Introduction. The observation of elevated heavy metal ions in arthroplasty patients in association with complications has led to concern on the part of patients and surgeons. The aim of this study was to determine the levels of cobalt
Aims. The aim of this study was to present the first retrieval analysis findings of PRECICE STRYDE intermedullary nails removed from patients, providing useful information in the post-market surveillance of these recently introduced devices. Methods. We collected ten nails removed from six patients, together with patient clinical data and plain radiograph imaging. We performed macro- and microscopic analysis of all surfaces and graded the presence of corrosion using validated semiquantitative scoring methods. We determined the elemental composition of surface debris using energy dispersive x-ray spectroscopy (EDS) and used metrology analysis to characterize the surface adjacent to the extendable junctions. Results. All nails were removed at the end of treatment, having achieved their intended lengthening (20 mm to 65 mm) and after regenerate consolidation. All nails had evidence of corrosion localized to the screw holes and the extendable junctions; corrosion was graded as moderate at the junction of one nail and severe at the junctions of five nails. EDS analysis showed surface deposits to be
Aim. Adverse tissue reactions have been a concern in relation to metal components, particularly in hip replacements. We look at a possible correlation between hip joint effusion and metal ion levels. Materials and methods. 56 patients,(42M, 14F) agreed to the study. All had metal-on-mental arthroplasties. Average age was 64.2 (SD 9.8). All patients were asymptomatic. Ultrasound examination performed by one ultrasonographer, using a Sonosite M-Turbo machine with a C60X/5-2 MHz transducer. Cobalt levels were assessed using an inductively coupled plasma mass spectrometer.
Introduction. Total hip replacement with metal-on-polymer (MoP) hip prostheses is a successful treatment for late-stage osteoarthritis. However, the wear debris generated from the polymer acetabular liners remains a problem as it can be associated with osteolysis and aseptic loosening of the implant. This has led to the investigation of more wear resistant polymers in orthopaedics. Cross-linked polyethylene (XLPE) is now the gold-standard acetabular liner material. However, we asked if carbon fibre reinforced polyether ether ketone (CFR-PEEK) might be a lower wear material. In addition, we sought to understand the influence of contact stress on the wear of both XLPE and CFR-PEEK as this has not previously been reported. Materials and Methods. A 50-station circularly translating pin-on-disc (SuperCTPOD) machine was used to wear test both XLPE and CFR-PEEK pins against cobalt
Introduction. Revision of total hip replacements (THRS) is predominantly due to aseptic loosening, pain and infection [1]. The current method used to address the risk of infection is to administer antibiotics and to include antibacterial agents into bone cement (if used) and on implant coatings [2–4]. Currently, silver (Ag) coatings have only been applied to titanium hip stems [3]. Cobalt
Metal on metal total hip arthroplasty provides the potential improvement in articular wear and the use of large-diameter femoral heads following the prospect for reduction in the risk of dislocation. The purpose of this study was to compare the clinical and radiographic outcomes as well as serum metal ion level between the two different component designs with small and large femoral heads in metal on metal total hip arthroplasty. We studied 39 patients with large head (Magnum®, Biomet; cup size minus 6 mm) and 37 patients with small head (M2a taper®, Biomet; 28 or 32 mm head) of metal on metal total hip arthroplasty between December 2009 to October 2011 with follow-up of 2.1 years (1.0–3.3 years) after surgery. Harris Hip Score, UCLA activity score, EQ-5D, radiographic assessment, and serum cobalt and
Introduction. The metal-on-metal (MoM) total hip prosthesis is widely used. However, the adverse reactions such as pseudotumor around the total hip prosthesis are observed. This is considered the effect of the corrosion of alloy which includes metal ion release and the wear particle generation. As materials for total hip prostheses, cobalt
PURPOSE:. Wright Medical has a long history of modular neck hip implants but had fracture issues with the original titanium necks. They subsequently changed to chrome cobalt modular necks. Direct contact between these dissimilar metal parts in the modular femoral component brings into consideration the possibility of similar adverse reactions of metal-on-metal articulations that have been previously described in other designs. METHODS:. A retrospective review of 10 patients with Wright Medical chrome cobalt modular necks who were evaluated with
Demand for TKR surgery is rising, including a more diverse patient demographic with increasing expectations [1]. Therefore, greater efforts are being devoted to laboratory testing. As a result, laboratory testing may set a clinical performance presumption for surgeons and patients. For example, oxidized ZrNB (Oxinium) femoral components have been projected to show 85% less wear than CoCr femoral components in bench-top testing [2]. However, recent clinical data show no difference in outcomes between Oxinium® and CoCr for the same design [3]. While it does not show lagging peformance for the Oxinium components, it does call into question the predictive ability of simulation. To better understand the performance of these two materials, a non standardized simulator evaluation was conducted. One commercially available design (Legion PS) was evaluated with two variations of femoral component material (n = 3/material) Oxinium® and Cobalt
Trunnionosis in modular hip arthroplasty has recently been recognised to be clinically important. Gaining an understanding of how the material interface at the head-trunnion affects the tribology at the modular junctions has current clinical implications as well as an implication on future implant selection and material choice. This matched-cohort study aims to compare tribocorrosion between ceramic and cobalt-chromium trunnions and to investigate other factors that contribute to the difference in tribocorrosion if present. All hip prostheses retrieved between 1999 and 2015 at one centre were reviewed. Fifty two ceramic heads were retrieved, and these were matched to a cobalt-chromium cohort according to taper design, head size, neck length and implantation time in that order. The two cohorts were similar in male:female ratio (p=0.32) and body mass index (p=0.15) though the ceramic group was younger than the cobalt-chromium group (56.6 (+/−)13.5 years for ceramic group vs 66.3 (+/−14.4) years for cobalt-chromium group; p=0.001). There was no significant difference in the reasons for revision between the two groups (p=0.42). The femoral head trunnions were examined by two independent observers using a previously published 4-point scoring technique. The trunnions were divided into three zones: apex, middle and base. The observers were blinded to clinical and manufacturing data where possible. Ceramic head trunnions demonstrated a lower median fretting and corrosion score at the base zone (p<0.001), middle zone (p<0.001) and in the combined score (p<0.001). In a subgroup analysis by head size, ceramic heads had a lower fretting and corrosion score at 28mm head diameter (p<0.001). Within the ceramic group, taper design had a significant effect on fretting and corrosion in the apex zone (p=0.04). Taper design also had a similar effect in the cobalt-chromium group in the apex zone (p=0.03). For the ceramic trunnions, the largest effect was contributed by the difference between the 11/13 taper and the 12/14 taper. For the cobalt-chromium trunnions, the largest effect was contributed by the difference between the 5 degree 38′ 37″ taper and type 1 taper. Ceramic head trunnions showed a significantly lower fretting and corrosion score as compared to cobalt-chromium trunnions. Ceramic heads had a lower score than cobalt-chromium heads at 28mm head diameter. Taper design had an effect on fretting and corrosion within each cohort.
Silicon nitride (SiN) is a recently introduced bearing material for THR that has shown potential in its bulk form and as a coating material on cobalt-chromium (CoCr) substrates. Previous studies have shown that SiN has low friction characteristics, low wear rates and high mechanical strength. Moreover, it has been shown to have osseointegration properties. However, there is limited evidence to support its biocompatibility as an implant material. The aim of this study was to investigate the responses of peripheral blood mononuclear cells (PBMNCs) isolated from healthy human volunteers and U937 human histiocytes (U937s) to SiN nanoparticles and CoCr wear particles. SiN nanopowder (<50nm, Sigma UK) and CoCr wear particles (nanoscale, generated in a multidirectional pin-on-plate reciprocator) were heat-treated for 4 h at 180°C and dispersed by sonication for 10 min prior to their use in cell culture experiments. Whole peripheral blood was collected from healthy donors (ethics approval BIOSCI 10–108, University of Leeds). The PBMNCs were isolated using Lymphoprep® as a density gradient medium and incubated for 24 h in 5% (v/v) CO2at 37°C to allow attachment of mononuclear phagocytes. SiN and CoCr particles were then added to the phagocytes at a volume concentration of 50 µm3 particles per cell and cultured for 24 h in RPMI-1640 culture medium in 5% (v/v) CO2 at 37°C. Cells alone were used as a negative control and lipopolysaccharide (LPS; 200ng/ml) was used as a positive control. Cell viability was measured after 24 h by ATPLite assay and tumour necrosis factor alpha (TNF-α) release was measured by sandwich ELISA. U937s were co-cultured with SiN and CoCr particles at doses of 0.05, 0.5, 5 and 50 µm3 particles per cell for 24h in 5% (v/v) CO2 at 37 C. Cells alone were used as a negative control and camptothecin (2 µg/ml) was used as a positive control. Cell viability was measured after 0, 1, 3, 6 and 9 days. Results from cell viability assays and TNF-α response were expressed as mean ±95% confidence limits and the data was analysed using one-way ANOVA and Tukey-Kramer post-hoc analysis.Introduction
Methods
Implant related hypersensitivity is an infrequent complication after total knee replacement. It remains a relatively unpredictable and poorly understood cause of failure of an implant. We present a report of five patients who presented with persistent hypertrophic synovitis after total knee replacement using a cobalt chrome component. Extensive preoperative and intraoperative attempts ruled out infection as a cause of symptoms. The knees had good ligamentous balance and were well aligned and fixed. The clinical condition improved after revision to a zirconium femoral and titanium metal backed tibial components. Intraoperative histopathology revealed thickened synovium with a predominantly monocellular (lymphocytic or histiocytic) response. Where infection has been excluded as a cause of persistent pain and swelling, consideration should be given to metal allergy as a cause of failure in primary knee replacement surgery.
Introduction. Metal-on-Metal (MoM) bearing surfaces were historically used for young patients undergoing total hip arthroplasty, and remain commonplace in modern hip resurfacing. In theory, it has been postulated that metal ions released from such implants may cross the placental barrier and cause harm to the fetus. In light of this potential risk, recommendations against the use of MoM components in women of child-bearing age have been advocated. The purpose of this systematic review was to evaluate: 1) the Metal-on-Metal bearing types and ion levels found; 2) the concentrations of metals in maternal circulation and the umbilical cord; and 3) the presence of abnormalities in the fetus. Methods. A comprehensive literature review was conducted of studies published between January 1st, 1975 and April 1st, 2019 using specific keywords. (See Fig 1). We defined the inclusion criteria for qualifying studies for this review as follows: 1) studies that reported on the women who experienced pregnancy and who had a Metal-on-Metal hip implant; 2) studies that reported on maternal metal ions blood and umbilical cord levels; and 3) studies that reported on the occurrence of fetal complications. Data on cobalt and
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
Aims. This study aims to enhance understanding of clinical and radiological consequences and involved mechanisms that led to corrosion of the Precice Stryde (Stryde) intramedullary lengthening nail in the post market surveillance era of the device. Between 2018 and 2021 more than 2,000 Stryde nails have been implanted worldwide. However, the outcome of treatment with the Stryde system is insufficiently reported. Methods. This is a retrospective single-centre study analyzing outcome of 57 consecutive lengthening procedures performed with the Stryde nail at the authors’ institution from February 2019 until November 2020. Macro- and microscopic metallographic analysis of four retrieved nails was conducted. To investigate observed corrosion at telescoping junction, scanning electron microscopy (SEM) and energy dispersive x-ray spectroscopy (EDX) were performed. Results. Adjacent to the nail’s telescoping junction, osteolytic changes were observed in bi-planar radiographs of 20/57 segments (35%) after a mean of 9.5 months (95% confidence interval 7.2 to 11.9) after surgery. A total of 8/20 patients with osseous alterations (40%) reported rest and ambulation pain of the lengthened segment during consolidation. So far, 24 Stryde nails were retrieved and in 20 (83%) macroscopic corrosion was observed at the nail’s telescoping junction. Before implant removal 11/20 radiographs (55%) of lengthened segments with these 20 nails revealed osteolysis. Implant retrieval analysis by means of SEM showed pitting and crevice corrosion. EDX detected
A concern of metal on metal hip resurfacing arthroplasty is long term exposure to Cobalt (Co) and
High short-term failure rates have been observed with a number of metal-on-metal (MoM) hip designs. Most patients require follow-up with blood metal ions, whichprovide a surrogate marker of in-vivo bearing wear. Given these results are used in clinical decision making it is important values obtained within and between laboratories are reproducible. To assess the intra-laboratory and inter-laboratory variability of blood metal ion concentrations analysed by four accredited laboratories. Whole blood was taken from two participants in this prospective study. The study specimen was obtained from a 42 year-old female with ceramic-on-ceramic hip arthroplasty failure resulting in unintended metal-on-ceramic wear and excessively high systemic metal ion levels. The control specimen was from a 52 year-old healthy male with no metal exposure. The two specimens were serially diluted to produce a total of 25 samples with different metal ion concentrations in two different anticoagulants each. Thus 50 samples were sent blinded in duplicate (total 100) to four accredited laboratories (A, B, C, D) to independently analyse blood metal ion concentrations. Ten commercially available reference specimens spiked with different amounts of metal ions were also obtained with known blood metal ion concentrations (range for cobalt 0.15µg/l-11.30µg/l and
There are numerous benefits of femoral head/neck modularity in both primary and revision surgery. Taper corrosion necessitating revision surgery was recognised decades ago, and there are concerns that the incidence is increasing. Variables in design, manufacturing, biomechanics, and modular head assembly have all been implicated. While the incidence of clinically significant taper corrosion is unknown, the adverse local tissue reaction (ALTR) does not appear to occur absent a cobalt
Summary. We report the first use of synchrotron xray spectroscopy to characterize and compare the chemical form and distribution of metals found in tissues surrounding patients with metal-on-metal hip replacements that failed with (Ultima hips) or without (current generation, large diameter hips) corrosion. Introduction. The commonest clinical category of failure of metal-on-metal (MOM) hip replacements is “unexplained” and commonly involved a soft tissue inflammatory response. The mechanism of failure of the Ultima MOM total hip replacement includes severe corrosion of the metal stem and was severe enough to be removed from clinical use. Corrosion is not a feature that we have found in the currently used MOM bearings. To better understand the biological response to MOM wear debris we hypothesized that tissue from failed hips with implant corrosion contained a different type of metal species when compared to those without corrosion. Method. Tissue from patients with two types of MOM hip arthroplasty were analysed: Ultima that failed with severely corroded femoral stems (n=12); and large diameter, current generation MOM hips that failed without visible corrosion (n=7). Comparison was also made to samples of cobalt,
ARMD (Adverse Reaction to Metal Debris) is an increasingly recognised complication of metal on metal hip replacements. The MHRA (Medical and Healthcare Related Devices Agency) have advised a blood cobalt or