Insights into Imprinting: How Is the Phenomenon of Tribocorrosion at Head-Neck Taper Interfaces Related to Corrosion, Fretting, and Implant Design Parameters?

BACKGROUND: Wear and corrosion at modular neck tapers in THA can lead to major clinical implications such as periprosthetic osteolysis, adverse local tissue reactions, or implant failure. The material degradation processes at the taper interface are complex and involve fretting corrosion, third-body abrasion, as well as electrochemical and crevice corrosion. One phenomenon in this context is imprinting of the head taper, where the initially smooth surface develops a topography that reflects the rougher neck taper profile. The formation mechanism of this specific phenomenon, and its relation to other observed damage features, is unclear. An analysis of retrieved implants may offer some insights into this process. QUESTIONS/PURPOSES: (1) Is imprinting related to time in situ of the implants and to the taper damage modes of corrosion and fretting? (2) Are implant design parameters like neck taper profile, stem material, or head seating associated with the formation of imprinting? (3) Is imprinting created by an impression of the neck taper profile or can a different mechanistic explanation for imprinting be derived? METHODS: Thirty-one THAs with cobalt-chromium-molybdenum-alloy (CoCrMo) heads retrieved between 2013 and 2019 at revision surgery from an institutional registry were investigated. Inclusion criteria were: 12/14 tapers, a head size of 36 mm or smaller, time in situ more than 1 year, and intact nonmodular stems without sleeve adaptors. After grouping the residual THAs according to stem type, stem material, and manufacturer, all groups of three or more were included. Of the resulting subset of 31 retrievals, nine THAs exhibited a still assembled head-neck taper connection. The median (range) time in situ was 5 years (1 to 23). Two stem materials (21 titanium-alloy and 10 stainless steel), three kinds of bearing couples (11 metal-on-metal, 13 metal-on-polyethylene, and seven dual-mobility heads), and two different neck taper profiles (six wavy profile and 25 fluted profile) were present in the collection. Four THAs exhibited signs of eccentric head seating. The 31 investigated THAs represented 21% of the retrieved THAs with a CoCrMo alloy head during the specified period.At the head tapers, the damage modes of corrosion, fretting, and imprinting were semiquantitatively rated on a scale between 0 (no corrosion/fretting/imprinting) and 3 (severe corrosion/fretting/imprinting). Corrosion and fretting were assessed applying the Goldberg score, with the modification that the scale started at 0 and not at 1. Imprinting was assessed with a custom scoring system. Rating was done individually at the proximal and distal head taper half and summed to one total damage score for each retrieval and damage mode. Correlations between the damage modes and time in situ and between the damage modes among each other, were assessed using the Spearman rank order correlation coefficient (ρ). Associations between imprinting and implant design parameters were investigated by comparing the total imprinting score distributions with the Mann-Whitney U-test. Metallographically prepared cross-sections of assembled head-neck taper connections were examined by optical microscopy and disassembled head and neck taper surfaces were assessed by scanning electron microscopy (SEM). RESULTS: The imprinting damage score increased with time in-situ (ρ = 0.72; p < 0.001) and the corrosion damage score (ρ = 0.63; p < 0.001) but not with the fretting damage score (ρ = 0.35; p = 0.05). There was no difference in total imprinting score comparing neck taper profiles or stem materials, with the numbers available. Eccentric head seating had elevated total imprinting score (median 6 [interquartile range 0]) compared with centric seating (median 1 [2]; p = 0.001). Light optical investigations showed that imprinting can be present on the head taper surfaces even if the depth of abraded material exceeds the neck taper profile height. SEM investigations showed bands of pitting corrosion in the imprinted grooves. CONCLUSION: The microscopic investigations suggest that imprinting is not an independent phenomenon but a process that accompanies the continuous material degradation of the head taper surface because of circular damage on the passive layer induced by grooved neck tapers. CLINICAL RELEVANCE: Material loss from head-neck taper connections involving CoCrMo alloy heads is a source of metal ions and could potentially be reduced if hip stems with smooth neck tapers were used. Surgeons should pay attention to the exact centric seating of the femoral head onto the stem taper during joining of the parts.

Does Kinematic Alignment Increase Polyethylene Wear Compared With Mechanically Aligned Components? A Wear Simulation Study.

BACKGROUND: Kinematic alignment is an alternative approach to mechanical alignment. Kinematic alignment can restore the joint line to its prearthritic condition, and its advocates have suggested it may be associated with other benefits. But this alignment approach often results in tibial components that are placed in varus and femoral components that are placed in valgus alignment, which may result in an increased risk of component loosening because of wear. Like malaligned implant components, kinematically aligned knee implants could increase wear in vivo, but we lack comparative data about wear behavior between these approaches. QUESTIONS/PURPOSES: (1) Do the different alignment approaches (kinematic, mechanical, and purposefully malaligned components) result in different wear rates in a wear simulator? (2) Do the different alignment approaches lead to different worn areas on the polyethylene inserts in a wear simulator? (3) Do the different alignment approaches result in different joint kinematics in a wear simulator? METHODS: Mechanical alignment was simulated in a force-controlled manner with a virtual ligament structure according to the International Organization for Standardization (ISO 14243-1) using a knee wear simulator. To simulate kinematic alignment, flexion-extension motion, internal-external torque, and the joint line were tilted by 4°, using a novel mechanical setup, without changing the force axis. The setup includes bearings with inclinations of 4° so that the joint axis of 4° is determined. To verify the angle of 4°, a digital spirit level was used. To simulate malalignment, we tilted the implant and, therefore, the joint axis by 4° using a wedge with an angle of 4° without tilting the torque axes of the simulator. This leads to a purposefully malaligned tibial varus and femoral valgus of 4°. For each condition, three cruciate-retaining knee implants were tested for 3.0 x 10 6 cycles, and one additional implant was used as soak control. Gravimetric wear analyses were performed every 0.5 x 10 6 cycles to determine the linear wear rate of each group by linear regression. The wear area was measured after 3.0 x 10 6 cycles by outlining the worn areas on the polyethylene inserts, then photographing the inserts and determining the worn areas using imaging software. The joint kinematics (AP translation and internal-external rotation) were recorded by the knee simulator software and analyzed during each of the six simulation intervals. RESULTS: Comparing the wear rates of the different groups, no difference could be found between the mechanical alignment and the kinematic alignment (3.8 ± 0.5 mg/million cycles versus 4.1 ± 0.2 mg/million cycles; p > 0.99). However, there was a lower wear rate in the malaligned group (2.7 ± 0.2 mg/million cycles) than in the other two groups (p < 0.01). When comparing the total wear areas of the polyethylene inserts among the three different alignment groups, the lowest worn area could be found for the malaligned group (716 ± 19 mm 2 ; p ≤ 0.003), but there was no difference between kinematic alignment and mechanical alignment (823 ± 19 mm 2 versus 825 ± 26 mm 2 ; p > 0.99). Comparing the AP translation, no difference was found between the mechanical alignment, the kinematic alignment, and the malalignment group (6.6 ± 0.1 mm versus 6.9 ± 0.2 mm versus 6.8 ± 0.3 mm; p = 0.06). In addition, the internal-external rotation between mechanical alignment, kinematic alignment, and malalignment also revealed no difference (9.9° ± 0.4° versus 10.2° ± 0.1° versus 10.1° ± 0.6°; p = 0.44). CONCLUSION: In the current wear simulation study, the wear rates of mechanical alignment and kinematic alignment of 4° were in a comparable range. CLINICAL RELEVANCE: The results suggest that kinematic alignment with up to 4° of component inclination may give the surgeon confidence that the reconstruction will have good wear-related performance when using a modern cruciate-retaining implant. The malaligned group had the lowest wear rate, which may be a function of the smaller worn area on the inserts compared with the other two alignment groups. This smaller articulation area between the femoral condyles and polyethylene insert could increase the risk of delamination of malaligned components over longer test durations and during high-load activities. For that reason, and because malalignment can cause nonwear-related revisions, malalignment should be avoided. Further in vitro and clinical studies must prove whether the wear simulation of different alignments can predict the wear behavior in vivo.

The effect of surgical suture material on osteoclast generation and implant-loosening.

Background: Implant loosening - either infectious or aseptic- is a still a major complication in the field of orthopaedic surgery. In both cases, a pro-inflammatory peri-prosthetic environment is generated by the immune system - either triggered by bacteria or by implant wear particles - which leads to osteoclast differentiation and osteolysis. Since infectious cases in particular often require multiple revision surgeries, we wondered whether commonly used surgical suture material may also activate the immune system and thus contribute to loss of bone substance by generation of osteoclasts. Methods: Tissue samples from patients suffering from infectious implant loosening were collected intraoperatively and presence of osteoclasts was evaluated by histopathology and immunohistochemistry. Further on, human monocytes were isolated from peripheral blood and stimulated with surgical suture material. Cell supernatant samples were collected and ELISA analysis for the pro-inflammatory cytokine IL-8 was performed. These experiments were additionally carried out on ivory slices to demonstrate functionality of osteoclasts. Whole blood samples were incubated with surgical suture material and up-regulation of activation-associated cell surface markers CD11b and CD66b on neutrophils was evaluated by flow cytofluorometry analysis. Results: We were able to demonstrate that multinucleated giant cells form in direct vicinity to surgical suture material. These cells stained positive for cathepsin K, which is a typical protease found in osteoclasts. By in vitro analysis, we were able to show that monocytes differentiated into osteoclasts when stimulated with surgical suture material. Resorption pits on ivory slices provided proof that the osteoclasts were functional. Release of IL-8 into cell supernatant was increased after stimulation with suture material and was further enhanced if minor amounts of bacterial lipoteichoic acid (LTA) were added. Neutrophils were also activated by surgical suture material and up-regulation of CD11b and CD66b could be seen. Conclusion: We were able to demonstrate that surgical suture material induces a pro-inflammatory response of immune cells which leads to osteoclast differentiation, in particular in combination with bacterial infection. In conclusion, surgical suture material -aside from bacteria and implant wear particles- is a contributing factor in implant loosening.

Effect of bone quality and quantity on the primary stability of dental implants in a simulated bicortical placement.

OBJECTIVES: Conventional dental implants inserted in the molar region of the maxilla will reach into the sinus maxillaris when alveolar ridge height is limited. When surgery is performed without prior augmentation of the sinus floor, primary stability of the implant is important for successful osseointegration. This study aimed at identifying the impact of bone quality and quantity at the implantation site on primary implant stability of a simulated bicortical placement. MATERIALS AND METHODS: In our in vitro measurements, bone mineral density, total bone thickness and overall cortical bone thickness were assessed by micro-computed tomography (µCT) of pig scapulae, which resembled well the bicortical situation found in human patients. Dental implants were inserted, and micromotion between bone and implant was measured while loading the implant with an axial torque. RESULTS: The main findings were that primary implant stability did not depend on total bone thickness but tended to increase with either increasing bone mineral density or overall cortical bone thickness. CLINICAL RELEVANCE: Limited bone height in the maxilla is a major problem when planning dental implants. To overcome this problem, several approaches, e.g. external or internal sinus floor elevation, have been established. When planning the insertion of a dental implant an important aspect is the primary stability which can be expected. With other factors, the dimensions of the cortical bone might be relevant in this context. It would, therefore, be helpful to define the minimum thickness of cortical bone required to achieve sufficient primary stability, thus avoiding additional surgical intervention.

Wear and damage in retrieved humeral inlays of reverse total shoulder arthroplasty-where, how much, and why?

BACKGROUND: Polyethylene (PE) wear and material degradation have been reported as complications in reverse total shoulder replacements (rTSAs). In this regard, scapular notching is associated with more clinical complications. Therefore, the purposes of the study were to quantify the linear and volumetric wear, as a measure for the amount of removed material, and to qualitatively assess the PE damage modes to describe the material degradation in retrieved rTSA humeral PE inlays that contribute to failure of shoulder replacements. Furthermore, this study aimed to evaluate the effect of scapular notching on PE wear and rim damage of the humeral components. METHODS: The total study population of 39 humeral inlays contains 2 cohorts that were used for the damage mode analysis and for the wear analysis, respectively. The extent and presence of wear damage modes in 5 defined zones were assessed by a grading system for all PE joint replacements. For quantitative wear analysis the most frequent design (n = 17) was chosen. Using a coordinate-measuring machine and postprocessing software, volumetric wear measurements for the retrieved humeral PE inlays were undertaken. Furthermore, prerevision radiographs were analyzed for scapular notching. Finally, retrieval findings were correlated with clinical and radiographic data to consider the effect of notching and to identify risk of failures for these prostheses. RESULTS: Damage on the rim of the humeral PE inlays was more frequent and severe than on the intended articulation surface. Irrespective of the damage mode, the inferior rim zone sustained the greatest amount of wear damage followed by the posterior zone. Burnishing, scratching, pitting, and embedded particles are most likely to occur in the articular surface area, whereas surface deformation, abrasion, delamination and gross material degradation are predominantly present in the inferior and posterior rim zones. The retrieved inlays exhibited a mean volumetric wear rate of 296.9 mm³/yr ± 87.0 mm³/yr. However, if the notched and non-notched components were compared, a significant higher volumetric wear rate (296.5 ± 106.1 mm³/yr) was found for the notched components compared to the non-notched group (65.7 ± 7.4 mm³/yr). Generally, there was a significantly greater incidence of damage and greater amount of wear if scapular notching occurred. CONCLUSION: The notched components showed a 5-fold increase in PE wear rate. Therefore, scapular notching has a strong effect on PE damage and wear. If scapular notching can be clinically avoided, the PE wear performance is in a similar magnitude as found for hip and knee replacements.

[Typing and particle analysis of squeaking hip endoprostheses : First histopathological analysis to examine the squeaking pathogenesis of ceramic-on-ceramic bearings]. / Typisierung und Partikelanalyse von Squeaking-Hüftendoprothesen : Erste histopathologische Analyse zur Untersuchung der Squeaking-Pathogenese von Keramik-Keramik-Gleitpaarungen.

BACKGROUND: Since the use of ceramic-on-ceramic (CoC) hip endoprostheses complications in the form of squeaking noises have occasionally occurred. OBJECTIVES: This is the first histopathological analysis of the synovia-like interface membrane (SLIM) of ceramic squeaking hip endoprostheses with the aim to gain new insights into the squeaking pathogenesis. MATERIALS AND METHODS: Seven CoC hip endoprostheses with squeaking pathogenesis are analyzed by SLIM consensus classification, particle algorithm, CD3 quantification, semiquantitative CD68 macrophages, Oil-Red positive macrophages, hemosiderin evaluation and in two cases by energy dispersive X­ray spectroscopy (EDX). RESULTS: In 1733 hip joint prosthesis pathology cases, a squeaking revision incidence of 0.40% was determined. In addition to SLIM type I (1/7), only SLIM type IV (6/7) was detected. 4/7 CoC cases showed combinations of micro, macro and, for the first time, supramacro (166.5 µm) ceramic wear particles. The EDX analysis confirmed the ceramic and an additional metallic abrasion. Increased focal concentrated low inflammatory markers (CD3/CD68) with hemosiderin (5/7) and lipid depositions (Oil-Red positive macrophages) (6/7) occurred. CONCLUSIONS: A pathogenetic connection between SLIM type I/IV and squeaking can be assumed. SLIM types showed a partly light microscopic ceramic particle-dependent, partly independent predominantly low-grade inflammation. Hemosiderin and Oil-Red positive macrophages are signs of synovial tissue damage and indicate biomechanical misload (impingement) and dysfunction as cause of the squeaking pathogenesis.

IgY Targeting Bacterial Quorum-Sensing Molecules in Implant-Associated Infections.

Background: Implant-associated infections are still a major complication in the field of orthopedics. Bacteria can form biofilms on implant surfaces, making them more difficult to detect and treat. Since standard antibiotic therapy is often impaired in biofilm infections, particular interest is directed towards finding treatment alternatives. Biofilm-formation is a well-organized process during which bacteria communicate via quorum-sensing molecules (QSM). The aim of this study was to inhibit bacterial communication by directing avian IgY against specific QSM. Methods: Chicken were immunized against the following QSM: (1) AtlE, a member of the autolysin family which mediates attachment to a surface in Staphylococcus epidermidis; (2) GroEL, the bacterial heat shock protein; (3) PIA (polysaccharide intercellular adhesion), which is essential for cell-cell adhesion in biofilms. Staphylococcus epidermidis biofilms were grown and inhibition of biofilm-formation by IgYs was evaluated. Additionally, human osteoblasts were cultivated and biocompatibility of IgYs was tested. Results: We were able to demonstrate that all IgYs reduced biofilm-formation, also without prior immunization. Therefore, the response was probably not specific with regard to the QSM. Osteoblasts were activated by all IgYs which was demonstrated by microscopy and an increased release of IL-8. Conclusions: In conclusion, avian IgY inhibits biofilm-formation, though the underlying mechanism is not yet clear. However, adverse effects on local tissue cells (osteoblasts) were also observed.

Influence of joint kinematics on polyethylene wear in anatomic shoulder joint arthroplasty.

BACKGROUND: Despite the positive results in total shoulder arthroplasties (TSAs), a higher revision rate is documented compared with total hip and knee replacements. Wear is the possible main cause of TSA failure in the long-term. This study investigated the effect of joint kinematics and the influence of the rotator cuff on the polyethylene wear performance in an anatomic TSA. METHODS: Lifting a load of 2 kg with an abduction/adduction of 0° to 90° was simulated for 2 × 106 cycles as a primary motion using a fully kinematic joint simulator. A combined rotation in anteversion-retroversion of ±5° and ±10° was also simulated. The force in the superior-inferior direction and the axial joint compression were applied under force control based on in vivo data of the shoulder. A soft tissue restraint model was used to simulate an intact and an insufficient rotator cuff. RESULTS: The highest wear rate in the intact rotator cuff group was 58.90 ± 1.20 mg/106 cycles with a combined rotation of ±10°. When an insufficient rotator cuff was simulated, the highest polyethylene wear rate determined was 79.67 ± 4.18 mg/106 cycles. CONCLUSIONS: This study confirms a high dependency of the polyethylene wear behavior and dimension on the joint kinematics in total shoulder replacement. This can be explained by an increasing cross-shear stress on the polyethylene component. The results obtained indicate that additional combined kinematics are an indispensable part of wear tests on anatomic shoulder replacements.

Ion release in ceramic bearings for total hip replacement: Results from an in vitro and an in vivo study.

INTRODUCTION: Literature on the potential release of trace elements following implantation of Zirconia-platelet toughened alumina (ZPTA) ceramic components is scant. The present study therefore analysed the in vitro and in vivo potential release of ions from ZPTA bearings. MATERIAL AND METHODS: An in vitro and in vivo study was conducted. The in vitro study compared leaching in bovine serum from two groups: ZPTA ceramic heads and Co-28Cr-6Mo alloy heads, both 28-mm diameter. A third group without implant served as reference group. An in vivo clinical study compared trace elements in the whole blood of patients with 36-mm diameter ZPTA ceramic-on-ceramic articulation after three and 12 months. A cohort of subjects without any prosthesis was used as control group. The release of ions was determined by high resolution-inductively coupled plasma-mass spectrometry. RESULTS: In the in vitro experiment, significant differences (p ≤ 0.01) in trace element release for chromium, cobalt and molybdenum were found, with increased levels of ion release in the Co-28Cr-6Mo metal group. The very low detection limit for yttrium allowed detection of a small yttrium release from the ZPTA heads, which was not confirmed by the in vivo study. No significant difference between the groups was found for strontium, aluminium, and zirconium. In the in vivo study, no relevant differences in ion levels between the reference group without any implant and the study group were found at the three and 12-month follow-up. CONCLUSION: This study supports that ZPTA ceramic articulation components are safe in terms of ion release, and may be an excellent alternative to bearings based on Co-28Cr-6Mo alloys.

The subchondral bone layer and glenoid implant design are relevant for primary stability in glenoid arthroplasty.

BACKGROUND: Clinical studies suggest that reaming of the subchondral bone layer to achieve good implant seating is a risk factor for glenoid loosening. This study aims to evaluate (1) the importance of the subchondral bone layer and (2) the influence of the design of the glenoid component. METHODS: Different techniques for preparation of an A1 glenoid were compared: (1) preserving the subchondral bone layer; (2) removal of the subchondral bone layer; (3) implantation of a glenoid component that does not adapt to the native anatomy. Artificial glenoid bones (n = 5 each) were used with a highly standardized preparation and implantation protocol. Biomechanical testing was performed during simulated physiological shoulder motion. Using a high-resolution optical system, the micromotions between implant and bone were measured up to 10,000 motion cycles. RESULTS: At the 10,000 cycle measuring point, significantly more micromotions were found in the subchondral layer removed group than in the subchondral layer preserved group (p = 0.0427). The number of micromotions in the nonadapted group was significantly higher than in the subchondral layer preserved group (p = 0.0003) or the subchondral layer removed group (p = 0.0207). CONCLUSION: Conservative reaming proved important to diminish the micromotions of the glenoid component. Implantation of a glenoid component that matches with the bony underlying glenoid can help to preserve the subchondral bone layer without sacrificing proper implant seating.

Replacement options for the B2 glenoid in osteoarthritis of the shoulder: a biomechanical study.

BACKGROUND: Glenoid replacement in cases of severe glenoid retroversion (RV) or eccentric wear is challenging. The aim of this study was to evaluate different treatment methods under standardized conditions to assist surgeons in the decision-making process. METHODS: Three treatment options for severe glenoid RV (15°) were compared: (1) no RV correction; (2) complete RV correction; (3) no RV correction and implantation of a posterior augmented glenoid (PAG). A highly standardized implantation protocol using artificial glenoid bones (five per group) was chosen, and a physiologic shoulder movement was applied in a biomechanical setting. Micromotions (MM) between glenoid components and bone were quantified using an optical 3D measuring system. RESULTS: In the uncorrected retroversion group, three instances of subluxation of the prosthetic head occurred between 2000 and 4000 cycles. At 2000 cycles, significantly more MM were observed in the uncorrected RV group than in the corrected RV group (p < 0.0001) or to the augmented group (p < 0.0001). At 10|000 cycles, more MM were observed in the posterior augmented group than in the corrected RV group (p < 0.0001). CONCLUSION: If sufficient bone stock is available, retroversion correction should be favored. Posterior augmented glenoids seem to be a suitable treatment option if complete correction of the retroversion is not possible without compromising the glenoid vault. Without correction of the retroversion, high failure rates were observed.

Influence of humeral head material on wear performance in anatomic shoulder joint arthroplasty.

BACKGROUND: The number of total shoulder arthroplasties has increased in the past years, with encouraging results. However, the survival of anatomic total shoulder arthroplasty (aTSA) is lower compared with that of knee and hip replacements. Wear-associated problems like loosening are well-known causes of long-term failure of aTSA. The main purpose of this study was to investigate the wear behavior of ceramic-polyethylene bearings compared with the standard metal-polyethylene bearings. Because there is a lack of valid experimental wear testing methods, the secondary aim was to develop a validated wear simulation. METHODS: The wear assessment was performed using a force-controlled joint simulator for 3 × 106 cycles, and polyethylene wear was assessed gravimetrically and by particle analysis. Kinetic and kinematic data were adopted from in vivo loading measurements and from several clinical studies on shoulder joint kinematics. The reaction of the rotator cuff was simulated on the basis of a virtual soft tissue model. As activity, an abduction-adduction motion of 0°-90° lifting a load of 2 kg superimposed by an anteversion-retroversion has been chosen. RESULTS: The studied aTSA resulted in a polyethylene wear rate of 62.75 ± 1.60 mg/106 cycles in combination with metallic heads. The ceramic heads significantly reduced the wear rate by 26.7% to 45.99 ± 1.31 mg/106. There were no relevant differences in terms of the particle characteristics. CONCLUSION: This is the first study that experimentally studied the wear behavior of aTSA based on patient-related and biomechanical data under load-controlled conditions. Regarding polyethylene wear, the analyzed aTSA could benefit from ceramic humeral heads.

Experimental testing of total knee replacements with UHMW-PE inserts: impact of severe wear test conditions.

Aseptic implant loosening due to inflammatory reactions to wear debris is the main reason for the revision of total knee replacements (TKR). Hence, the decrease in polyethylene wear particle generation from the articulating surfaces is aimed at improving implant design and material. For preclinical testing of new TKR systems standardized wear tests are required. However, these wear tests do not reproduce the entire in vivo situation, since the pattern and amount of wear and subsequent implant failure are underestimated. Therefore, daily activity, kinematics, implant aging and position, third-body-wear and surface properties have to be considered to estimate the wear of implant components in vivo. Hence, severe test conditions are in demand for a better reproduction of the in vivo situation of TKR. In the present article an overview of different experimental wear test scenarios considering clinically relevant polyethylene wear situations using severe test conditions is presented.

On the inflammatory response in metal-on-metal implants.

BACKGROUND: Metal-on-metal implants are a special form of hip endoprostheses that despite many advantages can entail serious complications due to release of wear particles from the implanted material. Metal wear particles presumably activate local host defence mechanisms, which causes a persistent inflammatory response with destruction of bone followed by a loosening of the implant. To better characterize this inflammatory response and to link inflammation to bone degradation, the local generation of proinflammatory and osteoclast-inducing cytokines was analysed, as was systemic T cell activation. METHODS: By quantitative RT-PCR, gene expression of cytokines and markers for T lymphocytes, monocytes/macrophages and osteoclasts, respectively, was analysed in tissue samples obtained intraoperatively during exchange surgery of the loosened implant. Peripheral T cells were characterized by cytofluorometry before surgery and 7 to 10 days thereafter. RESULTS: At sites of osteolysis, gene expression of cathepsin K, CD14 and CD3 was seen, indicating the generation of osteoclasts, and the presence of monocytes and of T cells, respectively. Also cytokines were highly expressed, including CXCL8, IL-1ß, CXCL2, MRP-14 and CXCL-10. The latter suggest T cell activation, a notion that could be confirmed by detecting a small, though conspicuous population of activated CD4+ cells in the peripheral blood T cells prior to surgery. CONCLUSION: Our data support the concept that metallosis is the result of a local inflammatory response, which according to histomorphology and the composition of the cellular infiltrate classifies as an acute phase of a chronic inflammatory disease. The proinflammatory environment, particularly the generation of the osteoclast-inducing cytokines CXCL8 and IL1-ß, promotes bone resorption. Loss of bone results in implant loosening, which then causes the major symptoms of metallosis, pain and reduced range of motion.

How do gait frequency and serum-replacement interval affect polyethylene wear in knee-wear simulator tests?

Polyethylene wear (PE) is known to be a limiting factor in total joint replacements. However, a standardized wear test (e.g. ISO standard) can only replicate the complex in vivo loading condition in a simplified form. In this study, two different parameters were analyzed: (a) Bovine serum, as a substitute for synovial fluid, is typically replaced every 500,000 cycles. However, a continuous regeneration takes place in vivo. How does serum-replacement interval affect the wear rate of total knee replacements? (b) Patients with an artificial joint show reduced gait frequencies compared to standardized testing. What is the influence of a reduced frequency? Three knee wear tests were run: (a) reference test (ISO), (b) testing with a shortened lubricant replacement interval, (c) testing with reduced frequency. The wear behavior was determined based on gravimetric measurements and wear particle analysis. The results showed that the reduced test frequency only had a small effect on wear behavior. Testing with 1 Hz frequency is therefore a valid method for wear testing. However, testing with a shortened replacement interval nearly doubled the wear rate. Wear particle analysis revealed only small differences in wear particle size between the different tests. Wear particles were not linearly released within one replacement interval. The ISO standard should be revised to address the marked effects of lubricant replacement interval on wear rate.

Wear in total knee arthroplasty--just a question of polyethylene?: Metal ion release in total knee arthroplasty.

PURPOSE: Biological reactions against wear particles are a common cause for revision in total knee arthroplasty. To date, wear has mainly been attributed to polyethylene. However, the implants have large metallic surfaces that also could potentially lead to metal wear products (metal ions and debris). The aim of this study was to determine the local release of cobalt, chromium, molybdenum and titanium in total knee arthroplasty during a standard knee wear test. METHODS: Four moderately conforming fixed-bearing implants were subjected to physiological loadings and motions for 5×10(6) walking cycles in a knee wear simulator. Polyethylene wear was determined gravimetrically and the release of metallic wear products was measured using high resolution-inductively coupled plasma-mass spectrometry. RESULTS: A polyethylene wear rate of 7.28 ± 0.27 mg/10(6) cycles was determined and the cumulative mass of released metals measured 1.63 ± 0.28 mg for cobalt, 0.47 ± 0.06 mg for chromium, 0.42 ± 0.06 mg for molybdenum and 1.28 ± 0.14 mg for titanium. CONCLUSION: For other metallic implants such as metal-on-metal total hip arthroplasty, the metal wear products can interact with the immune system, potentially leading to immunotoxic effects. In this study about 12 % by weight of the wear products were metallic, and these particles and ions may become clinically relevant for patients sensitive to these materials in particular. Non-metallic materials (e.g. ceramics or suitable coatings) may be considered for an alternative treatment for those patients.

Minimum ten-year results of a 28-mm metal-on-metal bearing in cementless total hip arthroplasty in patients fifty years of age and younger.

PURPOSE: Concerns have been raised in relation to metal-on-metal (MoM) articulations with catastrophic soft-tissue reactions due to metal debris. We reviewed how small head MoM articulations perform in primary uncemented total hip arthroplasty (THA) in young patients at a minimum of ten years. METHODS: We retrospectively evaluated the clinical and radiographic results of the first 100 consecutive primary cementless THAs using the 28-mm Metasul MoM articulation in 91 patients younger than 50 years of age at the time of surgery. RESULTS: After 13 years, survival for the endpoint revision due to any reason was 90.9 % and 98.9 % for revision due to aseptic implant loosening. The cumulative incidence of MoM related revisions was 1.2 %. Small proximal femoral osteolysis was found in 18 % of hips. No acetabular osteolysis or loosening was detected. Two hips showed signs of femoral neck impingement with severe damage to the neck. CONCLUSIONS: Early in the second decade, MoM-associated complications were rare using the 28-mm Metasul articulation, and aseptic loosening was not a major mode of failure in this cohort of young patients. LEVEL OF EVIDENCE: Therapeutic Level IV.

Mechanical properties of a cemented porous implant interface.

BACKGROUND: Revision arthroplasty often requires anchoring of prostheses to poor-quality or deficient bone stock. Recently, newer porous materials have been introduced onto the market as additional, and perhaps better, treatment options for revision arthroplasty. To date, there is no information on how these porous metals interface with bone cement. This is of clinical importance, since these components may require cementing to other prosthesis components and occasionally to bone. METHODS: We created porous metal and bone cylinders of the same size and geometry and cemented them in a well-established standardized setting. These were then placed under tensile loading and torsional loading until failure was achieved. This permitted comparison of the porous metal/cement interface (group A) with the well-studied bone/cement interface (group B). RESULTS: The group A interface was statistically significantly stronger than the group B interface, despite having significantly reduced depth of cement penetration: it showed a larger maximum tensile force (effect size 2.7), superior maximum tensile strength (effect size 2.6), greater maximum torsional force (effect size 2.2), and higher rotational stiffness (effect size 1.5). INTERPRETATION: The newer porous implants showed good interface properties when cemented using medium-viscosity bone cement. The axial and rotational mechanical strength of a porous metal/cement interface appeared to be greater than the strength of the standard bone/cement interface. These results indicate that cementing of porous implants can provide great stability in situations where it is needed.

Influence of stem design on the primary stability of megaprostheses of the proximal femur.

PURPOSE: Extended bone defects of the proximal femur can be reconstructed by megaprostheses for which aseptic loosening constitutes one of the major failure modes. The basic requirement for long-term success of endoprostheses is primary stability. We therefore assessed whether sufficient primary stability can be achieved by four different megaprostheses in a standardised bone defect of the proximal femur and whether their different design leads to different fixation patterns. METHODS: Four different designs of proximal femoral replacements were implanted into 16 Sawbones® after preparing segmental bone defects (AAOS type II). Primary rotational stability was analysed by application of a cyclic torque of ±7 Nm and measuring the relative micromotions between bone and implant at different levels. The main fixation zones and differences of fixation patterns of the stem designs were determined by an analysis of variance. RESULTS: All four implants exhibited micromotions below 150 µm, indicating adequate primary stability. Lowest micromotions for all designs were located near the femoral isthmus. The extent of primary stability and the global implant fixation pattern differed considerably and could be related to the different design concepts. CONCLUSIONS: All megaprostheses studied provided sufficient primary stability if the fixation conditions of the femoral isthmus were intact. The design characteristics of the different stems largely determined the extent of primary stability and fixation pattern. Understanding these different fixation types could help the surgeon to choose the most suitable implant if the fixation conditions in the isthmus are compromised.

Pulsatile lavage systems and their potential to penetrate soft tissue.

BACKGROUND: In orthopedic and trauma surgery, pulsatile lavage systems are used to clean soft tissue. This may be necessary in septic surgeries or in case of contaminated wounds after trauma. Positive features such as reduction of bacterial contamination and removal of foreign particles are counterbalanced by negative aspects such as bacterial seeding in deeper tissue layers, damage to various tissues and even cases of air embolism. PURPOSE: The aim of this prospective experimental in vitro study was to compare impact pressure and flow rate in three different pulsatile lavage systems and to determine, whether these parameters alter their ability to reach deeper soft tissue layers. METHODS: To test the penetration of soft tissue, the muscle tissue was flushed with contrast medium instead of saline fluid and afterwards scanned by computed tomography. RESULTS: Impact pressure and flow rate showed significant differences between the different systems. There were no significant differences between the three devices in terms of total penetration volume, but there were significant differences in penetration depth. CONCLUSION: In this study, we found that higher impact pressure leads to deeper penetration and therefore bacteria are likely to be transferred to deeper tissue layers.