Release Of Metal Debris Research Articles

Debonding of Porous Coating: A Late Failure Mode of Uncemented, Partially Threaded Acetabular Components—Retrieval Analysis

Titanium plasma-sprayed (TPS) porous coatings have been used in total hip arthroplasty for decades. They are considered reliable, and very few failure cases have been described so far. This retrieval study described a series of 20 acetabular components—where total or partial debonding occurred during in vivo use and aimed to explain the underlying failure mechanisms. Implants were examined using optical and electron microscopy (SEM), metallographic sections of retrievals were prepared while pathologic samples of periprosthetic tissues were examined for presence of wear debris. Data from metallographic slides indicated that debonding was initiated at free borders of the coating and tended to progress at the interface between the TPS layer and the shell. In some cases, total debonding occurred leading material wear of both the TPS layer and acetabular shell leading to massive release of metallic debris and accelerated polyethylene wear in third body mechanism. SEM examination demonstrated that splats forming the TPS layer exhibited features suggesting a high temperature gradient between the plasma sprayed layer and the substrate material existed, leading to porosity of splats and suboptimal bonding strength. This study demonstrated that coating application parameters and certain design features (screw holes, fins) may promote long-term failure due to debonding. Surgeons should be aware of this complication as it is most likely underreported, while manufacturers should consider more rigorous pre-clinical testing as suboptimal coating bonding may result in failures during long-term clinical use.

Translated article] Evolution of chromium and cobalt serum levels after the use of a modular neck stem in primary total hip arthroplasty

Introduction and objectivesModular neck primary stems were introduced with the theoretical advantage of restoring the hip anatomy more precisely. However, the presence of a second junction has been associated with increased corrosion and release of metal debris. The objective of our study is to quantify of chromium and cobalt serum values, and to analyse their temporal evolution during five years. Material and methodsWe present a prospective series of 61 patients who underwent primary total hip arthroplasty by implantation of the H MAX-M® stem (Limacorporate, San Daniele, Italy). Serum chromium and cobalt determinations were performed at six months, two years and five years. ResultsOur series shows a progressive elevation in chromium levels with a significant difference between chromium values at six months (0.35±0.18) and five years (0.52±0.36), p=.01. Regarding cobalt, a statistically significant elevation is observed between six months and two years and a subsequent stabilisation of values between two and five years, with a cobalt mean at six months (1.17±0.8) significantly lower than at two (2.63±1.76) and five years (2.84±2.1), p=.001. ConclusionElevated serum cobalt levels have been observed in patients who underwent modular neck stem implantation. The results obtained in this study have limited the use of stems with a modular neck in our clinical practice.

Evolución de los niveles séricos de cromo y cobalto tras el empleo de un vástago con cuello modular en la artroplastia total de cadera primaria

Introduction and objectivesModular neck primary stems were introduced with the theoretical advantage of restoring the hip anatomy more precisely. However, the presence of a second junction has been associated with increased corrosion and release of metal debris. The objective of our study is to quantify of chromium and cobalt serum values, and to analyze their temporal evolution during five years. Material and methodsWe present a prospective series of 61 patients who underwent primary total hip arthroplasty by implantation of the HMAX-M® stem (Limacorporate, San Daniele, Italy). Serum chromium and cobalt determinations were performed at six months, two years and five years. ResultsOur series shows a progressive elevation in chromium levels with a significant difference between chromium values at six months (0.35±0.18) and five years (0.52±0.36), P=.01. Regarding cobalt, a statistically significant elevation is observed between six months and two years and a subsequent stabilization of values between two and five years, with a cobalt mean at six months (1.17±0.8) significantly lower than at two (2.63±1.76) and five years (2.84±2.1), P=.001. ConclusionElevated serum cobalt levels have been observed in patients who underwent modular neck stem implantation. The results obtained in this study have limited the use of stems with a modular neck in our clinical practice.

Metal debris release is commonly seen from explanted total ankle replacements

This study aimed to characterise the damage mechanisms present on the metal components used in various contemporary total ankle replacements. Twenty-seven explanted total ankle replacements comprising 8 different designs (3 fixed bearing and 5 mobile bearing) were analysed using various explant analysis techniques. Pitting and scratching were the most commonly observed wear features. Microscopic analysis revealed metallic pitting on 52% of tibial components and 95% of talar components. Pitting was identified on more cobalt-chromium than titanium alloy tibial components (63% versus 0%). Non-contact profilometry confirmed the presence of pitting, with significant (p < 0.05) differences in the measured average surface roughness values of pitted and unpitted areas for tibial and talar components. There was macroscopically visible sliding plane scratching, indicating the presence of hard third body particles, on 78% of talar components. Changes to the non-articulating surfaces coatings in terms of coating loss and/or changes in reflectivity was identified visually on 80% of metal components. Scanning electron microscopy with energy dispersive X-ray spectroscopy identified metallic embedded debris in 19% of polyethylene inserts. This explant study demonstrates the release of metal debris from both the metallic tibial and talar component articulating surfaces and non-articulating surface coatings of various contemporary total ankle replacements. Metal particulate debris release from total ankle replacements may be more common than previously recognised. Metal debris should be considered in further study into the aetiology of failed total ankle arthroplasty.

Poly (Ether-Ether-Ketone) for Biomedical Applications: From Enhancing Bioactivity to Reinforced-Bioactive Composites-An Overview.

The global orthopedic market is forecasted to reach US$79.5 billion by the end of this decade. Factors driving the increase in this market are population aging, sports injury, road traffic accidents, and overweight, which justify a growing demand for orthopedic implants. Therefore, it is of utmost importance to develop bone implants with superior mechanical and biological properties to face the demand and improve patients' quality of life. Today, metallic implants still hold a dominant position in the global orthopedic implant market, mainly due to their superior mechanical resistance. However, their performance might be jeopardized due to the possible release of metallic debris, leading to cytotoxic effects and inflammatory responses in the body. Poly (ether-ether-ketone) (PEEK) is a biocompatible, high-performance polymer and one of the most prominent candidates to be used in manufacturing bone implants due to its similarity to the mechanical properties of bone. Unfortunately, the bioinert nature of PEEK culminates in its diminished osseointegration. Notwithstanding, PEEK's bioactivity can be improved through surface modification techniques and by the development of bioactive composites. This paper overviews the advantages of using PEEK for manufacturing implants and addresses the most common strategies to improve the bioactivity of PEEK in order to promote enhanced biomechanical performance.

Whole Blood Titanium Concentration after Limb Salvage Surgery with Three-Dimensional-Printed Ti6Al4V Implants.

Three-dimensional (3D)-printed customized implants can be fabricated and utilized for all bones with massive bone defects. The main safety issues with 3D-printed implants made of Ti6Al4V alloy are related to the release of metal debris and residual powder. In this study, we investigated the perioperative titanium concentrations in whole blood and peri-implant fluid samples of patients who underwent limb salvage surgery with a 3D-printed Ti6Al4V implant. Nineteen patients who underwent limb salvage surgery with 3D-printed Ti6Al4V implants were divided into two groups: the serial samples group and the follow-up group. To observe metal distribution and clearance in the body, serial samples of blood and peri-implant fluid from the surgical drain were prospectively collected for five patients in the serial samples group. For the remaining 14 patients who were followed up for more than a year, blood samples were collected only once. In the serial samples group, the mean baseline titanium concentration was 0.78 µg/L (range, 0.1-2.2 µg/L): 3 patients showed peak concentration before the third postoperative month, while 2 patients still showed an increasing pattern at this point. Total titanium mass in the surgical drain showed a wash-out phenomenon in a week, with a significant uniform decrease (p = 0.04). In 14 patients in the follow-up group, the mean titanium concentration in the whole blood was 10.8 µg/L (range, 0.3-36.6 µg/L). For the 14 patients with a long-term follow-up, the aluminum and vanadium concentrations were all negligible. Whole blood titanium concentrations were higher after surgery using 3D-printed implants than after that using conventional orthopedic implants, but markedly lower than in patients with implant failure. None of the patients developed serious clinical adverse effects during follow-up.

Systemic toxicity of metal ions release from specific types of implanted medical devices: Systemic review of clinical studies

There is public concern over the long term systemic health effects of metal released from implanted medical devices that use metal alloys. Systemic toxic side effects have been associated with excessive metal ion release from implants into human biological specimen's circulation, in which cobalt and chromium plays an important role. Cobalt intoxication has become more frequent due to the wide use of metallic medical implants. Despite the technological improvements in replacement metallic medical implants, wear and corrosion products associated with the metal compounds of these implants may result in systemic reactions and toxicities. The current review encompasses a literature of the systemic toxicity studies concerning the effect of metallic wear debris released from wear and corrosion of specific types of implanted medical devices, resulting in a postoperative increase in metal ion levels in bodily fluids and at different organ sites. Release of metallic debris is mainly in the form of particles and ions of different valences, and oxides composed of cobalt and chromium. Toxicological, clinically significant, data regarding "potential hazards" of circulating metals after systemic chronic exposure to the metal ions from metals have been included. This review further highlights some of the clinical features of cobalt toxicity.

Comparison and appraisal of techniques for the determination of material loss from tapered orthopaedic surfaces

This review examines the challenges associated with quantifying material loss at modular junctions. Determination of material loss from retrieved orthopaedic surfaces is regarded as a prerequisite for the evaluation of long-term implant performance. Methods previously adopted to overcome the challenges associated with determining material loss from non-articular surfaces will be presented and discussed in this paper.Total Hip Replacement (THR) is regarded as one of the most successful and cost-effective surgical interventions for the treatment of advanced osteoarthritis. The use of modular components offers surgeons an array of possible implant combinations to intraoperatively optimise range of motion and soft tissue tension. However, the taper interface used to connect modular components has been suggested to contribute to premature implant failure through the release of metal debris and corrosion products. Geometrical and topographical measurement of explanted modular interfaces has been used to correlate multifarious variables with an absolute volumetric value for material loss. To improve modular implant performance, medical device manufacturers have adopted numerous design philosophies, each presenting a unique set of challenges for the measurement of material loss. This review summarises the approaches used in previous studies to overcome these challenges and identifies future work required in this area. This field of research is currently the subject of discussion within standards bodies to create recommended best practices for centres to follow.

Analytical modeling of contact mechanics of helical gear tooth by considering surface roughness effects

Release of metal debris from a pair of gear teeth is a consequence of their contact. Any excessive metal debris can lead to the onset of fatigue and failure. This paper aims to derive a contact mechanics-based model to obtain the energy absorption of helical gear teeth. The proposed model includes the roughness effect of teeth contact surfaces. The mean value of the asperity summit curvature, the standard deviation of the asperity height distribution and the area density of the asperity height distribution are the three statistical parameters that describe the micron-scale surface roughness. An explicit approximation is obtained to relate the contact load and the minimum surface separation and to estimate the energy loss. Then an analytical expression is derived for the plastic energy dissipation per cycle as a function of plasticity index for gear teeth. The proposed function can be applied in the design of gears by engineers and manufacturers. Additionally, a pertinent lumped mass at the area of interaction is assumed to describe the contact frequency and damping ratio using a nonlinear dynamic model.

Prosthetic Impingement in Total Hip Arthroplasty—The Trigger for Adverse Wear

Development of total hip arthroplasty (THA) now spans more than 5 decades encompassing combinations of metal-on-metal (MOM), ceramic-on-metal (COM), metal-on-plastic (MOP), ceramic-on-plastic (COM), and ceramic-on-ceramic (COC). In every arena of extensive technical development, there exists a data set that when viewed in isolation seemed of little import, but when assembled in-toto may produce a generational shift in perception. Our review focused on two such THA events. Firstly, COC retrieval studies (1999-2001) noted habitual wear patterns on heads and peripheral wear stripes, along with femoral-neck impingement, and ceramic surfaces stained gray by metal debris. These COC data indicated THA risks included, 1) cup edge-loading (E/L) on heads producing “stripe wear”, 2) component impingement releasing metal particles resulting in 3) tissues contaminated by metal debris. A corresponding MOM impingement-debris mechanism was only perceived by Howie (2005) in a McKee-Farrar retrieval study. Our anticipation at LLUMC was that MOM retrievals would provide superior wear details to those seen on COC retrievals. We noted stripe wear in the polar zone of CoCr heads and basal stripes in the non-wear areas. The basal-polar stripe combinations were found in all MOM retrievals. Basal-polar stripe combinations followed cup-rim profiles in our LLUMC simulations of prosthetic impingement. LPUH videos demonstrated the formation of stripe wear in functional-standing and functional-sitting postures for both impingement and subluxation episodes using THA and RA designs. The stripes on CoCr heads revealed the large scratches we now term “microgrooves”. Microgroove width varied from 40 - 400 um with 100 um being typical. The longitudinal striations in microgrooves, the raised jagged lips, scratches with shallow entry and exit termini, were all indicative of a classic 3rd-body wear mechanism. The THA impingement simulations denoted four sites of edge-loading, i.e. neck-E/L, inferior cup-E/L, superior cup-E/l and head-E/L, and ingress of Ti64 particles as a contaminating-roughness effect. Individual MOM cases referred to LLUMC demonstrated dramatic evidence of neck notching. At one end of the debris spectrum, a Ti64-notch model predicting a 6 mm3 annual wear-rate represented the release of 5700 particles of 126 um-size (approximating daily release of 16 particles). At the other end of the spectrum, if metal particles were crushed between MOM surfaces to the equivalent nanometer size found in tissues, our notch model represented approximately 22-trillion Ti64 particles annually deposited in tissues. The anatomical THA models represented in LPUH videos demonstrated that even 1-degree of head subluxation from a rigid cup created a cup “lift-off” scenario (CLO) that would open a gap of 250 - 400 microns between femoral head and cup. This would void all lubrication potential and focus the total hip-joint force along the beveled cup rim, i.e. stripe wear. It is therefore interesting that MOM impingement/debris predictions by Howie et al. have not been confirmed until now or discussed in contemporary literature. Therefore, this review of 50 years of THA data demonstrated that hip impingement was always the trigger for adverse wear and that metal-backed cups represent the potential for release of metal debris at extremes of functional standing and sitting postures.

Tuning the tribofilm nanostructures of polymer-on-metal joint replacements for simultaneously enhancing anti-wear performance and corrosion resistance

Total joint replacement is currently the most successful clinical treatment for improving the life quality of individuals afflicted with end-stage osteoarthritis of knee or hip joints. However, release of wear and corrosion products from the prostheses is a critical issue causing adverse physiological responses of local issues. β-SiC nanoparticles were dispersed into polyetheretherketone (PEEK) materials and their role in tribocorrosion performance of PEEK-steel joints exposed to simulated body fluid was investigated. It is demonstrated that β-SiC nanoparticles increase greatly the wear resistance of the PEEK materials, and meanwhile mitigate significantly corrosion of the steel counterpart. It is revealed that tribochemical reactions of β-SiC nanoparticles promoted formation of a robust tribofilm having complex structures providing protection and shielding effects. The present work proposes a strategy for developing high-performance polymer-on-metal joint replacement materials of enhanced lifespan and biocompatibility via tuning interface nanostructures. Statement of SignificanceAdverse tissue responses to metal wear and corrosion products from metal base implants remain a challenge to surgeons and patients. We demonstrated that leaching of metal ions and release of metallic debris are well decreased via tuning interface nanostructures of metal-polymer joint bearings by dispersing β-SiC nanoparticles into polyetheretherketone (PEEK). It is identified that the addition of β-SiC greatly improves the tribological performances of the PEEK materials and mitigated corrosion of the steel. Tribo-chemistry reactions of SiC induce the formation of complex structures which provide protection and shielding effects. Nanostructures of the tribofilm were also comprehensively investigated. These novel findings proposed a potential route for designing high performance metal-polymer joint replacement materials.

The Sequelae of Metallosis Resulting in Skin Pigmentation and Tattooing: A Case Presentation and Literature Review.

With advancing technologies in orthopedics and increasing demands of the population for orthopedic interventions, younger patients are now receiving joint replacements. One of the potential risks of joint replacement is metallosis, or the local and systemic release of metal ions. Metallosis is caused by the release of metallic debris, secondary to hardware failure. The phenomenon is most commonly associated with failed metal-on-metal hip prostheses and is characterized locally by heavy staining of surrounding soft tissue, metallic synovitis, joint effusion, and gradual loosening of the prosthesis. Additionally, metallic debris can also lead to periarticular superficial skin manifestations. The release of metal ions has further been known to lead to systemic upsets including neurologic deficit (declining vision, hearing, or cognition; headaches), cardiac failure, and hypothyroidism. As the number of patients seeking major orthopedic interventions grows, the incidence of metallosis-related skin tattooing will also increase. The structural components of a failed joint replacement can be revised (improving patients' pain and functioning). However, any skin tattooing secondary to metallosis presents the treating dermatologist with clinical challenge, due to lack of research regarding treatment of this condition. Our aim is to review the published literature on metallosis, including the pathophysiology. After assessing publications on the treatment of traumatic and cosmetic tattooing, we hope to stimulate further research regarding treatment. This article should also serve to remind orthopedic surgeons that with increasing patient concern regarding cosmesis, a multispecialty approach including referral to a dermatologist is valuable.

Influence of the machining parameters and cooling strategies on the wear behavior of wrought and additive manufactured Ti6Al4V for biomedical applications

The paper presents the effect of the machining parameters and cooling strategies on the wear behavior of the wrought and Additive Manufactured Ti6Al4V used for biomedical applications. Wear tests were performed using a cylinder-on-plate configuration in a wet and temperature-controlled environment in order to investigate the reciprocating sliding wear behavior under human body conditions. The obtained results showed that the adoption of the cryogenic cooling during machining significantly affected the Ti6Al4V surface properties improving its wear performances, in terms of lower friction coefficient and less release of metal debris due to abrasive wear compared to dry cutting conditions, regardless the alloy as-delivered condition.

Nano-scale wear characterization of CoCrMo biomedical alloys

Low amplitude motions at the micro and the nano-scale at the femoral stem–cement interface under physiological loads can result in fretting and nano-wear on the stem surface. These are important wear processes in cemented total hip replacements as the release of metal debris and ions can trigger adverse local tissue reactions within the body, bone resorption and subsequent aseptic loosening of the femoral component resulting in the implant failure. However, the influence of the microstructure and manufacturing processes on the nano-wear behaviour of different cobalt chromium molybdenum (CoCrMo) alloys has not been studied extensively. Four CoCrMo alloys were tested under reciprocating wear conditions at the nano-scale level. Tangential friction forces, coefficient of friction and plastic deformation values were recorded. A new white-light-interferometer system was validated against atomic force microscopy and Nano Vantage Test System measurements to analyse the permanent plastic deformation caused in each of the samples. Significant differences were found in the total plastic deformation achieved by the as cast alloy compared to the forged, as cast single thermal treated and as cast double thermal treated samples. In addition thermal treated samples presented a tendency to produce a higher quantity of wear debris around the nano-wear scars. These findings indicate a possible relation between the wear resistance at the nano-scale and the manufacturing and thermal processes applied on the CoCrMo biomedical alloys.

Stochastic Simulation of Modular Connections in Total Hip Replacement

Several modern Total Hip Arthroplasty (THA) implants have been associated with increased release of metallic debris through combined mechanical fretting wear and chemical corrosion. These particles can lead to painful Adverse Reaction to Metallic Debris, often requiring early revision [1]. While much research has focused on improving the performance of bearing surfaces, the key parameters driving release of metallic debris at modular junctions remains unclear.© 2013 ASME

Magnetresonanztomographische Untersuchungen bei Problemen mit Metall-auf-Metall-Implantaten

Until recently, metal-on-metal (MoM) hip implants were commonly used for joint replacement and resurfacings. Their use has rapidly declined following reports of Frühversagen and soft tissue disease caused by the release of metal debris from the prosthesis. Detection of these soft tissue lesions has proven difficult using conventional imaging techniques and blood metal ion tests. Current guidelines recommend the use of imaging modalities including metal artefact reduction sequence (MARS) magnetic resonance imaging (MRI), computed tomography and ultrasound but provide little indication which is best. MARS significantly reduces the susceptibility artefact induced by the presence of metal objects, thereby producing diagnostic quality images that can be shared with other physicians and compared over time. The clinical interpretation of MRI findings of solid pseudotumours and severe muscle atrophy is straightforward: revision is usually recommended. However, the most common MRI findings are of a cystic pseudotumour and minor muscle wasting. In these cases decision-making is difficult and we currently use multi-disciplinary and multi-colleague based meetings to make decisions regarding patient management. This article presents a comparison of imaging modalities and an update on the interpretation of MARS MRI for the investigation of patients with MoM hip implants.The English full-text version of this article is available at Springer Link (under "Supplemental").

(iii) Bearing surfaces

Abstract Alternative bearings surfaces to polyethylene have reduced wear and have led to improved patient outcomes, allowing younger and more active patients to be considered for joint replacements. These bearing surfaces have been developed largely as a response to osteolysis and loosening associated with polyethylene particulate debris. This has led to the evolution of various forms of cross-linked polyethylene and to the greater use of hard-on-hard bearings. The use of metal-on-metal led to resurfacing hip replacements and to the use of large head metal-on-metal hip replacements. Although metal-on-metal bearings have a number of theoretical advantages, the release of metal debris and ions from some designs has been catastrophic. In the future new bearing surfaces must be more thoroughly tested pre-clinically and in well-designed clinical series.

Metal release from hip prostheses: cobalt and chromium toxicity and the role of the clinical laboratory

Individuals with advanced hip disease suffer from pain, impaired hip function, and decreased quality of life. Roughly one million metal-on-metal (MoM) hip prostheses have been implanted worldwide in order to ameliorate these issues. While most MoM hip replacements are successful, some patients suffer from serious adverse effects secondary to the release of metal debris due to implant wear and corrosion. MoM hip prostheses are comprised predominantly of cobalt and chromium, and the serum concentration of these metal ions has been shown to correlate with both implant wear and the accumulation of metal debris in the periprosthetic tissue. Consequently, measurement of cobalt and chromium concentrations may be useful in the assessment of implant function and the potential for adverse effects in the follow-up of patients with MoM hip prostheses. The purpose of this Mini Review is to describe the adverse biological consequences of metal release from hip prostheses, provide an overview of the clinical utility of cobalt and chromium measurement and the current recommendations for testing, and alert laboratorians and physicians to the many challenges associated with measuring these metal ions.

Severe corrosion after malpositioning of a metallic head over the Morse taper of a cementless hip arthroplasty. A case report

Morse tapers are frequently used in total hip replacement to achieve precise adjustment of lengths and femoral offset. Mechanically, they do not raise any specific problems so long as strict positioning requirements are observed and elements from different manufacturers are not mixed together. We report a case in which the implant induced unexplained pain at 2 years, in relation to a defective fit between the metallic head and the Morse taper. Asymmetric partial fit of the head onto the taper was detected on control X-ray and was implicated as causing metallosis due to excessive release of metal debris from the Morse taper. Revision required femoral stem exchange because of the damage to the Morse taper as well as replacing the cup with new metal-metal bearings. Evolution was favorable at 3 years' follow-up. Most hip replacements include a Morse taper; the present clinical case is a reminder that strict positioning rules are to be respected, without which corrosion and wear may lead to mechanical failure.