In severe cases of total knee & hip arthroplasty, where off-the-shelf implants are not suitable (i.e., in cases with extended bone defects or periprosthetic fractures), 3D-printed custom-made knee & hip revision implants out of titanium or cobalt-chromium alloy represent one of the few remaining clinical treatment options. Design verification and validation of such custom-made implants is very challenging. Therefore, a methodology was developed to support surgeons and engineers in their decision on whether a developed design is suitable for the specific case. A novel method for the pre-clinical testing of 3D-printed custom-made knee implants has been established, which relies on the biomechanical test and finite element analysis (FEA) of a comparable clinically established reference implant. The method comprises different steps, such as identification of the main potential failure mechanism, reproduction of the biomechanical test of the reference implant via FEA, identification of the maximum value of the corresponding FEA quantity of interest at the required load level, definition of this value as the acceptance criterion for the FEA of the custom-made implant, reproduction of the biomechanical test with the custom-made implant via FEA, decision making for realization or re-design based on the acceptance criterion is fulfilled or not. Exemplary cases of custom-made knee & hip implants were evaluated with this new methodology. The FEA acceptance criterion derived from the reference implants was fulfilled in both custom-made implants and subsequent biomechanical tests verified the FEA results. The suggested method allows a quantitative evaluation of the biomechanical properties of custom-made knee & hip implant without performing physical bench testing. This represents an important contribution to achieve a sustainable patient treatment in complex revision total knee & hip arthroplasty with custom-made 3D printed implants in a safe and timely manner.

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.

In severe cases of total knee arthroplasty which cannot be treated with off-the-shelf implants anymore custom-made knee implants may serve as one of the few remaining options to restore joint function or to prevent limb amputation. Custom-made implants are specifically designed and manufactured for one individual patient in a single-unit production, in which the surgeon is responsible for the implant design characteristics in consultation with the corresponding engineer.

The mechanical performance of these custom-made implants is challenging to evaluate due to the unique design characteristics and the limited time until which the implant is needed. Nevertheless, the custom-made implant must comply with clinical and regulatory requirements. The design of custom-made implants is often based on a underlying reference implant with available biomechanical test results and well-known clinical performance. To support surgeons and engineers in their decision whether a specific implant design is suitable, a method is proposed to evaluate its mechanical performance.

The method uses finite element analysis (FEA) and comprises six steps: (1) Identification of the main potential failure mechanism and its corresponding FEA quantity of interest. (2) Reproduction of the biomechanical test of the reference implant via FEA. (3) Identification of the maximum value of the corresponding FEA quantity of interest at the required load level. (4) Definition of this value as the acceptance criteria for the FEA of the custom-made implant. (5) Reproduction of the biomechanical test with the custom-made implant via FEA. (6) Conclusion whether the acceptance criteria is fulfilled or not.

The method was applied to two exemplary cases of custom-made knee implants. The FEA acceptance criteria derived from the reference implants were fulfilled in both custom-made implants. Subsequent biomechanical tests verified the FEA results.

This study suggests and applies a non-destructive and efficient method for pre-clinical testing of a single-unit custom-made knee implant to evaluate whether the design is mechanically suitable.

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.

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.

Introduction

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.

Objectives

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.

Introduction

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.

Introduction

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].

Introduction

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).

Introduction

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.

Total knee arthroplasty is a well-established treatment for degenerative joint disease, on the other hand metal ion release of cobalt or chromium and particle formation can trigger intolerance reactions. Biotribological examinations can help to assess the metal ion release in different settings. The purpose of this study was the evaluation of inter-laboratory differences in the metal ion concentration analysis. Samples were generated in a 3+1 station knee wear simulator (EndoLab GmbH, Thansau, Germany) with a medium size Columbus Knee System with or without AS multilayer coating. The wear simulation was performed under highly demanding activity (HDA) profile and samples were taken after 0.5, 5.0, 5.5. and 8.0 million cycles. The samples were blinded and sent to three different laboratories and the content of chromium, cobalt, molybdenum, nickel, and zirconium was assessed by inductively coupled plasma mass spectrometry (ICP-MS). The AS multilayer coating clearly reduced the release of chromium, cobalt and molybdenum. Mean levels were: Chromium 9329.78µg/l ± 985.44 vs 503.75µg/l ± 54.19, cobalt 10419.00µg/l ± 15.517.53 vs 2.60µg/l ± 1.35, molybdenum 2496.33µg/l ± 102.62 vs 2.46µg/l ± 2.31. Interestingly we found especially for nickel and zirconium big inter-laboratory differences in the metal assessment. There were up to 10-fold higher values in comparison of one laboratory to another. The data demonstrate that results of metal ion assessment should be evaluated by interlaboratory comparison and should be critically interpreted.

Crosslinking has been already used for about 80 years to enhance the longevity of polyethylene cables. The polymer alteration has been achieved with peroxide, silane or irradiation. The medical devices industry discovered the benefit of this technology for its tribological applications like hip or knee bearings in the 2000s as crosslinking improves considerably the abrasion resistance of the material. The more current methods used are Gamma and Beta irradiation. On the basis of economical (rising prices of Cobalt), environmental (the radioactive source can not be turned off), technological (low dose rate) drawbacks for Gamma respectively low penetration for Beta irradiation we decided to investigate an alternative technology: the X-Ray irradiation, which provides a homogeneous crosslinking in a relatively short time. We analyzed the wear, mechanical, thermal, oxidative and network properties of two vitamin E doped UHMWPE: first crosslinked with E-Beam, second with X-Ray. There wasn't any significant difference between the X-Ray and the E-Beam crosslinked material.

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.

Knee arthroplasty with a rotating hinge knee (RHK) prosthesis has become an important clinical treatment option for knee revisions and primary patients with severe varus or valgus deformities and instable ligaments. The rotational axle constraints the anterior-posterior shear and varus-valgus moments, but currently used polyethylene bushings may fail in the mid-term due to insufficient creep and wear resistance of the material. Due to that carbon-fibre-reinforced (CFR) PEEK as an alternativ bushing material with enhanced creep, wear and fatigue behaviour has been introduced in a RHK design [Grupp 2011, Giurea 2014]. The objective of our study was to compare results from the pre-clinical biotribological characterisation to ex vivo findings on a series of retrieved implants.

In vitro wear simulation according to ISO 14243-1 was performed on rotating hinge knee devices (EnduRo® Aesculap, Germany) made out of cobalt-chromium and of a ZrN multi-layer ceramic coating for 5 million cycles. The mobile gliding surfaces were made out of polyethylene (GUR 1020, β-irradiated 30 ± 2 kGy). For the bushings of the rotational and flexion axles and the flanges a new bearing material based on CFR-PEEK with 30% PAN fiber content was used.

Analysis of 12 retrieved EnduRo^® RHK systems in cobalt-chromium and ZrN multi-layer in regard to

-

loosening torques in comparison with initial fastening torques

with a focus on the four CFR-PEEK components integrated in the EnduRo^® RHK design.

For the rotating hinge knee design with flexion bushing and flanges out of CFR-PEEK the volumetric wear rates were 2.3 ± 0.48 mm³/million cycles (cobalt-chromium) and 0.21 ± 0.02 mm³/million cycles (ZrN multi-layer), a 10.9-fold reduction (p = 0.0016). The UHMWPE and CFR-PEEK particles were comparable in size and morphology and predominantly in submicron size [5]. The biological response to representative sub-micron sized CFR-PEEK particles has been demonstrated in vivo based on the leucoyte-endothelian-cell interactions in the synovia of a murine intra-articular knee model by Utzschneider 2010. Schwiesau 2013 extracted the frequency of daily activities in hip and knee replacement patients from literature and estimated an average of 1.76 million gait cycles per year. Thus, the 5 million cycles of in vitro wear testing reflect a mean in vivo service life of 2.9 years, which fits to the time in vivo of 12–60 months of the retrieved RHK devices. The in vitro surface articulation pattern of the wear simulation tests are comparable to findings on retrieved CFR-PEEK components for both types of articulations – cobalt-chromium and ZrN multi-layer coating.

For the rotating hinge knee 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 multi-layer coating.

The stem and the rasp for cemented arthroplasty are typically designed to obtain a cement mantle 2–5 mm thick. However, sometimes a line-to-line cementation is preferred, where the femoral cavity is prepared with the same dimension as the actual stem. There are contrasting reports [1,2] about the suitability of this technique to withstand the long-term fatigue loads. While the theoretical geometry allows no space for the cement, a sort of cement mantle is formed as the cement penetrates in the spongy bone. The scopes of this study were: 1) developing a dedicated in vitro method to test line-to-line cementation; 2) assessing if a short, polished hip stem designed for a standard cementation can be safely cemented line-to-line.

In order to perform long-term mechanical in vitro tests, composite bones must be used, as cadaveric bones cannot withstand millions of loading cycles [3]. For this study, the Sawbones Mod. 3406-4 were chosen: they feature an open-cell polyurethane core simulating low-density spongy bone. Post-implantation x-rays confirmed that a relevant cement-bone interdigitation was obtained. Four femurs were prepared with a CoreHip (Aesculap) with regular cement mantle (Regular). Another 4 femurs were rasped to the same rasp size, and implanted with line-to-line cementation with a larger stem (Line-to-line). The implanted femurs were subjected to an accelerated test derived from a validated protocol [3] which replicates the most demanding motor tasks of 24 years of patient activity. Implant elastic micromotions and permanent migrations were measured throughout the test. The implants were then sectioned and treated with dye penetrants to highlight the cement cracks.

Elastic and permanent motions did not show any loosening trend, and never exceeded few micrometers. As expected, some damage was visible in the cement mantles after test completion, for both types of implantation (similar to retrieved cement mantles surrounding stable implants [3]. The cement damage was similar in all specimens. No sign of major disruption was visible, neither within the Regular nor in the Line-to-line specimens: in fact, the cracks were limited in length, did not seem to cross the entire mantle thickness, and did not result in any loose cement fragments. The cracks in the line-to-line implants showed the same position and distribution compared to those found in the regular implants, but were slightly longer in some specimens.

This in vitro study confirmed the feasibility of simulating line-to-line cementation in vitro. Our results suggest that a stem designed for a regular cement mantle could induce slightly more damage when implanted line-to-line, but no significant trend toward loosening.

Introduction

The complex process of inflammation and osteolysis due to wear particles still is not understood in detail. So far, Ultra-high-molecular-weight-polyethylene (UHMWPE) is the bearing material of choice in knee arthroplasty and revision knee arthroplasty, but there is a growing demand for alternative bearing materials with improved wear properties. Lately, increasing interest developed in the use of natural and carbon-fiber-reinforced-poly-ether-ether-ketones (CFR-PEEK).

While there is a lack of data concerning the effects of CFR-PEEK particles on human tissue, the effects of such wear debris in vitro and in animal studies is controversially discussed.

The aim of this study was to analyze human tissue containing CFR-PEEK as well as UHMWPE wear debris.

The authors hypothesized no difference between the used biomaterials because of similar size parameters of the wear particles in a prior knee simulator study of this implant.

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.