ZrN-multilayer coating is clinically well established in total knee arthroplasty [1–3] and has demonstrated significant reduction in polyethylene wear and metal ion release [4,5]. The goal of our study was to analyze the biotribological behaviour of the ZrN-multilayer coating on a polished cobalt-chromium cemented hip stem. CoCr28Mo6 alloy hip stems with ZrN-multilayer coating (CoreHip®AS) were tested versus an un-coated version. In a worst-case-scenario the stems with ceramic heads have been tested in bovine serum in a severe cement interface debonding condition under a cyclic load of 3,875 N for 15 million cycles. After 1, 3, 5, 10 & 15 million cycles the surface texture was analysed by scanning-electron-microscopy (SEM) and energy-dispersive x-ray (EDX). Metal ion concentration of Co,Cr,Mo was measured by inductively coupled plasma mass spectroscopy (ICP-MS) after each test interval. Based on SEM/EDX analysis, it has been demonstrated that the ZrN-multilayer coating keeps his integrity over 15 million cycles of severe stem cemented interface debonding without any exposure of the CoCr28Mo6 substrate. The ZrN-multilayer coated polished cobalt-chromium cemented hip stem has shown a reduction of Co & Cr metal ion release by two orders of a magnitude, even under severe stem debonding and high interface micro-motion conditions. ZrN-multilayer coating on polished cobalt-chromium cemented hip stems might be a suitable option for further minimisation of Co & Cr metal ion release in total hip arthroplasty. Clinical evidence has to be proven during the next years.
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 mm3 in articulation to cobalt-chromium and 1.3±0.21 mm3 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 mm3/million cycles (cobalt-chromium) and 0.21±0.02 mm3/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.
Polyethylene wear represents a significant risk factor for the long-term success of knee arthroplasty [1]. This work aimed to develop and in vivo validate an automated algorithm for accurate and precise AI based wear measurement in knee arthroplasty using clinical AP radiographs for scientifically meaningful multi-centre studies. Twenty postoperative radiographs (knee joint AP in standing position) after knee arthroplasty were analysed using the novel algorithm. A convolutional neural network-based segmentation is used to localize the implant components on the X-Ray, and a 2D-3D registration of the CAD implant models precisely calculates the three-dimensional position and orientation of the implants in the joint at the time of acquisition. From this, the minimal distance between the involved implant components is determined, and its postoperative change over time enables the determination of wear in the radiographs. The measured minimum inlay height of 335 unloaded inlays excluding the weight-induced deformation, served as ground truth for validation and was compared to the algorithmically calculated component distances from 20 radiographs. With an average weight of 94 kg in the studied TKA patient cohort, it was determined that an average inlay height of 6.160 mm is expected in the patient. Based on the radiographs, the algorithm calculated a minimum component distance of 6.158 mm (SD = 81 µm), which deviated by 2 µm in comparison to the expected inlay height. An automated method was presented that allows accurate and precise determination of the inlay height and subsequently the wear in knee arthroplasty based on a clinical radiograph and the CAD models. Precision and accuracy are comparable to the current gold standard RSA [2], but without relying on special radiographic setups. The developed method can therefore be used to objectively investigate novel implant materials with meaningful clinical cohorts, thus improving the quality of patient care.
Cementless total knee arthroplasty (TKA) implants use an interference fit to achieve fixation, which depends on the difference between the inner dimensions of the implant and outer dimensions of the bone. However, the most optimal interference fit is still unclear. A higher interference fit could lead to a superior fixation, but it could also cause bone abrasion and permanent deformation during implantation. Therefore, this study aims to investigate the effect of increasing the interference fit from 350 µm to 700 µm on the primary stability of cementless tibial implants by measuring micromotions and gaps at the bone-implant interface when subjected to two loading conditions. Two cementless e.motion® tibial components (Total Knee System, B. Braun) with different interference fit and surface coating were implanted in six pairs of relatively young human cadaver tibias (47–60 years). The Orthoload peak loads of gait (1960N) and squat (1935N) were applied to the specimens with a custom made load applicator (Figure 1A). The micromotions (shear displacement) and opening/closing gaps (normal displacement) were measured with Digital Image Correlation (DIC) in 6 different regions of interest (ROIs - Figure 1B). Two General Linear Mixed Models (GLMMs) were created with micromotions and interfacial gaps as dependent variables, bone quality, loading conditions, ROIs, and interference fit implants as independent variables, and the cadaver specimens as subject variables.Introduction
Methods
Restoring more natural kinematics is crucial for the success of knee TKA. The relative size of the tibia to the femur may differ in each patient and requires the possibility to combine different tibia sizes for a given femur size. Therefore, TKA systems need to be designed to allow for different size combinations. In literature some report higher revision rates when the femoral size is greater than the tibia, while others find no impact of the size mismatch on the clinical outcome. The tibio-femoral kinematics resulting from different size combinations has not been analyzed yet. The Columbus Deep Dish implant (Aesculap, Tuttlingen, Germany) is designed to allow a full size compatibility. Therefore we hypothesized that the kinematics would not be affected by the different size combinations. The goal of this study was to investigate the impact on kinematics of different tibio-femoral size combinations with the Columbus Deep Dish implant. 6 fresh frozen cadavers were tested in a force controlled well established knee rig after implantation of a cruciate retaining, fixed bearing Columbus Deep Dish TKA (Aesculap, Tuttlingen, Germany). Femoro-tibial kinematics were recorded while performing a loaded squat from 30° to 130°. Specifically developed and manufactured inlays allowed simulating different tibia sizes on each bone/tibial implant. For each cadaver, a total of 4 different tibia sizes were tested (1 original size, 3 simulated different sizes). Tibio-femoral internal/external rotation and antero-posterior translation of the medial and of the lateral condyles were computed for all size combinations. The kinematics obtained with the simulated sizes were compared to the kinematics obtained with the original inlay. For each flexion angle from 30° to 130°, the difference between the rotation (resp. translation) obtained with the original inlay was subtracted from the rotation obtained with the simulated tibia size. The mean value and standard deviation of the differences were computed.Objectives
Methods
Persistent patellofemoral (PF) pain is a common postoperative complication after total knee arthroplasty (TKA). In the USA, patella resurfacing is conducted in more than 80% of primary TKAs [1], and is, therefore, an important factor during surgery. Studies have revealed that the position of the patellar component is still controversially discussed [2–4]. However, only a limited number of studies address the biomechanical impact of patellar component malalignment on PF dynamics [2]. Hence, the purpose of our present study was to analyze the effect of patellar component positioning on PF dynamics by means of musculoskeletal multibody simulation in which a detailed knee joint model resembled the loading of an unconstrained cruciate-retaining (CR) total knee replacement (TKR) with dome patella button. Our musculoskeletal multibody model simulation of a dynamic squat motion bases on the SimTK data set (male, 88 years, 66.7 kg) [5] and was implemented in the multibody dynamics software SIMPACK (V9.7, Dassault Systèmes Deutschland GmbH, Gilching, Germany). The model served as a reference for our parameter analyses on the impact on the patellar surfacing, as it resembles an unconstrained CR-TKR (P.F.C. Sigma, DePuy Synthes, Warsaw, IN) while offering the opportunity for experimental validation on the basis of instrumented implant components [5]. Relevant ligaments and muscle structures were considered within the model. Muscle forces were calculated using a variant of the computed muscle control algorithm. PF and tibiofemoral (TF) joints were modeled with six degrees of freedom by implementing a polygon-contact model, enabling roll-glide kinematics. Relative to the reference model, we analyzed six patellar component alignments: superior-inferior position, mediolateral position, patella spin, patella tilt, flexion-extension and thickness. The effect of each configuration was evaluated by taking the root-mean-square error (RMSE) of the PF contact force, patellar shift and patellar tilt with respect to the reference model along knee flexion angle.Introduction
Material and Methods
Metal ion and particle release, particularly cobalt, has become an important subject in total hip arthroplasty, as it has shown to induce metal hypersensitivity, adverse local tissue reactions and systemic ion related diseases. The purpose of the following study was compare the ion release barrier function of a zirconium nitride (ZrN) multilayer coated hip stem for cemented use, designed for patients with metal ion hypersensitivity, against its uncoated version in a test configuration simulating the worst case scenario of a severely debonded hip stem. The ZrN multilayer coating is applied on a CoCrMo hip stem and consists of a thin adhesive chromium layer, five alternating intermediate layers out of chromium nitride (CrN) and chromium carbonitride (CrCN) and a final zirconium nitride (ZrN) shielding layer [1]. Hip stems with a ZrN multilayer coating (CoreHip AS, Aesculap AG, Germany) were tested in comparison with a cobalt-chrome uncoated version (CoreHip, Aesculap AG, Germany). In order to create a worst case scenario, the smallest stem size with the biggest offset in combination with an XL ceramic head (offset +7 mm) was used. The stems were embedded according to the ISO 7206-6 test in a bone cement sheet. Once the bone cement was bonded, the stem was pulled out and a PMMA grain was placed inside the femoral cavity in order to uprise the hip stem above its embedding line and simulate a debonded cemented hip stem with a severe toggling condition. The dynamic test was performed under bovine serum environment with an axial force of 3.875 kN [2] at 11.6 Hz for 15 million cycles. The test was interrupted after 1, 3, 5, 10 and 15 million cycles and the surfaces of the stems were analyzed through scanning electron microscopy (SEM) with energy dispersive X-Ray (EDX). Moreover, the test medium was analyzed for metal ion concentration (cobalt, chromium and molybdenum) using ICP-MS.Introduction
Methods
Primary stability is an important factor for long-term implant survival in total hip arthroplasty. In revision surgery, implant fixation becomes especially challenging due the acetabular bone defects, which are often present. Previous studies on primary stability of revision components often applied simplified geometrical defect shapes in a variety of sizes and locations. The objectives of this study were to (1) develop a realistic defect model in terms of defect volume and shape based on a clinically existing acetabular bone defect, (2) develop a surrogate acetabular test model, and (3) exemplarily apply the developed approach by testing the primary stability of a pressfit-cup with and without bone graft substitute (BGS). Based on clinical computed tomography data and a method previously published [1], volume and shape information of a representative defect, chosen in consultation with four senior hip revision surgeons, was derived. Volume and shape of the representative defect was approximated by nine reaming procedures with hemispherical acetabular reamers, resulting in a simplified defect with comparable volume (18.9 ml original vs. 18.8 ml simplified) and shape. From this simplified defect (Introduction
Materials & Methods
Revision total hip arthroplasty is often associated with acetabular bone defects. In most cases, assessment of such defects is still qualitative and biased by subjective interpretations. Three-dimensional imaging techniques and novel anatomical reconstructions using statistical shape models (SSM) allow a more impartial and quantitative assessment of acetabular bone defects [1]. The objectives of this study are to define five clinically relevant parameters and to assess 50 acetabular bone defects in a quantitative way. Anonymized CT-data of 50 hemi-pelvises with acetabular bone defects were included in the study. The assessment was based on solid models of the defect pelvis (i.e. pelvis with bone defect) and its anatomical reconstruction (i.e. native pelvis without bone defect) (Fig.1A). Five clinically relevant parameters were defined: (1) Bone loss, defined by subtracting defect pelvis from native pelvis. (2) Bone formation, defined by subtracting native pelvis from defect pelvis. Bone formation represents bone structures, which were not present in the native pelvis (e.g. caused by remodeling processes around a migrated implant). (3) Ovality, defined by the length to width ratio of an ellipse fitted in the defect acetabulum. A ratio of 1.0 would represent a circular acetabulum. (4) Lateral center-edge angle (LCE angle), defined by the angle between the most lateral edge of the cranial roof and the body Z-axis, and (5) implant migration, defined by the distance between center of rotation (CoR) of the existing implant and CoR of native pelvis (Fig. 1B).Introduction
Methods
The complex process of inflammation and osteolysis due to wear particles still is not understood in detail. So far, Ultra-high-molecular-weight-polyethylene (UHMWPE) is the bearing material of choice in knee arthroplasty and revision knee arthroplasty, but there is a growing demand for alternative bearing materials with improved wear properties. Lately, increasing interest developed in the use of natural and carbon-fiber-reinforced-poly-ether-ether-ketones (CFR-PEEK). While there is a lack of data concerning the effects of CFR-PEEK particles on human tissue, the effects of such wear debris The aim of this study was to analyze human tissue containing CFR-PEEK as well as UHMWPE wear debris. The authors hypothesized no difference between the used biomaterials because of similar size parameters of the wear particles in a prior knee simulator study of this implant. Synovial tissue samples of 10 patients while knee revision surgery of a rotating hinge knee implant design (Enduro®, Aesculap, Germany) were achieved. The tibial inserts of this design were made from UHMWPE (GUR 1020), whereas the bushings and flanges are made of CFR-PEEK containing 30% polyacrylonitrile (PAN) based carbon fibers (PEEK-Optima LT1, Invibio Ltd. Thornton-Cleveleys, UK). In a prior The tissue was fixed with 4% paraformaldehyde, embedded in paraffin, sliced into 2 µm thick sections stained with hematoxylin and eosin in a standard process. A modified panoptical staining (preincubation in propylenglycol; >3h; 35°C) was also done which stained the UHMWPE particles turquoise. The study was approved by the ethics committee of the local university.Introduction
Methods and Materials
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. 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.INTRODUCTION
MATERIALS & METHODS
The complex cellular mechanisms of the aseptic loosening of total joint arthroplasties still remain not completely understood in detail. Especially the role of adherent endotoxins in this process remains unclear, as lipopolysaccharides (LPS) are known to be very potent modulators of the cell response on wear particle debris. Contributing factors on the LPS affinity of used orthopedic biomaterials as their surface roughness have to be investigated. The aim of this study was to evaluate the affinity of LPS on the surface roughness of different biomaterials Cubes with a side length from ultra-high-molecular-weight-polyethylene (UHMWPE), crosslinked polytethylene (XPE), carbon fibre reinforced poly-ether-ether-ketone (CFR-PEEK), titanium, titanium alloy, Polymethyl methacrylate (PMMA), implant steel (CoCr) and instrument steel (BC) were produced (figure 1). Cubes of each material have been produced with a rough and a smooth surface. Before the testings, all cubes and used materials were treated with E-Toxa-Clean(®) to eliminate pre-existing LPS on the used surfaces. The cubes were then fixed on the cap of a glass that was filled with a LPS solution with a concentration of 5 IE/ml. After 30 minutes the cube was removed and the LPS concentration in the supernatant was measured. The endotoxin content of each sample was evaluated by a Limulus Amoebocyte Lysate (LAL) - Test (Lonza, Verviers, Belgium). The detection level of endotoxin was set at < 0.005 EU/ml diluted 1/10.Introduction
Materials and methods
Dual modular hip prostheses were introduced to optimize the individual and intra-surgical adaptation of the implant design to the native anatomics und biomechanics of the hip. The downside of a modular implant design with an additional modular interface is the potential susceptibility to fretting, crevice corrosion and wear [1–2]. The purpose of this study was to characterize the metal ion release of a modular hip implant system with different modular junctions and material combinations in consideration of the corrosive physiological environment. One design of a dual modular hip prosthesis (Ti6Al4V, Metha®, Aesculap AG, Germany) with a high offset neck adapter (CoCrMo, CCD-angle of 130°, neutral antetorsion) and a monobloc prosthesis (stem size 4) of the same implant type were used to characterize the metal ion release of modular and non-modular hip implants. Stems were embedded in PMMA with 10° adduction and 9° flexion according to ISO 7206-6 and assembled with ceramic (Biolox® delta) or CoCrMo femoral heads (XL-offset) by three light impacts with a hammer. All implant options were tested in four different test fluids: Ringer's solution, bovine calf serum and iron chloride solution (FeCl3-concentration: 10 g/L and 114 g/L). Cyclic axial sinusoidal compressive load (Fmax = 3800 N, peak load level of walking based on in vivo force measurements [3]) was applied for 10 million cycles using a servohydraulic testing machine (MTS MiniBionix 370). The test frequency was continuously varied between 15 Hz (9900 cycles) followed by 1 Hz (100 cycles). The metal ion concentration (cobalt, chromium and titanium) of the test fluids were analysed using ICP-OES and ICP-MS at intervals of 0, 5·105, 2·106 and 10·106 cycles (measuring sensitivity < 1 µg/L).Introduction
Methods
