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Bone & Joint Open
Vol. 5, Issue 10 | Pages 818 - 824
2 Oct 2024
Moroder P Herbst E Pawelke J Lappen S Schulz E

Aims

The liner design is a key determinant of the constraint of a reverse total shoulder arthroplasty (rTSA). The aim of this study was to compare the degree of constraint of rTSA liners between different implant systems.

Methods

An implant company’s independent 3D shoulder arthroplasty planning software (mediCAD 3D shoulder v. 7.0, module v. 2.1.84.173.43) was used to determine the jump height of standard and constrained liners of different sizes (radius of curvature) of all available companies. The obtained parameters were used to calculate the stability ratio (degree of constraint) and angle of coverage (degree of glenosphere coverage by liner) of the different systems. Measurements were independently performed by two raters, and intraclass correlation coefficients were calculated to perform a reliability analysis. Additionally, measurements were compared with parameters provided by the companies themselves, when available, to ensure validity of the software-derived measurements.


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_3 | Pages 11 - 11
23 Jan 2024
Raj S Magan A Jones SA
Full Access

Dual mobility (DM) is an established bearing option in Total Hip Arthroplasty (THA). The traditional mono-block DM designs have limited ability for additional fixation, whereas the modular DM designs allow additional screw fixation but limit internal diameter and have the potential to generate metal debris. We report the early results of a CoCrMo alloy mono-block implant manufactured by additive technology with a highly porous ingrowth surface to enhance primary fixation and osseointegration. Prospective follow-up of the Duplex. TM. implant first inserted in March 2016 enrolled into Beyond Compliance (BC). Primary outcome measure was all-cause revision and secondary outcomes dislocation, peri-prosthetic fracture (PPF) and Oxford Hip Score (OHS). Patients were risk stratified and all considered to be high risk for instability. Complications were identified via hospital records, clinical coding linkage using national database and via BC website. 159 implants in 154 patients with a mean age 74.0 years and a maximum F/U of 7 years. Survivorship for all-cause revision 99.4% (95% CI 96.2–99.8). One femoral only revision. Mean gain in OHS 27.4. Dislocation rate 0.6% with a single event. Patients with a cemented Polished taper stem (PTS) had a Type B PPF rate of 2.1% requiring revision/fixation. Compared to conventional THA this cohort was significantly older (74.0 vs 68.3 years), more co-morbidity (ASA 3 46.5% vs 14.4%) and more non-OA indications (32.4% vs 8.5%). Every patient had at least one risk factor for falling and >50% of cohort had 4 or more risk factors using NICE tool. We believe our results demonstrate that risk stratification successfully aids implant selection to prevent dislocation in high-risk patients. This novel design has provided excellent early results in a challenging cohort where individuals are very different to the “average” THA patient. NJR data on DM has reported an increase in revision for PPF. A “perfect storm” maybe created using DM in high-risk falls risk population. This re-enforces the need to consider all patient and implant factors when deciding bearing selection


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_7 | Pages 78 - 78
4 Apr 2023
Voropai V Nieher M Kratsch A Kirchner W Giggel B Lohmann C Bertrand J Weißmantel S Döring J
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Total knee arthroplasty is one of the most common surgeries. About 92% of all implanted knee endorposthesis in 2020 were manufactured from uncoated CoCrMo articulating on ultra-high-molecular-weight polyethylene. All articluations generate wear particles and subsequent emission of metal ions due to the mechanical loading. These wear particles cause diverse negative reactions in the surrounding tissues and can lead to implant loosening. Coating technologies might offer the possibility to reduce this wear. Therefore, we investigated the applicability of tetrahedral amorphous carbon (ta-C) coating on CoCrMo alloy. Polished specimens made of CoCrMo wrought alloy according to ISO 5832-12 were coated with ta-C coatings with different layer structure using pulsed laser deposition (PLD). This process allows the deposition of ta-C coatings with low internal stress using an additional relaxation laser. Surface quality and mechanical properties of the coating were characterised using optical surface measurements (NanoFocus μsurf expert, NanoFocus AG) and a nanoindentation tester NHT. 3. (Anton Paar GmbH). Scratch tests were performed on Micro Scratch Tester MST. 3. (Anton Paar TriTec SA) to define the coating adhesion. Pin-on-plate tribological tests, with a polyethylene ball sliding on the ta-C-coated plate under a defined load according to ISO 14243-1 were performed using a linear tribometer (Anton Paar GmbH) to evaluate the tribological and wear properties. The ta-C coatings showed a mean roughness Ra of 5-20 nm and a hardness up to 60 GPa (n=3). The adhesion of the ta-C coatings (n=3) was comparable to the commercial coatings like TiN and TiNbN. The pin-on-plate tests showed an improvement of tribological properties in comparison with the polished uncoated CoCrMo specimens (n=3). The ta-C coatings applied by DLP technology show increased hardness compared to the base material and sufficient adhesion. Further research will be needed to investigate the optimal coating strategy for implant coating


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_7 | Pages 85 - 85
4 Apr 2023
Wulfhorst M Büssemaker H Meinshausen A Herbster M Döring J Mai V Lohmann C Kautz A Laube T Wyrwa R Schnabelrauch M Bertrand J
Full Access

The implantation of endoprosthesis is a routine procedure in orthopaedics. Endoprosthesis are mainly manufactured from ceramics, polymers, metals or metal alloys. To ensure longevity of the implants they should be as biocompatible as possible and ideally have antibacterial properties, to avoid periprosthetic joint infections (PJI). Various antibacterial implant materials have been proposed, but have so far only been used sporadically in patients. PJI is one of the main risk factors for revision surgeries. The aim of the study was to identify novel implant coatings that both exhibit antibacterial properties whilst having optimal biocompatibility. Six different novel implant coatings and surface modifications (EBM TiAl6V4, strontium, TiCuN, TiNbN, gentamicin phosphate (GP), gentamicin phosphate+cationic polymer (GP+CP)) were compared to standard CoCrMo-alloy. The coatings were further characterized with regard to the surface roughness. E. coli and S. capitis were cultured on the modified surfaces to investigate the antibacterial properties. To quantify bacterial proliferation the optical density (OD) was measured and viability was determined using colony forming units (CFU). Murine bone marrow derived macrophages (BMMs) were cultured on the surfaces and differentiated into osteoblasts to quantify the mineralisation using the alizarin red assay. All novel coatings showed reduced bacterial proliferation and viability compared to standard CoCrMo-alloy. A significant reduction was observed for GP and GP+CP coated samples compared to CoCrMo (OD. GP,E.coli. = 0.18±0.4; OD. GP+CP,E.coli. = 0.13±0.3; p≤0.0002; N≥7-8). An increase in osteoblast-mediated mineralisation was observed on all surfaces tested compared to CoCrMo. Furthermore, GP and GP+CP coated samples showed a statistically significant increase (M. GP. = 0.21±0.1; M. GP+CP. = 0.25±0.2; p<0.0001; N≥3-6). The preliminary data indicates that the gentamicin containing surfaces have the most effective antibacterial property and the highest osseointegrative capacity. The use of antibiotic coatings on prostheses could reduce the risk of PJI while being applied on osseointegrative implant surfaces


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_7 | Pages 31 - 31
1 Jul 2022
Lodge C Matar H Berber R Radford P Bloch B
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Abstract. Aims. Ceramic coatings in total knee arthroplasty have been introduced with the aim of reducing wear and consequently improving implant survivorship. We studied both cobalt-chrome-molybdenum and ceramic-coated components of the same implant design from a single centre to identify if the ceramic coating conferred any benefit at mid-term review. Patients and Methods. We identified 1641 Columbus TKAs (Aesculap AG, Tüttlingen, Germany) from a prospectively collected arthroplasty database. 983 were traditional CoCrMo and 659 had the AS ceramic coating. Patients were followed up until death or revision of the implant. Results. A slightly younger patient population was seen in the AS ceramic cohort which was statistically significant, mean 68.3 (p=<0.0001). There was no significant difference in implant survivorship between the CoCrMo femur and the ceramic coated femur at a mean of 9.2 years follow-up for the CoCrMo group and 5 years for the ceramic coated group (p=0.76). There was no reduction in the proportion of components revised for aseptic loosening or infection in the ceramic coated cohort. Conclusion. The reported benefits of ceramic coatings are note clearly demonstrated within our current cohort. All knee replacements within our cohort were performed by a user of both CoCrMo and AS and therefore implant familiarity does not explain the revision rate within the AS cohort. At mid-term follow-up, there was no benefit in terms of implant survivorship in using a ceramic coating


Bone & Joint Research
Vol. 10, Issue 10 | Pages 639 - 649
19 Oct 2021
Bergiers S Hothi H Henckel J Di Laura A Belzunce M Skinner J Hart A

Aims

Acetabular edge-loading was a cause of increased wear rates in metal-on-metal hip arthroplasties, ultimately contributing to their failure. Although such wear patterns have been regularly reported in retrieval analyses, this study aimed to determine their in vivo location and investigate their relationship with acetabular component positioning.

Methods

3D CT imaging was combined with a recently validated method of mapping bearing surface wear in retrieved hip implants. The asymmetrical stabilizing fins of Birmingham hip replacements (BHRs) allowed the co-registration of their acetabular wear maps and their computational models, segmented from CT scans. The in vivo location of edge-wear was measured within a standardized coordinate system, defined using the anterior pelvic plane.


Bone & Joint Open
Vol. 2, Issue 10 | Pages 785 - 795
1 Oct 2021
Matar HE Porter PJ Porter ML

Aims

Metal allergy in knee arthroplasty patients is a controversial topic. We aimed to conduct a scoping review to clarify the management of metal allergy in primary and revision total knee arthroplasty (TKA).

Methods

Studies were identified by searching electronic databases: Cochrane Central Register of Controlled Trials, Ovid MEDLINE, and Embase, from their inception to November 2020, for studies evaluating TKA patients with metal hypersensitivity/allergy. All studies reporting on diagnosing or managing metal hypersensitivity in TKA were included. Data were extracted and summarized based on study design, study population, interventions and outcomes. A practical guide is then formulated based on the available evidence.


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_1 | Pages 40 - 40
1 Feb 2021
Neto M Hall D Frisch N Fischer A Jacobs J Pourzal R
Full Access

Ti-6Al-4V is the most common alloy used for orthopaedic implants. Its popularity is due to low density, superior corrosion resistance, good osseointegration and lower elastic modulus when compared to other commonly used alloys such as CoCrMo and stainless steel. In fact, the use of Ti64 has even further increased lately since recent controversy around adverse local tissue reactions and implant failure related to taper corrosion of CoCrMo alloy. However, implants made from Ti64 can fail in some cases due to fatigue fracture, sometimes related to oxide induced stress corrosion cracking or hydrogen embrittlement, or preferential corrosion of the beta phase. Studies performed with Ti-6Al-4V do often not consider that the alloy itself may have a range of characteristics that can vary and could significantly impact the implant properties. These variations are related to the material microstructure which depends not only on chemical composition, but also the manufacturing process and subsequent heat treatments. Different microstructures can occur in implants made form wrought alloys, cast alloys, and more recently, additive manufactured (AM) alloys. Implant alloy microstructure drives mechanical and electrochemical properties. Therefore, this study aims to analyse the microstructure of Ti-6Al-4V alloy of additive manufactured and conventional retrieved orthopaedic implants such as acetabular cups, tibial trays, femoral stem and modular neck by means of electron backscatter diffraction (EBSD). Microstructural features of interest include grains shape and size, phase content and distribution, preferred grain orientation (texture), alloying elements distribution (homogenization) and presence of impurities. Additionally, we demonstrate the direct impact of different microstructural features on hardness. We analysed 17 conventional devices from 6 different manufacturers, 3 additive manufactured devices from 2 different manufactures and 1 control alloy (bar stock). The preliminary results showed that even though all implants have the same chemical composition, their microstructural characteristics vary broadly. Ti64 microstructure of conventional alloys could be categorized in 3 groups: equiaxed grains alloys (Fine and Coarse), bimodal alloys and dendritic alloys. The additive manufactured implants were classified in an additional group on its own which consists of a needle-like microstructures - similar to Widmanstätten patterns, Fig. 1, with a network of β phase along α phase grains. Furthermore, AM alloys exhibited residual grain boundaries from the original β grains from the early stage of the solidification process, Fig. 2. These characteristics may have implication on the fatigue and corrosion behaviour. In addition, it we observed inhomogeneous alloying element distribution in some cases, Fig. 3, especially for the additive manufactured alloys, which also may have consequences on corrosion behaviour. Finally, the hardness testing revealed that the implants with large grain size, such as AM alloys, exhibit low hardness values, as expected, but also the amount of beta phase correlated positively with lower hardness. Grain aspect ratio and beta phase grain size correlated positively with higher hardness. In summary, we found that common Ti64 implants can exhibit a broad variety of different alloy microstructures and the advent of AM alloys introduces an entirely new category. It is imperative to determine the ideal microstructure for specific applications


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_10 | Pages 45 - 45
1 Oct 2020
Jacobs JJ McCarthy SM Hall DJ Levine BR Lundberg HJ Pourzal R
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Introduction. Total hip replacement failure due to fretting-corrosion remains a clinical concern. We recently described that damage within CoCrMo femoral heads can occur either by mechanically-dominated fretting processes leading to imprinting (via rough trunnions) and surface fretting (via smooth trunnions), or by a chemically-dominated etching process along preferential corrosion sites, termed “column damage”. These corrosion sites occur due to banding of the alloy microstructure. Banding is likely caused during thermo-mechanical processing of the alloy and is characterized by local molybdenum depletion. It was the objective of this study to quantify material loss from femoral heads with severe corrosion, identify the underlying damage modes, and to correlate the damage to the alloy's microstructure. Methods. 105 femoral heads with a Goldberg score 4 were evaluated. Coordinate measuring machine data was used to compute material loss and visualize damage features. Time in situ and stem alloy were identified. Metallographic samples were produced for each case. Grain size and banding were identified using light-microscopy. Mann-Whitney tests were conducted to compare material loss between groups. Results. Heads exhibited imprinting and column damage in 72 and 51 cases, respectively, with an overlap of 36 cases. 18 heads exhibited surface fretting only. All heads with column damage exhibited a banded microstructure. Heads with column damage had higher material loss (p=0.05) than those without. Also, heads with a banded microstructure had higher material loss (p=0.035) than those with a homogenous microstructure. Grain size, carbide content, and time did not correlate with material loss. Conclusion. Column damage is a detrimental damage mode within CoCrMo femoral heads that is directly linked to banding within its microstructure. It appears that banding even affects material loss before column damage is identifiable. These results indicate that implant alloy microstructure must be optimized to minimize the release of fretting-corrosion products and related implant failure


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_6 | Pages 68 - 68
1 Jul 2020
Hall D Pourzal R Jacobs J Urban R
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Little is known about the relationship between head-neck corrosion and its effect on the periprosthetic tissues and distant organs of patients hosting well-functioning devices. The purpose of this study was to investigate in postmortem retrieved specimens the degree and type of taper damage, and the corresponding histologic responses in periprosthetic tissues and distant organs. Fifty postmortem THRs (34 primaries, 16 revisions) retrieved after 0.5 to 26 years were analyzed. Forty-three implants had a CoCrMo stem and seven had a Ti6Al4V stem. All heads were CoCrMo and articulated against polyethylene cups (19 XLPE, 31 UHMWPE). H&E sections of joint pseudocapsules, liver, spleen, kidneys and lymph nodes were graded 1–4 for the intensity of various inflammatory cell infiltrates and tissue characteristics. Corrosion damage of the taper surfaces was assessed using visual scoring and quantitated with an optical coordinate measuring machine. SEM analysis was used to determine the acting corrosion mode. Polyethylene wear was assessed optically. The majority of tapers had minimal to mild damage characterized by local plastic deformation of machining line peaks. Imprinting of the stem topography onto the head taper surface was observed in 18 cases. Column damage on the head taper surface occurred in three cases. All taper surfaces scored moderate or severe exhibited local damage features of fretting and/or pitting corrosion. Moderate or severe corrosion of the head and/or trunnion was present in nine hips. In one asymptomatic patient with bilateral hips, lymphocyte-dominated tissue reactions involving perivascular infiltrates of lymphocytes and plasmacytes were observed. In this patient, mild, focal lymphocytic infiltrates were also present in the liver and kidneys, and there was focal histiocytosis and necrosis of the para-aortic lymph nodes. These two implants, which had been in place for 58.6 and 60.1 months, had severe intergranular corrosion of the CoCrMo trunnion, and column damage and imprinting on the head taper. In the other 41 hips, macrophage responses in the joint pseudocapsule to metallic and/or polyethylene wear particles ranged widely from minimal to marked. Focal necrosis in the pseudocapsules of 12 arthroplasties was related to high concentrations of CoCrMo, TiAl4V, TiO, BaSO4 and polyethylene wear particles. High concentrations of these particles were also detected in para-aortic lymph nodes. Rare to mild macrophages were observed in liver and spleen. This is a comprehensive study of wear and corrosion within well-functioning postmortem retrieved THRs, and the resulting local and distant tissue reactions. One of eight patients with moderate or severe corrosion did have a subclinical inflammatory response dominated by lymphocytes after five years. To what extent such an inflammatory process might progress to become symptomatic is not known. Ionic and particulate products generated by corrosion disseminated systemically. The minor lymphocytic infiltrate in the liver and kidneys of one subject with bilateral severely corroded head-neck junctions might suggest possible metal toxicity. The diagnosis of adverse tissue reactions to corrosion of modular junctions can be challenging. Postmortem retrieval studies add to our understanding of the nature and progression of lymphocyte-dominated adverse local and potentially systemic tissue reactions to corrosion of modular junctions


The Bone & Joint Journal
Vol. 102-B, Issue 7 Supple B | Pages 116 - 121
1 Jul 2020
Heise G Black CM Smith R Morrow BR Mihalko WM

Aims. This study aimed to determine if macrophages can attach and directly affect the oxide layers of 316L stainless steel, titanium alloy (Ti6Al4V), and cobalt-chromium-molybdenum alloy (CoCrMo) by releasing components of these alloys. Methods. Murine peritoneal macrophages were cultured and placed on stainless steel, CoCrMo, and Ti6Al4V discs into a 96-well plate. Cells were activated with interferon gamma and lipopolysaccharide. Macrophages on stainless steel discs produced significantly more nitric oxide (NO) compared to their control counterparts after eight to ten days and remained elevated for the duration of the experiment. Results. On stainless steel, both nonactivated and activated cell groups were shown to have a significant increase in metal ion release for Cr, Fe, and Ni (p < 0.001, p = 0.002, and p = 0.020 respectively) compared with medium only and showed macrophage-sized corrosive pits on the stainless steel surface. On titanium alloy discs there was a significant increase in aluminum (p < 0.001) among all groups compared with medium only. Conclusion. These results indicated that macrophages were able to attach to and affect the oxide surface of stainless steel and titanium alloy discs. Cite this article: Bone Joint J 2020;102-B(7 Supple B):116–121


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_1 | Pages 30 - 30
1 Feb 2020
Hermle T Reyna AP Pfaff A Bader U Fink B Grupp T
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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]. Methods. Hip stems with a ZrN multilayer coating (CoreHip AS, Aesculap AG, Germany) were tested in comparison with a cobalt-chrome uncoated version (CoreHip, Aesculap AG, Germany). In order to create a worst case scenario, the smallest stem size with the biggest offset in combination with an XL ceramic head (offset +7 mm) was used. The stems were embedded according to the ISO 7206-6 test in a bone cement sheet. Once the bone cement was bonded, the stem was pulled out and a PMMA grain was placed inside the femoral cavity in order to uprise the hip stem above its embedding line and simulate a debonded cemented hip stem with a severe toggling condition. The dynamic test was performed under bovine serum environment with an axial force of 3.875 kN [2] at 11.6 Hz for 15 million cycles. The test was interrupted after 1, 3, 5, 10 and 15 million cycles and the surfaces of the stems were analyzed through scanning electron microscopy (SEM) with energy dispersive X-Ray (EDX). Moreover, the test medium was analyzed for metal ion concentration (cobalt, chromium and molybdenum) using ICP-MS. Results. The SEM/EDX analysis demonstrated that the ZrN multilayer coating kept its integrity, as no trace of the substrate material (CoCrMo) could be detected. Furthermore, the taper of the ZrN group showed less fretting and corrosion than the taper of the CoCrMo stem (Fig.1). Moreover, the ion concentration analysis showed a reduction of up to two orders of magnitude in the release of cobalt, chromium and molybdenum in the ZrN coated stems in comparison with the uncoated version. Discussion. The results showed that, even in a worst case scenario of high micro-motion due to a severe stem debonding within the cement mantle, the hip stems with a ZrN multilayer coating substantially reduce the release of ions from the substrate material. For any figures or tables, please contact the authors directly


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_2 | Pages 29 - 29
1 Feb 2020
Gustafson J Levine B Pourzal R Lundberg H
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Introduction. Improper seating during head/stem assembly can lead to unintended micromotion between the femoral head and stem taper—resulting in fretting corrosion and implant failure. There is no consensus—either by manufacturers or by the surgical community—on what head/stem taper assembly method maximizes modular junction stability in total hip arthroplasty (THA). A 2018 clinical survey found that orthopedic surgeons prefer applying one strike or three, subsequent strikes when assembling head/stem taper. However, it has been suggested that additional strikes may lead to decreased interference. Additionally, the taper surface finish—micro-grooves—has been shown to affect taper interference and may be influenced by assembly method. Objective. The objective of this study was to employ a novel, micro-grooved finite element (FEA) model of the hip taper interface and assess the role of head/stem assembly method—one vs three strikes—on modular taper junction stability. Methods. A two-dimensional, axisymmetric model representative of a CoCrMo femoral head taper and Ti6Al4V stem taper was created using median geometrical measurements taken from over 100 retrieved implants. Surface finish—micro-grooves—of the head/stem taper were modeled using a sinusoidal function with amplitude and period corresponding to median retrieval measurements of micro-groove height and spacing, respectively (“smooth” stem taper: height=2µm, spacing=50µm; “rough” stem taper: height=11µm, spacing=200µm; head taper: height=2µm, spacing=50µm). All models had a 3’ (0.05°), proximal-locked angular mismatch between the tapers. To simulate modular assembly during surgery, multiple dynamic loads (4kN, 8kN, and 12kN) were applied to the femoral head taper as either one or three sequence of strikes. The input load profile (Figure 1) used for both cases was collected from surgeons assembling an experimental setup with a three-dimensional load sensor. Models were assembled and meshed in ABAQUS Standard (v 6.17) using four-node linear hexahedral, reduced integration elements. Friction was modeled between the stem and head taper using surface-to-surface formulation with penalty contact (µ=0.2). A total of 12 implicit, dynamic simulations (3 loads x 2 assembly sequences x 2 stem taper surface finishes) were run, with 2 static simulations at 4kN for evaluating inertial effects. Outcome variables included contact area, contact pressure, equivalent plastic strain, and pull-off force. Results. As expected, increasing assembly load led to increased contact area, pressures, and plasticity for both taper finishes. Rough tapers exhibited less total contact area at each loading level as compared to the smooth taper. Contact pressures were relatively similar across the stem taper finishes, except the 3-strike smooth taper, which exhibited the lowest contact pressures (Figure 2) and pull-off forces. The models assembled with one strike exhibited the greatest contact pressures, pull-off forces, and micro-groove plastic deformation. Conclusion. Employing 1-strike loads led to greater contact areas, pressures, pull-off forces, and plastic deformation of the stem taper micro-grooves as compared to tapers assembled with three strikes. Residual energy may be lost with subsequent assembly strikes, suggesting that one, firm strike maximizes taper assembly mechanics. These models will be used to identify the optimal design factors and impaction method to maximize stability of modular taper junctions. For any figures or tables, please contact authors directly


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_1 | Pages 103 - 103
1 Feb 2020
Liu S Hall D McCarthy S Chen S Jacobs J Urban R Pourzal R
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Wear and corrosion debris generated from total hip replacements (THR) can cause adverse local tissue reactions (ALTR) or osteolysis, often leading to premature implant failure. The tissue response can be best characterized by histopathological analysis, which accurately determines the presence of cell types, but is limited in the characterization of biochemical changes (e.g. protein conformation alteration). Fourier transform infrared micro-spectroscopy imaging (FTIRI) enables rapid analysis of the chemical structure of biological tissue with a high spatial resolution, and minimal additional sample preparation. The data provides the most information through multivariate method carried out by hierarchical clustering analysis (HCA). It is the goal of this study to demonstrate the beneficial use of this multivariate approach in providing pathologist with biochemical information from cellular and subcellular organization within joint capsule tissue retrieved from THR patients. Joint capsule tissue from 2 retrieved THRs was studied. Case 1: a metal-on-polyethylene THR, and Case 2: a dual modular metal-on-metal THR. Prior to FTIRI analysis, tissue samples were formalin-fixed paraffin-embedded and 5μm thick microtome sectioned samples were prepared and mounted on BaF. 2. discs and deparaffinized. FTIRI data were collected using high-definition transmission mode (pixel size: ∼1.1 μm. 2. ). Hyperspectral images were exported to CytoSpec V2.0.06 for processing and reconstruction into pseudo-color maps based on cluster assignments. Case 1 exhibited a strong presence of lymphocytes and macrophages (Fig. 1a). Since the process of taking second derivatives reduces the half width of the spectral peaks, it increases the sensitivity toward detecting shoulders or second peaks that may not be apparent in the raw spectra (Fig. 1b). Thus, areas occupied by lymphocytes and macrophages can be easily distinguished providing a fast tissue screening method. Here, HCA was able to distinguish macrophages and lymphocytes based on the infrared response, even in areas where both occurred intermixed. (Fig. 1c) The tissue in direct proximity to cells had a slightly altered collagenous structure. Case 1 also exhibited multiple glassy, green particles which can typically observed around THRs that underwent taper corrosion (Fig. 2a). HCA image was able to visualize and distinguish large CrPO. 4. particles, embedded within fibrin exudate rich areas, collagenous tissue without inflammatory cells, and a nearby area with a strong macrophage presence and some finer CrPO. 4. particles (Fig. 2d). Moreover, this method can not only locate macrophages, but distinguish particle-laden macrophages depending the type of particles within the cells. In Case 2 (Fig. 3a), clustering results (Fig. 3 b&c) are consistent with the fact that different particle types are associated with MoM bearing surface wear (Co rich particles), corrosion of the CoCrMo taper junctions (Cr-oxides and –phosphate), fretting of Ti-alloy dual modular tapers (Ti-oxides, Ti alloy particles), and even suture debris, which all occurred in this case. Although details of debris types are not available, specifications are possible by coupling other techniques. The results demonstrate that multivariate FTIRI based spectral histopathology is a powerful tool to characterize the chemical structure and foreign body response within periprosthetic tissue, thus providing insights into the biological impact of different types of implant debris. For any figures or tables, please contact the authors directly


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_2 | Pages 96 - 96
1 Feb 2020
Gustafson J Levine B Pourzal R Lundberg H
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Introduction. Modular junctions in total hip replacement (THR) have been a primary source of fretting and corrosion which can lead to implant failure. Fretting is a result of unintended micromotion between the femoral head and stem tapers and is suspected to result after improper taper seating during assembly. Two design factors known to influence in-vitro taper assembly mechanics are relative taper alignment—mismatch angle—and the surface finish—micro-grooves. However, these factors have not been systematically evaluated together. Objective. The objective of this study was to employ a novel, micro-grooved finite element (FEA) model of the hip taper interface and assess the role of taper mismatch angle and taper surface finish—smooth and rough—on the modular junction mechanics during assembly. Methods. A two-dimensional, axisymmetric model of a CoCrMo femoral head taper and Ti6Al4V stem taper was created using median measurements taken from over 100 retrieved implants. Micro-grooves on the stem and head taper were modeled using a sinusoidal function with amplitude and period corresponding to median retrieval measurements. To evaluate effects of a “smooth” head taper surface finish, additional models were run with a head taper having a flat edge (no micro-grooves). Lastly, mismatch between the stem and head taper was varied between distal-locked, no mismatch, and proximal-locked. To simulate assembly during surgery, boundary conditions were applied to move the femoral head taper at a constant velocity onto the stem taper until a 4kN reaction load was achieved. Models were assembled and meshed in ABAQUS Standard (v 6.17) using four-node linear hexahedral, reduced integration elements. Contact was modeled between the stem and head taper using surface-to-surface formulation with penalty contact and a coefficient of friction of 0.2. Forty simulations (5 mismatch angles x 2 head taper surface types x 4 stem taper surface finishes) were run. Outcome variables included contact area, contact pressure, equivalent plastic strain, and number of micro-grooves undergoing plasticity. Results. As expected, taper mismatch angle drove the location of contact to the distal or proximal ends. Increasing taper mismatch led to significant decreases in contact area for both micro-grooved and flat head taper models (Figure 1A). Taper mismatch had minimal effects on contact pressure (∼2.15 GPa) with the “rough” head taper surface finish but influenced the range of contact pressures (1.30 – 1.91 GPa) in the “smooth” head taper models (Figure 1B). Stress at the micro-grooves varied depending on the stem taper surface finish (Figure 2). Significant plastic deformation of the micro-grooves was only found in models with the “rough” head taper surface finish. Conclusion. Regardless of the taper surface finish, contact area decreased by 30% – 58% when going from a 3’ – 12’ mismatch. Reduced contact area may significantly influence the long-term stability of the implant. Modeling the taper micro-grooves led to plastic deformation consistent with those found from retrieved implants—indicating the importance of modeling the surface finish of tapers. These models will be used to identify the optimal design factors to maximize stability of the modular taper junctions. For any figures or tables, please contact authors directly


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_12 | Pages 12 - 12
1 Oct 2019
Heise GM Black CM Morrow BR Smith RA Mihalko WM
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Introduction. Metal alloys have been commonly used for surgical applications due to their suitable mechanical characteristics and relatively good biocompatibility. However, direct cellular corrosion of orthopaedic implants remains a controversial topic and is still not fully understood. This study aims to examine a possible aspect of this corrosion mechanism by determining if macrophages can attach and directly affect the surfaces of 316L stainless steel, Ti6Al4V, and CoCrMo by releasing components of the alloy oxide layer. Methods. IC-21 ATCC peritoneal macrophages were cultured with growth medium of RPMI 1640 with 10%FBS, L-glutamine, and gentamicin. Interferon Gamma (IFNy) and Lipopolysaccharide (LPS) were used to induce activation of macrophages. Stainless Steel, CoCr, and Titanium disks cut, polished, and placed into a 96 well plate. Stainless steel testing included 6 groups: standard medium, 20,000 cells, 40,000 cells, 20,000 activated cells, 40,000 activated cells. CoCr and Ti testing included the following: medium, 40,000 cells, 20,000 activated cells, cells, no disk + 20,000 cells, no disk + 40,000 cells. After cells were attached to the surface, culture media was replaced and collected every 24 hours for stainless steel and every 12 hours for Ti and CoCr. ICP-MS, conducted at Brooks Applied Labs (Bothell, WA), was used to determine metal concentrations found in the supernatant. Results. A Kurskal-Wallis test and Tukey test were used to compare the groups in Table 2 (medium only, IFNy/LPS 20K, medium 20K cells, medium 40K cells). On stainless steel, both non-activated and activated cell groups were shown to have a statistically significant increase in metal ion release for Cr, Fe, and Ni (p<0.05) compared to medium only. On Ti, there was a significant increase in Al (<0.001) and decrease in V (p=0.003) among all groups compared to medium. No differences were seen among disk groups on CoCr. No difference was seen among activated and non-activated cells placed on all three types of disks. Discussion. This study was successful in showing that macrophages are capable of affecting the oxide layer of stainless steel and Ti by releasing more components of the oxide surface within 30 days. A significant increase in Cr, Fe, and Ni ion release was realized when cells were cultured on the surface of stainless steel disks for 30 days. A previous study, also involving 316L stainless steel, has shown that osteoclasts cause a greater increase in Cr compared to Ni under similar conditions. Our results show that macrophages lead to a greater increase of Ni ions compared to Cr. This suggest that various cell types may effectively change metal ion release profiles in different ways. Surprisingly, V content decreased when cells were attached to Ti disks, possibly indicating uptake of the V particles into the cells instead of release into the supernatant. No differences where seen among CoCr disk groups, therefore we cannot determine if corrosion is occurring during the 30 period. To get a more accurate representation a longer testing time may be necessary. For any tables or figures, please contact the authors directly


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_12 | Pages 13 - 13
1 Oct 2019
Gustafson JA Levine BR Jacobs JJ Pourzal R Lundberg HJ
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Introduction. Improper seating during head/stem assembly can lead to unintended micromotion between the femoral head and stem taper—resulting in fretting corrosion and implant failure. 1. There is no consensus—either by manufacturers or by the surgical community—on what head/stem taper assembly method maximizes modular junction stability in total hip arthroplasty (THA). A 2018 clinical survey. 2. found that orthopedic surgeons prefer applying one strike or three, subsequent strikes when assembling head/stem taper. However, it has been suggested that additional strikes may lead to decreased interference strength. Additionally, the taper surface finish—micro-grooves—has been shown to affect taper interference strength and may be influenced by assembly method. The objective of this study was to employ a novel, micro-grooved finite element (FEA) model of the hip taper interface and assess the role of head/stem assembly method—one vs three strikes—on modular taper junction stability. Methods. A two-dimensional, axisymmetric FEA model representative of a CoCrMo femoral head taper and Ti6Al4V stem taper was created using median geometrical measurements taken from over 100 retrieved implants. 3. Surface finish—micro-grooves—of the head/stem taper were modeled using a sinusoidal function with amplitude and period corresponding to retrieval measurements of micro-groove height and spacing, respectively. Two stem taper micro-groove geometries— “rough” and “smooth”—were modeled corresponding to the median and 5. th. percentile height and spacing measurements from retrievals. All models had a 3' (0.05°), proximal-locked angular mismatch between the tapers. To simulate implant assembly during surgery, multiple dynamic loads (4kN, 8kN, and 12kN) were applied to the femoral head taper in a sequence of one or three strikes. The input load profile (Figure 1) used for both cases was collected from surgeons assembling an experimental setup with a three-dimensional load sensor. Models were assembled and meshed in ABAQUS Standard (v 6.17) using four-node linear hexahedral, reduced integration elements. Friction was modeled between the stem and head taper using surface-to-surface formulation with penalty contact (µ=0.2). A total of 12 implicit, dynamic simulations (3 loads × 2 assembly sequences × 2 stem taper surface finishes) were run, with 2 static simulations at 4kN for evaluating inertial effects. Outcome variables included contact area, contact pressure, equivalent plastic strain, and pull-off force. Results. As expected, increasing assembly load led to increased contact area, pressures, and plasticity for both taper finishes. Rough tapers exhibited less total contact area at each loading level as compared to the smooth taper. Contact pressures were relatively similar across the stem taper finishes, except the 3-strike smooth taper, which exhibited the lowest contact pressures (Figure 2) and pull-off forces. The models assembled with one strike exhibited the greatest contact pressures, pull-off forces, and micro-groove plastic deformation (Figure 3). Conclusion. Employing 1-strike loads led to greater contact areas, pressures, pull-off forces, and plastic deformation of the stem taper micro-grooves as compared to tapers assembled with three strikes. Residual energy may be lost with subsequent assembly strikes, suggesting that one, firm strike maximizes taper assembly mechanics. These models will be used to identify the optimal design factors and impaction method to maximize stability of modular taper junctions. For any tables or figures, please contact the authors directly


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_5 | Pages 21 - 21
1 Apr 2019
Fischer A Nair SB Herbig M Raabe D Wimmer M
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Fretting corrosion of taper junctions is long known and of great concern, because of metal ion and particle release and their related adverse local and systemic effects on the human body (1–3). Orthopedic taper junctions are often comprised of CoCr29Mo6/TiAl6V4 pairings. Beside others the imprinting of the TiAlV-machining marks into the CoCrMo-taper is of clinical interest (4, 5). Thus, the multifactorial details and their interdependencies on the macro-, micro, and nanoscale are still a matter of research (6). This contribution presents the mechanisms of imprinting found in an in-vitro fretting corrosion test. The worn surfaces, the lubricant as well as its remains were analyzed after test and the findings brought into relation to the characteristic wear sub-mechanisms. The fretting tests were conducted by means of a cylinder-on-pin set-up. All details about the test and the sequence of analyses can be found in (7, 8). A marked tribofilm of C-rich organic matter and oxidized wear particles of both bodies was generated at the TiAlV/CoCrMo contact area (Figure 1a, c). After removing the tribofilm chemically, extremely fine scratches of sub-µm depth became visible on the CoCrMo body (Figure 1b). The TiAlV body showed shallow shelves leaving troughs filled with grainy debris (Figure 1d) mainly of Ti-oxide wear particles. The shelves stick to the surfaces and, therefore, move relatively to the counterbody. In combination with the grainy debris this brings about “Microploughing” on the CoCrMo surfaces. Microploughing is known for destroying any passive film resulting in “Tribocorrosion”. The question remains how the shelves are formed. From the surface analyses one could conclude that they point towards “Delamination”. But this would also mean that they would not stick rigidly to the surfaces but be ejected from the contact area. Focused Ion Beam (FIB) cuts were done in order to investigate the near- and subsurface structure of the shelves in order to clarify the governing mechanisms (Figure 2). Below the platinum protection layer appears a laminated structure of highly deformed nanocrystalline and amorphous areas. EDS confirmed that the lighter intermediate layers consist mainly of Ti-oxide. This microstructure is supposedly formed by severe plastic deformation and the generation of shear bands, which under fretting pile up on top of each other. This cannot be connected to “Delamination”. We therefore propose to categorize the formation mechanism of these shelves as a specific form of microploughing. Thus, imprinting is neither driven by any galvanic effects (9) nor by hardness differences of TiO. 2. and Cr. 2. O. 3. (10) but by microploughing on the TiAlV-body leading to tribocorrosion at specific sites of CoCrMo what imprints the surface grooves of the softer TiAlV into the harder CoCrMo. For any figures or tables, please contact the authors directly


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_5 | Pages 142 - 142
1 Apr 2019
Higgs G Rimnac C Mihalko W Gilbert J Kurtz S
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Introduction. Corrosion at modular junctions of total hip replacements has been identified as a potential threat to implant longevity, resulting in efforts to determine appropriate countermeasures. Visual scoring and volumetric material loss measurements have been useful tools to elucidate various clinical and design factors associated with corrosion damage. However, corrosion involves electron exchange that results in chemical changes to biomedical alloys, and electrochemical assessment may therefore be a more appropriate approach to understand the phenomenon. The purpose of this pilot study was to electrochemically distinguish the severity of corrosion in retrieved femoral heads. A secondary goal was to identify the potential of electrochemical impedance spectroscopy (EIS) as a method to identify different forms of corrosion damage. Methods. Twenty femoral heads were identified from a larger study of total hip replacements, obtained as part of an ongoing multi- center IRB-approved retrieval program. Using a previously established 4-point scoring method, components were binned by taper damage: 10 components were identified as having severe damage, 7 with moderate damage and 2 with mild damage. One (1) unimplanted control was included to represent minimal corrosion damage. All components were then characterized using electrochemical impedance spectroscopy under the frequency domain: a 10 mV sinusoidal voltage, ranging from 20 kHz to 2 mHz, was applied to the taper of a femoral head (working electrode) filled with a 1M solution of PBS, a platinum counter electrode and a chlorided silver reference electrode. Absolute impedance at 2 mHz (|Z. 0.002. |), and max phase angle (θ) were assessed relative to taper damage severity. After least-squares fitting of the EIS data to a Randles circuit with a constant phase element, circuit elements: polarization resistance (Rp), CPE-capacitance, and CPE-exponent were also evaluated. The seven (7) most severely corroded components were further examined with scanning electron microscopy to identify corrosion modes. For all statistical analyses, significance was determined at alpha=0.05. Results. Taper damage was strongly correlated with both |Z. 0.002. | (ρ = −0.857, p<0.001) and CPE-capacitance (ρ=0.913, p<0.001). Taper damage was moderately associated with max phase angle (ρ= −0.483, p=0.031), CPE-exponent (ρ= −0.653, p=0.002) and Rp (ρ=0.556, p=0.011). Log-log plots of the strongest predictors of taper damage (|Z. 0.002. | and CPE- capacitance) identified some clustering among severely corroded components. SEM analysis identified evidence of grain/phase boundary corrosion on four components, all with log CPE-capacitance ≥ −4.4. Discussion. The results of this pilot study highlight that electrochemical impedance spectroscopy is useful in determining corrosion severity in retrieved femoral heads, and may also identify intergranular corrosion attack. For an undamaged taper, the self- passivating behavior of CoCrMo creates a surface that opposes charge transfer, but greater corrosion appears to compromise this barrier. The observed trend of low impedance but high capacitance for severely corroded components with intergranular corrosion may signal charge storage at the boundaries of individual grains. Additional work is underway to characterize this behavior


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_5 | Pages 97 - 97
1 Apr 2019
Justin D Nguyen YS Walsh W Pelletier M Friedrich CR Baker E Jin SH Pratt C
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Recent clinical data suggest improvement in the fixation of tibia trays for total knee arthroplasty when the trays are additive manufactured with highly porous bone ingrowth structures. Currently, press-fit TKA is less common than press-fit THA. This is partly because the loads on the relatively flat, porous, bony apposition area of a tibial tray are more demanding than those same porous materials surrounding a hip stem. Even the most advanced additive manufactured (AM) highly porous structures have bone ingrowth limitations clinically as aseptic loosening still remains more common in press-fit TKA vs. THA implants. Osseointegration and antibacterial properties have been shown in vitro and in vivo to improve when implants have modified surfaces that have biomimetic nanostructures designed to mimic and interact with biological structures on the nano-scale. Pre-clinical evaluations show that TiO. 2. nanotubes (TNT), produced by anodization, on Ti6Al4V surfaces positively enhance the rate at which osseointegration occurs and TNT nano-texturization enhances the antibacterial properties of the implant surface. 2. In this in vivo sheep study, identical Direct Metal laser Sintered (DMLS) highly porous Ti6Al4V specimens with and without TNT surface treatment are compared to sintered bead specimens with plasma sprayed hydroxyapatite-coated surface treatment. Identical DMLS specimens made from CoCrMo were also implanted in sheep tibia bi-cortically (3 per tibia) and in the cancellous bone of the distal femur and proximal tibia (1 per site). Animals were injected with fluorochrome labels at weeks 1, 2 and 3 after surgery to assess the rate of bone integration. The cortical specimens were mechanically tested and processed for PMMA histology and histomorphometry after 4 or 12 weeks. The cancellous samples were also processed for PMMA histology and histomorphometry. The three types of bone labels were visualized under UV light to examine the rate of new bony integration. At 4 weeks, a 42% increase in average pull-out shear strength between nanotube treated specimens and non-nanotube treated specimens was shown. A 21% increase in average pull-out shear strength between nanotube treated specimens and hydroxyapatite-coated specimens was shown. At 12 weeks, all specimens had statistically similar pull-out values. Bone labels demonstrated new bone formation into the porous domains on the materials as early as 2 weeks. A separate in vivo study on 8 rabbits infected with methicillin-resistant Staphylococcus aureus showed bacterial colonization reduction on the surface of the implants treated with TNT. In vitro and in vivo evidence suggests that nanoscale surfaces have an antibacterial effect due to surface energy changes that reduce the ability of bacteria to adhere. These in vivo studies show that TNT on highly porous AM specimens made from Ti6Al4V enhances new bone integration and also reduce microbial attachment