Aims. Wear of the polyethylene (PE) tibial insert of total knee arthroplasty (TKA) increases the risk of revision surgery with a significant cost burden on the healthcare system. This study quantifies wear performance of tibial inserts in a large and diverse series of retrieved TKAs to evaluate the effect of factors related to the patient, knee design, and bearing material on tibial insert wear performance. Methods. An institutional review board-approved retrieval archive was surveyed for modular PE tibial inserts over a range of in vivo duration (mean 58 months (0 to 290)). Five knee designs, totalling 1,585 devices, were studied. Insert wear was estimated from measured thickness change using a previously published method. Linear regression statistical analyses were used to test association of 12 patient and implant design variables with calculated wear rate. Results. Five patient-specific variables and seven implant-specific variables were evaluated for significant association with lower insert wear rate. Six were significant when controlling for other factors: greater patient age, female sex, shorter duration in vivo, polished tray, highly cross-linked PE (HXLPE), and constrained knee design. Conclusion. This study confirmed that knee wear rate increased with duration in vivo. Older patients and females had significantly lower wear rates. Polished modular tibial tray surfaces, HXLPE, and constrained TKA designs were device design factors associated with significantly reduced wear rate. Cite this article: Bone Joint J 2021;103-B(11):1695–1701

Aim of this study was the development of a dynamic FE-framework to identify worst-case size combinations and kinematics in a virtual wear simulator setup covering five daily activities and high, dynamic loads.

Two cruciate sacrificing knee designs (D1 & D2) were tested physically on a wear-testing machine prior the model development using a high demanding, daily activity protocol (HDA) [1]. A simplified FE-setup was generated, reduced to the 3D geometries of the assembly whereas the representation of the mechanical wear simulator conditions and the load transmission was achieved by joint elements. Inertial and other time-related effects of the physical situation were compensated by a system of spring- and damper elements.

Using a time-series signal optimization approach on the anterior-posterior translation and the internal-external rotation results for each activity, 38 variable parameters were varied in between pre-defined limits in a semiautomatic workflow. For each design, two consecutive cycles of a single activity were analysed and the results of the second cycle were used for the optimization. Based on the determined values, a single set of averaged parameter settings was identified that covers all activity cycles sufficiently.

A total of 1010 dynamic analyses were carried out in order to find a sharable set of parameter values.

In this study, an efficient simulation workflow for design evaluation was developed. Therefore, a HDA wear-testing machine was simplified to boundary conditions and stabilizing elements, using a single set of parameters for all activities. The calculated kinematics were in a comparable range to the machine output. Further applications of the method were found in systematic analyses of entire implant systems to achieve consistent kinematics over the size compatibility range in the design process of new implant systems.

Total knee arthroplasty is a well established treatment for degenerative joint disease with good clinical results. However, complications may occur due to a biological response to polyethylene wear particles, leading to osteolysis and aseptic loosening, as well as local and systemic hypersensitivity reactions triggered by metal ions and particles such as chromium, cobalt and molybdenum. Moreover, there is an increasing demand on the performance of these implants, as this treatment is also performed in heavier, younger and middle-aged adults who have a significant physical activity and higher life expectancy. The purpose of the following study was to compare the wear characteristics and performance of a zirconium nitride (ZrN) coated knee implant, designed for patients with metal ion hypersensitivity, against the clinically established cobalt-chromium (CoCr) version under a high demanding activities wear simulation. Medium size AS Columbus® DD (Aesculap AG, Tuttlingen, Germany) femoral and tibial components with a ZrN surface were tested in comparison with the cobalt-chromium version Columbus® DD. For both groups, ultra-high-molecular weight polyethylene (UHMWPE) gliding surfaces (size T3, high 10 mm) were used. Wear simulation was performed on a load controlled 4 station knee wear simulator (EndoLab GmbH, Thansau, Germany) capable of reproducing loads and movement of daily activities measured in vivo (Bergmann et al, 2014) on 8 patients and normalized to a patient weight of 100 kg (Schwiesau et al, 2014). The load profiles were applied for 5 million cycles in a combination of 40% stairs up, 40% stairs down, 10% level walking, 8% chair raising and 2% deep squatting. Test serum was changed every 0.5 million cycles and all the components were cleaned and analyzed according to ISO 14243-2:2009(E). The gliding surfaces were evaluated for gravimetric wear and wear patterns, femur components analyzed for scratches and the test medium analyzed for metal ion concentration (cobalt, chromium, molybdenum and zirconium) using ICP-MS according to ISO 17294-2. The present study showed a wear rate reduction for the ZrN group (1.01 ± 0.29 mg/million) in comparison with the CoCr group (2.40 ± 1.18 mg/million cycles). The articulation surface of the ZrN coated femurs remained polished after the testing period, whereas the uncoated femurs showed wear scratches. Furthermore, the metal ion release from the ZrN coated implants was reduced orders of magnitude in comparison with the CoCr implants through the entire test. These results demonstrate the efficiency of ZrN coated knee implants to reduce wear as well as to prevent metal ion release in the knee joint

Improving the wear resistance of polyethylene is considered paramount to improving knee implant longevity. Consequently, a range of polymer fabrication techniques have evolved in the quest for a highly wear resistant material. The objective of this study was to explore the wear performance of polyethylene as fabricated in a variety of ways.

The following materials were prepared, sterilised, artificially aged, and machined into wear specimens (n = 4 for each material): Compression molded GUR1050 with three levels of cross-linking (120 kGy, 65 kGy, and 0 kGy irradiation – control); ram extruded GUR4150 high modulus material; compression molded GUR4150 low modulus material; and HSS/PolySolidur/Hoechst reference polyethylene. Using a custom designed joint articular wear simulator, samples were loaded for 2 million cycles at a frequency of 0.5 Hz under loads of 2.1 kN. Tests were stopped every 250 000 cycles; and wear surfaces were examined microscopically for surface damage (pitting, cracking, delamination).

After 2 million loading cycles the following specimens were pitted and delaminated: 2 GUR1050 control samples, 3 GUR4150 high modulus specimens, and all 4 reference polyethylene specimens. Burnishing, but no pitting, was seen in all GUR1050 elevated cross-linked polyethylene specimens, and in all GUR4150 low modulus specimens.

The materials tested in this study represent a broad range of fabrication techniques. Differences in starting resin cannot fully account for the differences in wear behaviour seen between the groups; as damage was not limited to one resin group. The cross-linked specimens were melt-annealed, prior to cross-linking. It is possible that this processing step, and not the actual cross-linking, contributed to the improved wear performance of this group. However, of most interest is the comparable wear performance of GUR1050 cross-linked polyethylene and GUR4150 low modulus polyethylene suggesting that cross-linking polyethylene is not the only route towards obtaining a polyethylene with superior wear characteristics.

Background

Polyethylene (PE) wear is known as a limiting factor for total knee replacements (TKR). Thus, preclinical wear testing is an important tool to assess the suitability of new designs and new materials. However, standardized testing (e.g. according to ISO 14243) does not cover the individual situation in the patient. Consequentially, this study investigates the following two parameters:a)

Testing-Frequency: Patients with TKR's show a humiliated walking frequency (down to 0,5Hz) compared to standardized testing (1Hz±0.1). In the first part of this study, the influence of a decreased test frequency on the PE wear behavior is investigated

Purpose: Posters of study: To produce a virtual reality model of prosthetic knee joint motion, giving detail regarding contact area and contact pressures during the process of walking. Method: Using serial CT scans and data regarding the material properties of bone, cartilage, ligaments and other soft tissue structures a computational “virtual reality model” of the knee has been constructed. This computational model which is a 3D dynamic representation of a human knee joint, may be programmed to replicate the standard gait pattern of the human knee. This study details the development of this model and its validation against the accepted Stenmore Test Rig for modelling of knee joint movement and knee prosthetic wear. The validation results will be presented,. The model allows the calculation and representation of contact pressures and contact areas in the knee joint as it moves through the gait cycle. This study also shows the effect of uni-condular loading and varus mal-positioning which may occur at surgery and the effect this has on the contact area and contact pressures of a prosthetic knee in ambulation. The resultant gait pattern produced by uni-condular loading and exhibited by the virtual knee closely resembles that seen in In Vivo Kinematic Studies reported by other authors. In conclusion we present this as a valid computational dynamic model of knee prosthetic wear and kinematics which represents an enormous advantage over standard mechanical testing and presents possibilities for rapid analysis in new knee joint designs and the effect of abnormalities of gait and wear

Wear of ultra-high molecular weight polyethylene (UHMWPE) is a major factor that affects longevity of the total joint replacement. In total hips, cross-linking of polyethylene acetabular cup has been shown highly effective in reducing wear both clinically and experimentally. In TKR, Schmidig 2000 showed 90% reduction of wear rate in 10 Mrad irradiated tibial inserts compared to 3 Mrad irradiated tibial inserts. Thus crosslinking should provide substantial improvement also in the wear resistance of UHMWPE tibial inserts. Our objective was to compare 3 Mrad UHMWPE with 10 Mrad HCLPE in same design but comparing standard kinematics to more severe mal-rotation kinematics. The latter offsets the tibial tray with 15 degrees internal rotation such the central tibial eminencies became involved in the wear process. Our hypothesis was that HCLPE would be more resistant than the standard UHMPE even in the mal-rotation model. The control material was Duracon 3 Mrad UHMWPE. HCLPE was radiation crosslinked to 10 Mrad mater

Polyethylene wear in total knee arthroplasty (TKA) is a complex and mutifactorial process. It is generally recognized that wear is directly related to a material wear factor, contact stress, and sliding distance. Conventional methods of predicting polyethylene wear in TKA mainly focus on peak contact stress or subsurface shear stress using finite element method analysis. By incorporating kinematics and contact stress, a new predictor for polyethylene wear in TKA (“Wear Index”) has been developed. The Wear Index was defined by multiplying deformation by femoro-tibial sliding velocity. The purpose of this study was to determine the predictive value of the Wear Index for polyethylene wear in TKA using both a numeric and an in vitro model.

Four commercially available total knee prostheses were modeled for this study. Deformation and sliding velocity were calculated based on the three-dimensional geometry of the components and the gait kinematic inputs using Hertz’s formula. One specimen of each of the four types of total knee prostheses was mounted on a custom-designed knee simulator. Vertical loads and flexion-extension uni-axial motion were simulated using computer controlled servohydraulic actuators. The same gait kinematic inputs used in the theoretical study were used in the simulation test. After the simulations, the surface of the tibial insert was examined microscopically and macroscopically and compared with the theoretically generated Wear Index.

This study showed a high correlation between the numeric model and the simulation. The depth of wear on the tibial insert correlated significantly with the Wear Index. Microscopic findings also demonstrated a good correlation between the Wear Index and observed wear patterns. Sliding velocity is an important factor for understanding wear in TKA. In conclusion, this study suggests that the Wear Index is a reliable predictor of polyethylene wear in TKA, as it incorporates both contact stress and kinematics in its calculation.

The introduction of mobile bearings for unicompartimental knee implants resulted in heightened interest in this implant design in the field of orthopaedics. This study aims to determine the effect of the mobile and fixed design concepts on the wear progression in unicompartmental knee implants using a knee simulator.

An unicompartmental knee implant design, which is available in a fixed and mobile version, was tested using a knee simulator. For the wear test, the medial and lateral compartments were implemented in the simulator. To account for the physiologically higher medial load compared to the lateral compartment, a medially-biased load distribution was implemented. The wear test was performed force controlled according to ISO 14243. Wear was measured gravimetrically separately for the medial and lateral compartments. To evaluate implant kinematics, AP-translation and IE-rotation were measured during the simulation.

Gravimetric wear was higher medially than laterally for both designs. The mean wear rate of the medial mobile compartment was found to be 10.70 mg/10E6 cycles, whereas a mean wear rate of 6.05 mg/10E6cycles was found for the medial compartment of the fixed design. Lateral wear rates, which were about 50% lower than medial wear rates, were found to be 5.38 mg/10E6 cycles in the mobile design and 3.23 mg/10E6 cycles in the lateral design. Wear of the mobile design was higher compared to the fixed design, both medially and laterally. Surprisingly the kinematics of both designs were very similar. A low AP-translation of 2.7 mm in the mobile and 2.4 mm in the fixed designs was documented. High IE-rotations of 6.5° and 6.7° for the mobile and the fixed design, respectively, were observed.

In bicondylar bearing knee designs, reduced wear has been reported for mobile polyethylene inlays. This study showed that the wear behaviour of unicompartmental knee implants differs from bicondylar implants and that the introduction of the mobile concept may lead to increased wear.

The purpose of the study was to compare the mechanical properties, oxidation and wear resistance of a vitamin E blended and moderately crosslinked polyethylene for total knee arthroplasty (MXE) in comparison with clinically established polyethylene materials. The following polyethylene materials were tested: CPE (30 kGy e-beam sterilized), XLPE (75 kGy gamma crosslinked @ 100°C), ViXLPE (0.1 % vitamin E blended, 80 kGy e-beam crosslinked @ 100°C), and MXE (0.1 % vitamin E blended polyethylene, 30 kGy gamma sterilized). For the different tests, the polyethylene materials were either unaged or artificially aged for two or six weeks according to ASTM F2003-02. The oxidation index was measured based on ASTM F2102 at a 1 mm depth. Small punch testing was performed based on ASTM F2977. Mechanical properties were measured on unaged materials according to ASTM D638. Wear simulation was performed on a load controlled 3 + 1 station knee wear simulator (EndoLab GmbH, Thansau, Germany) capable of reproducing loads and movement of highly demanding activities (HDA) as well as ISO 14243-1 load profiles. The load profiles were applied for 5 million cycles (mc) or delamination of the polyethylene components. Medium size AS e.motion. ®. PS Pro (Aesculap AG, Tuttlingen, Germany) femoral and tibial components with a ZrN-multilayer surface, as well as Columbus. ®. CR cobalt-chrome alloy femoral and tibial components were tested. Particle analysis was performed on the serum samples of the ISO 14243-1 wear simulations based on ISO 17853:2011 and ASTM F1877. The analysis of the mechanical properties show that moderately crosslinked polyethylene (MXE) might be a superior material for total knee arthroplasty applications [Schwiesau et al. 2021]. The addition of vitamin E in a moderately crosslinked polyethylene prevented its oxidation, kept its mechanical characteristics, and maintained a low wear, even under a HDA knee wear simulation

Aims. The aims of this study were to evaluate wear on the surface of cobalt-chromium (CoCr) femoral components used in total knee arthroplasty (TKA) and compare the wear of these components with that of ceramic femoral components. Methods. Optical profilometry was used to evaluate surface roughness and to examine the features created by the wear process in a knee wear simulator. We developed a method of measuring surface changes on five CoCr femoral components and quantifying the loss of material from the articular surface during the wear process. We also examined the articular surface of three ceramic femoral components from a previous test for evidence of surface damage, and compared it with that of CoCr components. Results. We found that the surface roughness of CoCr components rapidly increased during the first 1,000 wear cycles, then reached a steady state, but material loss from the surface continued at a rate of 1,778,000 μm. 3. per million cycles as carbides were removed from its matrix. These carbides formed third-body wear particles, leading to the formation of new scratches even as older scratches were worn away. In contrast, no scratching, loss of material, or other surface damage, when evaluated with one nanometer resolution, was found on the surface of the ceramic components after a 15 M wear cycle test. Conclusion. This study showed wear and loss of CoCr material from scratching and microabrasive wear in TKA. The material loss from the surface continued in a linear relationship with increasing cycles. We also found the absence of scratching and roughening of ceramic femoral components in simulated wear, suggesting an advantage in wear rate and avoiding metal sensitivity. This may have implications in the management of persistent pain after TKA. Cite this article: Bone Joint J 2021;103-B(6 Supple A):94–101

Majority of ultra-high molecular weight polyethylene (UHMWPE) medical devices used in total joint arthroplasty are crosslinked using gamma radiation to improve wear resistance. Alternative methods of crosslinking are urgently needed to replace gamma radiation due to rapid decline in its supply. Peroxide crosslinking is a candidate method with widespread industrial applications. Oxidative stability and biocompatibility, which are critical requirements for medical device applications, can be achieved using vitamin-E as an additive and by removing peroxide by-products through high temperature melting, respectively. We investigated compression molded UHMWPE/vitamin-E/di-cumyl peroxide blends followed by high-temperature melting in inert gas as a material candidate for tibial knee inserts. Wear resistance increased and mechanical properties remained largely unchanged. Oxidation induction time was higher than most of the other clinically available formulations. The material passed the local-end point biocompatibility tests per ISO 10993. Compounds found in exhaustive extraction were of no concern with margin-of-safety values well above the accepted level, indicating a desirable toxicological risk profile. Peroxide crosslinked, vitamin-E stabilized, and high temperature melted UHMWPE has recently been cleared for clinical use in tibial knee inserts. With all the salient characteristics needed in a material that can provide superior long-term performance in total joint patients, peroxide crosslinking can replace gamma radiation crosslinking of UHMWPE for use in all total joint replacement implant including acetabular liners

Background. Wear and fatigue damage to polyethylene components remain major factors leading to complications after total knee and unicompartmental arthroplasty. A number of wear simulations have been reported using mechanical test equipment as well as computer models. Computational models of knee wear have generally not replicated experimental wear under diverse conditions. This is partly because of the complexity of quantifying the effect of cross-shear at the articular interface and partly because the results of pin-on-disk experiments cannot be extrapolated to total knee arthroplasty wear. Our premise is that diverse experimental knee wear simulation studies are needed to generate validated computational models. We combined five experimental wear simulation studies to develop and validate a finite-element model that accurately predicted polyethylene wear in high and low crosslinked polyethylene, mobile and fixed bearing, and unicompartmental (UKA) and tricompartmental knee arthroplasty (TKA). Methods. Low crosslinked polyethylene (PE). A finite element analysis (FEA) of two different experimental wear simulations involving TKA components of low crosslinked polyethylene inserts, with two different loading patterns and knee kinematics conducted in an AMTI knee wear simulator: a low intensity and a high intensity. Wear coefficients incorporating contact pressure, sliding distance, and cross-shear were generated by inverse FEA using the experimentally measured volume of wear loss as the target outcome measure. The FE models and wear coefficients were validated by predicting wear in a mobile bearing UKA design. Highly crosslinked polyethylene (XLPE). Two FEA models were constructed involving TKA and UKA XLPE inserts with different loading patterns and knee kinematics conducted in an AMTI knee wear simulator. Wear coefficients were generated by inverse FEA. Results. Predicted wear rates were within 5% of experimental wear rates during validation tests. Unicompartmental mobile bearing back-side wear accounted for 46% of the total wear in the mobile bearing. Wear during the swing phase was 38% to 44% of total wear. Discussion & Conclusions. Crosslinking polyethylene primarily decreased (by nearly 10-fold) the wear generated by cross-shear. This result can be explained by the reduced propensity of crosslinked polyethylene molecules to orient in the dominant direction of sliding. A highly crosslinked fixed-bearing polyethylene insert can provide high wear performance without the increased risk for mobile bearing dislocation. Finite element analysis can be a robust and efficient method for predicting experimental wear. The value of this model is in rapidly conducting screening studies for design development, assessing the effect of varying patient activity, and assessing newer biomaterials. This FEA model was experimentally validated but requires clinical validation

Introduction. Wear of polyethylene tibial inserts has been cited as being responsible for up to 25% of revision surgeries, imposing a very significant cost burden on the health care system and increasing patient risk. Accurate measurement of material loss from retrieved knee bearings presents difficult challenges because gravimetric methods are not useful with retrievals and unworn reference dimensions are often unavailable. Geometry and the local anatomy restrict in vivo radiographic wear analysis, and no large-scale analyses have illuminated long-term comparative wear rates and their dependence on design and patient factors. Our study of a large retrieval archive of knee inserts indicates that abrasive/adhesive wear of polyethylene inserts, both on the articular surface and on the backside of modular knees is an important contributor to wear, generation of debris and integrity of locking geometry. The objective of the current study is to quantify wear performance of tibial inserts in a large archive of retrieved knees of different designs. By assessing wear in a large and diverse series, the goal is to discern the effect on wear performance of a number of different factors: patient factors that might help guide treatment, knee design factors and bearing material factors that may inform a surgeon's choice from among the array of arthroplasty device options. Methods. An IRB approved retrieval database was queried for TKA designs implanted between 1997 and 2017. 1385 devices from 5 TKA designs were evaluated. Damage was ranked according to Hood's method, oxidation was determined through FTIR, and wear was determined through direct measurement of retrieved inserts using a previously established protocol. Design features (e.g. materials, conformity, locking mechanisms, stabilization, etc.) and patient demographics (e.g. age, weight, BMI, etc.) were cataloged. Multivariate analysis was performed to isolate factors contributing to wear, oxidation, and damage. Results. Wear and oxidation were both found to scale with time in vivo in conventional and crosslinked polyethylene. Wear rate was also found to scale with time in vivo, but was not found to be a function of oxidation. Regression shows patient age and female sex to correlate negatively with wear rate. Polished trays, crosslinked polyethylene, and constrained knee designs are all correlated with decreased wear rates. Discussion. While this study indicates that loosening and infection are predominant causes for TKA revision, wear related failure remains common. We believe this to be the largest existing comparative study of modern TKA wear rates. Insert wear is shown to correlate with several patient factors. Wear performance also varies significantly between knee designs, polyethylene material choice and tray surface finish. When compared to a historical standard for knee wear rates, all designs evaluated in the current study exhibited significant improvements in wear rates. Retrieval analysis can provide insight into implant and patient related factors that contribute to knee wear, with the goal of improving patient outcomes and best matching design decisions to patient populations

Introduction. Orthopedic implants are subject to wear and release ultra-high molecular weight polyethylene (UHMWPE) debris. Analysis of UHMWPE wear particles is critical in determining the safety and effectiveness of novel orthopedic implants. Complete digestion of periprosthetic tissue and wear fluid is necessary to ensure accurate morphological and quantitative particle analysis. Acid digestion methods are more effective than enzymatic and base digestion approaches [Baxter+ 2009]. However, optimal digestion times, quantity, and type of acid are unclear for particle isolation. In addition, imaging and analysis techniques are critical to ensure accurate reporting of particle characteristics. Here, we 1) compared the efficacy of three acid-based digestion methods in isolating particles from a) bovine serum and b) animal/human tissue, and 2) analyzed the effects of imaging location on particle quantity/morphology results. Methods. 1a) UHMWPE (GUR 150) particles were generated by Mode I knee wear testing for 1 million cycles in bovine serum. Serum was digested in one of four solutions: 12.2M HCl, 15.8M HNO. 3. , a 1:1 volume ratio of HNO. 3. :HCl (aqua regia), or filtered H. 2. O (control). The serum:solution volume ratio was 1:5 [Niedzwiecki+ 2001, ISO 17853:2011]. Digestion occurred for 60min on a stir plate at 60°C. Each digest was combined with MeOH at a 1:5 digest:MeOH volume ratio and filtered using a 100 nm polycarbonate membrane. The particle-containing membranes were imaged (12 images/membrane) using scanning electron microscopy (SEM) to determine particle characteristics, including quantity, equivalent circular diameter (ECD) and aspect ratio (AR). 1b) Based on 1a, HNO. 3. was used to digest porcine and human tissue at concentrations of 1:40, 1:60, or 1:80 tissue:HNO. 3. volume ratios for either 1, 12, or 24 hours, followed by SEM analysis. 2) Particle characteristics were compared at nine locations (20 images/location) across a particle-containing membrane to determine the effects of imaging location. Results. 1a) HNO. 3. and aqua regia methods successfully digested the bovine serum, whereas the HCl and H. 2. O methods were unsuccessful (Fig.1A). Comparing HNO. 3. and aqua regia groups, particle characteristics and ECD frequency distribution were nearly identical (Fig.1B). 1b) Nitric acid did not fully digest porcine or human tissues. 2) Similar particle characteristics were observed in all nine locations analyzed across the polycarbonate membrane. The particle quantity, ECD, and AR for a representative center vs. intermediate location were 808 vs. 780 particles, 0.33±0.28 vs. 0.35±0.29 µm, and 1.57±0.56 vs. 1.51±0.4, respectively (Fig.2). Conclusions. Nitric acid and aqua regia are capable of digesting bovine serum using low quantities of acid for short duration, allowing precise analysis of UHMWPE particle debris from orthopedic implants. However, further optimization of digestion techniques for animal/human tissue is warranted. In addition, an accurate representation of particle distribution can be achieved without analyzing hundreds of images, because membrane location does not strongly influence particle results. Finally, ASTM F1877-16 – Standard Practice for Characterization of Particles – could benefit from adding software-based automated particle characterization as an optional method. An automated approach that uses k-means clustering image segmentation to identify particles and computer vision tools to extract relevant morphological features is under development and validation

Background. Wear simulation in total knee arthroplasty (TKA) is currently based on the most frequent activity – level walking. A decade ago multi-station knee wear simulators were introduced leading to optimisations of TKA designs, component surface finish and bearing materials. One major limitation is that current wear testing is mainly focused on abrasive-adhesive wear and in vitro testing does not reflect “delamination” as an essential clinical failure mode. The objective of our study was to use a highly demanding daily activities wear simulation to evaluate the delamination risk of polyethylene materials with and without vitamin E stabilisation. Methods. A cruciate retaining fixed bearing TKA design (Columbus CR) with artificially aged polyethylene knee bearings (irradiation 30±2 kGy) blended with and without 0.1% vitamin E was used under medio-lateral load distribution and soft tissue restrain simulation. Daily patient activities with high flexion (2×40% stairs up and down, 10% level walking, 8% chair raising, 2% deep squatting) were applied for 5 million cycles. The specimens were evaluated for gravimetric wear and analysed for abrasive-adhesive and delamination wear modes. Results. The total amount of gliding surface wear was 28.7±1.9 mg for the vitamin E stabilised polyethylene compared to 355.9±119.8 mg for the standard material. The combination of artificial ageing and high demanding knee wear simulation leads to visible signs of delamination in the articulating bearing areas in vitro. Conclusion. To evaluate Vitamin E stabilised polyethylenes in regard to ageing and wear behaviour in vitro, conditions are simulated to create clinical relevant failure modes in the reference material

Background. The anatomy of the human knee is very different than the tibiofemoral surface geometry of most modern total knee replacements (TKRs). Many TKRs are designed with simplified articulating surfaces that are mediolaterally symmetrical, resulting in non-natural patterns of motion of the knee joint [1]. Recent orthopaedic trends portray a shift away from basic tibiofemoral geometry towards designs which better replicate natural knee kinematics by adding constraint to the medial condyle and decreasing constraint on the lateral condyle [2]. A recent design concept has paired this theory with the concept of guided kinematic motion throughout the flexion range [3]. The purpose of this study was to validate the kinematic pattern of motion of the surface-guided knee concept through in vitro, mechanical testing. Methods. Prototypes of the surface-guided knee implant were manufactured using cobalt chromium alloy (femoral component) and ultra-high molecular weight polyethylene (tibial component). The prototypes were installed in a force-controlled knee wear simulator (AMTI, Watertown, MA) to assess kinematic behavior of the tibiofemoral articulation (Figure 1). Axial joint load and knee flexion experienced during lunging and squatting exercises were extracted from literature and used as the primary inputs for the test. Anteroposterior and internal-external rotation of the implant components were left unconstrained so as to be passively driven by the tibiofemoral surface geometry. One hundred cycles of each exercise were performed on the simulator at 0.33 Hz using diluted bovine calf serum as the articular surface lubricant. Component motion and reaction force outputs were collected from the knee simulator and compared against the kinematic targets of the design in order to validate the surface-guided knee concept. Results. Under deep flexion conditions of up to 140° of squatting the surface-guided knee implants were found to undergo a maximum of 22.2° of tibial internal rotation and 20.4 mm of posterior rollback on the lateral condyle. Pivoting of the knee joint was centered about the highly congruent medial condyle which experienced only 1.6 mm of posterior rollback. Experimental results were within 2° (internal-external rotation) and 1 mm (anteroposterior translation) agreement with the design target throughout the applied exercises (Figure 2). Conclusion. The results of this test confirm that by combining a constrained medial condyle with guiding geometry on the lateral condyle, deep knee flexion activities of up to 140° can be performed while maintaining near-natural kinematics of the knee joint. The authors believe that the tested surface-guided implant concept is a significant step toward the development of novel TKR which allows a greater range of motion and could improve the quality of life for active patients undergoing knee replacement. For any figures or tables, please contact the authors directly

Background. Additive manufacturing (AM) has created many new avenues for material and manufacturing innovation. In orthopaedics, metal additive manufacturing is now widely used for production of joint replacements, spinal fusion devices, and cranial maxillofacial reconstruction. Plastic additive manufacturing on the other hand, has mostly been utilized for pre-surgical planning models and surgical cutting guides. The addition of pharmaceuticals to additively manufactured plastics is novel, particularly when done at the raw material level. The purpose of this study was to prove the concept of antibiotic elution from additively manufactured polymeric articles and demonstrate feasibility of application in orthopaedics. Methods. Using patented processes, three heat-stable antibiotics commonly used in orthopaedics were combined with six biocompatible polymers (2 bioresorbable) into filament and powder base materials for fused deposition modeling (FDM) and selective laser sintering (SLS) AM processes. Raw materials of 1%, 2%, and 5% antibiotic concentrations (by mass) were produced as well as a blend of all three antibiotics each at 1% concentration. Thin disks of 25 mm diameter were manufactured of each polymer with each antibiotic at all concentrations. Disks were applied to the center of circular petri dishes inoculated with a bacterium as per a standard zone of inhibition, or Kirby-Bauer disk diffusion tests. After 72 hours incubation, the zone of inhibited bacterial growth was measured. Periprosthetic joint infection (PJI) of the knee was selected as the proof-of-concept application in orthopaedics. A series of tibial inserts mimicking those of a common TKR system were manufactured via SLS using a bioresorbable base material (Figure 1). Three prototype inserts were tested on a knee wear simulator for 333,000 cycles following ISO 14242–1:2014 to approximate 2–4 months of in vivo use between surgeries of a 2-stage procedure for PJI. Gravimetric measurement and visual damage assessment was performed. Results. Bacterial growth was inhibited to a mean diameter of 32.3 mm (FDM) and 42.2 mm (SLS) for nearly all combinations of polymers and concentrations of antibiotics. Prototype tibial inserts experienced an average of 200 mg of wear during testing and demonstrated no evidence of cracking, delamination or significant deformation (Figure 2). Conclusion. Bench-level testing of these novel antibiotic-eluting polymers demonstrates feasibility for their application in orthopaedic medicine. In particular, treatment of stubborn PJI with potential for increased and sustained antibiotic elution, patient-specific cocktailing, and maintenance of knee joint structure and function compared to existing PJI products and practices. Subsequent testing for these novel polymers will determine static and dynamic (wear-induced) antibiotic elution rates. For any figures or tables, please contact the authors directly

Introduction. Ideally, a patient receiving a unicondylar knee replacement will have fully functional anterior and posterior cruciate ligaments. When at least one of the cruciate ligaments is not fully functional, femoral and tibial implant contact position can potentially increase along the anterior-posterior (AP) axis. Where unicondylar implant wear testing typically uses AP resistance assuming fully functional cruciate ligaments, the authors used reduced AP resistance intended to simulate deficient cruciate ligaments. Methods. Optetrak Logic® Uni (Exactech Inc, Gainesville, FL USA) unicondylar test specimens featuring an all-UHMWPE tibial component and a cobalt chromium femoral component were used in this study. The system has a semi-constrained articular geometry. Testing was conducted at an independent testing facility (EndoLab GMBH, Thansau, Rosenheim, Germany). A four-station knee simulator was used (EndoLab knee simulator) with two unicondylar knee implants per station, giving a total of eight test specimens. Two different tibial fixation designs (keeled and peg) with identical articulating surfaces were tested. Tibial test specimens were 6 mm in thickness. Unloaded soak controls were stored in distilled water at 37°C. The test was conducted according to ISO 14243–1: 2009 [1]. Test specimens were immersed in calf serum (PAA GmBH, Cölbe, LOT B00111-5126) with a protein content of 20 g/l. Custom polyurethane molds allowed for individual component measurement. Per the ISO 14243-1, a 7% medial offset was incorporated into the set-up. The unicondylar knee implants were set at neutral position in extension. Tibial rotational restraint was 0.36 Nm/° and zero when the test specimen was within ± 6° of the reference position. This test was conducted with an AP resistance of 9.3N/mm to maximize AP displacement and simulate deficient cruciate ligaments. Typical unicondylar knee wear testing is conducted with an AP resistance of 44N/mm, which assumes functional cruciate ligaments. Results. Wear data was separated by component design (keeled and peg) as well as for medial and lateral placement [Table 1]. There was no significant difference between lateral components but there was for medial components. This difference could be due to the small sample size. Contact area of the UHMWPE tibial components was elliptical, with the longer portion along the AP axis. Mean wear rates were comparable to historical unicondylar knee systems tested at the same laboratory using the standard AP resistance (i.e., 44 N/mm). Discussion/Conclusion. This study demonstrated using an AP resistance 9.3 N/mm to simulate the presence of deficient cruciate ligaments in a unicondylar knee wear test produced similar wear rates and greater AP displacement when compared to testing using an AP resistance of 44 N/mm, which assumes functioning ligaments. This being said, design and material information about historical unicondylar knee systems tested are not known, so a direct comparison cannot be made. Performing unicondylar knee wear tests with reduced AP resistance could provide realistic wear information for devices implanted in patients without fully functioning cruciate ligaments

INTRODUCTION. Highly cross-linked polyethylene (XLPE) inserts have shown significant improvements in decreasing wear and osteolysis in total hip arthroplasty [1]. In contrast to that, XLPE has not shown to reduce wear or aseptic loosening in total knee arthroplasty [2,3,4]. One major limitation is that current wear testing in vitro is mainly focused on abrasive-adhesive wear due to level walking test conditions and does not reflect “delamination” as an essential clinical failure mode [5,6]. The objective of our study was to use a highly demanding daily activities wear simulation to evaluate the delamination risk of polyethylene materials with and without vitamin E stabilisation. MATERIALS & METHODS. A cruciate retaining fixed bearing TKA design (Columbus® CR) with artificially aged polyethylene knee bearings (irradiation 30 & 50 kGy) blended with and without 0.1% vitamin E was used under medio-lateral load distribution and soft tissue restrain simulation. Daily patient activities measured by Bergmann et al. [7] in vivo, were applied for 5 million knee wear cycles in a combination of 40% stairs up, 40 % stairs down, 10% level walking, 8% chair raising and 2% deep squatting with up to 100° flexion [8] (Fig. 1). The specimens were evaluated for gravimetric wear and analysed for abrasive-adhesive and delamination wear modes. RESULTS. The total amount of gliding surface wear was 28.7±1.9 mg for the vitamin E stabilised polyethylene irradiated with 30 kGy and 26.5±5.7 mg with 50 kGy irradiation, compared to 355.9±119.8 mg for the standard material. The combination of artificial ageing and high demanding knee wear simulation leads to visible signs of delamination in the articulating standard polyethylene bearing areas in vitro. Delamination began after 2 million test cycles for the standard polyethylene, indicated by the transition between linear and exponential slope in Fig. 2. Delamination was not found in the Vitamin E blended gliding surfaces. CONCLUSION. To evaluate moderately or highly cross-linked polyethylenes in regard to ageing and wear behaviour in vitro, conditions are simulated to create clinical relevant failure modes given in total knee arthroplasty. With the applied test protocol it is possible to discriminate between the polyethylene bearing materials with and without Vitamin E stabilisation. To view tables/figures, please contact authors directly