature UHMWPE wear proved correct. The measured amount of UHMWPE wear is consistent with the few other studies published on this subject. Although we present a retrospective study, limiting the strength of our results, we have included a large group of patients with acceptable loss to follow up. It is unclear if the observed wear will lead to a sharp increase in the number of revisions within the next few years. Possibly, future revisions will be complicated by loss of acetabular bone stock following the pathofysiological reaction to wear particles. Our results can probably be generalised for any district hospital

Introduction. Minimally invasive implanted unicompartmental knee arthroplasty (UKA) leads to excellent functional results. Due to the reduced intraoperative visibility it is difficult to remove extruded bone cement particles, as well as bone particles generated through the sawing. These loose third body particles are frequently found in minimally invasive implanted UKA. The aim of this study was to analyse the influence of bone and cement particles on the wear rate of unicompartmental knee prostheses in vitro. Material & Methods. Fixed- bearing unicompartmental knee prostheses (n = 3; Univation F®, Aesculap, Tuttlingen) were tested with a customized four-station servo-hydraulic knee wear simulator (EndoLab GmbH, Thansau, Germany) reproducing exactly the walking cycle as specified in ISO 14243-1:2002. After 5.0 million cycles crushed cortical bone chips were added to the test fluid for 1.5 million cycles to simulate bone particles, followed by 1.5 million cycles blended with PMMA- particles (concentration of the third-body particles: 5g/l; particle diameter: 0.5- 0.7 mm). Every 500 000 cycles the volumetric wear rate was measured (ISO 14243-2) and the knee kinematics were recorded. For the interpretation of the test results we considered four different phases: breaking in- (during the first 2.0 million cycles), the steady state- (from 2.0 million to 5 million cycles), bone particle- and cement particle phase. Finally, a statistical analysis was carried out to verify the normal distribution (Kolmogorov-Smirnov test), followed by direct comparisons to differentiate the volumetric wear amount between the gliding surfaces (paired Student's t-test, p<0.05). Results. The wear rate was 12.5±0.99 mm. 3. /mio. cycles in the breaking-in phase and decreased during the steady state phase to 4.4±0.91 mm. 3. /mio cycles (not significant, p = 0,3). The bone particles did not have any influence on the wear rate (3.0±1.27 mm. 3. /mio cycles; p = 0,83) compared to the steady state phase. The cement particles, however, lead to a significantly higher wear rate compared to the steady state phase (25.0±16.93 mm. 3. /mio cycles; p<0.05). Discussion. To our knowledge this is the first study demonstrating that free cement debris which can be found after minimally invasive implanted UKA increases significantly the wear- rate. Bone particles generated for instance through sawing during implantation, however, had no influence on the prostheses wear rate. Our Data suggests, that it is extremely important to remove all the extruded cement debris accurately during implantation in order to avoid a higher wear rate which could result in an early loosening of the prostheses