Introduction. Laser marking of implants surfaces is necessary in order to provide traceability during revisions which will help identify product problems more quickly, better execute product recalls and improve patient safety. There are several methods of marking employed within the medical field such as chemical etching, electro pencil marking, mechanical imprinting, casting of markings, marking with vibratory type contact, ink jet, hot foil and screen printing. However, these methods have various drawbacks including marking durability or addition of potentially toxic chemical compounds. As a result laser marking has become the preferred identification process for orthopedic implants. Laser marking is known for its high visual quality, good reproducibility and precision. However there are concerns about the laser marking potential to affect fatigue life of a device. There is a limited number of research papers that studied the effect of laser marking on fatigue life of implants. The objective of the current study is to investigate the effects of laser marking on the fatigue life of titanium alloy material. Material and Methods. Two groups of four point bend specimens were used to investigate the effect of laser marking on the fatigue life. The first group comprised of the specimens without laser marking while the second group comprised of specimens with laser marking currently utilized for the implant surfaces. Prior to conducting the fatigue testing, a non-destructive X-ray diffraction (XRD) residual stress analysis was conducted to determine if the laser marking had introduced any residual stresses. Imaging analysis was also conducted to examine any potential surface damage on the test sample's surface. A servo-hydraulic test machine was used for the fatigue four point bend testing regime where the inner and outer spans were 30 mm and 90 mm respectively. All testing was conducted at a frequency of 10 Hz, a stress ratio R=0.1, and sine-wave loading in air. Testing was stopped at 10 Million cycles or at failure of the specimen. Results & Discussion. Figure 1 shows that laser marking process can create a fine network of surface cracks. Table 1 shows the results of residual stress measurements. Laser making introduced high tensile stresses on the components whereas “as machined” component without laser marking exhibited compressive stresses inherent due to machining. The result from the S-N curve testing is shown in Figure 2. The current laser marking components demonstrated 41% reduction in fatigue strength compared to non-laser marked specimens. The reduction in fatigue strength is due to the residual tensile stresses generated at the laser marking location which can lead to crack propagation from small micro fractures created during the surface melting process. Conclusion. This study has shown conclusively that laser marking of implants if located at high stress regions can lead to early fatigue failure. Based on the results from the study it is advisable to locate the laser markings at the region of lowest or compressive stress areas and when possible the laser marking process should be selected as to create the minimal damage to the surface. For figures/tables, please contact authors directly.

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. During revision surgery, the active electrode of an electrocautery device may get close to the implant, potentially provoking a flashover. Incidents have been reported, where in situ retained hip stems failed after isolated cup revision. Different sizes of discoloured areas, probably induced by electrocautery contact, were found at the starting point of the fracture. The effect of the flashover on the implant material is yet not fully understood. The aim of this study was to investigate the fatigue strength reduction of Ti-6Al-4V titanium alloy after electrocautery contact. Material and Methods. 16 titanium rods (Ti-6Al-4V, extra low interstitial elements, according to DIN 17851, ⊘ 5 mm, 120 mm length) were stress-relief annealed (normal atmosphere, holding temperature 622 °C, holding time 2 h) and cooled in air. An implant specific surface roughness was achieved by chemical and electrolytic polishing (Ra = 0.307, Rz = 1.910). Dry (n = 6) and wet (n = 6, 5 µl phosphate buffered saline) flashovers were applied with a hand-held electrode of a high-frequency generator (Aesculap AG, GN 640, monopolar cut mode, output power 300 W, modelled patient resistance 500 Ω). The size of the generated discoloured area on the rod's surface - representative for the heat affected zone (HAZ) - was determined using laser microscopy (VK-150x, Keyence, Japan). Rods without flashover (n = 4) served as control. The fatigue strength of the rods was determined under dynamic (10 Hz, load ratio R = 0.1), force-controlled four-point bending (FGB Steinbach GmbH, Germany) with swelling load (numerical bending stress 852 MPa with a bending moment of 17.8 Nm) until failure of the rods. The applied bending stress was estimated using a finite-element-model of a hip stem during stumbling. Metallurgical cuts were made to analyse the microstructure. Results. The control rods failed at the pushers of the setup (median: 94,550, range: 194,000 cycles). The rods with flashover failed directly at the HAZ significantly earlier than the control rods (p = 0.018). The analysis of the microstructure showed a transformation of the equiaxed α+β microstructure to a bimodal state. The size of the HAZs were equal for the dry (median: 1.51 mm. 2. , range: 5.68 mm. 2. ) and wet flashovers (median: 0.92 mm. 2. , range: 2.50 mm. 2. , p = 0.792). The cycles to failure were smaller for the dry flashover (median: 22,650 cycles, range: 5,700) than the wet flashover but not reaching statistical significance (median: 32,200, range: 57,900; p = 0.052). No correlation between the dimension of the HAZs and the cycles to failure was found (dry: r. 2. = 0.019, p = 0.8; wet: r. 2. = 0.015, p = 0.721). Discussion. Flashovers induced by an electrocautery device reduce the fatigue strength of Ti-6Al-4V. Since no correlation between the size of the HAZs and the cycles to failure was found, every contact between electrocautery devices and metal implants should be avoided. For any figures or tables, please contact authors directly

Introduction. The fatigue strength of ultrahigh molecular weight polyethylene (UHMWPE) in total joint implants is crucial to its long term success in high demand applications, such as in the knee, and is typically determined by measuring the crack propagation resistance in razor-notched specimens under cyclic load [1]. This only tells part of the story: that is, how well the material resists crack propagation once a crack is present. A second, equally important component of fatigue strength is how well the material resists crack formation. Previous studies cyclically loaded a cantilevered post until failure [2], postulating that the post would break very quickly after crack initiation. Parran et. al. proposed a novel method to measure the crack initiation time by holding a sample in constant tension until a crack was visually observed [3]. We hypothesize that the crack initiation times of various UHMWPEs will follow similar trends as the more omnipresent crack propagation resistance tests. Materials and Methods. The following UHMWPE formulations were tested: (i) virgin, (ii) gamma sterilized in vacuum, (iii) 91 kGy gamma irradiated, and (iv) 91 kGy gamma irradiated and subsequently melted. GUR1020 and GUR1050 bar stock of varying irradiation doses were machined into compact tension specimens [4] with a notch depth of 17 mm and a blunt notch root radius of 0.25 mm, mimicking a geometry of a joint replacement component. Specimens were held in constant tension until failure; 3 to 5 different loads between 1 kN and 2.25 kN (n=3 samples per load per material) were tested. A video camera was focused on the face of the notch and took a picture every 10 seconds. The photos were reviewed to manually determine the crack initiation time (Fig 1). The time it took for the sample to completely fail – that is, shear into two separate pieces – was also recorded. Results. For all materials tested, the crack initiation time (Fig 2a,b) and the time to failure (Fig 2c,d) decreased as the applied load increased. The crack initiation time increased for the gamma sterilized materials when compared to the virgin materials while the time to failure decreased. The highly crosslinked, 91 kGy materials had crack initiation times and times to failure that were less than that of the virgin material. Post irradiation melting greatly diminished the fatigue strength of the material, yielding the lowest crack initiation time and time to failure. Discussion. The test yielded results consistent with current knowledge: that is, high-dose irradiation yields a slight drop in fatigue strength, and post-irradiation melting greatly reduces strength. This test was simple to set up and run and can be a good tool to determine the relative fatigue strengths of UHMWPE formulations for orthopaedic applications. For figures/tables, please contact authors directly.

There is an increasing prevalence of haptic devices in many engineering fields, especially in medicine and specifically in surgery. The stereotactic haptic boundaries used in Computer Aided Orthopaedic Surgery Unicomparmental Knee Arthroplasty (CAOS UKA) systems for assistive milling control can lead to an increase in the force required to manipulate the device; this study presented here has seen a several fold increase in peak forces between haptic and non-haptic conditions of a semi-active preoperative image system. Orthopaedic Arthroplasty surgeons are required to apply forces ranging from large gripping forces to small forces for delicate manipulation of tools and through a large range of postures. There is also a need for surgeons to move around and position themselves to gain line of sight with the object of interest and to operate while wearing additional clothing such as the protective headwear and double gloves. These factors further complicate comparison with other ergonomic studies of other robotics systems. While robotics has been implemented to reduce fatigue in surgery one area of concern in CAOS is localised user muscle fatigue in high volume use. In order to create the conditions necessary for the generation of fatigue in a realistic user experience, but in the time available for the participants, an extended period of controlled and prolonged cutting and manipulation of the robotic arm was needed. This pragmatic test requirement makes the test conditions slightly artificial but does indicate areas of high potential for fatigue when interacting with the system in high volume instances. The surgeon-robotic system interaction was captured using 3 dimensional motion analysis and a force transducer embedded in the end effector of the robotic arm and modelled using an existing upper body model in Anybody software. The kinematic and force information allowed initial calculations of the interaction between the user and the Robotic system. Validation of the model was conducted using Electromyography assessment of activity and fatigue. Optimisation of the model sought to create an efficient cutting regime to reduce cutting time with reduced muscle force in an attempt to reduce users discomfort/fatigue while taking into account anthropometric variations in the users and minimising overall energy requirements, burr path length and maximum muscle force. From the assessment of a small group of three surgeons with experience of the Robotic system there was little to no experience of above normal localised fatigue during small volume use of the system. Observation of these surgeons operating the robot state otherwise with examples of reactions to discomfort. There is also anecdotal evidence that fatigue becomes more problematic in higher volume work loads

Introduction. Total hip arthroplasty (THA) using short design stem is surging with increasing movement of minimally invasive techniques. Short stems are easier to insert through small incisions preserving muscles. We have used these types of short stems since 2010. Almost all of the patients have shown good clinical results. However, two patients developed fatigue fractures on femurs post operatively. We have reviewed the clinical and radiographic results of these patients. Patients and methods. From April 2010, we have performed 621 THAs with short design stems, Microplasty. R. , Biomet, using a muscle preservation approach, the Direct Anterior Approach (DAA). The age ranged from 31 to 88 years old. Case1: 56y.o. male, BMI 23.1kg/m. 2. Preoperative diagnosis was bilateral osteoarthritis. Simultaneous THAs were performed on bilateral hips. He was allowed to bear as much weight as he could tolerate using an assistive device immediately after surgery, and followed standard hip precautions for the first 3 weeks. He was discharged from hospital seven days after surgery and returned to his job two weeks after surgery. He noticed sudden left thigh pain three weeks after surgery without any obvious cause. Crutches were recommended to partially bear his weight. Six weeks after surgery, a fracture line became visible on the radiographs and new callus formation also became visible. Three months after surgery, he felt no pain and was able to walk without any crutches. Case2: 66y.o. female, BMI 27.5 kg/m. 2. Preoperative diagnosis was bilateral osteoarthritis. THAs were performed on the hips at a six month interval. The right hip was operated on first, followed by the left hip. She was discharged from hospital four days after surgery and returned to her job six weeks after surgery. Two months later after left hip surgery, she suddenly felt pain on her left femur without any obvious cause, and was unable to walk. Three weeks later, X-rays showed fatigue fracture lines and new callus formations. After two or three months using crutches, her pain improved and X-rays showed good callus formation and no stem subsidence. Discussions. Several reports showed insufficiency fractures of the pelvis following THA. But most of them occurred due to repetitive stress on fragile bones. But our cases showed no evidence of osteoporosis. They had no history of trauma. But they had some points in common, which were they were bilateral cases and their BMI were not low. The incident rate of fatigue fractures of femur with this short stem THAs was 0.3% in our cases. We suggested that one of the causes of these fatigue fractures was the shortness of the stems. The shortness of the stems concentrate the body weight to limited contact area of the femur, and the stress causes the fatigue fractures. We should consider the risk of fatigue fractures on the patients who are operated on bilaterally. However these two patients showed good callus formations and no stem subsidence after a few weeks of partial weight bearing

Representative pre-clinical analysis is essential to ensure that novel prosthesis concepts offer an improvement over the state-of-the-art. Proposed designs must, fundamentally, be assessed against cyclic loads representing common daily activities [Bergmann 2001] to ensure that they will withstand conceivable in-vivo loading conditions. Fatigue assessment involves:. –. cyclic mechanical testing, representing worst-case peak loads encountered in-vivo, typically for 10 million cycles, or. –. prediction of peak fatigue stresses using Finite Element (FE) methods, and comparison with the material's endurance limit. Cyclic stresses from gait loading are super-imposed upon residual assembly stresses. In thick walled devices, the residual component is small in comparison to the cyclic component, but in thin section, bone preserving devices, residual assembly stresses may be a multiple of the cyclic stresses, so a different approach to fatigue assessment is required. Modular devices provide intraoperative flexibility with minimal inventories. Components are assembled in surgery with taper interfaces, but resulting residual stresses are variable due to differing assembly forces and potential misalignment or interface contamination. Incorrect assembly can lead to incomplete seating and dissociation [Langdown 2007], or fracture due to excessive press-fit stress or point loading [Hamilton 2010]. Pre-assembly in clean conditions, with reproducible force and alignment, gives close control of assembly stresses. Clinical results indicate that this is only a concern with thick sectioned devices in a small percentage of cases [Hamilton 2010], but it may be critical for thin walled devices. A pre-clinical analysis method is proposed for this new scenario, with a case study example: a thin modular cup featuring a ceramic bearing insert and a Ti-6Al-4V shell (Fig. 1). The design was assessed using FE predictions, and manufacturing variability from tolerances, surface finish effects and residual stresses was assessed, in addition to loading variability, to ensure physical testing is performed at worst case:. –. assembly loads were applied, predicting assembly residual stress, verified by strain gauging, and a range of service loads were superimposed. The predicted worst-case stress conditions were analysed against three ‘constant life’ limits [Gerber, 1874, Goodman 1899, Soderberg 1930], a common aerospace approach, giving predicted safety factors. Finally, equivalent fatigue tests were conducted on ten prototype implants. Taking a worst-case size (thinnest-walled 48 mm inner/58 mm outer), under assembly loading the peak tensile stress in the titanium shell was 274 MPa (Fig. 2). With 5kN superimposed jogging loading, at an extreme 75° inclination, 29 MPa additional tensile stress was predicted. This gave mean fatigue stress of 288.5 MPa and stress amplitude of 14.5 MPa (R=0.9). Against the most conservative infinite life limit (Soderberg), the predicted safety factor was 2.40 for machined material, and 2.03 for forged material, or if a stress-concentrating surface scratch occurs during manufacturing or implantation (Fig. 3). All cups survived 10,000,000 fatigue cycles. This study employed computational modelling and physical testing to verify the strength of a joint prosthesis concept, under worst case static and fatigue loading conditions. The analysis technique represents an improvement in the state of the art where testing standards refer to conventional prostheses; similar methods could be applied to a wide range of novel prosthesis designs

Background. Titanium, in particular Ti6Al4V, is the standard material used in cementless joint arthroplasty. Implants are subjected to cyclic loading where fracture is the reason for re-operation in 1.5–2.4% of all revisions in total hip arthroplasty. In order to strengthen critical regions, surface treatments such as shot peening may be applied. A superficial titanium oxide layer is naturally formed on the surface as a protective film at ambient conditions. However, as its thickness is only in the range of several nanometers, it is prone to be destroyed by high loads - as present at the surface during bending - leading to an ‘oxidative wear’ in a corrosive environment [1]. The present study aims to evaluate the shot peening treatment on Ti6Al4V regarding its potential for cyclically loaded parts under a dry and a corrosive testing medium. Materials and Methods. Hour-glass shaped titanium specimens (Ti6Al4V) with a minimal diameter of 10 mm have been subjected to an annealing treatment at 620°C for 10h to remove initial residual stresses introduced during machining. Subsequently, a high-intensity shot peening treatment with cut wire followed by a low-intensity cleaning process with glass beads have been performed (Metal Improvement, Germany). Arithmetic mean roughness R. a. of the treated surfaces was measured (Mahr Perthometer M2, Germany). Residual stress depth profiles prior to and after shot peening have been measured by a Fe-filtered Co-K(alpha) radiation (GE Measurement&Control, USA) and calculated using the sin. 2. (psi) method. Fatigue strength has been determined by two servo-hydraulic hydropulsers (Bosch Rexroth, Germany) at 10 Hz and a load ratio of R=0.1 either under dry conditions (8 specimens) or surrounded by a 0.9-% saline solution (6 specimens) (BBraun, Germany) (Fig. 1). Testing has been performed until fracture occurred or the total number of 10 × 10. 6. cycles has been reached. All fracture surfaces have been analyzed after testing using FEG-SEM (Zeiss LEO 1530 VP Gemini, Germany). Results. Surface roughness increased significantly (p<0.01) after shot peening treatment from R. a, annealed. = 0.24 μm (±0.09 μm) to R. a, peened. = 2.02 μm (±0.16μm). Residual stresses have been introduced during shot peening up to a depth of 200μm with a maximum of 870 MPa at the surface (Fig. 2, left). All specimens showed clear signs of fatigue fracture after failure. Regarding fatigue strength, no differences have been observed between testing in saline solution or a dry environment (Fig. 2, right). Discussion. Shot peening has shown to significantly increase fatigue strength of a Ti6Al4V alloy after testing up to 10 × 10. 6. cycles. Thus, it seems to be an appropriate treatment for highly loaded components in cementless joint arthroplasty. In this context, a corrosive environment around a cyclically loaded implant does not seem to have any influence on their long term mechanical behaviour. However, it still needs to be clarified to which extend shot peening might decrease the risk of an early implant failure due to micro-motion between assembled parts (fretting) [2]

Unicompartmental knee replacement components have gained favor because they replace only the most damaged areas of articular cartilage and the less invasive operation results in a faster patient recovery than traditional TKR. Additionally, they can provide a solution when a full TKR is not yet needed. However, the wear magnitude of such implants is not well understood, primarily due the variation in design and the difficulty of testing them in knee simulators designed to test full TKRs. Modern innovative partial cartilage replacement knee components which are typically even smaller and more bone conservative than unicompartmental implants, are even less common in testing with added challenges. This study investigates the fatigue characteristics of partial cartilage replacement knee components, and the wear of the UHMWPE bearing of a new, truly less invasive unicompartmental design by Arthrex Inc./Florida. Fatigue testing was performed on MTS 858 MiniBionix machines. Two 12mm diameter UHMWPE tibial components were cemented into jigs at 0° posterior slope and were axially loaded at 2Hz for 10 million cycles (Mc) with a sinusoidal profile peaking at 60% of 8 average human bodyweights (3800N) and a load ratio R of 0.1. Two femoral components were tested with the same load profile at 10Hz for 10 million loading cycles (Mc). The femoral components were mounted at 15° flexion and only the anterior half of the implant was supported, replicating a worst-case scenario where fixation had failed on the posterior half of the implant. This resulted in a large bending moment when force was applied that would fatigue the femoral implant. Following the fatigue test, two full wear simulation tests were conducted on four 12mm and four 20mm unicompartmental components on a four-station Instron-Stanmore force-control knee simulator. The spring-based system to simulate soft-tissue restraining forces and torques was adapted to operate the machine in a displacement control mode to achieve the motions of the medial compartment based on ISO 14243-3. The specimens were lubricated with bovine serum (20g/L protein, 37°C) and the simulator was operated at 1Hz. Liquid absorption was corrected through passive-soak-control bearing inserts. The tibial specimens were cleaned and weighed at standard intervals with the usual ISO test protocols. After 10Mc of fatigue testing, both tibial components had deformed by some flattening out but were able to sustain the full load without failure and displayed average stiffness (over the whole 10Mc) of 27,600±1,180 N/mm. Neither partially supported femoral component failed, and the femorals displayed average stiffness (over 10Mc) of 37,500 ±3,280N/mm. After 5Mc of wear testing, the 12mm tibial components displayed a wear rate of 4.56±1.45mg/Mc while the larger 20mm size wore at a lower 2.80±0.39mg/Mc. The results from the fatigue test suggest that this unicompartmental cartilage replacement design will not fail under simple axial loading, even under the extreme case where the tibial implant is receiving the entire share of the load, and the femoral component is only partially supported. In the clinical application, of course some load-sharing with the native unworn cartilage would occur, reducing the stresses on the implant. The results from the wear test showed very low wear for tibial components of this design, lower than many successful TKRs. The larger size tibial components wore less likely due to reduced contact stress. Based on the results of this test, an implant of this type could be a viable option prior to TKR

PEEK rods construct has been proposed to allow better load sharing among spinal components when compared to the more traditional Titanium rods constructs. However, such proposal has largely derived from single-load in-vitro testing and the biomechanical differences between the two constructs when subjected to fatigue loading remain unknown. Current study comparatively analyzed the in-vitro biomechanical performance of PEEK and Titanium rod constructs as spinal implants through a 5 hour fatigue loading test. The disc height and intradiscal pressure of the instrumented and adjacent levels pre- and post-loading were recorded for analysis. The stress levels on the rods and bone stress near the screw-bone interface were also collected to investigate the likely failure rates of the two constructs. The results showed that the Titanium rods construct demonstrated a minimum amount of loss of disc height and intradiscal pressure at the instrumented level, however, a significant loss of the disc height and intradiscal pressure at adjacent levels compared to the intact spine were identified. In contrast, the disc height and intradiscal pressure of the PEEK rods were found to be comparable to those of the intact spine for all levels. The PEEK rods group also showed significantly less bone stress near the screw-bone interface compared to the Titanium rods group. Current study has demonstrated the potential benefits of the PEEK rods construct in reducing the risks of adjacent segment disease and implant failure rates when compared to the more traditional Titanium rods construct

Introduction. Modern hip replacements all have encapsulated the design concept of proximal modularity. The factors contributing to the increased wear and corrosion at the taper junction are trunnion geometry, surface characteristics, head size, impaction forces, and material coupling. This study maps the inferior and superior region of the trunnion and bore to provide a visual identification of the corrosion severity. The corrosion/wear generated inferiorly and superiorly at the bore and trunnion will be quantified to understand how corrosion is affected by mechanical stresses in relation to anatomical orientation. Methodology. Three neck tapers generated from bar stock containing a threaded trunnion Ti-6Al-4V and 3× 32mm femoral heads (Co-Cr-Mo) with a +4 offset manufactured by Signature Orthopaedics were used within this study. Rectangular Rozzette strain gauges (Tokyo Sokki Kenkyujo Co., Ltd.) were adhered onto the inferior and superior sections of the neck section. The tapers were fatigued in accordance to ISO 7206 at 5Hz for 5 million cycles at 37 degrees Celsius in phosphate buffered saline. The tapers were sectioned from the center of the femoral head to split both trunnion and bore into superior and inferior components. SEM imaging of all surface areas for each component, per taper (4) was done under ×100 magnification. The images were used to quantify the corrosion present across the surface area using a MATLAB based program called Histomorph. To obtain a visual observation of the variation of corrosion across the bore and trunnion the proximal, medial, and distal regions were mapped together for both the superior and inferior sections. Results. The superior region of the trunnion had a dominant tensile strain in comparison to the inferior region, which had a dominant compressive strain. Corrosion/wear of the inferior section of the trunnion was significantly higher (p<0.05) in comparison to the superior section (Figure 1). The bore had more corrosion/wear on the superior side in comparison to the inferior side however the difference was not significant. The mapping of the trunnion shows corrosion/wear along the whole length of the inferior side and dominantly at the distal region for the superior side (Figure 2 & 3). The superior section of the trunnion had higher corrosion/wear damage across the center and distal regions of the trunnion. The subdivision of the superior section reveals that the majority of the distal section contains higher wear/corrosion damage. However the central region also has sufficient corrosion/wear extending across the width of the bore. Conclusion. The corroded regions have shown that the type of stress present on the regions of the taper junction determines the severity of corrosion. The inferior section of the trunnion under compressive stress has significantly (p<0.05) higher corrosion/wear in comparison to the superior section dominated by tensile stress

Introduction. Comprehensive research and retrieval analyses of metal on metal / metal on polyethylene hip fretting and corrosion have been reported. Design choices such as modularity, material couples, geometry and offsets, as well as surgical variability and patient sensitivity have been cited as factors contributing to revision. Findings are informing new designs, surgical techniques and patient testing. However, similar efforts have not been performed on the shoulder. Do reduced joint reaction forces imply lower risk of fretting and corrosion? In this study we designed an accelerated corrosion fatigue (ACF) test specific for the shoulder to allow for evaluation of varying designs, and compared results to a reported shoulder retrieval study [Day ORS 2015]. Methods. Anatomic configuration and reverse shoulder ACF tests were developed with loads and orientations determined from instrumented shoulder data and reported literature. Scaled loads of 1480 N and 962 N were applied to anatomic (Fig 1.A) and reverse (Fig 1.B) prostheses, respectively (n=5 each, with additional assembly control), in potential worse case loading directions (α=25°, β=20°: anatomic; α=0°, β=0°: reverse), at 5 Hz for 3.0 Mc with R=0.1. Test environment included 0.9% NaCl solution at elevated temperature (50° C) and a decreased pH (3.5). Mass, roughness (Ra) and taper damage (modified Goldberg scoring system) measures were taken before and after testing. Taper connections were assembled at impact loads of 3600 N +/− 20% based on cadaveric studies. Goldberg scores for 79 humeral heads and 61 stems from an IRB approved collection served as the comparator. Results. The ACF test methodology caused only fretting in anatomic testing (Fig 2) but both fretting and corrosion in reverse tests (Fig 3). Alloys of Titanium (Ti-6V-4Al and Ti-6Al-7Nb) exhibited higher levels of fretting than CoCr alloys in both test configurations. Significant Ra decreases post-test were noted on all Ti based components, with Ra increases on CoCr based heads and glenospheres (p<0.05). The average mass loss measured in anatomical testing was 1.44 ± 0.35 mg with an average Goldberg score of 1.8 ± 0.3. In the reverse test mass loss was 1.51 ± 0.36 mg with a Goldberg score of 2.4 ± 0.3. Retrievals (implanted 4.6 ± 4.3 years) had weighted average Goldberg scores of 1.6 for heads compared to 2.0 for stems, with the majority of damage from fretting. Discussion. Anatomic and reverse shoulder ACF tests were created that result in levels of taper damage similar to those noted in clinical retrievals (Fig 2, Fig 3). Reverse implant tapers, under reduced loads compared to anatomic but with higher humeral load offset, tend to show higher levels of taper damage in vitro. Under the same assembly conditions, offset is a large contributor to micromotion, fretting, and likely corrosion. With offset and modularity as design options for the shoulder surgeon, care must be taken not to introduce offerings which may lead to significant metal and particle release in vivo. The proposed ACF testing may be one method to evaluate current and proposed shoulder designs

Femoral component fracture is a rarely reported but devastating complication of total knee arthroplasty. It has occurred most frequently with Whiteside Ortholoc II replacements uncemented knee replacements. Presentation may be with acute pain, progressive pain or returning deformity. It occurs more commonly in the medial condyle of the femoral component. It is rarely seen in cemented replacements. All currently available literature describing fractures of condylar replacements, both cemented and uncemented. Predisposing factors include varus deformity either pre or post operatively. The mechanism of failure is thought to be failure of the infiltration of bone into the replacement. This is often due to polyethylene wear or metallosis causing abnormal tissue reaction with or without osteolysis. We present the case of a fractured Press Fit Condylar (PFC) cemented implant (DePuy, Johnson&Johnson, Raynham, Massachusettes, USA) affecting the medial condyle. To our knowledge this is only the third reported case of fracture in a PFC implant, and the first in a cemented PFC implant. Our patient was a 64 year old male who presented with unresolving knee pain post total knee arthroplasty, caused by fatigue fracture of the medial condyle of the femoral component. This was identified as loosening on plain radiographs and replaced with a revision prosthesis with a good post operative result. Given our aging population and with the increase of joint arthroplasty, this case sheds light on a potentially under recognised and increasingly important cause of knee pain following arthroplasty

Revision surgeries for orthopaedic infections are done in two stages – one surgery to implant an antibiotic spacer to clear the infection and another to install a permanent implant. A permanent porous implant, that can be loaded with antibiotics and allow for single-stage revision surgery, will benefit patients and save healthcare resources. Gyroid structures can be constructed with high porosity, without stress concentrations that can develop in other period porous structures [1] [2]. The purpose of this research is to compare the resulting bone and prosthesis stress distributions when porous versus solid stems are implanted into three proximal humeri with varying bone densities, using finite element models (FEM). Porous humeral stems were constructed in a gyroid structure at porosities of 60%, 70%, and 80% using computer-aided design (CAD) software. These CAD models were analyzed using FEM (Abaqus) to look at the stress distributions within the proximal humerus and the stem components with loads and boundary conditions representing the arm actively maintained at 120˚ of flexion. The stem was assumed to be made of titanium (Ti6Al4V). Three different bone densities were investigated, representing a healthy, an osteopenic, and an osteoporotic humerus, with an average bone shape created using a statistical shape and density model (SSDM) based on 75 cadaveric shoulders (57 males and 18 females, 73 12 years) [3]. The Young's moduli (E) of the cortical and trabecular bones were defined on an element-by-element basis, with a minimum allowable E of 15 MPa. The Von Mises stress distributions in the bone and the stems were compared between different stem scenarios for each bone density model. A preliminary analysis shows an increase in stress values at the proximal-lateral region of the humerus when using the porous stems compared to the solid stem, which becomes more prominent as bone density decreases. With the exception of a few mesh dependent singularities, all three porous stems show stress distributions below the fatigue strength of Ti-6Al-4V (410 MPa) for this loading scenario when employed in the osteopenic and osteoporotic humeri [4]. The 80% porosity stem had a single strut exceeding the fatigue strength when employed in the healthy bone. The results of this study indicate that the more compliant nature of the porous stem geometries may allow for better load transmission through the proximal humeral bone, better matching the stress distributions of the intact bone and possibly mitigating stress-shielding effects. Importantly, this study also indicates that these porous stems have adequate strength for long-term use, as none were predicted to have catastrophic failure under the physiologically-relevant loads. Although these results are limited to a single boney geometry, it is based on the average shape of 75 shoulders and different bone densities are considered. Future work could leverage the shape model for probabilistic models that could explore the effect of stem porosity across a broader population. The development of these models are instrumental in determining if these structures are a viable solution to combatting orthopaedic implant infections

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]

Total knee arthroplasty with a rotating hinge knee with carbon-fibre-reinforced (CFR)-PEEK as an alternative bushing material with enhanced creep, wear and fatigue behaviour has been clinically established [1-4]. The objective of our study was to compare results from in vitro biotribological characterisation to ex vivo findings on a retrievals. A modified in vitro wear simulation based on ISO 14243-1 was performed for 5 million cycles on rotating hinge knee (RHK) designs (EnduRo®) out of cobalt-chromium and ZrN-multilayer ceramic coating. The rotational & flexion axles-bushings and the flanges are made of CFR-PEEK with 30% polyacrylonitrile fibre content. Analysis of 12 retrieved EnduRo® RHK systems in cobalt-chromium and ZrN-multilayer in regard to loosening torques, microscopic surface analysis, distinction between different wear modes and classification with a modified HOOD-score has been performed. For the RHK design with the polyethylene gliding surface and bushings and flanges made out of CFR-PEEK, a cumulative volumetric wear was measured to be 12.9±3.95 mm. 3. in articulation to cobalt-chromium and 1.3±0.21 mm. 3. to ZrN-multilayer coating - a significant 9.9-fold decrease (p=0.0072). For the CFR-PEEK flexion bushing and flanges the volumetric wear rates were 2.3±0.48 mm. 3. /million cycles (cobalt-chromium) and 0.21±0.02 mm. 3. /million cycles (ZrN-multilayer) (p=0.0016). The 5 million cycles of in vitro wear testing reflect a mean in vivo service life of 2.9 years, which is in accordance to the time in vivo of 12–60 months of the retrieved RHK components [5]. The main wear modes were comparable between retrievals and in vitro specimens, whereby the size of affected area on the retrieved components showed a higher variation. For the EnduRo® RHK design the findings on retrieved implants demonstrate the high suitability of CFR-PEEK as a biomaterial for highly loaded bearings, such as RHK bushings and flanges in articulation to cobalt-chromium and to a ZrN-multilayer coating

It has been established that a dedicated orthopaedic trauma room (DOTR) provides significant clinical and organizational benefits to the management of trauma patients. After-hours care is associated with surgeon fatigue, a high risk of patient complications, and increased costs related to staffing. However, hesitation due to concerns of the associated opportunity cost at the hospital leadership level is a major barrier to wide-spread adoption. The primary aim of this study is to determine the impact of dedicated orthopaedic trauma room (DOTR) implementation on operating room efficiency. Secondly, we sought to evaluate the associated financial impact of the DOTR, with respect to both after-hours care costs as well as the opportunity cost of displaced elective cases. This was a retrospective cost-analysis study performed at a single academic-affiliated community hospital in Toronto, Canada. All patients that underwent the most frequently performed orthopedic trauma procedures (hip hemiarthroplasty, open reduction internal fixation of the ankle, femur, elbow and distal radius), over a four-year period from 2016-2019 were included. Patient data acquired for two-years prior and two-years after the implementation of a DOTR were compared, adjusting for the number of cases performed. Surgical duration and number of day-time and after-hours cases was recorded pre- and post-implementation. Cost savings of performing trauma cases during daytime and the opportunity cost of displacing elective cases by performing cases during the day was calculated. A sensitivity analysis accounting for varying overtime costs and hospital elective case profit was also performed. 1960 orthopaedic cases were examined pre- and post-DOTR. All procedures had reduced total operative time post-DOTR. After accounting for the total number of each procedure performed, the mean weighted reduction was 31.4% and the mean time saved was 29.6 minutes per surgery. The number of daytime surgical hours increased 21%, while nighttime hours decreased by 37.8%. Overtime staffing costs were reduced by $24,976 alongside increase in opportunity costs of $22,500. This resulted in a net profit of $2,476. Our results support the premise that DOTRs improve operating room efficiency and can be cost efficient. Through the regular scheduling of a DOTR at a single hospital in Canada, the number of surgeries occurring during daytime hours increased while the number of after-hours cases decreased. The same surgeries were also completed nearly one-third faster (30 minutes per case) on average. Our study also specifically addresses the hesitation regarding potential loss of profit from elective surgeries. Notably, the savings partially stem from decreased OR time as well as decreased nurse overtime. Widespread implementation can improve patient care while still remaining financially favourable

Introduction. Highly crosslinked, ultra-high molecular weight polyethylene (HXLPE) acetabular liners inherently have a risk of fatigue failure associated with femoral neck impingement. One of the potential reasons for liner failure was reported as crosslinking formulations of polyethylene, increasing the brittleness and structural rigidity. In addition, the acetabular component designs greatly affect the mechanical loading scenario, such as the offset (lateralized) liners with protruded rim above the metal shells, which commonly induce a weak resistance to rim impingement. The purpose of the present study was to compare the influence of the liner offset length on the impingement resistance in the annealed (first generation) and vitamin E-blended (second-generation) HXLPE liners with a commercial design. Materials and Methods. The materials tested were the 95-kGy irradiated annealed GUR1020, and the 300-kGy irradiated vitamin E-blended GUR1050 HXLPE offset liners, which were referred to as “20_95” and “50E_300”, respectively. These liners had 2, 3, 4-mm rim offset, 2.45-mm rim thickness, and 36-mm internal diameter. Their rims were protruded above the metal rim at 2, 3, 4mm. Rim impingement testing was performed using an electrodynamic axial-torsional machine. The cyclic impingement load of 25–250N was applied on the rims through the necks of the femoral stems at 1Hz. The rotational torque was simultaneously generated by swinging the stem necks on the rims at 1Hz and its rotational angle was set at the range of 0–10˚. The percent crystallinity was analyzed on the as-received (intact) and impinged HXLPE acetabular rims by confocal Raman microspectroscopy. Results. The number of cycles to failure was dependent on the offset length (2, 3, 4-mm) in 20_95 and 50E_300 liners. Our results showed that the shorter the rim offset, the shorter the number of cycles to failure. In both HXLPEs, accumulation of impingement damages significantly decreased crystallinity in their near-surfaces, indicating the occurrence of crystallographic breakdown. In each offset length tested, the fracture always occurred much earlier in 50E_300 than 20_95. However, the magnitudes of the microstructural changes at the time of failure were much less in 50E_300 than 20_95. Conclusions. Although it is known that vitamin E blend into HXLPE can improve the fatigue resistance of HXLPE, the impingement resistance of 50E_300 was lower than vitamin-E free 20_95, indicating a larger negative contribution of high-dose radiation (300kGy) over a positive contribution of the vitamin E blend in 50E_300. Our results implied that the reduction of the protruded rim length in the offset liners may increase the neck-rim contact stresses at the time of impingement, causing a decrease in the fatigue durability. Therefore, if HXLPE offset liner is used, surgeons should take special care in maximizing the volume of the protruded lip section

Introduction. Hip modular implants provide real advantages to patients and surgeons: the opportunity to restore the natural anatomy, to correct discrepancy is positioning, etc…. Nevertheless, recent publication showed the weakness of these prostheses. A review of the literature on this phenomenon is carried out, and shows that fretting fatigue and fretting wear is often pointed out to explain these issues. Objectives. The goal of this project is to optimise these products, carrying out advanced simulations with criterion that allow to compare the behaviour regarding fretting in the modularity. Methods. Different parameters are considered:. -. Geometric (length, width and height of the neck basis). -. Material (CrCo, TA6V4). -. Tribology (different friction coefficient to simulate different roughness). -. Environmental (load impaction). Several FEA simulations are carried out (Fig 1) in order to assess the sensitivity of these parameters. The choice of the criterion is of course an important point, and 2 main criterions are proposed to compare the designs regarding fretting wear and fretting fatigue. The experiment plan is exploited in order to find the best solutions for next designs. Fatigue tests are also carried out in ISO 7206–6 conditions (fig. 2): failure analyses are conducted and results are compared to simulation. Results and conclusion. To be correctly simulated, a failure of fretting fatigue need to be considered with appropriated criterion: FEA with Smith Watson Topper, a multi axial fatigue criteria, is an efficient way of improving the modularity design. The study also allows us to identify important parameters, like load impaction: it appears that a load too high or too low conducts to non-optimum behaviour. Similarly, simulations shows that a friction coefficient about 0, 4 leads a good behaviour regarding fatigue fretting as well as fatigue wear

Introduction. Computer hexapod assisted orthopaedic surgery (CHAOS) has previously been shown to provide a predictable and safe method for correcting multiplanar femoral deformity. We report the outcomes of tibial deformity correction using CHAOS, as well as a new cohort of femoral CHAOS procedures. Materials and Methods. Retrospective review of medical records and radiographs for patients who underwent CHAOS for lower limb deformity at our tertiary centre between 2012–2020. Results. There were 70 consecutive cases from 56 patients with no loss to follow-up. Mean age was 40 years (17 to 77); 59% male. There were 48 femoral and 22 tibial procedures. Method of fixation was intramedullary nailing in 47 cases and locking plates in 23. Multiplanar correction was required in 43 cases. The largest correction of rotation was 40 degrees, and angulation was 28 degrees. Mean mechanical axis deviation reduction per procedure was 17.2 mm, maximum 89 mm. Deformity correction was mechanically satisfactory in all patients bar one who was under-corrected, requiring revision. Complications from femoral surgery included one under-correction, two cases of non-union, and one pulmonary embolism. Complications from tibial surgery were one locking plate fatigue failure, one compartment syndrome, one pseudoaneurysm of the anterior tibial artery requiring stenting, and one transient neurapraxia of the common peroneal nerve. There were no deaths. Conclusions. CHAOS can be used for reliable correction of complex deformities of both the femur and tibia. The risk profile appears to differ between femoral and tibial surgeries