The frequency of revision hip arthroplasty is increasing with the increasing life expectancy and number of individuals treated with joint replacement. Newer porous implants have been introduced which may provide better treatment options for revision arthroplasty. These may require cementation to other prosthesis components and occasionally to bone, however, there is currently no information on how these porous implants interface with cement. Cylindrical bone (control group) and porous metal probes with a diameter and height of 10mm were created and subsequently cemented in a standardized setting. These were placed under tensile and torsional loading scenarios. In this experimental study, 10 human femoral heads were used to create 20 cylindrical probes with a diameter and height of 10mm. One side was tapered to 6mm for cementation and interface evaluation. A further set of 20 probes of a porous metal implant (Trabecular Metal®) was created with the same geometry. After the probes were created and lavaged, they were cemented at the tapered surface using a medium viscosity cement at a constant cementation pressure (1.2N/mm2). The setup allowed for comparison of the porous metal/cement interface (group A) with the well-studied control group interface bone/cement (group B). The maximal interface stability of groups A and B were evaluated under tensile and rotational loading scenarios and the cement penetration was measured.Introduction
Materials and Methods
Metal-on-metal bearings (MoM) have been reported to release metal ions that are potentially leading to adverse tissue reactions. Alternatively, ceramic-on-ceramic bearings (CoC) are an attractive treatment for young and active patients and composite materials like zirconia toughened alumina (ZTA) have been successfully introduced clinically. One of the most common ZTA-material in CoC is the Biolox® Within a clinical trial, three different patient groups were compared: a) a control group without any implants, b) patients, three months after unilateral treatment with Biolox® Introduction
Material and Methods
As there are many reports describing avascular reactions to metal debris (ARMD) after Metal-on-Metal Hip Arthroplasty (MoMHA), the use of MoMHA, especially hip resurfacing, is decreasing worldwide. In cases of ARMD or a rise of metal ion blood levels, revision is commended even in pain free patients with a well integrated implant. The revision of a well integrated implant will cause bone loss. As most of the patients with a hip resurfacing are young and a good bone stock is desirable for further revision surgeries, the purpose of this study was to evaluate the stability of a cemented polyethylene cup in a metal hip resurfacing cup. Two different hip resurfacing systems were investigated in this study (ASR™, DePuy Orthopaedics, Leatherhead, UK; Cormet™, Corin Group, Cirencester, UK). Six different groups were formed according to the treatment and preparation of the cement-cup-interface (table 1). Before instilling cement in groups 1, 3, 5 the surface, which was contaminated with blood, was cleaned just using a gauze bandage. In groups 2, 4, 6 saline, polyhexanid and a gauze were used to clean the surface prior to the cement application. In group one and two the polyethylene cup (PE) was cemented either into Cormet™ or ASR™, just the ASR™ was further investigated in group three to six. A monoaxial load was applied while the cup was fixed with 45 degrees inclination (group 1–4) and 90 degrees inclination (group 5, 6: rotatory stability) and the failure torque was measured. In contrast to group 1 and 2, the cement penetrated the peripheral groove of the ASR™ in groups 3–6. The mean failure torque of five tests for each group was compared between the groups and the implants. The ASR™ showed mean failure torque of 0.1 Nm in group one, of 0.14 Nm in group two, of 56.9 Nm in group three, of 61.5 Nm in group four, of 2.96 Nm in group five and of 3.04 Nm in group six. The mean failure torque of the Cormet™ was 0.14 Nm both in groups one and two (table 2). In groups 1–6 there were no significant differences between the different preparations of the interface. Furthermore, in groups 1 and 2 there were no significant differences between the Cormet™ and the ASR™. The mean failure torque of group 4 was significant increased compared to group 3 (p=0.008). We saw an early failure of the cement fixation due to the smooth surface of the Cormet™ and the ASR™ components in groups 1, 2, 5, 6. In contrast to other hip resurfacing cups the ASR™ has a peripheral groove, which was not cemented except in groups 3 and 4 and therefore the lever-out failure torque was significant increased in these groups. Nevertheless, the groove did not provide stability of the cement-PE compound in case of rotatory movements. In conclusion we do not recommend the use of these methods in clinical routine. The complete removal of hip resurfacing components seems to be the most reasonable procedure.
Good survival rates of cementless hip stems serve as motivation for further development, just like modular implant systems or short stems. New aims are worth striving for, e.g. soft tissue or bone sparing options with similar survival rates in case of short stems. Even minimal design modifications might result in complications, e.g. missing osseointegration, loosening of the implant or painful stem, as shown in the past. One of these developments is the Biomet – GTS™ stem [Fig. 1], a hybrid between conventional cementless straight stem and potentially sparing short stem. Aim of this biomechanical study was to analyze, if the biomechanical behavior of the stem is comparable to a clinically proofed design with respect to the stem fixation in the bone and to the mechanical behavior of the stem itself. That's why the primary stability of the GTS™ stem has been determined and subsequently was compared to the Zimmer – CLS® stem. Four GTS™ stems and four CLS® stems were implanted standardized in eight synthetic femurs. Micromotions of the stem and the bone were measured at different sites. A high precision measuring device was used to apply two different cyclic load situations: 1. Axial torque of +/−7 Nm around the longitudinal stem axis to determine the rotational implant stability. 2. Varus-valgus-torque of +/−3, 5 Nm to determine the bending behavior of the stem. Comparing the motions of the stem and femur at different sites allowed the calculation of relative micromotions at the bone-implant-interface.INTRODUCTION:
MATERIAL & METHODS
Hemi shoulder arthroplasty is an attractive treatment for shoulder arthritis in particular if the natural glenoid is still intact. However, comparing the clinical results of hemi and total shoulder arthroplasty clearly shows lower survival for the hemi arthroplasty. One of the most common reasons for revision surgery is gleniod erosion, where the cartilage or bone is worn of. Aim of the current study was to analyse if the metallic articular surface of retrieved hemi shoulder arthroplasty is different from new implants. We hypothesized that the surface roughness will increased due the articulation and that metallic wear is detectable on the implants. Twelve retrieved and three brand new hemi shoulder arthroplasty were included. The surface roughness (Ra, Rz, Rmax, Rsk) was measured on different sites of the surface (center of the head and at the edge). The implants were further measured using a coordinate measuring machine to gain information on volumetric wear and geometrical alterations. Compared to new implants the surface roughness on the retrievals was significantly increased (Tab. 1), except for skewness. Although the roughness parameters within the retrieval group were generally higher at the center of the head compared to the edge, this difference was not significant. Apart from form deviations no volumetric wear was detectable on the heads (Fig. 1). The current results indicate that the metallic articular implant surface changes in vivo and that the material is hurt due to the articulation against the softer cartilage or bone. Although it can't be finally clarified by that study, to what extend the higher roughness is taking part in the process of the clinically observed erosion of the gleniod, it can be assumed that an increased roughness is disadvantageous. Possibly, the observed surface alterations won't occur clinically with harder materiel (e.g. ceramic), but this even needs to be validated.
Extensive bone defects of the proximal femur e.g. due to aseptic loosening might require the implantation of megaprostheses. In the literature high loosening rates of such megaprostheses have been reported. However, different fixation methods have been developed to achieve adequate implant stability, which is reflected by differing design characteristics of the commonly used implants. Yet, a biomechanical comparison of these designs has not been reported. The aim of our study was to analyse potential differences in the biomechanical behaviour of three megaprostheses with different designs by measuring the primary rotational stability in vitro. Four different stem designs [Group A: Megasystem-C® (Link), Group B: MUTARS®(Implantcast), Group C: GMRS™ (Stryker) and Group D: Segmental System (Zimmer); see Fig. 1] were implanted into 16 Sawbones® after generating a segmental AAOS Typ 2 defect. Using an established method to analyse the rotational stability, a cyclic axial torque of ± 7.0 Nm along the longitudinal stem axis was applied. Micromotions were measured at defined levels of the bone and the implant [Fig. 2]. The calculation of relative micromotions at the bone-implant interface allowed classifying the rotational implant stability.Introduction:
Methods:
Migration analysis after total joint arthroplasty are performed using EBRA analysis (Krismer et al., 1997) or - more accurate but also much more cost-intensive and time-consuming – via radiostereometric analysis (RSA). For the latter, additional radiographs from two inclined perspectives are needed in regular intervals in order to define the position of the implant relative to tantalum bone markers which have been implanted during surgery of the artificial joint (Fig. 1). Modern analysis software promises a migration precision along the stem axis of a hip implant of less than 100 μm (Witvoet-Brahm et al., 2007). However, as the analysis is performed semi-automatically, the results are still dependent on the subjective evaluation of the X-rays by the observer. Thus, the present phantom study aims at evaluating the inter- and intra-observer reliability, the repeatability as well as the precision and gives insight into the potential and limits of the RSA method. Considering published models, an RSA phantom model has been developed which allows a continuous and exact positioning of the prostheses in all six degrees of freedom (Fig. 2). The position sensitivities of the translative and rotative positioning components are 1 μm and 5 to 24, respectively. The roentgen setup and Model-Based RSA software (3.3, Medis specials bv, Leiden, Netherlands) was evaluated using the SL-PLUS® standard hip stem (size 7, Smith & Nephew, Baar, Switzerland). The inter-observer (10 repetitions) and intra-observer (3 observers) reliability have been considered. Additionally, the influences of the model repositioning and inclination as well as the precision after migration and rotation along the stem axis are investigated.Background
Materials and Methods
Standardized preclinical wear testing cannot replicate the variations of wear rates and wear mechanisms seen in-vivo [1]. Therefore, a lot of studies focused on testing scenarios which replicate a wider range of patient-specific conditions such as different activities or malalignment of components. However, differences between the in-vivo and in-vitro situation regarding the environmental conditions are often neglected. Considerable differences between the in-vivo and the in-vitro situation are related to the surrounding synovial fluid and its in-vitro substitute (bovine serum). For the in-vivo knee only small volumes (1–4 ml) of synovial fluid are reported [2]. However, for in-vitro testing several hundreds of milliliters of bovine serum are typically used. Therefore, the hypothesis of this study is that fluid volume significantly influences the wear rates in simulator tests. For wear testing an established implant system (Sigma® PFC, DePuy, Warsaw, USA) has been used. Four wear tests with four different testing volumes of bovine serum were carried out: 250 ml; 150 ml; 75 ml; 45 ml. The testing volume of the original chamber (250 ml) was reduced using solids (Fig. 1). Care was taken, that the contact surfaces of the implants were completely immersed and the fluid level was kept constant in all cases (Fig. 1). The testing fluid was maintained at a temperature of 37 ± 1°. All wear tests were run displacement controlled according to ISO 14243-3: 2004 on an AMTI knee simulator.Background:
Material and Methods:
Total ankle replacements (TAR) are not as successful as total hip or total knee replacements. A three-time increased revision rate is reported in registry data [1]. Therefrom, wear associated revisions are frequent [2]. However, there is little knowledge about the wear behavior of TAR. This may be partly related to the fact, that currently no standard for wear testing of TAR exists. The aim of this study is to define a biomechanical valid, force-controlled test specification for level walking of TAR. Basic requirements for force-controlled testing of TAR is the definition joint flexion, as well as active forces and torques acting on the joint and the definition of the ligamental stabilization of the joint. To specify flexion of the ankle, gait analysis was performed on patients treated with a TAR (HINTEGRA, Smith & Nephew) using skin mounted markers. Data about in-vivo forces is missing for TAR. Hence, determination of active forces and torques was based on mathematical models as described in the literature. A new testing device (figure 1) has been developed to measure ligamental stabilization of the ankle joint. Measurements were performed on 10 paired cadaver feet (n = 20). Measurements were performed in different flexion angles when applying anterior-posterior forces (± 160N) and internal-external torques (± 2,5 Nm) between the talus and the tibia.Background:
Material and Methods:
There is little knowledge about wear performance of total ankle arthroplasties (TAR). However, revisions rates are high for TAR [1] and wear associated revisions are frequent [2]. Therefore, the aim of this study is
To test the wear behavior of a TAR using a biomechanically valid testing scenario. To test the influence of an alternative ceramic tibial component. To test the long term wear performance of TAR. In the first part of this study the HINTEGRA (Smith & Nephew) TAR has been used for wear testing. Wear testing was performed on a modified AMTI knee simulator. Level walking according to a previous described testing standard [see abstract: Development of a force controlled testing scenario for total ankle replacements] has been used. Level walking was simulated in three clinical relevant situations, first simulating the reduced loading after implantation, secondly simulating an increasing range of motion and at last a loading pattern orientating at the loadings in the native/healthy joint. Every simulation was run for 3 million cycles, resulting in 9 million total cycles. In the second part of this study the metal tibial plateau was replaced by a ceramic tibial component (Biolox® Delta, CeramTec). Simulation was run, as described above, for additional 9 million cycles. Termed as a long term test, in total 18 million cycles of testing are performed.Background:
Material and Methods:
Corrosion in modular taper connections of total joint replacement has become a hot topic in the orthopaedic community and failures of modular systems have been reported. The objective of the present study was to determine in vivo titanium ion levels following cementless total hip arthroplasty (THA) using a modular neck system. A consecutive series of 173 patients who underwent cementless modular neck THA and a ceramic on polyethylene bearing was evaluated retrospectively. According to a standardized protocol, titanium ion measurements were performed on 67 patients using high-resolution inductively coupled plasma-mass spectrometry. Ion levels were compared to a control group comprising patients with non-modular titanium implants and to individuals without implants. Although there was a higher range, modular-neck THA (unilateral THA: 3.0 μg/L (0.8–21.0); bilateral THA: 6.0 μg/L (2.0–20.0)) did not result in significant elevated titanium ion levels compared to non-modular THA (unilateral THA: 2.7 μg/L (1.1–7.0), p = 0.821; bilateral THA: 6.2 μg/L, (2.3–8.0), p = 0.638). In the modular-neck THA group, patients with bilateral implants had significantly higher titanium ion levels than patients with an unilateral implant (p < 0.001). Compared to healthy controls (0.9 μg/L (0.1–4.5)), both modular THA (unilateral: p = 0.029; bilateral p = 0.003) and non-modular THA (unilateral: p < 0.001; bilateral: p < 0.001) showed elevated titanium ion levels. The data suggest that the present modular stem system does not result in elevated systemic titanium ion levels in the medium term when compared to non-modular stems. However, more outliner were seen in modular-neck THA. Further longitudinal studies are needed to evaluate the use of systemic titanium ion levels as an objective diagnostic tool to identify THA failure and to monitor patients following revision surgery.
Concerning biomechanical research, human specimens are preferred to achieve conditions that are close to the clinical situation. On the other hand, synthetic femurs are used for biomechanical testing instead of fresh-frozen human femurs, to create standardized and comparable conditions. A new generation of synthetic femurs is currently available aiming to substitute the validated traditional one. Structural femoral properties of the new generation have already been validated, yet a biomechanical validation is missing. The aim of our study was to analyse potential differences in the biomechanical behaviour of two different synthetic femoral designs by measuring the primary rotational stability of a cementless femoral hip stem. The cementless SL-PLUS® standard stem (size 6, Smith&Nephew Orthopaedics AG, Rotkreuz, Swizerland) was implanted in two groups of synthetic femurs. Group A consists of three 2nd generation femurs and group B consists of three 4th generation femurs (both: size large, composite bone, Sawbones® Europe, Malmö, Sweden). Using an established method to analyse the rotational stability, a cyclic axial torque of ±7.0 Nm along the longitudinal stem axis was applied. Micromotions were measured at defined levels of the bone and the implant. The calculation of relative micromotions at the bone-implant interface allowed classifying the rotational implant stability.Introduction
Methods
Titanium, in particular Ti6Al4V, is the standard material used in cementless joint arthroplasty. Implants are subjected to cyclic loading where fracture is the reason for re-operation in 1.5–2.4% of all revisions in total hip arthroplasty. In order to strengthen critical regions, surface treatments such as shot peening may be applied. A superficial titanium oxide layer is naturally formed on the surface as a protective film at ambient conditions. However, as its thickness is only in the range of several nanometers, it is prone to be destroyed by high loads - as present at the surface during bending - leading to an ‘oxidative wear’ in a corrosive environment [1]. The present study aims to evaluate the shot peening treatment on Ti6Al4V regarding its potential for cyclically loaded parts under a dry and a corrosive testing medium. Hour-glass shaped titanium specimens (Ti6Al4V) with a minimal diameter of 10 mm have been subjected to an annealing treatment at 620°C for 10h to remove initial residual stresses introduced during machining. Subsequently, a high-intensity shot peening treatment with cut wire followed by a low-intensity cleaning process with glass beads have been performed (Metal Improvement, Germany). Arithmetic mean roughness Ra of the treated surfaces was measured (Mahr Perthometer M2, Germany). Residual stress depth profiles prior to and after shot peening have been measured by a Fe-filtered Co-K(alpha) radiation (GE Measurement&Control, USA) and calculated using the sin2(psi) method. Fatigue strength has been determined by two servo-hydraulic hydropulsers (Bosch Rexroth, Germany) at 10 Hz and a load ratio of R=0.1 either under dry conditions (8 specimens) or surrounded by a 0.9-% saline solution (6 specimens) (BBraun, Germany) (Fig. 1). Testing has been performed until fracture occurred or the total number of 10 × 106 cycles has been reached. All fracture surfaces have been analyzed after testing using FEG-SEM (Zeiss LEO 1530 VP Gemini, Germany).Background
Materials and Methods
Failure of total knee arthroplasty (TKA) is mainly caused by biological reactions against wear particles generated at the implant. So far, wear has been mainly attributed to polyethylene (PE) and much effort has been put into understanding and optimizing the wear mechanism of PE in recent years. However, evaluation of metal wear particles and ion release in TKR has been neglected so far although the implants present large metal surface areas. In the present study we aimed to analyse the wear performance of TKA and to study the kinetics of metal ion and particle release. We hypnotized that due to abrasion and corrosion TKA will release relevant levels of Cobalt (Co), Chromium (Cr), Molybdenum (Mo) and Titanium (Ti). Implants were subjected to an in-vitro simulation applying physiological loadings and motions for 5 million walking cycles. Wear processes were determined gravimetrically and by measuring the release of Co, Cr, Mo and Ti ions using HR-ICP-MS. Surface alterations were determined through surface roughness measurements.Introduction
Methods
Polyethylene (PE) as a bearing material for total joint replacements (TJR) represents the golden standard for the past forty years. However, over the past decade it becomes apparent that PE wear and the biological response to wear products are the limiting factor for the longevity of TJRs. For this reason research has focused onto PE wear particle analysis. A particle analysis highly depends on the methodological work and results often show discrepancies between different research groups. From there, our hypothesis was, that an often unattended influencing factor is the optical magnification which has been used for particle analyses. In the present study samples of a previous conducted knee wear simulator test were used. Wear particles were isolated from the bovine serum using an established method1. Briefly the serum was digested with hydrochloric acid and a continuous stirring and heating. Particles were filtered onto 20nm alumina filters and analyzed using high resolution field emission gun scanning electron microscopy (FEG-SEM). Filters were analyzed on the same points using three different magnifications: 5000, 15000 and 30000. To describe the size and morphology of the particles the equivalent circle diameter (ECD), aspect ratio (AR), roundness (R) and form factor (FF) were specified according to ASTM F 1877-05. The estimated total number (ETN) of particles was calculated based on the number of particles recovered on the filter, the analyzed area, the dilution, evaporation and the total serum volume.Background
Material and Methods
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: 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 Interval of lubricant replacement: For in-vitro testing bovine serum is used as a substitute for the synovial fluid. Physiologically a continuous regeneration and removement of destructed components is taking place. In contrast, for simulator testing the bovine serum is typically changed completely every 500.000 cycles/steps. Therefore the goal of the second part of this study was to test if the serum replacing interval affects the PE wear behavior. Wear tests were conducted on an AMTI force controlled knee simulator. A cruciate substituting (ultracongruent) implant design (TC Plus, Smith & Nephew, Rotkreuz, Switzerland) was used. First, a reference wear study with a test frequency of 1Hz and a lubricant replacement interval (RI) of 500.000 cycles according to ISO 14243-1:2009 was carried out. Tests were run to a total of 5 million cycles. A second wear test was run with a reduced frequency of 0.5 Hz. The reduced frequency resulted in an extended testing period for the same number of cycles. To exclude an influence of the extended time period, the lubricant was changed, in the first half of testing every 500.000 cycles corresponding to 12 days (cycle depending (CD)), and in the second part every 250.000 cycles corresponding to 6 days (time depending (TD)). Tests were run to a total of 3 million cycles. A third test was run with a frequency of 1 Hz. For this test a reduced serum RI of 150.000 cycles was choosen. This test was run to a total of 1.500.000 cycles.Background
Material and Methods
Infection following total joint arthroplasty is a major and devastating complication. After removal of the initial prosthesis, an antibiotic-impregnated cement spacer is inserted for approx. three months. Treatment is completed by a second stage revision arthroplasty. Up to now, spacers are produced from conventional bone cements that contain abrasive radio-opaque substances like zirconium dioxide or barium sulphate. As long as spacer wear products (cement particles containing these hard substances) are not fully removed during the final revision surgery they may enter the articulating surfaces of the revision implant leading to third body wear. In order to reduce the formation of reactive wear particles, a special cement (Copal(r) spacem) without abrasive zirconium dioxide or barium sulphate was developed. To date, no comparative tribological data for cement spacers have been published. Hence, we carried out a study on the wear properties of Copal(r) spacem (with and without gentamicin) in comparison to conventional bone cements (Palacos(r) R and SmartSet(r) GHV). In order to assure reproducible forms of the femoral and tibial components, silicon rubber moulds were produced and filled with the respective cement. Force-controlled simulation was carried out on an AMTI knee simulator (Figure I). The test parameters were in accordance to ISO 14243-1 with a 50% reduced axial force (partial weight bearing). Tests were carried out at 37 °C in closed chambers filled with circulating calf serum. Tests were run for 240,000 cycles (representing the average step rate during 6-8 weeks) at a frequency of 1 Hz. For wear analysis, digital photographs of the spacer were taken at the beginning and at the end of the testing period. The areas of wear scars were measured by the means of a digital image processing software.Introduction
Material and Methods
Osteolysis and aseptic loosening in total hip replacement (THR) is often associated with polyethylene (PE) wear. This caused interest in alternative bearing surfaces. Since the mid nineties, research focused on hard-hard bearings like metal-on-metal (MOM) or ceramic-on-ceramic (COC). However, concerns remain about biological reactions to metallic wear debris or failure of the ceramic components. A new approach to reduce wear with a minimized risk of failure may be the use of a metallic cup in combination with a ceramic head, the so called ceramic-on-metal bearing (COM). The aim of this study was to estimate the wear behaviour at an early stage of this COM bearing type in comparison to COC bearings using a hip simulator. Simulator studies were carried out on a single station hip simulator (MTS 858 Mini Bionix II, Eden Prairie, USA) in accordance to ISO 14242-1. Bovine serum was used as the test medium. Four COM and four COC bearings were used, both 36mm in diameter. The heads were made of a mixed-oxid ceramic (Biolox Delta(r)) paired with a high carbon wrought CoCrMo cup in the COM group whereas both components were made of Biolox Delta(r) in the COC group. Simulation was run to a total of 2.4×106 cycles. Wear measurements were performed in intervals of 0.2x106 cycles using a gravimetric method (Sartorius Genius ME235S, measuring solution: 15 μg, Sartorius, Göttingen, Germany).Introduction
Material and Methods
