INTRODUCTION. Joint replacement is one of the most common orthopaedic procedures, with over 2 million surgeries performed each year across the globe. Loss of implant fixation, or aseptic loosening, is the leading cause of revision following primary joint replacement, accounting for ∼25% of all revision cases [1]. However, diagnosis of aseptic loosening and its underlying causes remain challenging due to the low sensitivity and specificity of plain radiographs. To address this, we propose a novel approach inspired by [2] involving the use of a self-sensing bone cement (by imparting strain-dependent electrical conductivity or piezoresistivity) combined with electrical impedance tomography (EIT). Piezoresistivity is imparted to cement via incorporation of micro/nanoscale conductive fillers. Therefore mechanical effects such as loosening and cracks will manifest as a conductivity change of the cement. This work explores if EIT is able to detect strains and cracks within the bone cement volume. METHODS. Experiments were designed to determine whether EIT combined with piezoresistive cement can be used to detect strains and cracks (Fig. 1). The setup consists of a tank filled with water, 16 electrodes, sample, a loading machine (MTS), and an EIT system. To develop the piezoresistive bone cement, microscale carbon fibers were used with varying CF/PMMA volumetric ratios (VR) from VR = 0.25% to 3.0%. Three conical samples were made to model a loading condition similar to knee implants (Fig. 1). The samples were compressed while the conductivity map of the tank was measured with the EIT system. RESULTS. Figure 2 shows the conductivity of the piezoresistive bone cement with respect to the CF/PMMA VR, the percolation happens at VR = 1.0% and the maximum gradient occurs at VR = 1.5%. Three conical samples were built and experimented to examine the hypothesis. The samples were loaded from F = 0 to F = 4000 N for the strain measurement and then loaded until the first crack initiates. Figure 3 (a) and (b) show the conductivity difference map measured by EIT for strain measurement and crack detection respectively. It can be seen in Fig. 3(a) that due to the shear stresses within the bone cement the conductivity of the sample decreases under compression. At the crack initiation the conductivity of the samples increases significantly (Fig. 3(b)). Figure 3(c) shows evolution of sample conductivity difference measured by EIT as a function of the applied load, VR = 1.5% shows the largest sensitivity. DISCUSSION. The results validate our hypothesis; both cracks and strains resulted in electrical conductivity changes measurable by EIT. While these initial results are encouraging, the approach must be validated via testing of surrogate and cadaver bones in an EIT phantom. If successful, this approach could for the first time provide means of in-vivo studying of aseptic loosening, leading to a paradigm shift in the understanding of this important clinical problem. For any figures or tables, please contact the authors directly

Introduction. Total hip replacement with metal-on-polymer (MoP) hip prostheses is a successful treatment for late-stage osteoarthritis. However, the wear debris generated from the polymer acetabular liners remains a problem as it can be associated with osteolysis and aseptic loosening of the implant. This has led to the investigation of more wear resistant polymers in orthopaedics. Cross-linked polyethylene (XLPE) is now the gold-standard acetabular liner material. However, we asked if carbon fibre reinforced polyether ether ketone (CFR-PEEK) might be a lower wear material. In addition, we sought to understand the influence of contact stress on the wear of both XLPE and CFR-PEEK as this has not previously been reported. Materials and Methods. A 50-station circularly translating pin-on-disc (SuperCTPOD) machine was used to wear test both XLPE and CFR-PEEK pins against cobalt chromium (CoCr) discs to investigate the influence of contact stress on their wear rates. Fifty XLPE and 50 CFR-PEEK pins were articulated against CoCr discs. The pins, 9 mm in outer diameter and 12 mm in height, were drilled with different diameter holes to generate different sized annuli and thus, different contact areas. The pins were tested at 1.10, 1.38, 1.61, 2.00 and 5.30 MPa, which are typical contact stresses observed in the natural hip joint. An additional pin for every test group was used as a control to track the lubricant uptake. The discs were polished to 0.015 μm Sa prior to testing. The test stations contained 16 ml of diluted newborn calf serum (protein concentration: 22 g/L). Wear was measured gravimetrically with a balance (resolution: 10 μm) every 500,000 cycles. A standardised cleaning and weighing protocol was followed. Results and Discussion. The wear rates for the XLPE pins were calculated as 1.05, 0.90, 0.77, 0.48 and 0.28 mg/million cycles for the different pin stress groups respectively. The wear rates decreased with increasing contact stress, which was similar to what was observed for ultra-high molecular weight polyethylene (UHMWPE). The change in weight of the discs was insignificant (p-value:0.85). For the CFR-PEEK pin groups, the wear rates were calculated as 0.56, 0.65, 0.61, 0.58 and 0.65 mg/million cycles respectively. The difference between the wear rates was insignificant (p-value: 0.92). However, the weight of the discs decreased significantly (p-value: 0.00). At 1.11 MPa and taking data for UHMWPE tested in the same way, comparison of the three polymers showed that CFR-PEEK produced the lowest wear against CoCr. Although the wear rates for CFR-PEEK were found to be the lowest, the decrease in weight of the CoCr discs articulated against CFR-PEEK was indicative of metallic wear. Conclusion. CFR-PEEK should not be used against orthopaedic metals. XLPE articulating against CoCr was found to be the optimum combination, producing low wear without causing weight change from the counterface, under varying contact stresses

Introduction. The complex cellular mechanisms of the aseptic loosening of total joint arthroplasties still remain not completely understood in detail. Especially the role of adherent endotoxins in this process remains unclear, as lipopolysaccharides (LPS) are known to be very potent modulators of the cell response on wear particle debris. Contributing factors on the LPS affinity of used orthopedic biomaterials as their surface roughness have to be investigated. The aim of this study was to evaluate the affinity of LPS on the surface roughness of different biomaterials in vitro. The hypothesis of the study was that rough surfaces bind more LPS than smooth surfaces. Materials and methods. Cubes with a side length from ultra-high-molecular-weight-polyethylene (UHMWPE), crosslinked polytethylene (XPE), carbon fibre reinforced poly-ether-ether-ketone (CFR-PEEK), titanium, titanium alloy, Polymethyl methacrylate (PMMA), implant steel (CoCr) and instrument steel (BC) were produced (figure 1). Cubes of each material have been produced with a rough and a smooth surface. Before the testings, all cubes and used materials were treated with E-Toxa-Clean(®) to eliminate pre-existing LPS on the used surfaces. The cubes were then fixed on the cap of a glass that was filled with a LPS solution with a concentration of 5 IE/ml. After 30 minutes the cube was removed and the LPS concentration in the supernatant was measured. The endotoxin content of each sample was evaluated by a Limulus Amoebocyte Lysate (LAL) - Test (Lonza, Verviers, Belgium). The detection level of endotoxin was set at < 0.005 EU/ml diluted 1/10. Results. All tested rough biomaterials showed a higher affinity to LPS compared to the smooth surfaces. Conclusion. The initial hypothesis could be confirmed. The results prove that rough and therefore larger surfaces bind more LPS than smooth surfaces. A rough surfaces correlates with a larger total surface of the used biomaterial. In this context protheses should be avoided that show a large rough surface, as these endoprostheses might bind more LPS and trigger an enhanced inflammatory reaction that results in an early aseptic loosening

Introduction. In total hip arthroplasty, press-fit anchorage is one of the most common fixation methods for acetabular cups and mostly ensures sufficient primary stability. Nevertheless, implants may fail due to aseptic loosening over time, especially when the surrounding bone is affected by stress-shielding. The use of acetabular cups made of isoelastic materials might help to avoid stress-shielding and osteolysis. The aim of the present numerical study was to determine whether a modular acetabular cup with a shell made of polyetheretherketone (PEEK) may be an alternative to conventional titanium shells (Ti6Al4V). For this purpose, a 3D finite element analysis was performed, in which the implantation of modular acetabular cups into an artificial bone stock using shells made of either PEEK or Ti6Al4V, was simulated with respect to stresses and deformations within the implants. Methods. The implantation of a modular cup, consisting of a shell made of PEEK or Ti6Al4V and an insert made of either ceramic or polyethylene (PE), into a bone cavity made of polyurethane foam (20 pcf), was analysed by 3D finite element simulation. A two-point clamping cavity was chosen to represent a worst-case situation in terms of shell deformation. Five materials were considered; with Ti6Al4V and ceramic being defined as linear elastic and PE and PEEK as plastic materials. The artificial bone stock was simulated as a crushable foam. Contacts were generated between the cavity and shell (μ = 0.5) and between the shell and insert (μ = 0.16). In total, the FE models consisted of 45,282 linear hexahedron elements and the implantation process was simulated in four steps: 1. Displacement driven insertion of the cup; 2. Relief of the cup; 3. Displacement driven placement of the insert; 4. Load driven insertion of the insert (maximum push-in force of 500 N). The FE model was evaluated with respect to the radial deformations of the shell and insert as well as the principal stresses in case of the ceramic inserts. The model was experimentally validated via comparison of nominal strains of the titanium shells. Results. The maximum radial deformation of the shell made of PEEK was 581 μm (insertion) and 470 μm (relief) and therefore multiple times higher compared to the Ti6Al4V shell (42 μm and 21 μm). As a result, larger deformations occurred at the PE and ceramic inserts in combination with the PEEK shell. Partially, the deformations were above an usual clearance of 100 μm. When the ceramic insert was combined with the shell made of PEEK, maximum principal stresses in the ceramic insert amounted to 30 MPa and were clearly lower than approved bending strength of the ceramic material (948 MPa). Conclusion. The examined acetabular shell made of PEEK was intensively deformed during insertion compared to the geometrically identical Ti6Al4V shell and is therefore not suitable for modular acetabular cups. In future studies it should be clarified to what extent acetabular cups with shells made of carbon fiber reinforced PEEK materials with higher stiffness lead to reduced deformations during the insertion procedure

Introduction. The complex process of inflammation and osteolysis due to wear particles still is not understood in detail. So far, Ultra-high-molecular-weight-polyethylene (UHMWPE) is the bearing material of choice in knee arthroplasty and revision knee arthroplasty, but there is a growing demand for alternative bearing materials with improved wear properties. Lately, increasing interest developed in the use of natural and carbon-fiber-reinforced-poly-ether-ether-ketones (CFR-PEEK). While there is a lack of data concerning the effects of CFR-PEEK particles on human tissue, the effects of such wear debris in vitro and in animal studies is controversially discussed. The aim of this study was to analyze human tissue containing CFR-PEEK as well as UHMWPE wear debris. The authors hypothesized no difference between the used biomaterials because of similar size parameters of the wear particles in a prior knee simulator study of this implant. Methods and Materials. Synovial tissue samples of 10 patients while knee revision surgery of a rotating hinge knee implant design (Enduro®, Aesculap, Germany) were achieved. The tibial inserts of this design were made from UHMWPE (GUR 1020), whereas the bushings and flanges are made of CFR-PEEK containing 30% polyacrylonitrile (PAN) based carbon fibers (PEEK-Optima LT1, Invibio Ltd. Thornton-Cleveleys, UK). In a prior in vitro test most of the released CFR-PEEK particles were in a size range between 0.1 and 2μm. The implant survival until revision surgery was 22 (2.5–48 min.-max.) months. As a control synovial tissue out of a patient also got knee revision surgery without any PEEK components. The tissue was fixed with 4% paraformaldehyde, embedded in paraffin, sliced into 2 µm thick sections. stained with hematoxylin and eosin in a standard process. A modified panoptical staining (preincubation in propylenglycol; >3h; 35°C) was also done which stained the UHMWPE particles turquoise. The study was approved by the ethics committee of the local university. Results. Overall, histologically a “wear-type” reaction was seen in the testing and the control group similar as described for other materials in the common literature. In all samples of the testing group the UHMWPE particles were scattered in the tissue similar to the control. Larger UHWMPE particles were incorporated in giant cells. In contrast to these findings, CFR-PEEK particles were not scattered in tissue but located only as conglomerates. In addition, these conglomerates have been found exclusively near to or in vessels. Furthermore, CFR-PEEK particles were collected in macrophages, no CFR-PEEK particles were seen in giant cells. In conclusion, the hypothesis has to be rejected. Interestingely, different behaviour of UHMWPE and PEEK particles has been found in human synovial tissue. This aspect needs further investigation concerning the cytokine expression and also the surface texture of particles. Acknowledgement. This study was supported by Aesculap, Germany

Introduction. Hip replacements are falling short of matching the life expectancy of coxarthritis patients, due to implanting THR in younger patients and due to increasingly active patients. The most frequently implanted hip prostheses use cross linked (XL) polyethylene (PE) on metal bearings in the USA and most of the Western world. Concerns remain in the long term around the potential of wear debris-induced aseptic loosening. Thus exploring lower-wearing alternative bearings remains a major research goal. PEEK (poly-ether-ether-ketone) is a thermoplastic polymer with enhanced mechanical properties. This study compared the wear of PEEK to the wear of cross linked polyethylene, when sliding against cobalt chrome (CoCr) metallic counterfaces, and compared the wear of carbon-fibre reinforced (CFR)-PEEK to cross linked polyethylene when sliding against metallic and ceramic counterfaces under different contact stresses within the hip joint. Methods. The following materials were studied: unfilled PEEK (OPTIMA, Invibio) and CFR-PEEK (MOTIS, Invibio) against either high carbon (HC) CoCr or Biolox Delta ceramic plates. The comparative control material was a moderately cross-linked PE (Marathon, DePuy Synthes). A simple geometry wear study was undertaken. A rotational motion of ±30° across a sliding distance of ±28 mm (cross shear of 0.087), and contact pressures of 1.6 or 4 MPa were applied. The lubricant was 25% (v/v) bovine serum and the wear test was conducted for 1 million cycles at 1 Hz. Wear was assessed gravimetrically. A validated soak control method was used to adjust for serum absorption-induced mass changes during the wear test. Surface profilometry was assessed pre and post wear test. Results. Unfilled PEEK produced a six-fold higher wear factor than XL PE against HC Co Cr (p value <0.0001). CFR-PEEK vs. Biolox Delta produced a two-fold lower wear factor than XL PEvs. HC Co Cr (p value = 0.003). CFR-PEEK vs. Biolox Delta had the lowest wear factor among all studied combinations. The wear of CFR-PEEK vs. HC CoCr was higher than XL PEvs. HC CoCr (Figure 1). The counterface surfaces were scratched when articulating against CFR-PEEK. This was more evident on CoCr plates, with the average surface roughness increasing from 0.005 µm to 0.32 µm (p value = 0.0048). This might explain the accelerated wear in the CFR-PEEK vs. HC CoCr combinations. Higher contact pressures led to a 30 % reduction in the wear factor of CFR-PEEK vs. Biolox Delta combination (p value = 0.048), while no significant impact was noted against HC CoCr (Figure 2). Conclusions. The injection moulded carbon fibre reinforced PEEK vs. Biolox Delta ceramic generated significantly lower wear compared with XL PE (even under higher contact pressures). CFR-PEEK vs. Biolox Delta may lead to longer lasting hip replacements, and will be the subject of further investigations

Purpose. Radiostereometric Analysis (RSA) is a well developed imaging technique used to estimate implant fixation of orthopaedic implants in randomized clinical trials. The precision of RSA depends on a number of factors including image quality related to the individual modality properties. This study assesses the precision of RSA with a novel Digital Radiography (DR) system compared to a CR imaging system using different imaging techniques. Additionally, the study assesses the precision of locating beads embedded in a modified spine pedicle screw. Method. A modified titanium spinal pedicle screw 4.5 mm diameter, 35 mm length, marked with two 1.0 mm tantalum beads, one inside the head and one near the screw tip was inserted into a bovine tibia segment. Six additional 1.0 mm tantalum beads were inserted into the bone segment – superiorly, distally and adjacent to the pedicle screw. The phantom was placed on a standard clinical diagnostic imaging bed above a custom RSA carbon fiber calibration cage (Halifax Biomedical Inc.). A pair of DR or CR imaging plates were placed below the calibration cage and irradiated 15 times at 100, 125 kV at 2.5 mAs. To determine precision, the standard deviation of 3D vector distances between beads was determined using RSA for each of the different imaging parameters. Results. The precision error (PE), defined as the standard deviation of the 3D Bone Marker marker locations for CR is 35.5 m for 100kV at 0.5 mAs setting and 42.2, 39.4, and 26.7 m for the 2.5 mAs at 100, 125, and 150 kV settings respectively. However, for DR, the PE is 27.5 m for 100kV at 0.5 mAs setting and 25.7, 25.1, and 20.1 m for the 2.5 mAs at 100, 125, and 150 kV settings. The PE for Screw Marker 3D locations, for CR is 38.2 m for the 100kV at 0.5 mAs setting and 55.2, 47.3, and 37.1 m for the 2.5 mAs at 100, 125, and 150 kV settings respectively. However for DR, the PE is 40.3 m for 100kV at 0.5 mAs setting and 33.2, 24.9, and 17.0 m for the 2.5 mAs at 100, 125, and 150 kV settings respectively. The PE for all Bone Marker and Screw Marker 3D locations were significantly lower (P<0.05) for the DR technology than the CR technology except at the 100kV at 0.5 mAs exposure of the Screw Marker, P = 0.589. Conclusion. The PE decreases for increasing kV, especially in the case of screw markers where the error goes from 33 micron (100kV) to 17 micron (150 kV). Increasing the mAs reduces the error for the DR, but increases the error for CR. Increasing the kV did not significantly influence the precision in measuring bead locations in bone. For embedded tantalum beads within a titanium pedicle screw, imaging at higher kV values with the described DR imaging system did allow more precise localization. The current phantom design is basic in nature and does not account for any soft tissue scatter. However, initial results indicate a gain in precision when using DR compared to CR imaging equipment for RSA analysis

Introduction. Radiostereometric Analysis (RSA) is an imaging method that is increasingly being utilized for monitoring fixation of orthopaedic implants in randomized clinical trials. Extensive RSA research has been conducted over the last 35+ years using standard clinical x-ray acquisition modalities that irradiate screen/film media or Computed Radiography (CR) plates. The precision of RSA can depend on a number of factors including modality image quality. Objective. This study assesses the precision of RSA with a novel Digital Radiography (DR) system compared to a CR imaging system using different imaging techniques. Additionally, the study assesses the precision of locating beads embedded in a modified spine pedicle screw. Methods. A modified titanium spinal pedicle screw 4.5 mm diameter, 35 mm length, marked with two 1.0 mm tantalum beads, one inside the head and one near the screw tip was inserted into a bovine tibia segment. Six additional 1.0 mm tantalum beads were inserted into the bone segment superiorly, distally and adjacent to the pedicle screw. The phantom was placed on a standard clinical diagnostic imaging bed above a custom RSA carbon fiber calibration cage (Halifax Biomedical Inc.). A pair of DR or CR imaging plates were placed below the calibration cage and irradiated 8 times at 100, 125 kV at 2.5 mAs. For DR additional test were performed at 150 kV, and again at 100 kV at 0.5 mAs. At the time of abstract submission CR results at these settings were not available. To determine precision, the standard deviation of 3D vector distances between beads was determined using RSA for each of the different imaging parameters. Results. Standard deviations of the inter-bead distances measured in the pedicle screw were 44.4 and 32.1 μm (N=8) respectively for the 100 and 125 kV settings at 2.5 mAs using the DR system, compared to 109.0, 55.8 μm for CR [Fig. 1]. The distances between the bone implanted beads provided standard deviations of 24.4 and 22.7 μm respectively for the 100 and 125 kV settings at 2.5 mAs using the DR system, compared to 33.1 and 33.0 μm with the CR system. Further increasing the photon energy to 150 kV with the DR system reduces the precision error to 22.4 μm in the pedicle screw and remains approximately the same at 21.0 μm in bone. Lowering the mAs while maintaining 100 kV increases the precision error in the pedicle screw (64 μm) and showed no significant difference in bone (24.4 μm). Conclusion. The current phantom design is basic in nature and does not account for any soft tissue scatter. However, initial results indicate a considerable reduction in precision error when using DR compared to CR imaging equipment for RSA analysis. Increasing the kV did not significantly influence the precision in measuring bead locations in bone. For embedded tantalum beads within a titanium pedicle screw, imaging at higher kV values with the described DR imaging system did allow more precise localization. This approach may be useful in assessing the in vivo position of spine or other titanium implants