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.

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

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

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.

There is renewed concern surrounding the potential for corrosion at the modular head-neck junction to cause early failure in modern hip implants. Although taper corrosion involves a complex interplay of many factors, previous studies have correlated decreasing flexural rigidity of the femoral trunnion with an increased likelihood of corrosion at retrieval. A multicenter retrieval analysis of 85 modular femoral stems was performed to calculate the flexural rigidity of various femoral trunnions. Stems were implanted between 1991–2012 and retrieved between 2004–2012. There were 10 different taper designs from 16 manufacturers. Digital calipers were used to measure taper geometries by two independent observers. Mean flexural rigidity was 262 Nm², however there was a wide range of values among the various stems spanning nearly an order of magnitude between the most flexible (80 Nm²) and most rigid (623 Nm²) trunnions, which was due in part to the taper geometry and in part to the material properties of the base alloy. There was a modest but significant negative correlation between flexural rigidity of the trunnion and release date of the stem. This wide variability in flexural rigidity may predispose particular stem designs to an increased risk of corrosion at the modular head-neck taper, and may in part explain why taper corrosion is being seen with increasing frequency in modern hip arthroplasty.

Introduction

Taper corrosion at modular junctions can cause a spectrum of adverse local tissue reactions (ALTR) in the periprosthetic soft tissues in patients who have undergone total hip arthroplasty (THA). Because these reactions are usually painful, taper corrosion has become part of the differential diagnosis of hip pain following THA. However these destructive lesions may not always cause pain, and can occasionally result in other atypical presentations. The purpose of this study is to describe a cohort of patients presenting with late and recurrent instability following THA due to underlying ALTR and taper corrosion.

Purpose: To test a CaSO4/CaPO4-TCP composite bone graft substitute in a crtically sized bone defect.

Method: Twenty dogs had a contained medullary defect created in the proximal humerus. In ten dogs, the defect was treated with CaSO4/CaPO4-TCP composite graft (PRO-DENSE^™, Wright Medical) and studied for 13 weeks (N=5) and 26 weeks (N=5). In the other ten dogs, the defect was treated with autograft and followed for 13 weeks. An additional ten unoperated humeri were used to establish the properties of normal canine bone. The area fraction, ultimate compressive stress and modulus of elasticity of bone in the experimental and normal humeri were quantified using histomorphometric and mechanical methods and analyzed using the Mann-Whitney test.

Results: At 13 weeks, the area fraction, compressive stress and modulus of elasticity of new bone in the defects was several-fold greater (p ≤ 0.005) using CaSO4/CaPO4-TCP composite graft compared to defects treated with autograft. The area fraction and compressive stress of new bone using CaSO4/CaPO4-TCP composite graft were also several fold greater (p≤.009) compared to normal bone, but there was no difference in the modulus of elasticity. Although the compressive stress was still greater (p=0.047) at 26 weeks for defects treated with the composite graft compared to normal bone, the regenerated bone had remodeled to a normal cancellous architecture, incorporating minute fragments of residual graft.

Conclusion: CaSO4/CaPO4-TCP composite graft produced a several-fold greater amount and strength of bone than autogenous graft bone at 13 weeks. There was no modulus mismatch between the regenerated and native cancellous bone. The composite graft holds promise for non-load bearing applications where dense, strong bone formation at earlier time points would be advantageous, potentially resulting in quicker return to activity.