Objectives. There remains conflicting evidence regarding cortical bone strength following bisphosphonate therapy. As part of a study to assess the effects of bisphosphonate treatment on the healing of rat tibial fractures, the mechanical properties and radiological density of the uninjured contralateral tibia was assessed. Methods. Skeletally mature aged rats were used. A total of 14 rats received 1µg/kg ibandronate (iban) daily and 17 rats received 1 ml 0.9% sodium chloride (control) daily. Stress at failure and toughness of the tibial diaphysis were calculated following four-point bending tests. Results. Uninjured cortical bone in the iban group had a significantly greater mean (standard deviation (. sd. )), p < 0.001, stress at failure of 219.2 MPa (. sd. 45.99) compared with the control group (169.46 MPa (. sd. 43.32)) following only nine weeks of therapy. Despite this, the cortical bone toughness and work to failure was similar. There was no significant difference in radiological density or physical dimensions of the cortical bone. Conclusions. Iban therapy increases the stress at failure of uninjured cortical bone. This has relevance when normalising the strength of repair in a limb when comparing it with the unfractured limb. However, the 20% increase in stress at failure with iban therapy needs to be interpreted with caution as there was no corresponding increase in toughness or work to failure. Further research is required in this area, especially with the increasing clinical burden of low-energy diaphyseal femoral fractures following prolonged use of bisphosphonates. Cite this article: Bone Joint Res 2015;4:99–104

Introduction. In vivo, UHMWPE bearing surfaces are subject to wear and oxidation that can lead to bearing fatigue or fracture. A prior study in our laboratory of early antioxidant (AO) polyethylene retrievals, compared to gamma-sterilized and highly cross-linked (HXL) retrievals, showed them to be more effective at preventing in vivo oxidation. The current analysis expands that early study, addressing the effect of:. manufacturing-variables on as-manufactured UHMWPE;. in vivo time on these initial properties;. identifying important factors in selecting UHMWPE for the hip or knee. Methods. After our prior report, our IRB-approved retrieval laboratory received an additional 96 consecutive AO-retrievals (19 hips, 77 knees: in vivo time 0–6.7 years) of three currently-marketed AO-polyethylenes. These retrievals represented two different antioxidants (Vitamin E and Covernox) and two different delivery methods: blending-prior-to and diffusing-after irradiation cross-linking. Consecutive HXL acetabular and tibial inserts, received at retrieval, with in vivo time of 0–6.7 years (260 remelted, 170 annealed) were used for comparison with AO-retrievals. All retrievals were analyzed for oxidation and trans-vinylene index (TVI) using a Thermo-Scientific iN10 FTIR microscope. Mechanical properties were evaluated for 35 tibial inserts by uniaxial tensile testing using an INSTRON load frame. Cross-link density (n=289) was measured using a previously published gravimetric gel swell technique. Oxidation was reported as maximum ketone oxidation index (KOI) measured for each bearing. TVI was reported as the average of all scans for each material. Cross-link density and mechanical properties were evaluated as a function of both TVI and oxidation. Results. Minimal increase in oxidation was seen in these AO-retrievals, out to almost 7 years in vivo. In contrast, HXL-retrievals showed increasing KOI with time in vivo (annealed-HXL = 0.127/year, remelted-HXL = 0.036/year, p<0.001). HXL oxidation rate was higher in knees (0.091/year) than in hips (0.048/year), p<0.001. Cross-link density (XLD) correlated positively with TVI for both HXL (Pearson's correlation=0.591, p<0.001) and AO (Pearson's correlation=0.598, p<0.001) retrievals. AO-materials had higher TVI for the same or similar XLD than did HXL polyethylene. XLD correlated negatively with KOI for HXL retrievals (Pearson's correlation=−0.447, p<0.001). Mechanical properties varied by material across all materials evaluated, with tensile toughness correlating negatively with increasing TVI (Pearson Correlation=−0.795, p<0.001). Discussion. Irradiation cross-linking has been used effectively to improve wear resistance. Residual free radicals from irradiation are the target of AO-polyethylene, to prevent loss of UHMWPE XLD, resulting from in vivo oxidation of free radicals as seen in HXL retrievals, and toughness, resulting from oxidation or initial remelting. Despite different manufacturing variables, AO-polyethylene retrievals in this cohort had minimal oxidation and no change in XLD or toughness due to oxidation. However, toughness did vary with irradiation dose as did cross-link density. To achieve the same level of cross-linking as HXL-polyethylene required a higher irradiation dose in blended AO-polyethylene. AO-polyethylenes evaluated in this study had toughness that decreased with irradiation dose, but avoided loss of toughness due to remelting. Because AO-polyethylenes did not oxidize, they did not show the decrease of cross-link density, and potential loss of wear resistance, seen in HXL-polyethylene. For any figures or tables, please contact authors directly

Introduction. Bone fracture toughness is an important parameter in resistance of bone to monotonic and fatigue failure. Earlier studies on bone fracture toughness were focused on either cortical or cancellous bone, separately [1, 2]. Reported fracture toughness values indicated that cortical bone is tougher to break as compared to cancellous bone. In order to understand complete fracture of a whole bone, the interface between cortical and cancellous bone (named as corticellous bone) might play a crucial role and is interesting topic of research. The goal of this study was to identify fracture toughness in terms of J integral and fracture mechanism of the corticellous bone. Material and Methods. Corticellous bone samples (single edge notch bend specimen or SENB) were prepared from bovine proximal femur according to ASTM E399-90 standard (Fig.1). For corticellous bone, samples were prepared in such way that approximately half of the sample width consist of cortical bone and another half is cancellous bone. Precaution was taken while giving notch and pre-crack to corticellous bone that pre-crack should not enter from cortical to cancellous portion. All specimens were tested using a universal testing machine (Tinius Olsen, ± 100 N) under displacement rate of 100 µm/min until well beyond yield point. The fracture toughness parameter in terms of critical stress intensity (K. IC. ) was calculated according to ASTM E399-90 as given by, . (1). K. IC. =. PS. /. BW. 1.5. *. f. (. a. /. W. ). …. Where, P = applied load in kN, S = loading span in cm, B = specimen thickness in cm, W = specimen width in cm, a = total crack length, f(a/W) = geometric function. After the fracture test the J integral of each specimen was calculated using following equation. [ASTM E1820]. . (2). J. total. =. J. el. +. J. pl. =. K. IC. 2. /. E. ′. +. 2. A. pl. /. Bb. 0. …. Where, J. el. is J integral of the elastic deformation, J. pl. is J integral of the plastic deformation, E′=E for plane stress condition and E′= E/(1−ν. 2. ) for plane strain condition (E is elastic modulus; ν is Poisson's ratio), b. o. = W−a. o. , height of the un-cracked ligament, and A. pl. is the area of the plastic deformation part in the load–displacement curve. Result and Discussion. The fracture toughness in terms of critical stress intensity (K. IC. ) of corticellous bone was found to be 2.45 MPa.m. 1/2. The plastic part of J integral, J. pl. value of corticellous specimen was 9310 Jm. −2. , and shown to be 27 times of the J. el. value, 341 Jm. −. 2. Total J integral of corticellous bone was found to be 9651 Jm. −2. When crack travels through cortical portion and reaches at the interface, crack branching occurred and further it slows down (Fig.2). Indeed, more energy is required in plastic than elastic deformation. Conclusion. J integral of corticellous bone is found to higher which is due to plastic deformation and crack branches at the interface between cortical and cancellous bone. For any figures or tables, please contact the authors directly

Introduction. The in vivo evolution of surface material properties is important in determining the longevity of bioceramics. Fracture toughness is particularly relevant because of its role in wear resistance. Some bioceramics, such as zirconia (ZrO2) undergo in vivo phase transformation, resulting in a marked reduction in toughness and commensurate increased wear. Here, we investigated the effect of accelerated aging on the surface toughness of alumina (Al2O3), zirconia-toughened alumina (ZTA), and silicon nitride (Si3N4) femoral heads, in order to identify the optimal ceramic material for in vivo implantation and long-term durability. Materials. A newly developed Raman microprobe-assisted indentation method was applied to evaluate and compare surface fracture toughness mechanisms operative in Si3N4 (Amedica Corporation, Salt Lake City, UT, USA), Al2O3 and ZTA (BIOLOX® forte, and delta, respectively, CeramTec, GmbH, Plochingen, Germany) bioceramics. The Al2O3 and ZTA materials have long established histories in total hip arthroplasty; whereas Si3N4 has been newly developed for this purpose. The improved method proposed here consisted in coupling the “traditional” indentation technique with quantitative assessments of microscopic stress fields by confocal Raman microprobe piezo-spectroscopy. Concurrently, crack opening displacement (COD) profiles were also monitored by Raman spectroscopy. Toughness measurements were determined using both as-received and hydrothermally exposed (100–121°C for up to 300 hours) femoral heads. Results. The Raman microprobe visualized two main toughening mechanisms operative in Si3N4 and ZTA bioceramics, namely crack-face bridging by acicular Si3N4 grains and polymorphic transformation of ZrO2 dispersoids. Both mechanisms elevated the resistance to crack propagation above the brittle behavior of Al2O3, which experienced a low crack resistance of ∼1.5 MPaâ��m1/2 independent of crack length. The as-received Si3N4 showed a sharply rising R-curve, up to ∼7 MPaâ��m1/2 within a propagation distance of ∼110 µm. A rising R-curve was also observed in the as-received ZTA, although its increase was less pronounced, ∼4 MPaâ��m1/2 within ∼120 µm. After hydrothermal exposure, surface toughness values decreased by ∼5%, ∼10%, and ∼42% for Si3N4, Al2O3, and ZTA, respectively. Substantial embrittlement was particularly noted at the surface of the ZTA material, with its toughness value reduced to the level of Al2O3. At the micromechanical scale, such embrittlement is obviously related to decreased availability of transformable (metastable) tetragonal ZrO2dispersoids at the surface. In ZTA, the hydrothermal attack annihilated any rising R-curve effect; whereas this degradation mechanism was not present in either Al2O3 or Si3N4 (Fig. 1). Discussion. Empowered by the Raman microprobe, the indentation micro-fracture method was shown capable of providing reliable surface toughness measurements in dissimilar biomaterials. Different from bulk toughness, surface toughness is the most relevant parameter in designing bioceramic microstructures for use as hip arthroplasty bearing couples for improved tribological performance. It was demonstrated that the environmentally driven phase transformation in ZTA is detrimental to surface toughness. On the other hand, Si3N4 experienced surface toughness values conspicuously independent of hydrothermal attack. Conclusions. Unlike transformation toughening (which is operative in ZTA), crack-face bridging (which is the toughening mechanism in Si3N4) proved to be the most durable surface toughening effect for a biomaterial to be employed in joint arthroplasty

Introduction. The optimum UHMWPE orthopaedic implant bearing surface must balance wear, oxidation and fatigue resistance. Antioxidant polyethylene addresses free radicals, resulting from irradiation used in cross-linking, that could oxidize and potentially lead to fatigue damage under cycles of in vivo use. Assessing the effectiveness of antioxidant (AO) polyethylene compared to conventional gamma-sterilized or remelted highly cross-linked (HXL) polyethylene is necessary to set realistic expectations of the service lifetime of AO polyethylene in the knee. This study evaluates what short-term antioxidant UHMWPE retrievals can reveal about: (1) oxidation-resistance, and (2) fatigue-resistance of these new materials. Methods. An IRB-approved retrieval laboratory received 25 AO polyethylene tibial insert retrievals from three manufacturers with in vivo time of 0–3 years. These were compared with 20 conventional gamma-inert sterilized and 30 HXL (65-kGray, remelted) tibial inserts of the same in vivo duration range. The retrievals were. (1) analyzed for oxidation and trans-vinylene index (TVI) using an FTIR microscope, and (2) inserts of sufficient size and thickness were evaluated for mechanical properties by uniaxial tensile testing using an INSTRON load frame. Oxidation was reported as maximum oxidation measured in the scan from the articular surface to the backside of each bearing. TVI was reported as the average of all scans for each material. Average ultimate tensile strength (UTS), ultimate elongation (UE), and toughness were the reported mechanical properties for each material. Results. Maximum oxidation values differed significantly across material types (p=0.018, Figure 1). No antioxidant retrieval exhibited a subsurface oxidation peak, in contrast to conventional gamma-sterilized (55%) and highly cross-linked (37%) retrievals that exhibited subsurface oxidation peaks over the same in vivo time (Figure 2). Trans-vinylene index (TVI) correlated positively with nominal irradiation dose (p<0.001). Mechanical properties varied by material, with tensile toughness correlating negatively with increasing TVI (p<0.001, Figure 3). Discussion. AO polyethylene was developed to address the problem of free radicals in polyethylene resulting from irradiation used in cross-linking or sterilization. Each manufacturer used a different antioxidant or method of supplying the antioxidant. However, all of the antioxidant materials appeared to be effective at minimizing oxidation over the in vivo period of this study. The antioxidant materials prevented in vivo oxidation more effectively than both conventional gamma-sterilized and remelted HXL polyethylene, at least over the in vivo period represented. The toughness, or ability of the material to resist fatigue damage, decreased with increasing irradiation cross-linking dose (increasing TVI). The AO polyethylenes evaluated in this study had lower toughness than conventional gamma-sterilized polyethylene, but they avoided the loss of toughness due to remelting. Clinical relevance. Antioxidant polyethylene tibial retrievals showed superior oxidation resistance to conventional gamma-inert and remelted HXL inserts. Material toughness varied with the irradiation dose used to produce the material. Comparison of antioxidant retrieval tensile properties can be used as a guide for clinicians in choosing appropriate materials for the applications represented by their patients

Introduction. Radiation cross-linked UHMWPE is preferred in total hip replacements due to its wear resistance [1]. In total knees, where stresses are higher, there is concern of fatigue damage [2]. Antioxidant stabilization of radiation cross-linked UHMWPE by blending vitamin E into the polymer powder was recently introduced [3]. Vitamin E greatly hinders radiation cross-linking in UHMWPE [4]. In contrast peroxide cross-linking of UHMWPE is less sensitive to vitamin E concentration [5]. In addition, exposing UHMWPE to around 300°C, increases its toughness by inducing controlled chain scission and enhanced intergranular diffusion of chains, simultaneously [6]. We present a chemically cross-linked UHMWPE with high vitamin E content and improved toughness by high temperature melting. Methods and Materials. Medical grade GUR1050 UHMWPE was blended with vitamin E and with 2,5-Di(tert-butylperoxy)-2,5-dimethyl-3-hexyne or P130 (0.5% Vitamin-E and 0.9% P130). The mixed powder was consolidated into pucks. The pucks were melted for 5 hours in nitrogen at 300, 310 and 320°C. One set of pucks melted at 310°C was accelerated aged at 70°C at 5 atm. oxygen for 2 weeks. Tensile mechanical properties were determined using ASTM D638. Izod impact toughness was determined using ASTM D256 and F648. Wear rate was determined using a bidirectional pin-on-disc (POD) tester with cylindrical pins of UHMWPE against polished CoCr discs in undiluted, preserved bovine serum. Results. The vinyl index increased as a function of temperature (Fig 1a). Cross-link density steadily decreased and impact strength increased with increasing vinyl index (Fig 1b). The ultimate tensile strength (UTS) was not affected by HTM (Table 2). Impact strength was significantly improved for all treatment temperatures (P<0.05) and wear was significantly increased only for the sample melted at 320°C (Table 2). Discussion. High temperature melting (HTM) was shown to increase toughness of UHMWPEs presumably due to controlled chain scissioning and increased intergranular diffusion of chains [6]. For radiation cross-linked UHMWPE, it was shown that an increase in elongation-at-break and impact strength could be obtained without sacrificing wear resistance up to an elongation of about 500% [7]. This vitamin E-blended, peroxide cross-linked, high temperature melted UHMWPE has very high oxidation resistance due to its high antioxidant content, high wear resistance due to cross-linking and much improved toughness, representing an optimum joint replacement surface. For figures/tables, please contact authors directly.

INTRODUCTION. Ceramics are excellently suited for applications in arthroplasty, mainly total hip, knee and shoulder replacement. As the most prominent representative of this demanding type of material, BIOLOX. ®. delta is widely used and very successful in the market for more than 10 years. The ability of zirconia phase transformation (t-ZrO. 2. →m-ZrO. 2. ) in zirconia-platelet toughened alumina (ZPTA) ceramics is an indispensable prerequisite for their excellent mechanical properties. The degree of stabilization of the zirconia tetragonal phase at body temperature is essential for the desired toughening mechanism. Y. 2. O. 3. is the most widely used t-ZrO. 2. chemical stabilizer; also microstructure and grain size contribute to t-ZrO. 2. phase stabilization. Stabilization must be achieved such that no material degradation will occur in body environment, i.e. in aqueous liquid (synovia), which is known to potentially trigger phase transformation at the surface of ceramic components. In this study, it is shown how phase stabilization in BIOLOX. ®. delta as a reference material is excellently balanced by means of optimal mechanical performance and environmental stability. OBJECTIVES. To assess the influence of t-ZrO. 2. chemical stabilization on ZPTA properties, in terms of fracture toughness (i.e. the ability to resist crack extension), wear resistance and environmental stability. METHODS. Three ZPTA compositions with increasing yttria content (Y. 2. O. 3. /ZrO. 2. 2–4mol%) were produced and compared to the reference. Hardness and fracture toughness were assessed by Vickers indentation method. A micro scratch tester (CSM Instruments, Peseux Switzerland) loaded with a Rockwell C diamond tip with 50µm radius was used to assess the scratch resistance of the ceramic compositions. The scratch load was linearly increased from 0 to 30N, which simulates extremely heavy local wear conditions. The morphology and depth of the scratches as well as local damage has been analysed with a laser microscope (Olympus LEXT-OLS4000) and scanning electron microscope (Hitachi S4700). The hydrothermal aging resistance was measured by autoclaving the compositions up to 150 hours at 134°C and 2.2bar and the monoclinic zirconia volume fraction measured by XRD using the Garvie formula at each time interval (i.e. 0, 10, 50, 100 and 150h). Surface roughness after hydrothermal ageing was also evaluated by atomic force microscopy. RESULTS. As expected, t-ZrO. 2. stabilization improved with increasing yttria content. Consequently, hydrothermal aging resistance increased and fracture toughness decreased strongly to almost monolithic alumina values. The scratch resistance performances also decreased showing gradually lower critical load Lc1, where grain pull-out phenomenon appeared earlier with the higher zirconia stabilization composition. The materials kept almost the same hardness (about 18GPa). Surface roughness also remained unchanged for all compostions, even in extreme hydrothermal conditions. CONCLUSIONS. Higher tetragonal zirconia stabilization leads to the suppression of zirconia phase transformation toughening and consequently of low temperature degradation; annihilating almost all the improvements of ZPTA over the monolithic alumina material. It was demonstrated that the best performance is achieved by properly triggering the tetragonal zirconia transformation. This result is explaining the successful performance of BIOLOX. ®. delta bearing couples already observed in the clinical setting

Today, hip prostheses are validated with Standards for fatigue testing: The Standard ISO 7206-4 requires to test 6 components at 230daN during 5 × 10. 6. cycles without crack. For the neck region of stemmed femoral components, the Standard ISO 7206-6 requires 6 tests at 534daN during 10 × 10. 6. cycles without crack. But these tests don't provide provide any indication on reliability level for an implantation in population. At the same time, the number of hip prosthesis implantation is growing, patients are implanted younger and younger and they want to be able to maintain a “normal” life. This way the average “loading spectrum” is getting tougher and tougher, due to this modification of the use of prosthesis in comparison with some years ago. On the other hand, there is new materials, new processes (additive manufacturing), new methods (customized stems…) with no feedback on reliability. A method is then necessary to manage the reliability in fatigue for actual and new products. The objective of this study is to establish a statistical distribution of loading of hip prosthesis in order to define at best a minimum value of strength required for a good fatigue design. To define this strength, the Stress-Strength (well known in automotive sector) approach is applied (fig 1). This approach will allow better assess the reliability in a population, depending on the mean strength and the scattering in fatigue. The first step is to establish the distribution of the loads for a hip prosthesis. Then, for a given risk level, the required strength can be defined, knowing the scattering of this strength. The strategy to have the distribution is based on:. In vivo load recordings on hip prosthesis (find on . Orthoload.com. ),. Analysis of frequency of everyday activities,. Activity level of different category of the population,. Statistical distribution of key parameters, like weight, age…. All these data are collected in the literature, and combined, then processed with the software DEFFI. ®. The goal is first to assess the reliability reached by a “nominal” stem and compare it to the reliability described in implant registers. Another goal is to analyse the stress distribution and compare it to standard requests (ISO 7206-6), in order to assess the reliability of an implant that succeeded this standard. A last, this method is a way to define the minimum strength for implants dedicated to particular populations: young and active patients, patients with high Body Weight, etc…. For any figures or tables, please contact authors directly (see Info & Metrics tab above).

Introduction:. Concerns remain regarding both the toughness of alumina, and stability of zirconia ceramics in total hip arthroplasty (THA). A zirconia-toughened alumina (ZTA) bearing has been introduced, in which yttria-stabilized, zirconia polycrystals are uniformly distributed in an alumina matrix. The goal is to combine the wear resistance of alumina with the toughness of zirconia. Zirconia's toughness is attributed to a tetragonal to monoclinic (t-m) phase transformation that occurs in response to a crack, hindering its propagation; however, it might decrease material stability. The purposes of this study were to investigate the degree and position of metal transfer, and the occurrence of t-m phase transformation using Raman spectroscopy, in a series of retrieved, ZTA femoral heads. Materials and Methods:. Twenty-seven ZTA femoral heads were reviewed as part of an IRB-approved implant retrieval program. All acetabular liners were composed of highly cross-linked polyethylene. The length of implantation, age, body mass index (BMI), sex, and reason for revision were recorded. Two independent graders assessed each femoral head for metal transfer over three regions (apex, equator, and below equator), using a previously validated grading system (Figure 1). The female trunnion of each head was graded in two regions: the deep and superficial 50% (Figure 2). Raman spectra were collected with a confocal Raman imaging system (alpha300 R, WITec, Knoxville, TN) operating a 488 nm laser, using a microscope objective of 20X. Three scans were taken in each of the aforementioned regions of the femoral head surface. Scans were also performed in regions of visible wear or metal transfer. Interobserver correlation coefficients for the measurement of metal transfer between the two graders were determined. One-way ANOVAs were used to compare differences of metal transfer between the 3 surface regions (p < 0.05 = significant). Results:. The mean length of implantation was 2.2 + 3.4 years. The most common reasons for revision were osteolysis/aseptic loosening (9), device failure (6), and instability/dislocation (5). Of the femoral heads, 66.7% displayed metal transfer within the apex (mean score 1.7 + 0.5), 96.3% in the equator (mean score 2.2 + 0.6), and 100% below the equator (mean score 2.7 + 0.9), which was significantly greater than the apex (p = 0.002). All heads demonstrated metal transfer in both the superficial (mean score 3.1 + 0.3) and deep trunnion (mean score 3.6 + 0.5). Interobserver correlations were fair/moderate for all regions analyzed (r = 0.59 to 0.80). Raman spectra indicated the occurrence of the t-m phase transformation with monoclinic bands observed at 180, 383, 477, 537, 570 and 622 cm. −1. Similarly, tetragonal zirconia bands were noted at 146, 260, 641 cm. −1. (Figure 3). Discussion:. Current literature has limited information on the long–term results of ZTA femoral heads. Our study is the first large series of this kind to include visual assessment and Raman spectra analysis. While the metal transfer grade is less than reported for prior generations of alumina ceramic heads, the occurrence of t-m phase transformations may potentially compromise the long-term mechanical strength and stability of this material

Patients undergoing revision surgery of a primary total hip arthroplasty often exhibit bone loss and poor bone quality, which make achieving stable fixation and osseointegration challenging. Implant components coated in porous metals are used clinically to improve mechanical stability and encourage bone in-growth. We compared ultra-porous titanium coatings, known commercially as Gription and Porocoat, in an intra-articular model by press-fitting coated cylindrical implants into ovine femoral condyles and evaluating bone in-growth and fixation strength 4, 8 and 16 weeks post-operatively. Bilateral surgery using a mini-arthrotomy approach was performed on twenty-four Dorset-Rideau Arcott rams (3.4 ± 0.8 years old, 84.8 ± 9.3 kg) with Institutional Animal Care Committee approval in accordance with the Canadian Council on Animal Care. Cylindrical implants, 6.2 mm in diameter by 10 mm in length with surface radius of curvature of 35 mm, were composed of a titanium substrate coated in either Porocoat or Gription and press-fit into 6 mm diameter recipient holes in the weight-bearing regions of the medial (MFC) and lateral (LFC) femoral condyles. Each sheep received 4 implants; two Gription in one stifle (knee) and two Porocoat in the contralateral joint. Biomechanical push-out tests (Instron ElectroPuls E10000) were performed on LFCs, where implants were pushed out relative to the condyle at a rate of 2 mm/min. Force and displacement data were used to calculate force and displacement at failure, stiffness, energy, stress, strain, elastic modulus, and toughness. MFCs were fixed in 70% ethanol, processed undecalcified, and polished sections, approximately 70 µm thick (Exakt Micro Grinding system) were carbon-coated. Backscattered electron images were collected on a scanning electron microscope (Hitachi SU3500) at 5 kV and working distance of 5 mm. Bone in-growth within the porous coating was quantified using software (ImageJ). Statistical comparisons were made using a two-way ANOVA and Fisher's LSD post-hoc test (Statistica v.8). Biomechanical evaluation of the bone-implant interface revealed that by 16 weeks, Gription-coated implants exhibited higher force (2455±1362 N vs. 1002±1466 N, p=0.046) and stress (12.60±6.99 MPa vs. 5.14±7.53 MPa, p=0.046) at failure, and trended towards higher stiffness (11510±7645 N/mm vs. 5010±8374 N/mm, p=.061) and modulus of elasticity (591±392 MPa vs. 256±431 MPa, p=0.61). Similarly, by 16 weeks, bone in-growth in Gription-coated implants was approximately double that measured in Porocoat (6.73±3.86 % vs. 3.22±1.52 %, p=0.045). No statistically significant differences were detected at either 4 nor 8 weeks, however, qualitative observations of the exposed bone-implant interface, made following push-out testing, showed more bony material consistently adhered to Gription compared to Porocoat at all three time points. High variability is attributed to implant placement, resulting from the small visual window afforded during surgery, unique curvatures of the condyles, and presence of the extensor digitorum longus tendon which limited access to the LFC. Ultra-porous titanium coatings, know commercially as Gription and Porocoat, were compared for the first time in a challenging intra-articular ovine model. Gription provided superior fixation strength and bone in-growth, suggesting it may be beneficial in hip replacement surgeries where bone stock quality and quantity may be compromised

The development of more wear resistant biomaterials and better locking mechanisms for the polyethylene into the tibial base has significantly reduced polyethylene wear as a reason for revision TKA. Aseptic loosening is now the primary cause for revision TKA. Loosening can be caused by multifactorial operative issues: 1] patient selection, 2] implant alignment, 3] cementing technique. Furthermore, aseptic loosening occurs at a consistent rate over time. Increased cement penetration is important to counter bone resorption. Increasing penetration also improves cement mantle toughness leading to better mechanical integrity of the bone-cement interface and reduces bone-cement interface stress. It is important to recognise that a cleaner and drier interface does improve bone-cement penetration. Techniques to improve the process include better cement formulations, drilling sclerotic bone, devices and implant features to increase pressurization, using negative pressure suction ports in the tibia. We have extensive experience with CarboJet, a method of CO. 2. gas jet cleaning and drying. This experience was developed during 20 years of performing TKA with NO tourniquet. Schnetler et al found that the “use of a tourniquet in TKA causes a paradoxical increase in total blood loss”. So, NO tourniquet TKA is becoming the new paradigm for knee arthroplasty in reconstructive orthopaedics. Goldstein reported that pressurised carbon dioxide jet lavage resulted in a 35% increase in cement penetration depth when used vs. use of pulsatile saline lavage alone. Meneghini used this pressurised carbon dioxide system to study the influence of NO tourniquet use in TKA. He found a significant lowering of opioid consumption postoperatively. Another important factor in increasing the cement interdigitation is the influence of lipids which significantly weakens the bond at the interfaces. If motion is allowed during cementation there is additional loss of penetration and therefore fixation. The pressurised carbon dioxide delivered by the CarboJet system actually pushes the lipid, fatty marrow up and out of the bone allowing it to be suctioned or lap dried from the interface surface. The NO tourniquet technique and the use of carbon dioxide jet gas delivery to improve the bone-cement interface in TKA will be demonstrated

The development of more wear resistant biomaterials and better locking mechanisms for the polyethylene into the tibial base has significantly reduced polyethylene wear as a reason for revision TKA. Aseptic loosening is now the primary cause for revision TKA. Loosening can be caused by multifactorial operative issues: 1] patient selection, 2] implant alignment, 3] cementing technique. Furthermore, aseptic loosening occurs at a consistent rate over time. Increased cement penetration is important to counter bone resorption. Increasing penetration also improves cement mantle toughness leading to better mechanical integrity of the bone-cement interface and reduces bone-cement interface stress. It is important to recognise that a cleaner and drier interface does improve bone-cement penetration. Techniques to improve the process include better cement formulations, drilling sclerotic bone, devices and implant features to increase pressurization, using negative pressure suction ports in the tibia. We have extensive experience with CarboJet, a method of CO2 gas jet cleaning and drying. This experience was developed during 20 years of performing TKA with NO tourniquet. Schnetler et al found that the “use of a tourniquet in TKA causes a paradoxical increase in total blood loss”. So, NO tourniquet TKA is becoming the new paradigm for knee arthroplasty in reconstructive orthopaedics. Goldstein reported that pressurised carbon dioxide jet lavage resulted in a 35% increase in cement penetration depth when used versus use of pulsatile saline lavage alone. Another important factor in increasing the cement interdigitation is the influence of lipids which significantly weakens the bond at the interfaces. If motion is allowed during cementation there is additional loss of penetration and therefore fixation. The pressurised carbon dioxide delivered by the CarboJet system actually pushes the lipid, fatty marrow up and out of the bone allowing it to be suctioned or lap dried from the interface surface. The NO tourniquet technique and the use of carbon dioxide jet gas delivery to improve the bone-cement interface in TKA will be demonstrated

Introduction. While advances in joint-replacement technology have made total ankle arthroplasty a viable treatment for end-stage arthritis, revision rates for ankle replacements are higher than in hip or knee replacements [1]. The questions asked in this study were (1) what retrieved ankle devices demonstrate about ankle arthroplasty failures, and (2) how do these failures compare to those seen in the hip and the knee?. Materials and Methods. An IRB-approved retrieval laboratory received retrieved polyethylene inserts and surgeon-supplied reason for revision from 70 total-ankles (7 designs, including five currently-marketed designs) from 2002 to the present. All retrievals were rated for clinical damage. Polyethylene inserts received six months or less after retrieval (n=45) were analyzed for oxidation using Fourier Transform Infrared (FTIR) spectroscopy, reported as maximum ketone oxidation index [2]. Insert sterilization method was verified using trans-vinylene index [3]. Oxidation measured in the 45 ankle inserts versus their time in vivo was compared to oxidation rates previously published for gamma-sterilized hip and knee polyethylene retrievals [6]. Statistical analysis was performed using IBM SPSS v.22. Results. The ankle devices were retrieved most commonly for loosening (n=22) followed by polyethylene fracture (n=9). These failure modes occurred after statistically different in vivo time (loosening: mean=4.4±3.6 years; polyethylene insert fracture: mean=9.5±4.1 years; p=0.002). Presence of clinical fatigue (cracking and/or delamination) was identified in 24 of the 70 retrieved inserts, and its presence correlated with in vivo time (Spearman's rho =0.449, p<0.001). Thirteen of these fatigued inserts were analyzed by FTIR. TVI analysis confirmed the sterilization method of the fatigued inserts: 12 gamma, 1 non-gamma sterilized. All 13 fatigued inserts had maximum ketone oxidation index (KOI) of 1.2 or higher. Presence of fatigue correlated with measured oxidation (Spearman's rho =0.685, p<0.001). Six of the 9 inserts that fractured in vivo were analyzed by FTIR. All were gamma-sterilized, and all had oxidation of 1.2 or higher. Oxidation rate determined for most of the 45 ankle inserts was at or above oxidation rates previously published for gamma-sterilized hip and knee polyethylene retrievals [6]. Discussion. This retrieval study concurs with the ankle arthroplasty literature that loosening is the most common reason for ankle revision [4]. Ankle inserts retrieved as a result of implant loosening had lower oxidation and no fatigue damage resulting from their shorter in vivo time. Fatigued and/or fractured inserts were in vivo for longer times, allowing more oxidation to occur. The effect of oxidation on polyethylene tensile strength and ductility has been reported for tibial inserts [5]. Oxidation above the critical value [5] has a dramatic effect on the ability of the polyethylene to resist fatigue damage and fracture, since the toughness of the polyethylene drops to near zero. All fatigued and fractured ankle inserts had oxidation that exceeded this critical oxidation. Most ankle inserts, whether gamma or non-gamma sterilized, oxidized at or above the oxidation rates previously published for gamma-sterilized hip and knee polyethylene retrievals [6]

Contemporary polyethylene liners for total hip replacements were introduced in the late 1990's to address osteolysis associated with wear of conventional polyethylene. Every major device manufacturer introduced an “enhanced polyethylene”. In the ensuing decade plus, every major arthroplasty meeting had presentations and debates about the wear resistance and mechanical properties of these new polymers. The results have been remarkable and now with 17 to 18 years of use in patients, we have yet to see clinically significant osteolysis in our patients regardless age or activity level. The results can be summarised as follows: All currently commercially available highly crosslinked polyethylenes produced by major device companies have demonstrated a reduction in wear and osteolysis. At the 2016 Closed Meeting of The Hip Society, none of the surgeons attending had seen a clinically significant case of osteolysis associated with highly crosslinked polyethylene. Registry data demonstrates the superiority of the highly crosslinked materials over conventional polyethylenes. Historical concerns over a reduction in mechanical properties have not been borne out in clinical studies. Although highly crosslinked polyethylene liner fractures have been reported, they are rare and probably related to specific designs or surgical technique issues. It is important to remember that there were rare cases of fracture of conventional polyethylene as well. With currently reported wear rates of the enhanced polyethylenes, polyethylene thickness is unlikely to be a factor in long-term durability with well-designed sockets. Bench data has demonstrated that polyethylene thickness is not a risk factor for wear or fracture if well supported by the metal shell. Thin unsupported polyethylene is at risk for fracture. Although the new anti-oxidant polyethylenes (eg. Vitamin E) have performed well in wear studies, there is no clinically available evidence to support their use based on enhanced fracture toughness

Introduction. Radiation cross-linking of ultrahigh molecular weight polyethylene (UHMWPE) has reduced the in vivo wear and osteolysis associated with bearing surface wear (1), significantly reducing revisions associated with this complication (2). Currently, one of the major and most morbid complications of joint arthroplasty is peri-prosthetic infection (3). In this presentation, we will present the guiding principles in using the UHMWPE bearing surface as a delivery device for therapeutic agents and specifically antibiotics. We will also demonstrate efficacy in a clinically relevant intra-articular model. Materials and Methods. Medical grade UHMWPE was molded together with vancomycin at 2, 4, 6, 8, 10 and 14 wt%. Tensile mechanical testing and impact testing were performed to determine the effect of drug content on mechanical properties. Elution of the drug was performed in phosphate buffered saline (PBS) for up to 8 weeks and the detection of the drug in PBS was done by UV-Vis spectroscopy. A combination of vancomycin and rifampin in UHMWPE was developed to address chronic infection and layered construct containing 1 mm-thick drug-containing UHMWPE in the non-load bearing regions was developed for delivery. In a lapine (rabbit) intra-articular model (n=6 each), two plug of the layered UHMWPE construct were placed in the trochlear grove of the rabbit femoral surface and a porous titanium rod with a pre-grown biofilm of bioluminescent S. Aureus was implanted in the tibia. Bioluminescent imaging was employed to visualize and quantify the presence of the bacteria up to 3 weeks. Results and Discussion. Increasing drug content decreased both the ultimate tensile strength (UTS) and the impact toughness of vancomycin-containing UHMWPE (Figure 1). Elution data and structural analysis suggested that a percolation threshold was reached at above 6 wt% drug in UHMWPE, which resulted in sustained drug delivery above the minimum inhibitory concentration (MIC; 1 mg/ml) for up to 8 weeks (Figure 2). The layered constructs implanted in rabbits were able to eradicate all detectable bacteria from the biofilm on the titanium surfaces implanted on the counterface (Figure 3), suggesting clinically relevant efficacy. Significance. To our knowledge, this is the first study showing the design and efficacy of an antibiotic-eluting UHMWPE bearing surface. Such a device has the potential of reducing all two-stage revisions to single-stage treatment with load-bearing components, enhancing the mobility and quality of life for the patients and reducing the cost of infection treatment in arthroplasty. For figures/tables, please contact authors directly.

Since its introduction in total hip replacements in the 1960's, Ultra High Molecular Weight Polyethylene (UHMWPE) has played a major role as a bearing component material for joint arthroplasty. Concerns were raised when issues of wear resistance became apparent, and therefore Highly Crosslinked Polyethylenes were introduced. Such materials undergo a thermal treatment to quench the free radicals and reduce progressive oxidation. However, said thermal treatment weakens the material mechanical properties and hence the use of antioxidants has been proposed and implemented in clinical use, mainly Vitamin-E. This can be added to the material before or after irradiation. If it is done before, part of the anti-oxydant is consumed during irradiation and so will not be available for its main purpose, and part reacts before irradiation with the free radicals thus reducing the crosslinking effect. If it is added after irradiation, high temperatures are required in order to diffuse it in the bulk material, and anyway the surface will be mainly rich in antioxidant. However, Vitamin-E tends to neutralize the free radicals on the oxidized lipid chain present in our body fluids and so in direct contact with the prosthetic components: such mechanism reduces the Vitamin-E quantity available for anti-oxidation purposes in the long run. A UHMWPE doped with Hindered Amine Light Stabilizer (HALS) has been developed and tested for applications in large joint replacements where highest resistance to wear and tough mechanical properties are simultaneously required, such as tibial inserts for knee joints or acetabular inserts for large diameter heads. Mechanical and biocompatibility tests were run in accordance with ASTM F 2565-06 and ISO 10993-1 with successful results and good reproducibility. In particular, electro spin resonance exhibited a very high level of free radicals in the three samples, which confirms the properties of this new material. Free radicals are the result of the activation of the HALS molecules during irradiation, creating nitroxide radicals that will destroy the residual alkyl radicals responsible for the oxidation before and after implantation. Biocompatibility tests proved absence of cytotoxicity, sensitization, irritation, genotoxicity or pyrogenic reactions. The possible future applications for this new material in the arthroplasty field will be discussed along with the expected advances and advantages

Introduction. The continued improvement of ceramic materials for total hip arthroplasty led to the development of Zirconia and Zirconia toughened Alumina materials such as BIOLOX® delta. Zirconia exists in a tetragonal phase in new ceramic heads and can transform to a monoclinic phase in response to loading giving the material improved fracture toughness. It is known that surface transformation occurs in this material under hydrothermal conditions (i.e. in vivo condition), and ISO standards recommend parts are artificially aged prior to testing to include any effect of surface transformation on new designs. Accelerated aging procedures have been used to predict the amount of phase transformation that will occur in vivo, but validation of these models requires the study of retrieved hip joints. Here 26 BIOLOX® delta retrievals are analysed to determine the degree of phase transformation that occurs in vivo. The levels of phase transformation measured are compared with those predicted based on accelerated aging tests. Methods. Twenty-six retrieved BIOLOX® delta (CeramTec AG, Germany) femoral heads were investigated. Retrievals were obtained after implantation of between 1 month and 7 years with an average follow-up of 1.5 years. All retrievals were from ceramic-on-ceramic hip joints that were implanted between 2004 and 2012. Mean patient age was 69 years (range 48–87 years). Raman spectra were collected using a confocal Raman spectrometer (WITec Gmbh, Germany) a laser wavelength of 532nm, a 50× objective and a 100μm pinhole. Twenty-five measurements were made on each retrieval at random locations outside any visible wear scars and inside visible wear scars. The average monoclinic content was calculated based on the method of Clarke and Adar [1]. For comparison 5 new BIOLOX® delta femoral head resurfacings were measured using the same procedure. Results. The average monoclinic content of the new heads was 5%±2%. For unworn areas of the retrievals this increased to 23%±9% with the highest monoclinic content measured at 42%. There was no statistical correlation between implantation time and monoclinic content in the unworn areas. In worn areas of the retrievals the monoclinic content was higher and varied between 13% and 51%. Discussion. This is the largest set of retrieved BIOLOX® delta heads to be examined for changes in monoclinic content building on the work of Affatato et al. [2] who analysed 5 retrievals. All retrievals have a higher level of phase transformation than new heads in the unworn areas showing that hydrothermal aging does take place in the body. The results also show that on average there is more monoclinic transformation in worn areas and hence the material toughening effect of the Zirconia phase is utilised. The mean phase transformation found in vivo matched the 23%±5% reported as occurring under the conditions described in the ISO standard for hydrothermal aging [3]. However, the ISO standard is thought to be equivalent to 40 years in vivo whilst the retrievals measured had a mean follow-up of 1.5 years

Introduction. Silicon nitride (Si3N4) is a ceramic material presently implanted during spine surgery. It has a fortunate combination of material properties such as high strength and fracture toughness, inherent phase stability, scratch resistance, low wear, biocompatibility, hydrophilic behavior, easier radiographic imaging and resistance to bacterial biofilm formation, all of which make it an attractive choice for orthopaedic applications beyond spine surgery. Unlike oxide ceramics, (e.g., alumina or Al2O3) the surface chemistry and topography of Si3N4 can be precisely engineered to address in vivo demands. Si3N4 can be manufactured to have an ultra-smooth, or highly fibrous, or porous morphology. Its chemistry can be varied from that of a silica-like surface composed of silanol moieties to one which is predominately comprised of silicon-amine functional groups. Methods. In the present study, a Si3N4 bioceramic formulation was exposed to thermal, chemical, and mechanical treatments in order to induce changes in surface composition and features. The treatments included grinding and polishing, etching in hydrofluoric acid solution, and heating in nitrogen or air. Resulting surfaces were characterized using a variety of microscopy techniques to assess morphology. Surface chemical and phase composition were determined using x-ray photoelectron and Raman spectroscopy, respectively. Streaming potential measurements evaluated surface charging, and sessile water drop techniques assessed wetting behavior. Results. Induced changes to surface morphology and wetting behavior are shown in Figure 1. A wide variety of wetting behavior was observed, ranging from moderate hydrophilicity (θ ∼60°) in the case of untreated surfaces to extreme hydrophilicity (θ <10°) in the case of surfaces subjected to heat treatments in different atmospheres. Figure 2 shows the zeta potential as a function of solution pH for the surfaces shown in Figure 1. All samples exhibit strong negative surface charging at homeostatic pH (−40 mV or more), and the oxidized sample exhibits extremely strong charging (−75 mV). Conclusions. Our data show that Si3N4 is a facile biomaterial whose material properties can be engineered and optimized for specific applications. This work provides a basis for future in vitro and in vivo studies which will examine the effects of these treatments on important orthopaedic properties such as friction, wear, protein adsorption, bacteriostasis and osseointegration

INTRODUCTION. The reported revision rate for THA is below 10% at 10 years. Major factors for revision are aseptic loosening or dislocation of the articulating components. CoC bearings in total hip arthroplasty (THA) have demonstrated very low wear rates. Due to producing the least number of wear particles of any articular bearing used for THA, osteolysis is very rarely observed. Zirconia-platelet toughened alumina (ZPTA) has improved toughness and bending strength while maintaining all other advantageous properties of alumina. Consequently, its clinical fracture rate is minimal and wear resistance is superior to alumina. OBJECTIVES. Since a trend exists towards the usage of larger bearings the aim of this study was to compare the tribological behavior of different ZPTA/ZPTA THAs with respect to their ball head diameter. METHODS. Wear tests according to ISO14242-1 were performed in a servo-hydraulic hip simulator with ZPTA bearings from 28 to 48mm up to 5 million cycles (mc). Wear was measured every mc and surfaces were inspected at 5mc. The tests were carried out in 20g/l protein serum. RESULTS. All ZPTA articulations showed a characteristic running in period followed by a steady decrease in wear rate up to 5mc. The 48mm bearing showed highest running in wear. For all bearing sizes wear decreased to about 0.05mm³/mc or less throughout the testing period. For all couplings minimal differences in the wear rate was found. CONCLUSION. The current study supports the extremely low wear rates for ZPTA/ZPTA bearings and showed that increasing the diameter up to 48mm has only a small influence on the wear rate when tested under ISO14242-1 conditions. Larger diameter bearings increase the range of motion and joint stability and reduce the risk of impingement or dislocation. Thus, larger diameter ZPTA bearings seem a safe solution for active patients due to higher dislocation resistance and reduced wear. Other loading conditions such as subluxation are known to contribute to the clinical wear rate and will be investigated in future tests

The leading cause for total hip arthroplasty (THA) revision remains aseptic loosening due to bearing wear. The younger and more active patients currently undergoing arthroplasty present unprecedented demands on THA-bearings. Ceramic-on-ceramic (CoC) bearings have consistently shown the lowest wear rates. The recent advances, especially in alumina CoC bearings, have solved many past problems and produced preferable results in vitro. Alumina ceramics are extremely hard, scratch resistant, biocompatible, offer a low coefficient of friction, superior lubrication and lower wear rates in comparison to other bearings in THA. The major disadvantage of ceramics used to be fracture. The new generation of alumina ceramics, has reduced the risk of ball fracture to 0.03–0.05%. The risk for liner fracture is even lower. Assuming an impingement-free component implantation, CoC bearings have major advantages over other bearing combinations. Due to the superior hardness, CoC bearings produce less third body wear and are virtually impervious to damage from instruments during the implantation process. A complication specific to CoC bearings is squeaking. Squeaking occurs if the friction in the joint articulation is sufficient to excite vibrations to audible magnitudes (due to loss of lubrication). The high range of reported squeaking (0.45% to 10.7%) highlights the importance of correct implant position. If a correct implant position can be guaranteed, then squeaking is rare and without clinical significance. The improved tribology and presumable resulting implant longevity make CoC the bearing of choice for young and active patients. Especially the alumina matrix (Biolox delta) offers increased burst strength and greater fracture toughness