Proximal component modularity in THA--at what cost? An implant retrieval study.
ABSTRACT: BACKGROUND: While modular femoral heads have been used in THA for decades, a recent innovation is a second neck-stem taper junction. Clinical advantages include intraoperative adjustment of leg length, femoral anteversion, and easier revision, all providing flexibility to the surgeon; however, there have been reports of catastrophic fracture, cold welding, and corrosion and fretting of the modular junction. QUESTIONS/PURPOSES: We asked whether (1) the neck-stem junction showed the same degradation mechanisms, if any, as the head-neck junction, (2) the junction contributed to THA revision, (3) the alloy affected the degree of degradation, and (4) the trunion machine finish affected the degradation mechanisms. METHODS: We compared 57 retrievals from seven total hip modular designs, three cobalt-chromium-molybdenum and four titanium based: Bionik(®) (four), GMRS(®) (four), Margron(®) (22), Apex(®) (five), M-series(®) (five), ZMR(®) (two), and S-ROM(®) (15). Macroscopic inspection, microscopy, and micro-CT were conducted to determine the effects of materials and design. RESULTS: The cobalt-chromium-molybdenum components showed crevice corrosion and fretting of the neck-stem taper, whereas the titanium components had less corrosion; however, there were several cases of cold welding where disassembly could not be achieved in theater. CONCLUSIONS: Even with modern taper designs and corrosion-resistant materials, corrosion, fretting, and particulate debris were observed to a greater extent in the second neck-stem junction. Titanium-based modular arthroplasty may lessen the degree of degradation, but cold welding of the components may occur. CLINICAL RELEVANCE: Degradation of the second junction contributed to 8 cases of metallosis and two cases of aseptic lymphocyte-laminated vascular-associated lesions contributing to revision.
Project description:BACKGROUND:The BIOLOX® option system, consisting of a BIOLOX® delta ceramic femoral head with a titanium alloy adapter sleeve, is being increasingly utilized in revision hip arthroplasty. The sleeve protects the ceramic head from fracture and improper motion about the stem trunnion when a damaged trunnion is encountered at revision surgery. Corrosion and fretting due to metal-metal contact at the taper region of hip prosthesis create the potential of causing periprosthetic osteolysis and adverse local tissue reactions. QUESTIONS/PURPOSES:The objective of this study was to identify the type and extent of damage to retrieved sleeves and ceramic heads to determine their in vivo performance. METHODS:Twenty-four ceramic heads with titanium alloy sleeves were examined. The articular and taper surfaces for each ceramic head were assessed for metal transfer using a subjective grading system. All surfaces of the 24 titanium sleeves and stem trunnions (only available for 7 of 24 cases) were assessed for corrosion and fretting using an established grading system. Scanning electron microscopy and energy dispersive X-ray analysis were conducted on representative sample of sleeves. RESULTS:Fretting and corrosion were higher at the inner surface of the taper sleeve than the outer sleeve. Mean fretting scores at the inner taper and outer taper sleeve surfaces were 1.8 and 1.2, respectively. The mean corrosion score at the inner taper surface was 1.8; no corrosion was observed on the outer surface of any taper sleeve. SEM and EDS analyses provided further indications of low levels of damage. CONCLUSION:Fretting and corrosion were less severe than previously reported for conventional THA metal-metal taper connections, indicating that a ceramic head and titanium sleeve is a safe alternative in revision THA.
Project description:Titanium alloys are widely used in total-joint replacements due to a combination of outstanding mechanical properties, biocompatibility, passivity, and corrosion resistance. Nevertheless, retrieval studies have pointed out that these materials can be subjected to localized or general corrosion in modular interfaces when mechanical abrasion of the oxide film (fretting) occurs. Modularity adds large crevice environments, which are subject to micromotion between contacting interfaces and differential aeration of the surface. Titanium alloys are also known to be susceptible to hydrogen absorption, which can induce precipitation of hydrides and subsequent brittle failure. In this work, the surface of three designs of retrieved hip-implants with Ti-6Al-4V/Ti-6Al-4V modular taper interfaces in the stem were investigated for evidence of severe corrosion and precipitation of brittle hydrides during fretting-crevice corrosion in the modular connections. The devices were retrieved from patients and studied by means of scanning electron microscopy (SEM), X-ray diffraction (XRD), and chemical analysis. The surface qualitative investigation revealed severe corrosion attack in the mating interfaces with evidence of etching, pitting, delamination, and surface cracking. In vivo hydrogen embrittlement was shown to be a mechanism of degradation in modular connections resulting from electrochemical reactions induced in the crevice environment of the tapers during fretting-crevice corrosion.
Project description:Femoral stems with dual-taper modularity were introduced to allow additional options for hip-center restoration independent of femoral fixation in total hip arthroplasty. Despite the increasing availability and use of these femoral stems, concerns exist about potential complications arising from the modular neck-body junction.This was a multicenter retrospective case series of twelve hips (eleven patients) with adverse local tissue reactions secondary to corrosion at the modular neck-body junction. The cohort included eight women and three men who together had an average age of 60.1 years (range, forty-three to seventy-seven years); all hips were implanted with a titanium-alloy stem and cobalt-chromium-alloy neck. Patients presented with new-onset and increasing pain at a mean of 7.9 months (range, five to thirteen months) following total hip arthroplasty. After serum metal-ion studies and metal artifact reduction sequence (MARS) magnetic resonance imaging (MRI) revealed abnormal results, the patients underwent hip revision at a mean of 15.2 months (range, ten to twenty-three months). Tissue specimens were examined by a single histopathologist, and the retrieved implants were studied with use of light and scanning electron microscopy.Serum metal levels demonstrated greater elevation of cobalt (mean, 6.0 ng/mL) than chromium (mean, 0.6 ng/mL) or titanium (mean, 3.4 ng/mL). MRI with use of MARS demonstrated adverse tissue reactions in eight of nine patients in which it was performed. All hips showed large soft-tissue masses and surrounding tissue damage with visible corrosion at the modular femoral neck-body junction. Available histology demonstrated large areas of tissue necrosis in seven of ten cases, while remaining viable capsular tissue showed a dense lymphocytic infiltrate. Microscopic analysis was consistent with fretting and crevice corrosion at the modular neck-body interface.Corrosion at the modular neck-body junction in dual-tapered stems with a modular cobalt-chromium-alloy femoral neck can lead to release of metal ions and debris resulting in local soft-tissue destruction. Adverse local tissue reaction should be considered as a potential cause for new-onset pain in patients with these components, and early revision should be considered given the potentially destructive nature of these reactions. A workup including serologic studies (erythrocyte sedimentation rate and C-reactive protein), serum metal levels, and MARS MRI can be helpful in establishing this diagnosis.
Project description:An 81-year-old woman presented with progressive groin pain after metal-on-polyethylene total hip arthroplasty with a modular neck stem and was found to have adverse local tissue reaction. As we report for the first time with this implant, we observed titanium neck-titanium stem taper corrosion intraoperatively. We also found head-neck taper corrosion. The patient underwent revision surgery to a modular fluted tapered stem with ceramic head and was asymptomatic at 3-year follow-up visit. In conclusion, consideration should be given to avoiding the routine use of this modular neck stem in total hip arthroplasty. Patients with this prosthesis should be closely monitored for adverse local tissue reaction.
Project description:The purpose of this study was to investigate the stability of dual-taper modular implants following impaction forces delivered at varying locations as measured by the distraction forces required to disassemble the components.Distraction of the head-neck and neck-stem (NS) tapers of dual-taper modular implants with 0°, 8°, and 15° neck angles were measured utilizing a custom-made distraction fixture attached to a servohydraulic materials test machine. Distraction was measured after hand pressing the components as well as following a simulated firm hammer blow impaction. Impacts to the 0°, 8°, 15° necks were directed axially in line with the neck, 10° anterior, and 10° proximal to the axis of the neck, respectively.Impaction increased the range of NS component distraction forces when compared to hand pressed components (1125-1743 N vs 248-302 N, respectively). Off-axis impacts resulted in significantly reduced mean (±95% confidence interval) distraction forces (8° neck, 1125 ± 117 N; 15° neck, 1212 ± 73 N), which were up to 35% lower than the mean distraction force for axial impacts to the 0° neck (1743 ± 138 N).Direction of impaction influences stability of the modular interface. The greatest stability was achieved with impaction directed in line with the longitudinal axis of the taper junction. Off-axis impaction of the 8° and 15° neck led to significantly reduced stability at the NS. Improving stability of dual-taper modular hip prostheses with appropriately directed impaction may help to minimize micromotion, component settling, fretting corrosion, and subsequent failure.
Project description:The etiology of wear particle generation and subsequent corrosion in modular total hip arthroplasty implants likely begins with mechanical fretting. The purpose of this study was to determine geometric features of the male and female taper surfaces that drive stability within the neck-stem junction.Eighteen modular hip components received 3-dimensional surface scans to examine the neck-stem taper junction using an optical scanner. The normal distance between the surfaces of the neck taper as seated in the stem slot was measured and produced a color map of the contact proximity. Contour plots identified surface shape variation and contact. Angle measurements and neck seated depth were analyzed by regression.The typical features observed were (1) a vertical line of contact at one end of the transition from the flat surface to the radius surface; (2) a vertical line of contact in the radius surface just past the centerline; (3) a concavity along the flat surface between the neck and stem components; and (4) one of the neck flat surfaces was closer to its mating surface on the stem. The seated depth of the neck was dependent on the taper angles in the flat section of the neck (R2 = 0.5000, P = .0332).The shape of the neck and stem tapers deviate from ideal design dimensions, contributing to relative motions between the neck and stem. While these processes are not proven to directly cause implant failure, they may place the implants at higher risk for failure.
Project description:Recently, concerns have been raised about the potential effect of head-neck junction damage products at the local and systemic levels. Factors that may affect this damage process have not been fully established yet. This study investigated the possible correlations among head-neck junction damage level, implant design, material combination, and patient characteristics. Head-neck junctions of 148 retrieved implants were analysed, including both ceramic-on-ceramic (N = 61) and metal-on-metal (N = 87) bearings. In all cases, the male taper was made of titanium alloy. Damage was evaluated using a four-point scoring system based on damage morphology and extension. Patient age at implantation, implantation time, damage risk factor, and serum ion concentration were considered as independent potential predicting variables. The damage risk factor summarises head-neck design characteristics and junction loading condition. Junction damage correlated with both implantation time and damage factor risk when the head was made of ceramic. A poor correlation was found when the head was made of cobalt alloy. The fretting-corrosion phenomenon seemed mainly mechanically regulated, at least when cobalt alloy components were not involved. When a component was made of cobalt alloy, the role of chemical phenomena increased, likely becoming, over implantation time, the damage driving phenomena of highly stressed junctions.
Project description:Previous studies identified imprinting of the stem morphology onto the interior head bore, leading researchers to hypothesize an influence of taper topography on mechanically assisted crevice corrosion. The purpose of this study was to analyze whether microgrooved stem tapers result in greater fretting corrosion damage than smooth stem tapers.A matched cohort of 120 retrieved head-stem pairs from metal-on-polyethylene bearings was created controlling for implantation time, flexural rigidity, apparent length of engagement, and head size. There were 2 groups of 60 heads each, mated with either smooth or microgrooved stem tapers. A high-precision roundness machine was used to measure and categorize the surface morphology. Fretting corrosion damage at the head-neck junction was characterized using the Higgs-Goldberg scoring method. Fourteen of the most damaged heads were analyzed for the maximum depth of material loss and focused ion beam cross-sectioned to view oxide and base metal.Fretting corrosion damage was not different between the 2 cohorts at the femoral head (P = .14, Mann-Whitney) or stem tapers (P = .35). There was no difference in the maximum depths of material loss between the cohorts (P = .71). Cross-sectioning revealed contact damage, signs of micro-motion, and chromium-rich oxide layers in both cohorts. Microgroove imprinting did not appear to have a different effect on the fretting corrosion behavior.The results of this matched cohort retrieval study do not support the hypothesis that taper surfaces with microgrooved stems exhibit increased in vivo fretting corrosion damage or material release.
Project description:We report a case of bead shedding from a cylindrical extensively porous-coated cementless femoral component with concomitant taper corrosion at the modular head-neck junction of a metal-on-polyethylene total hip prosthesis. The patient presented with chronic thigh pain 4 years after primary total hip arthroplasty, and radiographs revealed significant osteolysis and metallic debris around the femoral stem. Intraoperatively, the patient had a grossly loose femoral component with debonding of sintered beads from the femoral stem, as well as evidence of taper corrosion. We identify a failure of a modern beaded femoral component in conjunction with taper corrosion.
Project description:Evidence that macrophages can play a role in accelerating corrosion in CoCrMo alloy in total hip replacement (THR) interfaces leads to questions regarding the underlying cellular mechanisms and immunological responses. Hence, we evaluated the role of macrophages in corrosion processes using the cell culture supernatant from different conditions and the effect of wear particles on macrophage dynamics. Monocytes were exposed to CoCrMo wear particles and their effect on macrophage differentiation was investigated by comparisons with M1 and M2 macrophage differentiation. Corrosion associated macrophages (MCA macrophages) exhibited upregulation of TNF-?, iNOS, STAT-6, and PPARG and down-regulation of CD86 and ARG, when compared to M1 and M2 macrophages. MCA cells also secreted higher levels of IL-8, IL-1?, IL-6, IL-10, TNF-?, and IL-12p70 than M1 macrophages and/or M2 macrophages. Our findings revealed variation in macrophage phenotype (MCA) induced by CoCrMo wear particles in generating a chemical environment that induces cell-accelerated corrosion of CoCrMo alloy at THR modular interfaces. STATEMENT OF SIGNIFICANCE: Fretting wear and corrosion within the implant's modular taper junction are prominent causes of implant failure, as they promote the release of corrosion products and subsequent development of adverse local tissue reactions. Being a multifactorial process, several in vitro models have been developed to recreate the in vivo corrosion process, often summarized as mechanically-assisted crevice corrosion. Considering the excellent corrosion properties of CoCrMo alloy, the severity of chemically-generated damage observed at the modular interface has been surprising and poorly understood. The aim of the current study is to provide a better understanding of macrophages and their plasticity at the THR taper interface when they encounter wear debris from CoCrMo alloy. This is a preliminary study along the path towards determining the mechanism(s) of CAC.