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.

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.

Introduction

Total hip arthroplasty (THA) is a commonly performed procedure to relieve arthritis or traumatic injury. However, implant failure can occur from implant loosening or crevice corrosion as a result of inadequate seating of the femoral head onto the stem during implantation. There is no consensus—either by manufacturers or by the surgical community—on what head/stem assembly procedure should be used to maximize modular junction stability. Furthermore, the role of “off-axis” loads—loads not aligned with the stem taper axis—during assembly may significantly affect modular junction stability, but has not been sufficiently evaluated.

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.

Introduction

The combined incidence of anatomic (aTSA) and reverse total shoulder arthroplasties (rTSA) in the US is 90,000 per annum and rising. There has been little attention given to potential long-term complications due to periprosthetic tissue reactions to implant debris. The shoulder has been felt to be relatively immune to these complications due to lower acting loads compared to other joint arthroplasties. In this study, retrieved aTSAs and rTSAs were examined to determine the extent of implant damage and to characterize the nature of the corresponding periprosthetic tissue responses.

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 BaF₂ discs and deparaffinized. FTIRI data were collected using high-definition transmission mode (pixel size: ∼1.1 μm²). 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 CrPO₄ particles, embedded within fibrin exudate rich areas, collagenous tissue without inflammatory cells, and a nearby area with a strong macrophage presence and some finer CrPO₄ 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.

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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.

INTRODUCTION

The lifetime of total hip replacements (THR) is often limited by adverse local tissue reactions to corrosion products generated from modular junctions. Two prominent damage modes are the imprinting of the rougher stem topography into the smoother head taper topography (imprinting) and the occurrence of column-like troughs running parallel to the taper axis (column damage). It was the purpose of this study to identify mechanisms that lead to imprinting and column damage based on a thorough analysis of retrieved implants.

Introduction

Little is known about the relationship between head-neck corrosion and its effect on periprosthetic tissues and distant organs in the majority of patients hosting apparently well-functioning devices. We studied the degree and type of taper damage and the histopathologic response in periprosthetic tissue and distant organs.

Introduction

Wear debris from polyethylene tibial inserts has been associated with limited longevity of total knee replacements (TKRs). While material factors were studied extensively and considerable progress has been made, there is little knowledge about surgical factors, particularly on how the wear rate is related to implant positioning.

It was the purpose of this study to determine the combined effect of patient and implant positioning factors on the volumetric wear rate of TKRs. Our hypothesis was that implant alignment has a significant impact on the wear rate when controlled for other patient factors.

Introduction

There are increasing reports of total hip replacement (THR) failure due to corrosion within modular taper junctions, and subsequent adverse local tissue reactions (ALTRs) to corrosion products. Modular junction corrosion is a multifactorial problem that depends on material, design, patient and surgical factors. However, the influence of alloy microstructure on corrosion has not been studied sufficiently. Especially for cast CoCrMo, there are concerns regarding microstructure variability with respect to grain size and hard-phase volume fraction. Therefore, it was the goal of this study to (1) identify different types of microstructures in contemporary implants, and (2) determine implications of alloy microstructure on the occurring corrosion modes.

Introduction

Failure of total knee replacements due to the generation of polyethylene wear debris remains a crucial issue in orthopedics. Unlike the hip, it is difficult to accurately determine knee implant wear rates from retrieved components. Several studies have relied on thickness measurements to estimate penetration, but the complicated geometry of contemporary tibial liners poses a challenge to accurately assess wear. In this study we address the question whether linear penetration can serve as a surrogate measure for volumetric material loss.

Introduction

Current pre-clinical testing is performed using knee wear simulators with standardized walking profiles. Differences in generated damage patterns to those observed on retrieved liners have been explained with the absence of activities other than walking, less severe loading conditions, and a discrepancy in the simulator's tibiofemoral contact mechanics and in vivo knee excursion. While it has been recognized that rotational alignment of the knee may also drive the location and shape of wear scars, to the best of our knowledge this parameter has not been investigated in knee simulator studies.

Introduction:

Many variables contribute to aseptic loosening, and the release of wear particles is a predominant source of late failure. It has been difficult to measure TKA wear quantitatively from retrieved devices; hence, there is a relative paucity of clinically observed TKA wear rates in the literature. Additionally, little is known about patient factors influencing wear rates. This study (a) establishes a clinically relevant TKA wear rate for a cruciate retaining TKA design and (b) relate those wear readings to gait measures of their hosts.