Fretting corrosion of taper junctions is long known and of great concern, because of metal ion and particle release and their related adverse local and systemic effects on the human body (1–3). Orthopedic taper junctions are often comprised of CoCr29Mo6/TiAl6V4 pairings. Beside others the imprinting of the TiAlV-machining marks into the CoCrMo-taper is of clinical interest (4, 5). Thus, the multifactorial details and their interdependencies on the macro-, micro, and nanoscale are still a matter of research (6). This contribution presents the mechanisms of imprinting found in an in-vitro fretting corrosion test. The worn surfaces, the lubricant as well as its remains were analyzed after test and the findings brought into relation to the characteristic wear sub-mechanisms. The fretting tests were conducted by means of a cylinder-on-pin set-up. All details about the test and the sequence of analyses can be found in (7, 8). A marked tribofilm of C-rich organic matter and oxidized wear particles of both bodies was generated at the TiAlV/CoCrMo contact area (Figure 1a, c). After removing the tribofilm chemically, extremely fine scratches of sub-µm depth became visible on the CoCrMo body (Figure 1b). The TiAlV body showed shallow shelves leaving troughs filled with grainy debris (Figure 1d) mainly of Ti-oxide wear particles. The shelves stick to the surfaces and, therefore, move relatively to the counterbody. In combination with the grainy debris this brings about “Microploughing” on the CoCrMo surfaces. Microploughing is known for destroying any passive film resulting in “Tribocorrosion”. The question remains how the shelves are formed. From the surface analyses one could conclude that they point towards “Delamination”. But this would also mean that they would not stick rigidly to the surfaces but be ejected from the contact area. Focused Ion Beam (FIB) cuts were done in order to investigate the near- and subsurface structure of the shelves in order to clarify the governing mechanisms (Figure 2). Below the platinum protection layer appears a laminated structure of highly deformed nanocrystalline and amorphous areas. EDS confirmed that the lighter intermediate layers consist mainly of Ti-oxide. This microstructure is supposedly formed by severe plastic deformation and the generation of shear bands, which under fretting pile up on top of each other. This cannot be connected to “Delamination”. We therefore propose to categorize the formation mechanism of these shelves as a specific form of microploughing. Thus, imprinting is neither driven by any galvanic effects (9) nor by hardness differences of TiO. 2. and Cr. 2. O. 3. (10) but by microploughing on the TiAlV-body leading to tribocorrosion at specific sites of CoCrMo what imprints the surface grooves of the softer TiAlV into the harder CoCrMo. For any figures or tables, please contact the authors directly

With its high wear and corrosion resistance, CoCrMo alloy has been widely used for metal-on-metal total hip replacements (THRs). However, the use of the metal-on-metal implants has dropped substantially as a result of several alerts issued by the Medicines and Healthcare products Regulatory Agency (MHRA) due to concern on metal ion release [1]. However, some of the first generation of metal-on-metal THRs have lasted for more than 20 years [2]. It is far from clear why some MoM joints have survived, while other failed. It is known that dynamic changes occur at the metal surface during articulation. For example, a nanocrystalline layer has been reported on the topmost surface of both in vivo and in vitro CoCrMo THRs [3, 4] but it is not known whether this layer is beneficial or detrimental. The current work focuses on the sub-surface damage evolution of explanted MoM hips, which is compared to in vitro tested CoCrMo hip prostheses. Site-specific TEM cross-section of both in vivo and in vitro CoCrMo samples were prepared by focused ion beam (FIB) in situ lift-out method (Quanta 200 3D with Omniprobe, FEI, the Netherlands). TEM of the FIB specimens was performed on various microscopes. Routine bright field imaging was performed on a Tecnai 20 (FEI, the Netherland) operating at 200 kV, while high resolution transmission electron microscopy (HRTEM) of the nanocrystalline layer and other surface species was undertaken on a Jeol 2010F (Jeol, Japan) operating at 200 kV. A nanocrystalline layer (which was not present on the starting surfaces) was observed on both explanted in vivo and in vitro tested materials. For the explanted joints, the nanocrystalline layer was thin (a few 100 nm) and the extent did not appear to correlate with the local wear rate. For in vitro samples, the nanocrystalline layer was thicker (up to micron). HRTEM from this layer are shown in Fig. 1 and Fig. 2. The nanocrystallite size was ∼5 nm and appeared to be a mixture of face centred cubic and hexagonal close packed phases. The formation of the nanocrystalline layer and its correlation with wear behaviour are discussed

Recently, our lab has made observations of metal damage patterns from retrieval studies that appeared to be cellular in nature [1]. This type of damage presented on about 74% of the retrieved implants and was attributed to inflammatory cells (termed ICI corrosion) [1]. An alternate hypothesis arose surrounding the use of electrosurgery in total joint arthroplasty (TJA). In TJA, where surgery occurs around metallic devices, the interactions of the high voltage, high frequency current created by an electrosurgical generator and the implant need to be better understood. In order to explore the effects electrosurgical currents have on metal implants, the interaction of a model system of highly polished metal disks and a standard electrosurgical generator (ConMed, Utica, NY) was evaluated in various modes and power settings. The disks were made of CoCrMo or Ti-6Al-4V alloys and were polished to a mirror finish for use and placed directly on the return electrode pad used in patients. Both coagulation and cut modes were evaluated, as well as both monopolar and bipolar configurations in wet and dry conditions using a blade-shaped tip. In wet cases, the disks were wet with phosphate buffered saline prior to the test to simulate body fluids in contact with the implant during current application. In all cases, surface damage was generated on both surfaces and was readily observed as a direct result of the current interacting with the metal (Fig. 1 and 2). Direct contact with the metal, regardless of a dry or wet surface, resulted in pitting and oxide buildup at the contact area. Non-contact activation in proximity to the surface or contact with fluid on the surface caused arcing and created damage that was more widespread over the area of fluid contact with the surface. The damage patterns created on the wetted surface by the electrosurgical unit looked very similar to the patterns we previously attributed to inflammatory cells. More specifically, it produced circular, ruffled areas with centralized pits and occasionally presented trail- and weld-like features (Fig. 2). While these results show that some of the damage previously reported to be from ICI corrosion is indeed the result of electrosurgery, there are still cases in retrievals that cannot be explained by this process and the corrosion reaction to alloys exposed to ROS-based molecules demonstrate significant acceleration of corrosion. Thus, ICI corrosion is still a viable hypothesis. Surgeons utilizing electrosurgical systems in proximity to metallic orthopedic implants need to exercise caution as the discharge of electrical energy through these implants can induce localized surface damage and may result in other adverse effects to the metal implants. Ultimately, we would like to update the community on the nature of the damage we previously reported and more importantly bring to light the possibility of surgeon-induced damage to the implant as a result of electrosurgical methods

In total hip arthroplasty (THA), aseptic loosening induced by polyethylene (PE) wear debris is the most important cause that limits the longevity of implants. Abrasive wear generated through the mechanism such that micrometer-roughened regions and small asperities on the metallic femoral heads surface locally plow through the PE cup surface. Abrasive wear results in the PE material being removed from the track traced by the asperity during the motion of the metallic femoral heads surface. For the purpose of reducing wear, alumina ceramics was introduced in Europe and Japan in 1970s. The clinical results of ceramic-on-PE bearings regarding the wear resistance have been superior to that of the metal-on-PE bearings. Compared with Co–Cr–Mo alloys, alumina ceramics is advantageous for precision machining because of its higher hardness, enable to form spherical and smooth surface. The fracture resistance of the alumina ceramics itself is related to grain size; the grain size reduction leads to the improvement of its resistance. In this study, we evaluated the roundness and the roughness of retrieved two distinct alumina ceramics having different grain size, and Co–Cr–Mo alloy heads.

Fourteen retrieved alumina ceramic femoral heads; ten heads with a diameter of 28 mm made of small grain size alumina (SG-alumina; mean grain size is 3.4 μm) with clinical use for 16–28 years and four heads with a diameter of 26 mm made of extra-small grain size alumina (XSG-alumina; mean grain size is 1.3 μm) with clinical use for 14–19 years, were examined. Six retrieved Co–Cr–Mo alloy femoral heads with a diameter of from 22 to 32 mm with average clinical use for 12–28 years were examined.

SG-alumina and XSG-alumina heads showed significantly lower roundness compared with Co–Cr–Mo alloy heads, due to higher precision machining [Fig. 1]. The surface roughness for the contact area of the heads increased in order of XSG-alumina, SG-alumina and Co–Cr–Mo alloy. The surface roughness of the non-contact area for all kinds of heads was lower than that for the contact area [Fig. 2]. Surface profiles of the SG-alumina and XSG-alumina showed the reentrant surface while Co–Cr–Mo alloy heads showed the protrusion surface. The roundness and roughness of the Co–Cr–Mo alloy or ceramic surface and the presence or absence of hard third-body particles correlate to the amount of abrasive PE wear. When the third-body was entrapped during the clinical use, a reentrant surface might be formed on the ceramic while protrusion surface formed on the Co–Cr–Mo alloy. The differences in clinical results may be due in part to the influence of third-body particles. The ceramic becomes more resistant than Co–Cr–Mo alloy against the scratching by the entrapped abrasive contaminants because of its harder surface. From the good clinical results of more than 20 years using SG-alumina, the greater long term clinical results using XSG-alumina will be expected.

The effect of an advanced porous surface morphology on the mechanical performance of an uncemented femoral knee prosthesis was investigated. Eighteen implants were inserted and then pushed-off from nine paired femurs (Left legs: advanced surface coating; right legs: Porocoat® surface coating as baseline). Bone mineral density (BMD) and anteroposterior dimension were measured, which both were not significantly different between groups. The insertion force was not significantly different, but push-off force was significantly higher in the advanced surface coating group (P = 0.007). BMD had direct relationship with the insertion force and push-off force (p < 0.001). The effect of surface morphology on implant alignment was very small. We suggest that the surface properties create a higher frictional resistance thereby providing a better inherent stability of implants featuring the advanced surface coating.

Little is known about the relationship between head-neck corrosion and its effect on the periprosthetic tissues and distant organs of patients hosting well-functioning devices. The purpose of this study was to investigate in postmortem retrieved specimens the degree and type of taper damage, and the corresponding histologic responses in periprosthetic tissues and distant organs. Fifty postmortem THRs (34 primaries, 16 revisions) retrieved after 0.5 to 26 years were analyzed. Forty-three implants had a CoCrMo stem and seven had a Ti6Al4V stem. All heads were CoCrMo and articulated against polyethylene cups (19 XLPE, 31 UHMWPE). H&E sections of joint pseudocapsules, liver, spleen, kidneys and lymph nodes were graded 1–4 for the intensity of various inflammatory cell infiltrates and tissue characteristics. Corrosion damage of the taper surfaces was assessed using visual scoring and quantitated with an optical coordinate measuring machine. SEM analysis was used to determine the acting corrosion mode. Polyethylene wear was assessed optically. The majority of tapers had minimal to mild damage characterized by local plastic deformation of machining line peaks. Imprinting of the stem topography onto the head taper surface was observed in 18 cases. Column damage on the head taper surface occurred in three cases. All taper surfaces scored moderate or severe exhibited local damage features of fretting and/or pitting corrosion. Moderate or severe corrosion of the head and/or trunnion was present in nine hips. In one asymptomatic patient with bilateral hips, lymphocyte-dominated tissue reactions involving perivascular infiltrates of lymphocytes and plasmacytes were observed. In this patient, mild, focal lymphocytic infiltrates were also present in the liver and kidneys, and there was focal histiocytosis and necrosis of the para-aortic lymph nodes. These two implants, which had been in place for 58.6 and 60.1 months, had severe intergranular corrosion of the CoCrMo trunnion, and column damage and imprinting on the head taper. In the other 41 hips, macrophage responses in the joint pseudocapsule to metallic and/or polyethylene wear particles ranged widely from minimal to marked. Focal necrosis in the pseudocapsules of 12 arthroplasties was related to high concentrations of CoCrMo, TiAl4V, TiO, BaSO4 and polyethylene wear particles. High concentrations of these particles were also detected in para-aortic lymph nodes. Rare to mild macrophages were observed in liver and spleen. This is a comprehensive study of wear and corrosion within well-functioning postmortem retrieved THRs, and the resulting local and distant tissue reactions. One of eight patients with moderate or severe corrosion did have a subclinical inflammatory response dominated by lymphocytes after five years. To what extent such an inflammatory process might progress to become symptomatic is not known. Ionic and particulate products generated by corrosion disseminated systemically. The minor lymphocytic infiltrate in the liver and kidneys of one subject with bilateral severely corroded head-neck junctions might suggest possible metal toxicity. The diagnosis of adverse tissue reactions to corrosion of modular junctions can be challenging. Postmortem retrieval studies add to our understanding of the nature and progression of lymphocyte-dominated adverse local and potentially systemic tissue reactions to corrosion of modular junctions

Introduction. Little is known about the relationship between head-neck corrosion and its effect on periprosthetic tissues and distant organs in the majority of patients hosting apparently well-functioning devices. We studied the degree and type of taper damage and the histopathologic response in periprosthetic tissue and distant organs. Methods. A total of 50 contemporary THRs (34 primary, 16 revision) retrieved postmortem from 40 patients after 0.4–26 years were studied. Forty-three femoral stems were CoCrMo and 7 were Ti6Al4V. In every case, a CoCrMo-alloy head articulated against a cementless polyethylene cup (19 XLPE and 31 UHMWPE). H&E and IHC sections of the joint pseudocapsules and liver were graded 1–4 for the intensity of various inflammatory cell infiltrates and tissue necrosis. The nature of the tissue response in the joint capsule, liver, spleen, kidneys and lymph nodes was assessed. Wear and corrosion products in the tissues were identified using SEM and EDS. Taper surfaces were graded for corrosion damage using modified Goldberg scoring and examined by SEM to determine the acting corrosion mode. Correlations between damage scores and the histologic variables were generated using the Spearman test. Results. No correlation was seen between taper damage scores and the macrophage response in the joint pseudocapsule. The distribution of corrosion scores for heads and femoral trunnions is shown in Figure 1. Moderate or severe corrosion of the head and/or trunnion was present in 9 hips (8 CoCr/CoCr and 1 CoCr/TiAlV). One patient with bilateral hips had local ALVAL-like lymphocyte-dominated tissue reactions (Figure 2) and mild focal lymphocytic infiltrates in the liver and kidneys (Figure 3). This was associated with severe intergranular corrosion of the CoCrMo trunnion and column damage on the head taper. Particle-laden macrophages in pseudocapsules were significantly correlated with liver macrophages (r=.382, p=0.012) and liver lymphocytes (r=.367, p=0.013). Pseudocapsule macrophage responses to metallic and/or polyethylene wear particles ranged widely from minimal to marked. Focal tissue necrosis was related to high concentrations of particulate wear debris. A minimal number of metallic particle-laden macrophages were also detected in the liver and spleen; and macrophage granulomas were present in para-aortic lymph nodes, especially in revision cases. DISCUSSION. The generation of metal ions and particulates at corroded CoCrMo heads and CoCrMo or Ti6Al4V trunnions was a significant contributor to the presence of perivascular lymphocytes within the joint pseudocapsule, with 1 patient showing a histologic pattern consistent with ALVAL. Patient factors and the rate of corrosion are among variables influencing whether an ALVAL-type reaction will develop and whether or not it will become symptomatic. Macrophages in the joint pseudocapsules were positively correlated with inflammatory cells in the liver. In this study, the intensity of inflammatory infiltrates in distant organs was mild. However, several cases of organ dysfunction have been reported in association with catastrophic wear of CoCrMo components. It continues to be essential to minimize the generation of metal ions and particulates and to improve strategies for identifying and managing patients exposed to high levels of degradation products. For any figures or tables, please contact the authors directly

Introduction. There is interest in minimally invasive solutions that reduce osteoarthritic symptoms and restore joint mobility in the early stages of cartilage degeneration or damage. The aim of the present study was to evaluate the Biolox®delta alumina-zirconia composite as a counterface for articulation against live cartilage in comparison to the clinically relevant CoCrMo alloy using a highly controlled in vitro ball-on-flat articulation bioreactor that has been shown to rank materials in accord with clinical experience. Methods. The four-station bioreactor was housed in an incubator. The dual axis concept of this simulator approximates the rolling-gliding kinematics of the joint. Twelve 32 mm alumina-zirconia composite femoral heads (Biolox®delta, CeramTec GmbH, Germany) and twelve 32 mm CoCrMo femoral heads (Peter Brehm GmbH, Germany) made up the testing groups. Each head articulated against a cartilage disk of 14 mm diam., harvested from six months old steers. Free-swelling control disks were obtained as well. Testing was conducted in Mini ITS medium for three hours daily over 10 days applying a load of 40 N (∼2 MPa). PG/GAG was determined using the dimethylmethylene blue (DMMB) assay. Hydroxyproline was analyzed by high performance liquid chromatography coupled to a mass spectrometer. Additionally, at test conclusion, chondrocyte survival was determined using Live/Dead assay. Histological analysis was performed using a modified Mankin score. The effect of articulating material (ceramic, CoCrMo) on the various outputs of interest was evaluated using ANOVA. Blocking was performed with respect to the animals. The Mankin scores were compared using the Kruskal–Wallis test. Results. Cells stayed alive during the course of the 3-week experiment with cell survival values close to or at 80% at test completion. There was no difference between ceramic and free swelling control tissue. However, cell count values were inferior for CoCrMo in the superficial zone (p= 0.003). Tested tissue suffered mostly structural abnormalities. In many samples, the superficial layer was disturbed (and sometimes absent), but deeper layers were little affected. The average Mankin scores were in the range of 2 (out of 14) for both materials (p=0.772; Fig. 1). PG/GAG content in medium was highest for CoCrMo (Fig. 2). Though despite a 10% difference between CoCrMo and ceramic, this did not manifest in statistical significance (p=0.315). Similarly, hydroxyproline release into medium was higher for CoCrMo than ceramic (Fig. 3). This difference (28%) was statistically significant (p=0.024). Discussion. Overall, the results indicate that ceramic-on-cartilage induces less tissue and cell damage than metal-on-cartilage. However, only the hydroxyproline measurements reached statistical significance, partially due to a large variation within both material groups. Current understanding of cartilage wear is still incomplete. While studies have utilized the coefficient of friction against artificial materials as a surrogate wear marker, the best way to determine wear in in-vitro experiments is not well-established. Here, we used the matrix components proteoglycan and hydroxyproline to predict cartilage damage, but further work is necessary to elucidate the mechanobiological reasons for damage. In summary, from this study, Biolox®delta ceramic is generally superior to CoCrMo in the articulation against hyaline cartilage. For any figures or tables, please contact authors directly (see Info & Metrics tab above).

Dual mobility (DM) is an established bearing option in Total Hip Arthroplasty (THA). The traditional mono-block DM designs have limited ability for additional fixation, whereas the modular DM designs allow additional screw fixation but limit internal diameter and have the potential to generate metal debris. We report the early results of a CoCrMo alloy mono-block implant manufactured by additive technology with a highly porous ingrowth surface to enhance primary fixation and osseointegration. Prospective follow-up of the Duplex. TM. implant first inserted in March 2016 enrolled into Beyond Compliance (BC). Primary outcome measure was all-cause revision and secondary outcomes dislocation, peri-prosthetic fracture (PPF) and Oxford Hip Score (OHS). Patients were risk stratified and all considered to be high risk for instability. Complications were identified via hospital records, clinical coding linkage using national database and via BC website. 159 implants in 154 patients with a mean age 74.0 years and a maximum F/U of 7 years. Survivorship for all-cause revision 99.4% (95% CI 96.2–99.8). One femoral only revision. Mean gain in OHS 27.4. Dislocation rate 0.6% with a single event. Patients with a cemented Polished taper stem (PTS) had a Type B PPF rate of 2.1% requiring revision/fixation. Compared to conventional THA this cohort was significantly older (74.0 vs 68.3 years), more co-morbidity (ASA 3 46.5% vs 14.4%) and more non-OA indications (32.4% vs 8.5%). Every patient had at least one risk factor for falling and >50% of cohort had 4 or more risk factors using NICE tool. We believe our results demonstrate that risk stratification successfully aids implant selection to prevent dislocation in high-risk patients. This novel design has provided excellent early results in a challenging cohort where individuals are very different to the “average” THA patient. NJR data on DM has reported an increase in revision for PPF. A “perfect storm” maybe created using DM in high-risk falls risk population. This re-enforces the need to consider all patient and implant factors when deciding bearing selection

Introduction. Titanium and its alloys are attractive biomaterials attributable to their desirable corrosion, mechanical, biocompatibility and osseointegration properties. In particular, β – titanium alloys like the TMZF possess other advantages such as its lower modulus compared to Ti6Al4V alloy. This reduces stress shielding effect in Total Hip Arthroplasty (THA) and the replacement of V in the Ti6Al4V alloy, eliminates in-vivo V-induced toxicity. Unfortunately, implants made of TMZF were later recalled by the FDA due to higher than acceptable revision rates. The purpose of this study was to compare the fretting corrosion characteristics of Ti6Al4V and TMZF titanium alloys. It is hoped the findings will inform better design of β – titanium alloys for future applications in THA. Method. A ball-on-flat configuration was utilised in this study to achieve a Hertzian point contact for CoCrMo – Ti6Al4V and CoCrMo – TMZF material combinations. These were assessed at a fretting displacement of ±50 µm at an initial contact pressure of 1 GPa. Each fretting test lasted 6000 cycles at a frequency of 1 Hz. A two-electrode cell set-up was used to monitor in-situ open circuit potential (OCP). The simulated physiological solution consisted of Foetal Bovine Serum (FBS) diluted to 25% with Phosphate Buffered Saline (PBS) and 0.03% Sodium Azide (SA) balance. The temperature was kept at ∼37°C. Corrosion products on the worn surfaces and subsurface transformations in both alloys were characterised using the Scanning and Transmission Electron Microscopy (SEM/TEM) to obtain high resolution micrographs. The samples were prepared using a FIB-SEM. Bright-field, dark-field and selected area electron diffraction (SAED) patterns were all captured using a scanning TEM (STEM) and Energy Dispersed X-Ray spectroscopy (EDX) mapping was carried out. Results. The results showed that fretting regime transition from partial-slip to gross slip was delayed a few hundred cycles for TMZF relative to the Ti6Al4V (Figure 1). This indicates that the lower modulus of TMZF influences the degree of elastic deformation accommodated prior to the initiation of plastic shear at the fretting interface. The OCP directly corresponded to the fretting regime for both material combinations (Figure 2). Surface and subsurface characterisation of both alloys show differences in the structure of their mechanically mixed corrosion products and metallurgical transformations. Interestingly, an amorphous Co-rich layer was seen across the TMZF surface (Figure 3) whereas, pitting corrosion products from the CoCrMo alloy was seen on the Ti6Al4V alloy. Conclusion. In summary, the difference in the fretting behavior of Ti6Al4V and TMZF directly corresponds to the combined differences in their elastic modulus and surface chemistry. This corresponds to the differences observed in their electrochemical behavior. However, the main differences observed were the properties of their corrosion products and subsurface metallurgical transformations. These observed characteristic differences are to be considered in further examination of the cause of higher failure rates in TMZF alloys. For any figures or tables, please contact the authors directly

Ti-6Al-4V is the most common alloy used for orthopaedic implants. Its popularity is due to low density, superior corrosion resistance, good osseointegration and lower elastic modulus when compared to other commonly used alloys such as CoCrMo and stainless steel. In fact, the use of Ti64 has even further increased lately since recent controversy around adverse local tissue reactions and implant failure related to taper corrosion of CoCrMo alloy. However, implants made from Ti64 can fail in some cases due to fatigue fracture, sometimes related to oxide induced stress corrosion cracking or hydrogen embrittlement, or preferential corrosion of the beta phase. Studies performed with Ti-6Al-4V do often not consider that the alloy itself may have a range of characteristics that can vary and could significantly impact the implant properties. These variations are related to the material microstructure which depends not only on chemical composition, but also the manufacturing process and subsequent heat treatments. Different microstructures can occur in implants made form wrought alloys, cast alloys, and more recently, additive manufactured (AM) alloys. Implant alloy microstructure drives mechanical and electrochemical properties. Therefore, this study aims to analyse the microstructure of Ti-6Al-4V alloy of additive manufactured and conventional retrieved orthopaedic implants such as acetabular cups, tibial trays, femoral stem and modular neck by means of electron backscatter diffraction (EBSD). Microstructural features of interest include grains shape and size, phase content and distribution, preferred grain orientation (texture), alloying elements distribution (homogenization) and presence of impurities. Additionally, we demonstrate the direct impact of different microstructural features on hardness. We analysed 17 conventional devices from 6 different manufacturers, 3 additive manufactured devices from 2 different manufactures and 1 control alloy (bar stock). The preliminary results showed that even though all implants have the same chemical composition, their microstructural characteristics vary broadly. Ti64 microstructure of conventional alloys could be categorized in 3 groups: equiaxed grains alloys (Fine and Coarse), bimodal alloys and dendritic alloys. The additive manufactured implants were classified in an additional group on its own which consists of a needle-like microstructures - similar to Widmanstätten patterns, Fig. 1, with a network of β phase along α phase grains. Furthermore, AM alloys exhibited residual grain boundaries from the original β grains from the early stage of the solidification process, Fig. 2. These characteristics may have implication on the fatigue and corrosion behaviour. In addition, it we observed inhomogeneous alloying element distribution in some cases, Fig. 3, especially for the additive manufactured alloys, which also may have consequences on corrosion behaviour. Finally, the hardness testing revealed that the implants with large grain size, such as AM alloys, exhibit low hardness values, as expected, but also the amount of beta phase correlated positively with lower hardness. Grain aspect ratio and beta phase grain size correlated positively with higher hardness. In summary, we found that common Ti64 implants can exhibit a broad variety of different alloy microstructures and the advent of AM alloys introduces an entirely new category. It is imperative to determine the ideal microstructure for specific applications

Introduction. Metal-on-polyethylene (MoP) is the most commonly used bearing couple in total hip replacements (THRs). Retrieval studies (Cooper et al, 2012, JBJS, Lindgren et al, 2011, JBJS) report adverse reactions to metal debris (ARMD) due to debris produced from the taper-trunnion junction of the modular MoP THRs. A recent retrospective observational study (Matharu et al, 2016, BMC Musc Dis) showed that the risk of ARMD revision surgery is increasing in MoP THRs. To the authors' best knowledge, no hip simulator tests have investigated material loss from the taper-trunnion junction of contemporary MoP THRs. Methods. A 6-station anatomical hip joint simulator was used to investigate material loss at the articulating and taper-trunnion surfaces of 32mm diameter metal-on-cross-linked polyethylene (MoXLPE) joints for 5 million cycles (Mc) with a sixth joint serving as a dynamically loaded soak control. Commercially available cobalt-chromium-molybdenum (CoCrMo) femoral heads articulating against XLPE acetabular liners (7.5Mrad) were used with a diluted new-born-calf-serum lubricant. Each CoCrMo femoral head was mounted on a 12/14 titanium alloy trunnion. The test was stopped every 0.5Mc, components were cleaned and gravimetric measurements performed following ISO 14242-2 and the lubricant was changed. Weight loss (mg) obtained from gravimetric measurements was converted into volume loss (mm. 3. ) and wear rates were calculated from the slopes of the linear regression lines in the volumetric loss versus number of cycles plot for heads, liners and trunnions. Additionally, volumetric measurements of the head tapers were obtained using a coordinate measuring machine (CMM) post-test. The surface roughness (Sa) of all heads and liners was measured pre and post-test. At the end of the test, the femoral heads were cut and the roughness of the worn and unworn area was measured. Statistical analysis was performed using a paired-t-test (for roughness measurements) and an independent sample t-test (for wear rates). Results and Discussion. The mean volumetric wear rates for CoCrMo heads, XLPE liners and titanium trunnions were 0.019, 2.74 and 0.013 mm. 3. /Mc respectively. There was a statistically significant decrease (p<0.001) in the Sa of the liners post-test. This is in contrast to the femoral heads roughness in which no change was observed (p = 0.338). This head roughness result matches with a previous MoP in vitro test (Saikko, 2005, IMechE-H). The Sa of the head tapers on the worn area showed a statistically significant increase (p<0.001) compared with unworn, with an associated removal of the original machining marks. The mean volumetric wear rate of the head tapers obtained using the CMM (0.028 ± 0.016 mm. 3. /Mc) was not statistically different (p=0.435) to the mean volumetric wear rate obtained gravimetrically (0.019 ± 0.020 mm. 3. /Mc) for the femoral heads. Therefore, wear of the heads arose mainly from the internal taper. The mean wear rates of the CoCrMo taper and titanium trunnion are in agreement with a MoP explant study (Kocagoz et al, 2016, CORR). Conclusion. This is the first long-term hip simulator study to report wear generated from the taper-trunnion junction of MoP hips

INTRODUCTION:. The use of tapered junctions in primary hip arthroplasty has excellent results. Large heads are being used to mitigate dislocation and optimize range of motion. The prevalence of larger heads, coupled with recent findings regarding corrosion artifacts at tapered surfaces, has spurred growing interest when considering revision rates. The purpose of this study was to determine if correlations exist between severity of corrosion artifacts and head size, head offset, time in vivo, orhead material in a 15 year retrieval database. METHODS:. Retrieved hip arthroplasty devices with CoCrMo or oxidized zirconium (OxZr) heads were investigated for corrosion artifacts in this study. Female tapered surfaces were scored independently by a panel according to the Goldberg system for assessment of corrosion. Exclusion criteria included less than 1 week in vivo, ceramic taper, and modular proximal stem sleeves. Evaluation was performed on only stem/head taper junctions. SEM analyses and a newly developed method of vertical straightness deviation (VSD) were used on a subset of devices as an additional measure to quantify corrosion within the taper contact region by measuring depth of material loss. RESULTS:. A total of 227 retrievals containing taper surfaces spanning 15 years were evaluated. Of these, 183 met the inclusion criteria (CoCrMo, n = 159; OxZr, n = 24). Time in vivo ranged from 1 week to 10 years. The majority of the head tapers were 12/14 in size. There was no correlation between head size and average Goldberg score (n = 183, R. 2. = 0.23). There was a parabolic correlation between head offset (9 offset sizes evaluated) and average Goldberg score (n = 156, R. 2. = 0.89), with the more negative offsets and the more positive offsets exhibiting higher scores. There was no correlation between time in vivo and Goldberg score (n = 104, R. 2. = 0.11). There was a correlation between head material and Goldberg score, with OxZr having a lower score as compared to CoCrMo heads (1.9 ± 0.6 vs. 2.5 ± 0.9, p = 0.002). VSD measurements made on CoCrMo heads with a Goldberg score of 4 showed that 5 of 6 CoCrMo heads had a measureable depth of material loss at the taper, with a maximum depth ranging from 8 to 103 microns. There were no OxZr heads with a Goldberg score of 4. SEM and VSD measurements corroborated scoring (Figures 1–3). CONCLUSIONS:. CoCrMo heads have 20+ years of clinical success, but as shown in this study may still generate a quantifiable amount of taper corrosion. Though impaction force, taper cleanliness, patient factors and other myriad multi-factorial issues may contribute to taper corrosion, in this study no correlation was observed for head size or time in vivo and Goldberg score. A correlation was found between head offset and Goldberg score. The use of an OxZr head material exhibited decreased corrosion by-products as compared to the traditional CoCrMo head material used in hip arthroplasty

Introduction. Metal ion and particle release, particularly cobalt, has become an important subject in total hip arthroplasty, as it has shown to induce metal hypersensitivity, adverse local tissue reactions and systemic ion related diseases. The purpose of the following study was compare the ion release barrier function of a zirconium nitride (ZrN) multilayer coated hip stem for cemented use, designed for patients with metal ion hypersensitivity, against its uncoated version in a test configuration simulating the worst case scenario of a severely debonded hip stem. The ZrN multilayer coating is applied on a CoCrMo hip stem and consists of a thin adhesive chromium layer, five alternating intermediate layers out of chromium nitride (CrN) and chromium carbonitride (CrCN) and a final zirconium nitride (ZrN) shielding layer [1]. Methods. Hip stems with a ZrN multilayer coating (CoreHip AS, Aesculap AG, Germany) were tested in comparison with a cobalt-chrome uncoated version (CoreHip, Aesculap AG, Germany). In order to create a worst case scenario, the smallest stem size with the biggest offset in combination with an XL ceramic head (offset +7 mm) was used. The stems were embedded according to the ISO 7206-6 test in a bone cement sheet. Once the bone cement was bonded, the stem was pulled out and a PMMA grain was placed inside the femoral cavity in order to uprise the hip stem above its embedding line and simulate a debonded cemented hip stem with a severe toggling condition. The dynamic test was performed under bovine serum environment with an axial force of 3.875 kN [2] at 11.6 Hz for 15 million cycles. The test was interrupted after 1, 3, 5, 10 and 15 million cycles and the surfaces of the stems were analyzed through scanning electron microscopy (SEM) with energy dispersive X-Ray (EDX). Moreover, the test medium was analyzed for metal ion concentration (cobalt, chromium and molybdenum) using ICP-MS. Results. The SEM/EDX analysis demonstrated that the ZrN multilayer coating kept its integrity, as no trace of the substrate material (CoCrMo) could be detected. Furthermore, the taper of the ZrN group showed less fretting and corrosion than the taper of the CoCrMo stem (Fig.1). Moreover, the ion concentration analysis showed a reduction of up to two orders of magnitude in the release of cobalt, chromium and molybdenum in the ZrN coated stems in comparison with the uncoated version. Discussion. The results showed that, even in a worst case scenario of high micro-motion due to a severe stem debonding within the cement mantle, the hip stems with a ZrN multilayer coating substantially reduce the release of ions from the substrate material. For any figures or tables, please contact the authors directly

Introduction. Titanium and its alloys are attractive biomaterials attributable to their desirable corrosion, mechanical, biocompatibility and osseointegration properties. Ti6Al4V alloy in particular remains a prominent biomaterial used in Total Hip Arthroplasty (THA) today. This is partly due to biocompatibility and stress shielding issues with CoCrMo alloys, resulting in its increasing side-lining from the THA construct. For several decades now, research efforts have been dedicated to understanding wear, corrosion and surface degradation processes in implant materials. Only recently have researchers shown interest in understanding the subsurface implications of fretting and the role it plays on implant fracture. The purpose of this study was to utilise advanced microscopy and spectroscopy techniques to characterise fretting-induced subsurface transformations in Ti6Al4V. This makes mapping specific regions that are most prone to wear and fatigue failures at the modular taper interface of THA probable. Thus, informing a proactive approach to component design and material selection. Method. A ball-on-flat configuration was utilised in this study to achieve a Hertzian point contact for a CoCrMo – Ti6Al4V material combination. Four fretting displacement amplitudes were assessed: ±10, ±25, ±50 and ±150 µm. An initial contact pressure of 1 GPa was used for all fretting tests in this study and each fretting test lasted 6000 cycles at a frequency of 1 Hz. The simulated physiological solution consisted of Foetal Bovine Serum (FBS) diluted to 25% with Phosphate Buffered Saline (PBS) and 0.03% Sodium Azide (SA) balance. The temperature was kept at ∼37°C. Subsurface transformations in the Ti6Al4V alloy was characterised using the Transmission Electron Microscopy (TEM) to obtain high resolution micrographs. The samples were prepared using a FIB-SEM. Bright-field, dark-field and selected area electron diffraction (SAED) patterns were all captured using a scanning TEM (STEM) and Energy Dispersed X-Ray spectroscopy (EDX) mapping was carried out. Results. At both ±10 and ±25 µm displacement, a stick fretting regime was realised. Subsurface transformation in the Ti6Al4V alloy was characterised as strain-induced orientation. At ±50 µm, a mixed fretting regime was realised, TEM and SAED micrographs as well as EDX spectroscopy identified complex but distinctive structures at the surface and subsurface of the Ti6Al4V alloy. This included a CoCrMo-rich fine particulate, mechanically mixed structure, an amorphous-transformed Ti6Al4V structure and a highly refined nano-crystalline Ti6Al4V structure. At ±150 µm, a full gross slip regime was realised and Ti6Al4V alloy was characterised mainly by subsurface cracks, formation and refinement of nano-crystalline structures. Conclusion. The degree of subsurface recrystallization within Ti6Al4V alloy was observed to be energy dependent. However, the manifestation of the dissipated energy was dependent on the contact condition. The interwoven relationship between energy dissipation, contact condition and mechanisms of clinical failure in Ti6Al4V was consolidated into a map (Figure 1). The map is intended to provide users with an indication of the failure modes to expect for an implant material subjected to specific tribocorrosion conditions. For any figures or tables, please contact the authors directly

Background. Published simulator studies for metal/UHMWPE bearings couples showed that increasing the femoral head diameter by 1 mm increases wear by approximately 10% due to increased contact area. Therefore, there are concerns about increased wear with dual mobility hip bearings. Purpose of the study. The purpose of the study was to compare wear from dual mobility hip bearings to that with traditional fixed bearings. In addition, for the dual mobility bearings, the effect of femoral head material type on the liner wear was also evaluated. Methods. The bearings selected for the study are listed in Table 1. Prior to the start of the test all liners were soaked in lubricant for 48 hours. Hip testing was performed on a Shore Western Orbital Bearing machine in the anatomically oriented position. A simulated gait profile (synchronized at +/-23° biaxial rocking motion) with a minimum/maximum 200/2000N force was applied to the bearings at frequency of 1Hz. The lubricant used for the testing was 25% bovine serum with 0.2 % sodium azide, 20 mMol EDTA and distilled water. The test was interrupted at regular intervals for gravimetric assessment of wear amount. Findings of Study. Figure 1 shows total wear at 3 Mc and wear rates (determined from the slope of the linear regression) for all the groups. At 3 Mc, dual mobility bearings with stainless steel femoral head demonstrated 5% lower wear rate than those articulated against CoCrMo femoral heads. However, there was no statistically significant difference in the observed wear rate due to the femoral head material type. The results from the study also exhibited lower wear and wear rate for dual mobility bearings compared to fixed bearings. Dual mobility bearings with CoCrMo femoral head and stainless steel femoral head demonstrated 17% and 21% lower wear rate when compared to fixed bearings. Although dual mobility bearings possess greater contact area (due to the contact between head-liner and liner-shell compared to only head-liner in fixed bearings), no such increased trend in wear was observed. Conclusions. Dual mobility hip bearings are designed to reduce the risk of dislocation and allow for increased range of motion thus improving joint function and stability. The results from the study demonstrate that dual mobility bearings have comparable wear properties when compared to fixed bearings. For figure/table, please contact authors directly

INTRODUCTION. Due to increasing interest into taper corrosion observed primarily in hip arthroplasty devices with modular tapers, efforts towards characterizing the corrosion byproducts are prevalent in the literature [1–4]. As a result of this motivation, several studies postulate cellular induced corrosion due to the presence of remarkable features in the regions near taper junction regions and articulating surfaces [3–5]. Observations made on explanted devices from a retrieval database as well as laboratory tests have led to the alternative proposal of electrocautery-electrosurgery damage as the cause of these features. These surgical instruments are commonly used for hemostasis or different degrees of tissue dissection. METHODS. Scanning electron microscopy (SEM) and energy dispersive spectroscopy (EDS) were used to evaluate the features observed on retrieved devices. Retrieved devices consisted of OXINIUM and cobalt-chromium-molybdenum (CoCrMo) femoral implants, a Titanium-alloy hip stem, and a CoCrMo metal-on-metal femoral head. Electrocautery-electrosurgery damage was created using a SurgiStat II (Valleylab, Colorado) onto various components (CoCrMo, OXINIUM femoral heads as well as Ti-6Al-4V and CoCrMo alloy test stem constructs). Test components were evaluated using the same methods as the retrieved devices. RESULTS. Remarkable features were present on retrieved devices (Figure 1) which were similar to previous studies (3–5). The appearance of these features could be described as crater-like, pitted, scratched, molten or splattered material, and ruffled. These features were present on articulating and non-articulating regions as well as near taper junctions. Testing performed on samples using the SurgiStat II, created features that were similar in appearance (Figure 1). Additionally, material transfer that included an iron peak based on EDS in addition to the cobalt and chromium (present due to native material) was detected in the regions of contact (Figure 2). CONCLUSIONS. It was possible to re-create damage features similar to those previously characterized as remarkable features created by cellular-induced corrosion [3–5]. It is theorized that the high-voltage based electrocautery (commonly Bovie) or high-frequency based electrosurgical devices can result in localized degradation/alteration of oxides and passive regions of commonly used orthopaedic alloys. These surgical instruments, specifically the cutting electrodes, are frequently made of stainless steels which can result in iron transfer during contact with the device. During the surgical use of the electrocautery-electrosurgery instrument, it may be necessary to remove tissue, bone, or cauterize near the implant or explant which may have led to the damage features noted in this study and the previous literature [3–5]. If this damage occurs during the initial implantation of the devices, it may further exacerbate corrosion in the damaged region and/or alter the mechanical integrity of the constructs (i.e. fatigue performance)

Modern hip implants feature a modular design, whereby the individual components of the implant are assembled during the surgery. Increased reported failure rates associated with the utilization of modular junctions have raised many clinical concerns about the increased release of metal ions/debris leading to adverse local tissue reactions. Implant materials are subject to a myriad of mechanical motion and forces, and varying electrochemical conditions and pH changes from the surrounding environment. To date, no studies have attempted to model the collected data in order to predict the performance of the materials so that precautions can be taken before the problem reaches the critical stage. This study reports the effects of pH variation, displacement variation, and load variation on the mechanical and corrosion behavior of the hip implant modular junction system, tested with a custom-built fretting-corrosion apparatus. The main objective of this study is to combine the complete data set of the in-vitro experiments to create fretting-corrosion wear maps that can predict the dangerous domains of the hip implant modular system. For each test, the flat portions of two CoCrMo pins were loaded perpendicularly against a Ti6Al4V Rod (Ti alloy) in a Flat-on-flat configuration in a simulated synovial fluid in order to simulate the modular hip implant system. A schematic diagram of contact conditions is presented in Figure 1. A sinusoidal displacement was applied onto the rod, which articulated against the CoCrMo alloy pins, at a frequency of 1Hz. The experiential data from the fretting-corrosion tests has been used to create fretting-corrosion maps. The variables incorporated into the maps include: total mass loss, electrochemical destabilization, pH variation, load variation, displacement variation, and visual examination of the wear features of the contact zone. Total mass loss has been estimated via measurement of the simulator fluid by ICP-MS technique. Electrochemical destabilization was evaluated by a single parameter (V. Drop. ). The electrochemical destabilization of the tribosystem was evaluated by measuring the drop in potential, V. Drop. (V vs. SCE), resultant from the initiation of the fretting phase. The V. Drop. refers to the initial cathodic drop in potential in response to the initial onset of fretting motion. The data from the in vitro fretting-corrosion experiments has been combined to create four fretting-corrosion maps (Figures 2A–3D). Partial slip wear features and mechanical behavior was observed at 25µm displacement. 25–150µm displacement amplitudes showed gross slip behavior. Anything larger than 150µm displayed wear features that were indistinguishable from sliding wear. In general, total mass loss and V. Drop. increased with increasing displacement. Samples that were tested at pH 6.0 or higher showed signs of material transfer and higher V. Drop. Finally, there was a general decrease in V. Drop. with increased applied load and pH. In general, the wears maps were able to offer some predictive validity, however, there were some discrepancies between visual observations and the observed damage parameters. It is possible that other parameters could offer better correlation. Future studies will be conducted to measure other parameters. For figures/tables, please contact authors directly.

Introduction. There are increasing reports of total hip replacement (THR) failure due to corrosion within modular taper junctions, and subsequent adverse local tissue reactions (ALTRs) to corrosion products. Modular junction corrosion is a multifactorial problem that depends on material, design, patient and surgical factors. However, the influence of alloy microstructure on corrosion has not been studied sufficiently. Especially for cast CoCrMo, there are concerns regarding microstructure variability with respect to grain size and hard-phase volume fraction. Therefore, it was the goal of this study to (1) identify different types of microstructures in contemporary implants, and (2) determine implications of alloy microstructure on the occurring corrosion modes. Methods. Fifteen surgically retrieved femoral stems made from cast CoCrMo alloy were analyzed for this study. Damage on the taper surfaces was investigated by scanning electron microscopy (SEM) and damage was assessed with the Goldberg Score. The alloy microstructure was evaluated by standard metallographic techniques. Alloy samples were sectioned off the femoral stem, and microstructural features were visualized by chemical etching. Cyclic potentio-dynamic polarization tests were carried out with alloy samples from two implants with different commonly occurring types of microstructures. Both had a similar grain size, but type 1 had no hard-phases, where as type 2 exhibited hard-phases along the grain boundaries, as well as intra-granular hard-phase clusters. Tests were performed in bovine serum at 37°C with a saturate calomel reference electrode and a graphite counter electrode. In vitro generated corrosion damage was then compared to in vivo generated damage features on the taper surfaces of the corresponding implants. Results. Tapers with high damage scores exhibited varying degrees of grain and phase boundary corrosion, along with fretting and pitting corrosion. In several cases thick chromium oxide films were observed. The metallographic analysis showed that nominally identical alloys (ASTM F75) exhibited a broad variability in grain size (250 micrometers to several millimeters), hard-phase volume fraction (0–6%), and hard-phase type (carbides and intermetallic phases). The corrosion tests revealed that the alloy without hard-phases (type 1) had a significantly higher pitting potential (p=0.001) than type 2 alloy without hard-phases. After testing, both alloys exhibited grain boundary corrosion. However, type 2 had a higher degree of material loss due to hard-phase detachment. Additionally, type 2 exhibited pitting within the grains around hard-phases, along with the formation of thick oxide films which was consistent with the lower pitting potential. The results also corresponded with the damage features on the corresponding tapers, where type 1 exhibited only mild damage features, and type 2 underwent severe grain and phase boundary corrosion along with thick oxide films (Figure 3). Discussion. It appears that the alloy microstructure drives local modes of corrosion. Additional phase boundaries due to hard-phase content promote corrosion. The fact that the same alloy can differ broadly even within the same design shows that material standards are currently not sufficient. Optimizing implant alloys will help to reduce in vivo corrosion processes, and subsequently the risk of implant failure due to ALTRs. For figures/tables, please contact authors directly.

Introduction. Modularity allows surgeons to use femoral heads of various materials, diameters and offsets to achieve the best possible outcome, nevertheless the fretting corrosion behaviour of modular junctions can be significantly affected. The aim of this study was to assess physiological friction moment and lubrication ratio in order to compare various tribological materials against different bearing sizes. This data is important as lubrication will affect the friction, wear and torque generated which may lead directly to the production of debris or to enhanced corrosion at modular junctions. Materials and methods. Hip joints were tested in lubricant condition on a hip simulator following the ISO14242-3 configuration. Three samples for each combinations were examined: 1) 36mm metal-on-metal made in CoCrMo 2) 36mm ceramic-on-ceramic made in ZTA 3) 58mm resurfacing metal-on-metal made in CoCrMo 4) 57mm resurfacing ceramic-on-ceramic made in ZTA. Preconditioning and dynamic loading steps were spaced out by rest periods (Fig. 1) and the entire series was repeated three times for each combination. Strains were measured on the Ti6Al4V neck's femoral stem with three couples of biaxial strain gauges and were converted into friction moments by means of analytical formulas. Mean maximum moment M and lubrication ratio λ were calculated. M. START-UP. and M. TURN-OFF. were respectively the first three and last three peak moment sampled for each consecutive step. Results. Fig. 2 reports the obtained results. It can be observed that MoM large bearings showed a mean maximum friction moment lower than MoM smaller bearings (p=0,001), whereas no effect of bearing diameter on friction moment was observed for CoC (p=0,162). There is no statistically significant difference on friction moment between Ø57mm ceramic-on-ceramic resurfacing bearing and Ø58mm metal-on-metal resurfacing (p=0,805). However the CoC Ø36 friction moment was significantly lower than with MoM Ø36 (p=0,001). The calculated lubrication ratio λ gave information on lubrication regime: in the case of standard bearings mixed lubrication (1≤λ≤3) occurred, while resurfacing bearings were in full film lubrication (λ>3). Correlating lubrication ratio λ with M. START-UP. and M. TURN-OFF. (Fig. 2) it can be observed that the peak friction moment increased during the dynamic step for bearing in mixed lubrication, while a decrease was observed for bearing in full film lubrication. The breaking point cycle between downward and flat peak friction moment trend decreased more than half with longer dynamic steps (Fig. 3), leading to a stable maximum friction moment. Discussion. Ceramic bearing friction moment monotonically increased with bearing diameter, this trend being not observed on metal couplings because the tested standard diameter was in mixed lubrication lower limit. Mixed lubrication regime energized the bearing by increasing the friction moment during the dynamic step such as a self-powered system, on the other side full film lubrication reduced friction moment to a lower asymptote, such as a self-stabilized system. Conclusion. Modern ceramic hip resurfacing was designed in full film lubrication and its friction moment was equivalent to metal-on-metal hip resurfacing. Modern ceramic resurfacing may reduce fretting corrosion compared to traditional metal resurfacing while keeping the same biomechanical advantages. For figures/tables, please contact authors directly.