Introduction. Currently, different techniques to evaluate biocompatibility of orthopaedic materials, including two-dimensional (2D) cell culture for metal and ceramic wear debris and floating 2D surfaces or three-dimensional (3D) agarose gels for UHMWPE wear debris, are used. We have developed a single method using 3D agarose gels that is suitable to test the biocompatibility of all three types of wear debris simultaneously. Moreover, stimulation of the cells by wear particles embedded in a 3D gel better mimics the in vivo environment. Materials and Methods. Clinically relevant sterile UHMWPE and CoCr wear particles were generated using methodologies described previously [1,2]. Commercially available nanoscale and micron-sized silicon nitride (Si. 3. N. 4. ) particles (<50 nm and <1 μm, Sigma UK) were sterilised by heat treatment for 4h at 180°C. Agarose-particle suspensions were prepared by mixing warm 2% (w/v) low-melting-point agarose solution with the particles dispersed by sonication in DMEM culture media. The suspensions were then allowed to set at room temperature for 10 min in 96 well culture plates. Sub-confluent L929 murine fibroblasts were cultured on the prepared gels for up to 6 days in 5% (v/v) CO. 2. at 37°C. After incubation, the viability of cells was measured using the ATP-lite assay. The results were expressed as mean ± 95% confidence limits and the data was analysed using one-way ANOVA and Tukey-Kramer post-hoc analysis. Results and Discussion. The gels were observed to ensure uniform distribution of particles and migration of cells into the gel. No significant reduction in viability was observed for nanoscale and micron-sized Si. 3. N. 4. particles at low doses (0.5 μm. 3. per cell) and high doses (50 μm. 3. per cell), or for UHMWPE wear debris at high doses (100 μm. 3. per cell) [Figure1]. Moreover, the viability was significantly reduced for high doses of CoCr wear debris (50 μm. 3. per cell) and the positive control, camptothecin (2 μg.ml. −1. ) at day 6 [Figure1]. These results are consistent with the literature [2,3] and therefore validate our 3D agarose cell culture method for comparing cytotoxicity of polymer, metal and ceramic particles in a single assay, simultaneously. Conclusion. Biocompatibility ofpolymer, metal and ceramic wear debris can be tested simultaneously by using 3D particle embedded agarose gels. Acknowledgements. The research leading to these results has received funding from the European Union's Seventh Framework Programme (FP7/2007-2013) under grant agreement no. GA-310477 LifeLongJoints

Introduction:. Unicompartmental knee arthroplasty (UKA) has been used in the past decades to treat progressive cartilage degeneration in a single compartment. Concern has been raised over the rate of revision procedures for polyethylene wear and osteoarthritic progression into the adjacent compartment. Few studies have examined the pathology of cartilage degeneration in the setting of UKA. This study aims to investigate the viability of knee chondrocytes introduced to high and low concentrations of orthopaedic wear debris particulate. Methods:. Normal human articular chondrocytes (nHAC-Kn) were expanded in DMEM/F12 containing 10% FBS, 1% Penicillin/Streptomycin (Pen/Strp), and 50 μg/mL ascorbic acid (Asc). 24 hours prior to the start of the experiment, cells were seeded on 96-well plates at a density of 3500 cells/cm. 2. and exposed to DMEM/F12 containing 5% FBS, 1% Pen/Strp, and 50 μg/mL Asc. Particles (equivalent circle diameter range: 0.2–7 μm) at a low dose of 100: 1 (particles: cells) and high dose 1000: 1 (particles: cells) were introduced to treatment wells (n = 6). Control wells (n = 6) contained particles with no cells. Treatment groups included high and low doses of TiAl. 6. V. 4. alloy, 316L Stainless Steel, and Co-Cr-Mo alloy. At days 1, 3, 5, and 7, cells were assayed with a 3-(4,5-Dimethylthiazol-2-yl)-2,5-dyphenyltetrazolium bromide (MTT) assay for determination of cell viability. Light microscopy was performed at each timepoint to assess change in cell morphology. Results:. All groups displayed a minor decrease in cell viability after 24 hours of exposure to particles. Similarly, a second distinct decrease in viability occurred at the day 3 timepoint. Days 5 and 7 yielded little change in cell viability. Results are displayed in Figure 1. Observations of light microscopy revealed cells may actively engulf particles over time. Images show particle concentrations at the same locations as chondrocytes with few particles present between cells. Conclusions:. Wear debris has been implicated as a contributing source to osteolysis and component loosening. A potential effect on the cellular level can ultimate lead to effects on the entire tissue and complications on the clinical level. A decrease in chondrocyte viability has been shown in response to the presence of particulate wear debris. Our results showed decreases in cell viability were most noticeable between 24 and 72 hours after introduction to particles. Chondrocyte death may contribute to progression of cartilage degeneration into healthy compartments of the knee. Continued experiments are underway further characterizing chondrocyte response to wear debris particulate with respect to protein and gene expression in an extended 7 day in vitro culture

Introduction. Wear debris generated by total hip replacements (THRs) may cause mechanical instability, inflammation, osteolysis and ultimately implant loosening, thus limiting the lifetime of such devices [1]. This has led to the development of biocompatible coatings for prostheses. Silicon nitride (SiN) coatings are highly wear resistant and any resultant wear debris are soluble, reducing the possibility of a chronic inflammatory reaction [2]. SiN wear debris produced from coatings have not been characterized in vivo. The aim of this research is to develop a sensitive method for isolating low volumes of SiN wear debris from periprosthetic tissue. Methods. Commercial silicon nitride particles of <50nm (Sigma Aldrich) were incubated with formalin fixed sheep synovium at a volume of 0.01mm. 3. /g of tissue (n=3). The tissue was digested with papain (1.56mg/ml) for 6h and subsequently proteinase K (1mg/ml) overnight. Proteinase K digestion was repeated for 6h and again overnight, after which samples appeared visibly homogeneous [Figure 1]. Samples were then subjected to density gradient ultracentrifugation using sodium polytungstate (SPT) [3]. The resulting protein band was removed from the pellet of particles. Control tissue samples, to which no particles were added, were also subjected to the procedure. Particles were washed with filtered water to remove residual SPT using ultracentrifugation and filtered onto 15nm polycarbonate filters. The filtered particles were imaged by cold field emission scanning electron microscopy (CFE-SEM) and positively identified by elemental analysis before and after the isolation procedure. To validate whether the isolation method affected particle size or morphology, imaging software (imageJ) was used to determine size distributions and morphological parameters of the particles. A Kolmogorov-Smirnov test was used to statistically analyse the particle morphology. Results. The appearance of particles was similar before and after the isolation procedure [Figure 2]. Scanning electron micrographs also demonstrated the complete removal of proteins and light impurities. Elemental analysis confirmed the identity of retrieved particles as SiN. The particle size distributions of isolated and non-isolated particles were similar [Figure 3]. Statistical analysis demonstrated that morphology in terms of roundness and aspect ratio was unchanged by the isolation procedure (P<0.05). Discussion. Results indicate that the particle isolation method effectively isolates low volumes of SiN particles whilst retaining particle characteristics and enabling particle characterisation. The method will therefore be validated for application to additional particle materials and applied to in vivo studies of novel SiN coated prostheses in a rabbit and sheep model

Summary. We report the first use of synchrotron xray spectroscopy to characterize and compare the chemical form and distribution of metals found in tissues surrounding patients with metal-on-metal hip replacements that failed with (Ultima hips) or without (current generation, large diameter hips) corrosion. Introduction. The commonest clinical category of failure of metal-on-metal (MOM) hip replacements is “unexplained” and commonly involved a soft tissue inflammatory response. The mechanism of failure of the Ultima MOM total hip replacement includes severe corrosion of the metal stem and was severe enough to be removed from clinical use. Corrosion is not a feature that we have found in the currently used MOM bearings. To better understand the biological response to MOM wear debris we hypothesized that tissue from failed hips with implant corrosion contained a different type of metal species when compared to those without corrosion. Method. Tissue from patients with two types of MOM hip arthroplasty were analysed: Ultima that failed with severely corroded femoral stems (n=12); and large diameter, current generation MOM hips that failed without visible corrosion (n=7). Comparison was also made to samples of cobalt, chromium and molybedanum standards. We used a high energy synchrotron xray beam to map and characterise the type of metal within the tissues. This enabled us to analyse the type of chemical in a situation that is as realistic as possible: without staining; without the use of a vacuum; and the use of fresh frozen tissue sections with metals at relatively low concentrations. This could not have been achieved without a synchrotron. Results. Comparison with standards revealed the chemical form of the chromium in the tissues surrounding metal-on-metal hip replacements was chromium (III). This was similar for both corroded (Ultima MOM) and non-corroded (large diameter, current generation MOM) hips. This was chromium (III) phosphate in the non-corroded hips but because the concentration of chromium was lower in the corroded hips it was difficult to differentiate chromium phosphate from oxide. There was some evidence of localistaion of cobalt and chromium, both in metallic form. One sample from corroded hips contained chromium (VI). Conclusion. Chromium (III) phosphate was the predominant metallic species in the tissues surrounding metal-on-metal hip replacements. This may have arisen from corrosion, wear or a combination of both

Statement of Purpose:. The wear rate of Ultra High Molecular Weight Polyethylene (UHMWPE) in joint replacements has been correlated to both contact area and contact stress in the literature, [1], [2]. In both publications and our experiment, UHMWPE articulated with a polished surface of cobalt-chromium alloy was evaluated using a Pin-On-Disk (POD) apparatus (AMTI) implementing bi-directional movement. In publication [1], volumetric wear was independent of normal load and dependent upon increasing contact area. The results demonstrated that increasing contact stress decreased wear rates twofold. In publication [2], at maximum cross-shear, wear was proportional to nominal contact area and wear factors normalized to area are more appropriate than load based wear factors. In both studies, the contact surface areas of the POD pins were reduced by decreasing the diameters of the POD Pins. In our experiment, the contact area was dependent on textured POD Pin 390 (T390) which had low wear [3]. T390 reduced the normal POD contact area from 71 mm. 2. to 8.26 mm. 2. Hydroxylapatite (HA) particles were introduced to the serum to simulate third body wear debris. We hypothesized that the normal POD Pins would have greater wear rates than the textured POD Pins. A measurement of 0.14 mg HA particles per 250 mL of serum was used for each test 0.33 million cycles. Methods:. The GUR 1020 resin XLK POD Pins were gamma irradiated to 50 kGy in a vacuum package and then remelted. Three (3) T390 POD pins and nine (9) untextured XLK POD Pins were used. Three untextured XLK POD Pins were tested against three T390 POD pins. The other six (6) untextured XLK POD Pins were used as soak controls. Each pin articulated against a polished, high carbon wrought CoCr metal alloy counterface (ASTM F1537; diameter = 38.1 mm; thickness = 12.7 mm). Wear rate tests were for 1.98 million cycles. In order to perform the t-test analysis, the wear rates for each pin were given by the slope of the linear regression line through the individual data points (cycle count, cumulative wear), excluding the (0, 0) point. Results:. The probability for the means between the T390 POD pins and the untextured XLK POD Pins was *p = 0.009. T390 wear rates were statistically significant as compared to the untextured XLK POD Pin wear rates. The T390 POD Pin is illustrated in Figure 1. Figures 2 and 3 summarize the wear rates between T390 POD Pins and the untextured POD Pins with and without HA particles. Conclusions:. The wear rates between T390 and untextured POD pins did not take into account that the POD pins were not cleaned using a solution to remove potentially embedded HA particles. The follow-on experiment will use a special cleaning method to remove all HA particles after each test cycle

There have been numerous reports regarding “pseudotumor” associated with hip arthroplasty. We present two reports in which main etiology in the pseudotumor formation was titanium (Ti), but not cobalt-chromium (Co-Cr). We should keep in mind that Ti analysis is essential in some cases.

(Case 1) A 68-year-old male presented to our institution because of right hip pain and lower extremity swelling four years after a bipolar hemiarthroplasty. MRI predicted a cystic pseudotumor. However, revision surgical findings showed no apparent cause of ARMD previously described in the literatures. Postoperative analysis showed that the metal debris mainly originated from the Ti alloy itself. (Case reports in Orthopedics, vol.2014, Article ID 209461, 4 pages)

(Case 2) A 77-year-old female presented to our institution because of right hip pain and swelling six years after a total hip arthroplasty using a cable trochanteric reattchment. Plain radiographs demonstrated evidences of severe osteolysis and multiple fragments of the broken cable. However, MRI predicted a psudotumor(See Figure 1). Postoperative analysis clarified that main etiology in the pseudotumor formation was the stem mede of Ti, but not the cable made of Co-Cr.

Introduction

Silicon nitride (SiN) is a recently introduced bearing material for THR that has shown potential in its bulk form and as a coating material on cobalt-chromium (CoCr) substrates. Previous studies have shown that SiN has low friction characteristics, low wear rates and high mechanical strength. Moreover, it has been shown to have osseointegration properties. However, there is limited evidence to support its biocompatibility as an implant material. The aim of this study was to investigate the responses of peripheral blood mononuclear cells (PBMNCs) isolated from healthy human volunteers and U937 human histiocytes (U937s) to SiN nanoparticles and CoCr wear particles.

Orthopaedic cobalt chromium particles and ions can induce indirect DNA damage and chromosome aberrations in human cells on the other side of a cellular barrier in tissue culture. This occurs by intercellular signalling across the barrier. We now show that the threshold for this effect depends on the metal form and the particle composition.

Ionic cobalt and chromium induced single strand breaks at concentrations equivalent to those found in the blood of patients with well functioning metal on metal hip prostheses. However, they only caused double strand breaks if the chromium was present as chromium (VI), and did not induce chromosome aberrations. Nanoparticles of cobalt chromium alloy caused DNA double strand breaks and chromosome aberrations, of which the majority were tetraploidy. Ceramic nanoparticles induced only single strand breaks and/or alkaline labile sites when indirectly exposed to human fibroblasts.

The assessment of reproductive risk from maternal exposure to biomaterials, especially those liberated by orthopaedic implants, is not yet possible with epidemiology. Whilst the barrier model used here differs from the in vivo situation in several respects, it may be useful as a framework to evaluate biomaterial induced damage across physiological barriers.

Aims. The STRYDE nail is an evolution of the PRECICE Intramedullary Limb Lengthening System, with unique features regarding its composition. It is designed for load bearing throughout treatment in order to improve patient experience and outcomes and allow for simultaneous bilateral lower limb lengthening. The literature published to date is limited regarding outcomes and potential problems. We report on our early experience and raise awareness for the potential of adverse effects from this device. Methods. This is a retrospective review of prospective data collected on all patients treated in our institution using this implant. We report the demographics, nail accuracy, reliability, consolidation index, and cases where concerning clinical and radiological findings were encountered. There were 14 STRYDE nails implanted in nine patients (three male and six female) between June 2019 and September 2020. Mean age at surgery was 33 years (14 to 65). Five patients underwent bilateral lengthening (two femoral and three tibial) and four patients unilateral femoral lengthening for multiple aetiologies. Results. At the time of reporting, eight patients (13 implants) had completed lengthening. Osteolysis and periosteal reaction at the junction of the telescopic nail was evident in nine implants. Five patients experienced localized pain and swelling. Macroscopic appearances following retrieval were consistent with corrosion at the telescopic junction. Tissue histology was consistent with effects of focal metallic wear debris. Conclusion. From our early experience with this implant we have found the process of lengthening to be accurate and reliable with good regenerate formation and consolidation. Proposed advantages of early load bearing and the ability for bilateral lengthening are promising. We have, however, encountered concerning clinical and radiological findings in several patients. We have elected to discontinue its use to allow further investigation into the retrieved implants and patient outcomes from users internationally. Cite this article: Bone Joint J 2021;103-B(6):1168–1172

Currently, different techniques to evaluate the biocompatibility of orthopaedic materials, including two-dimensional (2D) cell culture for metal/ceramic wear debris and floating 2D surfaces or three-dimensional (3D) agarose gels for UHMWPE wear debris, are used. Moreover, cell culture systems evaluate the biological responses of cells to a biomaterial as the combined effect of both particles and ions. We have developed a novel cell culture system suitable for testing the all three type of particles and ions, separately. The method was tested by evaluating the biological responses of human peripheral blood mononuclear cells (PBMNCs) to UHMWPE, cobalt-chromium alloy (CoCr), and Ti64 alloy wear particles. Methods. Clinically relevant sterile UHMWPE, CoCr, and Ti64 wear particles were generated in a pin-on-plate wear simulator. Whole peripheral blood was collected from healthy human donors (ethics approval BIOSCI 10–108, University of Leeds). The PBMNCs were isolated using Lymphoprep (Stemcell, UK) and seeded into the wells of 96-well and 384-well cell culture plates. The plates were then incubated for 24 h in 5% (v/v) CO. 2. at 37°C to allow the attachment of mononuclear phagocytes. Adherent phagocytes were incubated with UHMWPE and CoCr wear debris at volumetric concentrations of 0.5 to 100 µm. 3. particles per cell for 24 h in 5% (v/v) CO. 2. at 37°C. During the incubation of cells with particles, for each assay, two identical plates were set up in two configurations (one upright and one inverted). After incubation, cell viability was measured using the ATPlite assay (Perkin Elmer, UK). Intracellular oxidative stress was measured using the DCFDA-based reactive oxygen species detection assay (Abcam, UK). TNF-α cytokine was measured using sandwich ELISA. DNA damage was measured by alkaline comet assay. The results were expressed as mean ± 95% confidence limits and the data was analysed using one-way ANOVA and Tukey-Kramer post-hoc analysis. Results and Discussion. Cellular uptake of UHMWPE, CoCr and Ti64 particles was confirmed by optical microscopy. PBMNCs incubated with UHMWPE particles did not show any adverse responses except the release of significant levels of TNF-α cytokine at 100 µm. 3. particles per cell, when in contact with particles. PBMNCs incubated with CoCr wear particles showed adverse responses at high particle doses (100 µm. 3. particles per cell) for all the assays. Moreover, cytotoxicity was observed to be a combined effect of both particles and ions, whereas oxidative stress and DNA damage were mostly caused by ions. Ti64 wear particles did not show any adverse responses except cytotoxicity at high particle doses (100 µm. 3. particles per cell). Moreover, this cytotoxicity was mostly found to be a particle effect. In conclusion, the novel cell culture system is suitable for evaluating the biological impact of orthopaedic wear particles and ions, separately

Introduction. Significant reduction in the wear of current orthopaedic bearing materials has made it challenging to isolate wear debris from simulator lubricants. Ceramics such as silicon nitride (SiN), as well as ceramic-like surface coatings on metal substrates have been explored as potential alternatives to conventional implant materials. Current isolation methods were designed for isolating conventional metal, UHMWPE and ceramic wear debris. The objective of this study was to develop methodology for isolation and characterisation of modern ceramic or ceramic-like coating particles and metal wear particles from serum lubricants under ultra-low wearing conditions. Sodium polytungstate (SPT) was used as a novel density gradient medium due to its properties, such as high water solubility, the fact that it is non-toxic and acts as a protein denaturant, coupled with a large density range of 1.1–3.0 g/cm3 in water. Methods. SiN nanoparticles (<50nm nanopowder, Sigma-Aldrich) and clinically relevant cobalt-chromium wear debris were added to 25% (v/v) bovine serum lubricant at concentrations of 0.03 and 0.3 mm3/ million cycles. The particles were isolated by a newly developed method using SPT gradients. The sample volume was reduced by centrifuging the lubricant at 160,000 g for 3 h at 20°C. Then, re-suspended pellet was digested twice with 0.5 mg/ml proteinse K for 18 hours at 50°C in the presence of 0.5% (w/v) SDS. Particles were then isolated from partially hydrolysed proteins by density gradient ultracentrifugation at 270,000 g for 4 h using SPT gradients [Figure 1]. At the end of centrifugation, particles were pelleted at the bottom of the centrifuge tube, leaving protein fragments and other impurities suspended higher up the tube. Isolated particles were then washed with pyrogen free water, dispersed by sonication and filtered through 15 nm polycarbonate membrane filters for SEM and EDX analysis. Results and Discussion. The morphology and size distribution of the SiN and cobalt-chromium particles was not altered after isolation [Figure 2] [Figure 3]. The mode size of the SiN particles was 30–40 nm, while the mode size of cobalt-chromium particles was 10–20 nm [Figure 3]. Unlike current isolation methods, the present study developed a highly sensitive method which uses cost effective commercially available reagents and components. Furthermore, the particles are recovered in solution and can be readily analysed using commercial size analysers, prior to use in cell studies. This study also confirmed the aggregation characteristics of silicon nitride particles in aqueous medium as observed in previous studies. The above method may also be used to isolate wear debris of materials that have density higher than 1.6 g/cm3. This includes the majority of ceramics, metals and ceramic-like coatings used in TJR components such as alumina, zirconia toughened alumina, titanium, chromium nitride coating, titanium nitride coating and chromium carbon nitride coating. Conclusions. The new isolation method successfully isolated silicon nitride nanoparticles and cobalt-chromium wear debris from serum lubricant at ultra-low concentrations of 0.03 mm3/million cycles. Acknowledgements. The research leading to these results has received funding from the European Union's Seventh Framework Programme (FP7/2007-2013) under grant agreement no. GA-310477 LifeLongJoints

A concern of metal on metal hip resurfacing arthroplasty is long term exposure to Cobalt (Co) and Chromium (CR) wear debris from the bearing. This study compares whole blood metal ion levels from patients drawn at one-year following Birmingham Hip Resurfacing (BHR) to levels taken at a minimum 10-year follow-up. A retrospective chart review was conducted to identify all patients who underwent a BHR for osteoarthritis with a minimum 10-year follow-up. Whole blood metal ion levels were drawn at final follow-up in June 2019. These results were compared to values from patients with one-year metal ion levels. Of the 211 patients who received a BHR, 71 patients (54 males and 17 females) had long term metal ion levels assessed (mean follow-up 12.7 +/− 1.4 years). The mean Co and Cr levels for patients with unilateral BHRs (43 males and 13 females) were 3.12 ± 6.31 ug/L and 2.62 ± 2.69 ug/L, respectively, and 2.78 ± 1.02 ug/L and 1.83 ± 0.65 ug/L for patients with bilateral BHRs (11 males and 4 females). Thirty-five patients (27 male and 8 female) had metal-ion levels tested at one-year postoperatively. The mean changes in Co and Cr levels were 2.29 ug/l (p = 0.0919) and 0.57 (p = 0.1612), respectively, at one year compared to long-term. These changes were not statistically significant. This study reveals that whole blood metal ion levels do not change significantly when comparing one-year and ten-year Co and Cr levels. These ion levels appear to reach a steady state at one year. Our results also suggest that regular metal-ion testing as per current Medicines and Healthcare products Regulatory Agency (MHRA) guidelines may be impractical for asymptomatic patients. Metal-ion levels, in and of themselves, may in fact possess little utility in determining the risk of failure and should be paired with radiographic and clinical findings to determine the need for revision

BACKGROUND. The most common salvage of a failed metal-on-metal hip resurfacing is to remove both the femoral and acetabular resurfacing components and perform a total hip replacement. The other choices are to perform an acetabular or femoral only revision. A one or two piece acetabular component or a polyethylene bipolar femoral component that matches the retained metal resurfacing acetabular component is used. The considerations in favor of performing a one component resurfacing revision are maintaining the natural femoral head size, limiting the surgical effort for the patient and surgeon, and bone conservation. There are often favorable cost considerations with single component revision surgery. The reasons for femoral component revision are femoral neck fracture, femoral component loosening and an adverse reaction to metal wear debris. Performing a femoral component only revision requires a well fixed and well oriented acetabular component. Acetabular revision is most often performed for an adverse reaction to metal wear debris or loosening. METHODS. 81 acetabular revisions and 46 femoral revisions were evaluated 4 to 14 years after surgery. 83% of patients had their initial surgery at outside institutions. The mean age was 46 and 65% of patients were women. A two piece titanium backed polyethylene component was used in 44 patients and a one or two piece metal component was used in 37. A dual mobility femoral prosthesis mated to a retained metal acetabular component was used for the femoral revisions and no conversions to a metal-on-metal total hip replacement were performed. We selected polyethylene acetabular components for patients with adverse reactions to metal wear debris if their femoral component was less than 48 mm or if there was no matching metal acetabular component available for their femoral component. We used dual mobility components for femoral loosening, femoral neck fractures and adverse reactions to metal wear debris in patients with well-fixed and well oriented metal acetabular components. Dual mobility components were also used if there are any concerns about the femoral component or in some older patients. We performed one component revisions rather than conversion to total hip replacement on 88% of patients presenting with failed resurfacing prostheses. RESULTS. There were no failures with polyethylene acetabular components. There were two failures due to ongoing adverse metal reactions in patients receiving metal revision acetabular components. There was one failure with a dual mobility prosthesis due to accelerated polyethylene wear from undetected edge loading on a retained worn metal acetabular component. There were two infections and one patient with continued pain. There were no dislocations. The average Harris Hip Score was 94. The UCLA activity score was 6 or greater for all but 4 patients. There were 6 revisions to total hip replacement. The Kaplan-Meier survivorship was 94%. 95% of patients rated their outcome as excellent or good. CONCLUSIONS. Failed metal-on-metal hip resurfacing prostheses can be successfully revised without conversion to total hip replacement in most instances. A detailed knowledge of matching prostheses is necessary. Polyethylene prostheses for the acetabular or femoral reconstruction are often needed

Introduction. When osteoarthritis occurs, joint replacement is the most frequent treatment. Currently, the mean survival rate for total joint arthroplasty is ∼90% after 10 years: the main reason for long-term implant failure, that generally required a revision surgery, are osteolysis and aseptic loosening of the implant, which are strongly correlated with wear debris formation from the UHMWPE insert [Ingham, 2005], as a consequence of the cyclic loading against the metallic or ceramic counterface [Dumbleton, 2002]. Wear debris bring to chronic inflammation of periprosthetic tissues causing an increase of bone reabsorption that finally provoke aseptic loosening, so implant failure[Holt, 2007]. Different solutions were proposed to reduce wear debris production but agreement has not been achieved yet. Our challenging approach prefigures the direct coating of the plastic component with a hard and well-adherent ceramic film, in order to drastically reduce wear debris formation from the plastic substrate while preserving its well-established bulk mechanical properties, especially under high local loads [Bianchi, 2013]. Methods. 3%yttria-stabilized zirconia films were deposited by PPD technique. PPD is a new vapour deposition technique based on the ablation of a target material as a consequence of the impact of a high-energy electron beam. The plasma plume of ablated material is directed toward and deposited onto the substrate. Films were characterized by SEM-EDX, X-ray diffraction, nanoindentation, adhesion and tribological tests. Moreover, capability of ZrO2–UHMWPE system of carrying local loads – i.e. an estimation of the resistance to a third-body abrasion – was investigated. Results. X-ray diffraction measurements revealed that zirconia films grew in cubic phase, while scanning electron microscopy images showed a dense, columnar film microstructure, exhibiting a nanostructured top surface (grain size <500 nm) (Fig. 1). Nanoindentation tests revealed rather high hardness and Young's modulus values (17 GPa and 154 GPa respectively) (Fig. 2), while critical fracture tests revealed that, even under loads as high as 500 mN (equivalent to ∼8 times the maximum pressure exercised on a femoral head during normal walking activity) no lateral cracks, spalling or pile-up phenomena were observable, revealing a high fracture toughness and a very high adhesion degree of the ceramic film to the plastic substrate, despite the large mechanical mismatch between the two materials. Moreover, preliminary tribological tests carried out in air against an alumina ball counterpart showed wear rate as low as 3.2*10. −6. mm3N. −1. m. −1. after 500.000 cycles. Conclusions. We have presented the preliminary results of a novel approach aiming to the drastic reduction of plastic debris release from common joint prostheses. The results showed suggested the feasibility of pursuing this alternative and completely new route to improve UHMPWE performances while preserving its well-established mechanical properties. Hard and well-adherent zirconia films deposited directly on the surface of plastic component of a joint implant will allow a drastic reduction of wear debris production and plastic deformation of the component, without weakening primary and secondary stability of the implant

Traditional procedures for orthopedic total joint replacements have relied upon bone cement to achieve long-term implant fixation. This remains the gold standard in number of procedures including TKR and PKR. In many cases however, implants fixed with cement have proven susceptible to aseptic loosening and 3. rd. body wear concerns. These issues have led to a shift away from cement fixation and towards devices that rely on the natural osteoconductive properties of bone and the ability of porous-coated implants to initiate on-growth and in-growth at the bone interface, leading to more reliable fixation. To facilitate long-term fixation through osseointegration, several mechanical means have been utilized as supplemental mechanism to aid in stabilizing the prostheses. These methods have included integrated keels and bone screws. The intent of these components is to limit implant movement and provide a stable environment for bone ingrowth to occur. Both methods have demonstrated limitations on safety and performance including bone fracture due keel induced stresses, loosening due to inconsistent pressfit of the keel, screw-thread stripping in cancellous bone, head-stripping, screw fracture, screw loosening, and screw pullout. An alternative method of fixation utilizing blade-based anchoring has been developed to overcome these limitations. The bladed-based fixation concept consists of a titanium alloy anchor with a “T-shaped” cross-section and sharped-leading end that can be impacted directly into bone. The profile is configured to have a bladed region on the horizontal crossbar of the “T” for engagement into bone and a solid rail at the other end to mates with a conforming slot on the primary body of the prosthesis. A biased chisel tip is added to the surface of the leading blade edge to draw the bone between the anchor's horizontal surface and surface of the implant, thus generating a compressive force at the bone-to-prothesis interface. The anchoring mechanism has been successfully been integrated into the tibial tray component of a partial knee replacement; an implant component that has a clinical history of revision due to loosening. A detailed investigation into the pulloff strength, wear debris generation, compressive-force properties, and susceptibility to tibial bone fracture was carried out on the anchor technology when integrated in a standard tibial tray of a partial knee replacement. When tested in rigid polyurethane bone foam (Sawbones, Grade 15) the pulloff strength of the construct increased by 360% when utilizing the anchor. The tibial tray and anchor construct were cycled under compressive loading and demonstrated no evidence of interface corrosion or wear debris generation after 1 million cycles. In addition, the anchor mechanism was shown to generate 340N of compressive force at the tibial tray-to-bone interface when evaluated with pressure sensitive film (Fuji Prescale, Medium Grade). Finally, the ultimate compressive load to induce tibial fracture was shown to increase by 17% for the anchored tray as compared to a traditional keeled tray when tested in an anatomic tibial sawbones model; and by 19% when evaluated in human cadaveric tibias. For any figures or tables, please contact authors directly

Introduction. Particle-induced oxidative stress in cells is a unifying factor that determines toxicity and carcinogenicity potential in biomaterials. A previous study by Bladen et al. showed the production of significant levels of reactive oxygen species (ROS) following the stimulation of phagocytes by UHMWPE and CoCr wear debris [1]. Latest generation bearing materials such as silicon nitride also need to be tested for potential generation of ROS in phagocytic cells. This study aimed to investigate the production of reactive oxygen species in L929 fibroblasts stimulated with clinically relevant doses of nanoscale and micron-sized silicon nitride (Si. 3. N. 4. ) particles, silica nanoparticles, and CoCr wear debris. Silica nanoparticles were included as a comparison material for situations where the Si. 3. N. 4. particle's surface are oxidised to silicon dioxide [2]. Materials and Methods. Si. 3. N. 4. particles (<50 nm and <1 µm, Sigma), silica nanopowder (<100 nm, Sigma) and clinically relevant CoCr wear particles were heat-treated at 180°C for 4 h to remove endotoxin. Particles were then re-suspended in sterile water by sonication. L929 murine fibroblasts were cultured with low doses (0.5 µm. 3. /cell) and high doses (50 µm. 3. /cell) of Si. 3. N. 4. particles, and high doses (50 µm. 3. /cell) of silica nanoparticles and CoCr wear debris. Cells were incubated for three and six days at 37°C with 5% (v/v) CO. 2. tert-Butyl hydroperoxide (TBHP) was used as a positive control for the production of ROS in the cells. Intracellular ROS was measured using Image-IT LIVE kit (Invitrogen). This assay is based on carboxy-2',7'-dichlorodihydro-fluorescein diacetate (carboxy-H2DCFDA), which forms a non-fluorescent derivative by intracellular esterases and then reacts with intracellular ROS to form green fluoroscence producing derivative carboxy- dichlorodihydro-fluorescein. Images were captured using a confocal microscope and analysed using ImageJ for corrected total cell fluorescence (CTCF). The results were expressed as mean ± 95% confidence limits and the data was analysed using one-way ANOVA and Tukey-Kramer post-hoc tests. Results and Discussion. Si. 3. N. 4. nanoparticles significantly reduced the ROS levels in L929 fibroblasts at low doses (0.5 μm. 3. /cell) and high doses (50 μm. 3. /cell) over a period of six days; whereas no significant change in the levels of ROS was observed in cells treated with micron-sized Si. 3. N. 4. particles [Figure 1]. Only a few cells treated with high doses of CoCr wear particles (50 μm. 3. /cell) survived for up to six days and produced significantly higher levels of ROS [Figure 1, 2]. Interestingly, cells challenged with high doses (50 μm. 3. /cell) of Si. 3. N. 4. and silica nanoparticles produced statistically similar levels of ROS in cells [Figure 1]. This might be due to the potential surface oxidation of Si. 3. N. 4. nanoparticles, which makes their surface chemistry and biological identity similar to silica nanoparticles. Conclusion. Unlike existing implant materials such as UHMWPE and CoCr, silicon nitride has demonstrated the capacity to reduce or maintain normal levels of ROS in macrophages depending on the particle size and dose. Acknowledgements. The research leading to these results has received funding from the European Union's Seventh Framework Programme (FP7/2007-2013) under grant agreement no. GA-310477 LifeLongJoints

Introduction. The bearing surfaces of ceramic-on-ceramic (CoC) total hip replacements (THR) show a substantially lower wear rate than metal-on-polyethylene (MoP) THR in-vitro. However, revision rates for CoC THR are comparable with MoP. Our hypothesis that an explanation could be adverse reaction to metal debris (ARMD) from the trunnion led us to investigate the wear at both the bearing surfaces and the taper-trunnion interface of a contemporary CoC THR in an in-vitro study. Methods. Three 36mm CoC hips were tested in a hip simulator for 5 million cycles (Mc). BIOLOX. ®. delta ceramic femoral heads were mounted on 12/14 titanium (Ti6Al4V) trunnions. Wear of femoral heads, acetabular liners and trunnions was determined gravimetrically using the analytical balance. Roughness measurements (Sa) were taken on the articulating surfaces (pre and post-test) and on the trunnion surfaces (worn and unworn). Furthermore, Energy Dispersive X-ray Spectroscopy (EDX) was used to identify and quantify the wear debris present in the lubricant using scanning electron microscope (SEM). Results and Discussion. The total volumetric wear was 0.25 mm. 3. for CoC joints and 0.29 mm. 3. for titanium trunnions. The total wear volume of the titanium trunnions was in agreement with an explant study (Kocagoz et al, 2016, CORR) which quantified the volumetric material loss from retrieved trunnions with the total wear ranging from 0.0–0.74 mm. 3. The Sa values, pre-and post-test, for heads were 0.003 ± 0.002 and 0.004 ± 0.001 µm and for liners were 0.005 ± 0.001 and 0.005 ± 0.001 µm. Pre-and post-test measurements for Sa of heads (p = 0.184) and liners (p = 0.184) did not show a statistically significant change. The Sa of the trunnions on the unworn and worn areas showed a statistically significant decrease from 0.558 ± 0.060 to 0.312 ± 0.028 µm respectively (p < 0.001). Analysis of wear debris within the lubricant confirmed the presence of titanium. A recent clinical study (Matharu et al, 2016, BMC Musc Dis) found more ARMD in CoC hips than MoP hips. This is despite there being fewer metallic components in a CoC hip than a MoP hip. This in vitro study has shown that one source of metal debris in a CoC hip is the taper-trunnion junction. Conclusion. An explanation for wear related failures in ceramic-on-ceramic hip arthroplasty, despite the low wear arising at the articulating surfaces, may now exist; namely that titanium wear particles are generated from the trunnion. No other long-term hip simulator studies have measured wear at the taper-trunnion junction

Introduction. The STRYDE nail is an evolution of the PRECICE Intramedullary Limb Lengthening System, with unique features regarding its composition. It is designed for load bearing throughout treatment in order to improve patient experience and outcomes and allow for simultaneous bilateral lower limb lengthening. The literature published to date is limited with regards to both outcomes and potential issues. In this paper we report on our early experience and raise awareness for the potential of adverse effects from this device. Materials and Methods. This is a review of all patients treated in our institution using this implant. Data were prospectively recorded. We report on demographics, nail accuracy, reliability, consolidation index and cases where concerning clinical and radiological findings were encountered. Results. 14 Stryde nails were implanted in nine patients (three males and six females) between June 2019 and September 2020. Mean age at surgery was 33 years old (14–65 years old). Five patients underwent bilateral lengthening (two femoral and three tibial) and four patients unilateral femoral lengthening for multiple aetiologies. By the time of this report eight patients (13 implants) had completed lengthening. Osteolysis and periosteal reaction at the junction of the telescopic nail was evident in nine implants. Five patients experienced localised pain and swelling. Macroscopic appearances following retrieval were consistent with corrosion at the telescopic junction. Tissue histology was consistent with effects of focal metallic wear debris. Conclusions. From our early experience with this implant we have found the process of lengthening to be accurate and reliable with good regenerate formation and consolidation. Proposed advantages of early load bearing and the ability for bilateral lengthening are promising. We have, however, encountered cases with concerning clinical and radiological findings. We have elected to discontinue its use to allow further investigation into the retrieved implants and patient outcomes from users internationally

Introduction. Experimental wear simulation of an all-polymer knee implant has shown an equivalent rate of wear of UHMWPE tibial components against PEEK-OPTIMA™ and cobalt chrome femoral components of a similar initial geometry and surface topography. However, when the patella is resurfaced with an UHMWPE patella button, it is important to also ascertain the wear of the patella. Wear debris from the patella contributes to the total volume of wear debris produced by the implant which should be minimised to reduce the potential for osteolysis and subsequent implant loosening. The aim of this study was to investigate the wear of the patellofemoral joint in an all-polymer knee implant. The wear of UHMWPE patellae articulating against PEEK-OPTIMA™ femoral components was compared to UHMWPE articulating against cobalt chrome femoral components. Materials and Methods. Six mid-size (size C) PEEK-OPTIMA™ femoral components (Invibio Knee Ltd., UK) and six cobalt chrome femoral components of similar initial surface topography and geometry were coupled with 28mm all-polyethylene GUR1020 patellae (conventional, EO sterile) (Maxx Orthopaedics, USA). The implants were set up in a ProSim 6 station electromechanical knee simulator (Simulation Solutions, UK) which was modified for testing the patellofemoral joint. 3 million cycles (MC) of wear simulation was carried out under kinematics aiming to replicate a gait cycle adapted for an electromechanical simulator from previous work by Maiti et al. The simulator used has six degrees of freedom of which four were controlled; axial force up to 1200N, flexion/extension 22°, superior-inferior (SI) displacement (22mm) and Abduction-adduction (AA) (4°). The SI and AA were displacement controlled and driven through the patella. The medial-lateral displacement and tilt (internal/external rotation) of the patella were passive so the patella button was free to track the trochlear groove. The lubricant used was 25% bovine serum supplemented with 0.03% sodium azide to retard bacterial growth. The wear of patellae was determined gravimetrically with unloaded soak controls used to compensate for the uptake of moisture by the UHMWPE. The mean wear rate ± 95% confidence limits were calculated and statistical analysis was carried out using ANOVA with significance taken at p<0.05. Results. The mean wear rates of the UHMWPE patellae were 0.26±0.21 mm. 3. /MC and 0.35±0.17 mm. 3. /MC against PEEK-OPTIMA™ and cobalt chrome femoral components respectively. There was no significant difference in wear rate against the different femoral component materials (P=0.38). Against both femoral component materials, a ‘bow tie’ shaped wear scar was evident on the patellae typical of that seen in retrieval studies and reported in previous experimental wear simulation of the patellofemoral joint. Conclusion. The wear rate of the UHMWPE patellae was low against both PEEK-OPTIMA™ and cobalt chrome femoral components and comparable to previous work by Vanbiervliet et al. This study further shows that in terms of its wear performance, PEEK-OPTIMA™ has promise as an alternative bearing material to cobalt chrome in the femoral component of total knee replacements

Introduction. Wear debris and metal ions originating from metal on metal hip replacements have been widely shown to recruit and activate macrophages. These cells secrete chemokines and pro-inflammatory cytokines that lead to an adverse local tissue reaction (ALTR), frequently requiring early revision. The mechanism for this response is still poorly understood. It is well documented that cobalt gives rise to apoptosis, necrosis and reactive oxygen species generation. Additionally, cobalt stimulates T cell migration, although the effect on macrophage motility remains unknown. This study tests the hypothesis that cobalt ions and nanoparticles affect macrophage migration stimulating an ALTR. Methods. This study used Co. 2+. ions (200µM) and cobalt nanoparticles (CoNPs, 100µM, 2–60nm diameter). PMA differentiation of the U937 cell line was used as macrophage-like cells. The effect of cobalt on macrophage migration was investigated by live cell imaging. After 12 hours of each treatment, timelapse images of 20 cells were collected over a 6 hour period with images captured every 5 min. Migration of individual cells was tracked in 2D using ImageJ software. The transwell migration assay was also applied to study the effect of cobalt on macrophage directional migration. U937 cells in serum free medium were added to the upper chamber of a 8µm pore size Transwell insert in the presence of cobalt, whilst the lower chamber was filled with medium plus 10% FBS. After 6 hours treatment, cells remaining on the membrane were fixed, stained with crystal violet and counted. Cellular F-actin and podosomes were visualized by labeling with TRITCconjugated phalloidin and anti-vinculin antibody after 12 hours of cobalt exposure (Co. 2+. and CoNPs). Results. Cells incubated with cobalt ions and nanoparticles showed a substantial reduction in cell migration compared with control cells. The total migration path length of cells treated with Co. 2+. (362.4±96.6µm) and CoNPs (217.3±128.1µm) were significantly shorter than those for untreated cells (801.1±198.3µm). The ability of macrophages to migrate through the transwell membrane was significantly impaired by pre-treatment with cobalt, with 16±4 and 18± migrated cells/field for Co. 2+. and CoNPs respectively with the control at 42±7 migrated cells/field. In addition, cobalt influenced macrophage morphology and actin cytoskeletal organization with a dramatic increase in the presence of intracellular podosome-type adhesions structure. Discussion. Co. 2+. ions and nanoparticles dramatically inhibited the migration of U937 macrophages in contrast to the enhanced migration reported for T cells. We propose that macrophages recruited into the area of CoCr implants would lose their responsiveness to migration signals and be retained in situ due to cobalt-induced cytoskeleton rearrangement. This enhanced macrophage accumulation and cobalt-induced formation of podosomes may therefore represent a mechanism through which cobalt wear debris and metal ions from joint prostheses exacerbate the ALTR leading to revision surgery