Design, Material, and Seating Load Effects on In Vitro Fretting Corrosion Performance of Modular Head-Neck Tapers.

BACKGROUND: The short-term corrosion and micromechanical behavior of 32 unique head-neck taper design/material/assembly conditions was tested using an incremental cyclic fretting corrosion (ICFC) test method previously developed. METHODS: Seven materials, design, and simulated surgical parameters were evaluated, each being assigned 2 conditions for testing, using a 27-2 (7 factor, quarter factorial) design of experiments test matrix. The factors explored were (1) seating load, (2) head-neck offset, (3) material combination, (4) taper diameter, (5) taper roughness, (6) angular mismatch/engagement, and (7) taper length. Each sample underwent assembly, ICFC testing, pull off. RESULTS: Low seating load and high head offset correlated with increased fretting corrosion (P < .05). High head offset also contributed to a lower onset load for fretting current and higher micromotion (P < .05). Head subsidence measured over the ICFC test for samples seated at 100 N was significantly higher than samples seated at 4000 N. Micromotion for 12-mm head offsets was statistically higher than samples with a 1.5-mm head offset. A number of interactive effects were observed. For example, samples seated at 4000 N were less sensitive to head offset than samples seated at 100 N in terms of the resulting fretting current. CONCLUSION: Taper locking position, material combination, taper engagement length, taper roughness, and taper dimensions all had weak or no correlation with fretting current and taper micromotion. This test method and experimental design is a versatile means of assessing potential new taper designs in the future.

Effects of Seating Load Magnitude on Incremental Cyclic Fretting Corrosion in 5°40' Mixed Alloy Modular Taper Junctions.

BACKGROUND: Mechanically assisted crevice corrosion of modular tapers continues to be a concern in total joint arthroplasties. A surgical factor that may affect taper fretting corrosion during cyclic loading is seating load magnitude. In this study, modular head-neck taper junctions were seated, capturing load-displacement, over a range of axially oriented loads, and electrochemical and micromotion data were captured during short-term incremental cyclic fretting corrosion (ICFC) tests. The hypothesis is low seating loads result in greater motion and fretting corrosion in ICFC tests. The effect of assembly load on pull-off force post-ICFC testing was also evaluated. METHODS: The study employed custom-built test fixtures which measured head-neck micromotion and an electrochemical chamber to monitor electrochemical reactions. Head-neck motion measurements were captured using 2 noncontact differential variable reluctance transducers mounted to the head. Seating experiments ranged from 1000 to 8000 N. RESULTS: Significant differences due to seating loads were reported in seating displacement, ICFC subsidence, and fretting current at 4000 N cyclic load. Seating load decreased but did not eliminate currents. Fretting onset load remained fixed (approximately 1200 N) for tapers seated above 2000 N. Fretting subsidence was negligible for seating loads of 4000 N or higher, and increased subsidence was observed below 4000 N. CONCLUSION: This short-term test method evaluated the acute performance of modular implants which were assembled under various loads and demonstrated the link between seating loads, fretting motions, and electrochemical reactions. While increased seating loads reduced fretting corrosion and taper subsidence, it did not prevent fretting corrosion even at 8 kN seating.

Electrosurgery Induced Damage to Ti-6Al-4V and CoCrMo Alloy Surfaces in Orthopedic Implants In Vivo and In Vitro.

BACKGROUND: Recent observations of specific metal damage patterns on retrieved total joint implants implied a cellular origin and was termed inflammatory cell-induced (ICI) corrosion. Although ICI corrosion continues to present a potential damage source for metallic biomaterials surfaces, an alternate source of some damage patterns may arise from electrosurgery instruments in total joint arthroplasty. METHODS: To characterize electrosurgically-induced damage patterns on metal implants, a model system of highly polished CoCrMo and Ti-6Al-4V disks and commercial electrosurgical generator was evaluated in various modes and power settings using monopolar and bipolar configurations. Surfaces were tested dry, wet with phosphate-buffered saline, or covered with known thicknesses of hydrated 5% agarose hydrogel. RESULTS: In all cases, surface damage was generated on both alloy surfaces, directly resulting from plasma discharge interacting with the metal. Direct surface contact caused pitting and oxide buildup at the contact area. Damage was produced through 3 mm thickness of hydrogel on the surface and across metal-metal junctions representing modular tapers. Damage patterns on wetted surfaces were highly consistent with damage patterns observed on retrieved total joint implants; circular, ruffled areas with centralized pits, occasionally presenting trail- and weld-like features. CONCLUSION: Surgeons using electrosurgical systems in proximity to metallic implants should exercise caution. Discharge of electrical energy through implants can induce localized surface damage and may result in other adverse outcomes. Although these results show some damage reported to be ICI corrosion is indeed the result of electrosurgery, there remains damage observed in retrievals not explained by this process.

Properties and Corrosion Performance of Self-reinforced Composite PEEK for Proposed Use as a Modular Taper Gasket.

BACKGROUND: Fretting corrosion in medical alloys is a persistent problem, and the need for biomaterials that can effectively suppress mechanically assisted crevice corrosion in modular taper junctions or otherwise insulate metal-on-metal interfaces in mechanically demanding environments is as yet unmet. QUESTIONS/PURPOSES: The purpose of this study is to characterize a novel material, self-reinforced composite polyetheretherketone (SRC-PEEK) and to evaluate its ability to inhibit fretting corrosion in a pin-on-disk metal-on-metal interface test. METHODS: SRC-PEEK was fabricated by hot compaction of in-house-made PEEK fibers by compacting uniaxial layups at 344°C under a load of 18,000 N for 10 minutes. SRC-PEEK, bulk isotropic PEEK, and the in-house-made PEEK fibers were analyzed for thermal transitions (Tg, Tm) through differential scanning calorimetry, crystallinity, crystal size, crystalline orientation (Hermanns orientation parameter) through wide-angle x-ray scattering, and modulus, tensile strength, yield stress, and strain to failure through monotonic tensile testing. SRC-insulated pin-on-disk samples were compared with metal-on-metal control samples in pin-on-disk fretting corrosion experiments using fretting current and fretting mechanics measurements. Fifty-micron cyclic motion at 2.5 Hz was applied to the interface, first over a range of loads (0.5-35 N) while held at -0.05 V versus Ag/AgCl and then over a range of voltages (-0.5 to 0.5 V) at a constant contact stress of 73 ± 19 MPa for SRC-PEEK and 209 ± 41 MPa for metal-on-metal, which were different for each group as a result of changes in true contact area due to variations in modulus between sample groups. Pins, disks, and SRC samples were imaged for damage (on alloy and SRC surfaces) and evidence of corrosion (on alloy pin and disk surfaces). SRC specimens were analyzed for traces of alloy transferred to the surface using energy dispersive spectroscopy after pin-on-disk testing. RESULTS: SRC-PEEK showed improved mechanical properties to bulk PEEK (modulus = 5.0 ± 0.3 GPa, 2.8 ± 0.1 GPa, respectively, p < 0.001) and higher crystallinity to bulk PEEK (44.2% ± 3%, 39.5% ± 0.5%, respectively, p = 0.039), but had comparable crystalline orientation as compared with the initial PEEK fibers. SRC-PEEK reduced fretting currents compared with metal-on-metal controls by two to three orders of magnitude in both variable load (4.0E-5 ± 3.8E-5 µA versus 2.9E-3 ± 7.1E-4 µA, respectively, p = 0.018) and variable potential (7.5E-6 ± 4.7E-6 µA versus 5.3E-3 ± 1.4E-3 µA, respectively, p = 0.022) fretting corrosion testing. Minimal damage was observed on surfaces insulated with SRC-PEEK, whereas control surfaces showed considerable fretting corrosion damage and metal transfer. CONCLUSIONS: The SRC-PEEK gaskets in this study demonstrated higher crystallinity and crystalline orientation and improved monotonic tensile properties compared with bulk PEEK with the ability to effectively insulate Ti6Al4V and CoCrMo alloy surfaces and prevent the initiation of fretting corrosion under high contact-stress conditions. CLINICAL RELEVANCE: This novel SRC-PEEK material may offer potential as a thin film gasket material for modular tapers. Pending further in vitro and in vivo analyses, this approach may be able to preserve the advantages of modular junctions for surgeons while potentially limiting the downside risks associated with mechanically assisted crevice corrosion.

Ceramic Heads Decrease Metal Release Caused by Head-taper Fretting and Corrosion.

BACKGROUND: Metal release resulting from taper fretting and corrosion is a clinical concern, because wear and corrosion products may stimulate adverse local tissue reactions. Unimodular hip arthroplasties have a conical taper between the femoral head (head bore taper) and the femoral stem (stem cone taper). The use of ceramic heads has been suggested as a way of reducing the generation of wear and corrosion products from the head bore/stem cone taper junction. A previous semiquantitative study found that ceramic heads had less visual evidence of fretting-corrosion damage compared with CoCr heads; but, to our knowledge, no studies have quantified the volumetric material loss from the head bore and stem cone tapers of a matched cohort of ceramic and metal heads. QUESTIONS/PURPOSES: We asked: (1) Do ceramic heads result in less volume of material loss at the head-stem junction compared with CoCr heads; (2) do stem cone tapers have less volumetric material loss compared with CoCr head bore tapers; (3) do visual fretting-corrosion scores correlate with volumetric material loss; and (4) are device, patient, or intraoperative factors associated with volumetric material loss? METHODS: A quantitative method was developed to estimate volumetric material loss from the head and stem taper in previously matched cohorts of 50 ceramic and 50 CoCr head-stem pairs retrieved during revision surgery for causes not related to adverse reactions to metal particles. The cohorts were matched according to (1) implantation time, (2) stem flexural rigidity, and (3) lateral offset. Fretting corrosion was assessed visually using a previously published four-point, semiquantitative scoring system. The volumetric loss was measured using a precision roundness machine. Using 24 equally spaced axial traces, the volumetric loss was estimated using a linear least squares fit to interpolate the as-manufactured surfaces. The results of this analysis were considered in the context of device (taper angle clearance, head size, head offset, lateral offset, stem material, and stem surface finish) and patient factors that were obtained from the patients' operative records (implantation time, age at insertion, activity level, and BMI). RESULTS: The cumulative volumetric material losses estimated for the ceramic cohort had a median of 0.0 mm(3) per year (range, 0.0-0.4 mm(3)). The cumulative volumetric material losses estimated for the CoCr cohort had a median of 0.1 mm(3) per year (range, 0.0-8.8 mm(3)). An order of magnitude reduction in volumetric material loss was found when a ceramic head was used instead of a CoCr head (p < 0.0001). In the CoCr cohort, the femoral head bore tapers had a median material loss of 0.02 mm(3) (range, 0.0-8.7 mm(3)) and the stem cone tapers had a median material loss of 0.0 mm(3) (range, 0.0-0.32 mm(3)/year). There was greater material loss from femoral head bore tapers compared with stem cone tapers in the CoCr cohort (p < 0.001). There was a positive correlation between visual scoring and volumetric material loss (Spearman's ρ = 0.67, p < 0.01). Although visual scoring was effective for preliminary screening to separate tapers with no or mild damage from tapers with moderate to severe damage, it was not capable of discriminating in the large range of material loss observed at the taper surfaces with moderate to severe fretting-corrosion damage, indicated with a score of 3 or 4. We observed no correlations between volumetric material loss and device and patient factors. CONCLUSIONS: The majority of estimated material loss from the head bore-stem cone junctions resulting from taper fretting and corrosion was from the CoCr head bore tapers as opposed to the stem cone tapers. Additionally, the total material loss from the ceramic cohort showed a reduction in the amount of metal released by an order of magnitude compared with the CoCr cohort. CLINICAL RELEVANCE: We found that ceramic femoral heads may be an effective means by which to reduce metal release caused by taper fretting and corrosion at the head bore-stem cone modular interface in THAs.

Does Taper Size Have an Effect on Taper Damage in Retrieved Metal-on-Polyethylene Total Hip Devices?

BACKGROUND: Taper design has been identified as a possible contributor to fretting corrosion damage at modular connections in total hip arthroplasty systems, but variations in as-manufactured taper interfaces may confound this analysis. This study characterized taper damage in retrievals with 2 different taper sizes but comparable taper surface finishes and investigated if fretting and corrosion damage is related to taper size in the context of a multivariable analysis for metal-on-polyethylene bearings. METHODS: A total of 252 cobalt chromium femoral heads were identified in a collection of retrievals: 77 with taper A and 175 with taper B. Implantation time averaged 5.4 ± 6.0 years (range, 0-26 years). Explants were cleaned and analyzed using a 4-point semiquantitative method. Clinical and device factors related to head taper fretting corrosion damage were assessed using ordinal logistic regression with forward stepwise control. Components were then selected to create 2 balanced cohorts, matched on significant variables from the multivariable analysis. RESULTS: Increased head offset (P < .001), longer implantation time (P = .002), heavier patients (P < .001), and more flexible tapers (P < .001) were associated with increased taper fretting and corrosion damage. When damage scores were compared between the balanced groups, no significant differences were found. CONCLUSION: These results suggest that fretting and corrosion damage is insensitive to differences in taper size. The final model derived explains almost half of the fretting corrosion damage observed and identifies contributing factors that are consistent with other in vitro and retrieval studies.

Corrosion Damage and Wear Mechanisms in Long-Term Retrieved CoCr Femoral Components for Total Knee Arthroplasty.

BACKGROUND: Metal debris and ion release has raised concerns in joint arthroplasty. The purpose of this study was to characterize the sources of metallic ions and particulate debris released from long-term (in vivo >15 years) total knee arthroplasty femoral components. METHODS: A total of 52 CoCr femoral condyles were identified as having been implanted for more than 15 years. The femoral components were examined for incidence of 5 types of damage (metal-on-metal wear due to historical polyethylene insert failure, mechanically assisted crevice corrosion at taper interfaces, cement interface corrosion, third-body abrasive wear, and inflammatory cell-induced corrosion [ICIC]). Third-body abrasive wear was evaluated using the Hood method for polyethylene components and a similar method quantifying surface damage of the femoral condyle was used. The total area damaged by ICIC was quantified using digital photogrammetry. RESULTS: Surface damage associated with corrosion and/or CoCr debris release was identified in 51 (98%) CoCr femoral components. Five types of damage were identified: 98% of femoral components exhibited third-body abrasive wear (mostly observed as scratching, n = 51/52), 29% of femoral components exhibited ICIC damage (n = 15/52), 41% exhibited cement interface damage (n = 11/27), 17% exhibited metal-on-metal wear after wear-through of the polyethylene insert (n = 9/52), and 50% of the modular femoral components exhibited mechanically assisted crevice corrosion taper damage (n = 2/4). The total ICIC-damaged area was an average of 0.11 ± 0.12 mm2 (range: 0.01-0.46 mm2). CONCLUSION: Although implant damage in total knee arthroplasty is typically reported with regard to the polyethylene insert, the results of this study demonstrate that abrasive and corrosive damage occurs on the CoCr femoral condyle in vivo.

Modern trunnions are more flexible: a mechanical analysis of THA taper designs.

BACKGROUND: There is renewed concern surrounding the potential for corrosion at the modular head-neck junction to cause early failure in contemporary THAs. Although taper corrosion involves a complex interplay of many factors, a previous study suggested that a decrease in flexural rigidity of the femoral trunnion may be associated with an increased likelihood of corrosion at retrieval. QUESTIONS/PURPOSES: By analyzing a large revision retrieval database of femoral stems released during a span of three decades, we asked: (1) how much does flexural rigidity vary among different taper designs; (2) what is the contribution of taper geometry alone to flexural rigidity of the femoral trunnion; and (3) how have flexural rigidity and taper length changed with time in this group of revised retrievals? METHODS: A dual-center retrieval analysis of 85 modular femoral stems released between 1983 and 2012 was performed, and the flexural rigidity and length of the femoral trunnions were determined. These stems were implanted between 1991 and 2012 and retrieved at revision or removal surgery between 2004 and 2012. There were 10 different taper designs made from five different metal alloys from 16 manufacturers. Digital calipers were used to measure taper geometries by two independent observers. RESULTS: Median flexural rigidity was 228 N-m(2); however, there was a wide range of values among the various stems spanning nearly an order of magnitude between the most flexible (80 N-m(2)) and most rigid (623 N-m(2)) trunnions, which was partly attributable to the taper geometry and to the material properties of the base alloy. There was a negative correlation between flexural rigidity and length of the trunnion and release date of the stem. CONCLUSIONS: There is wide variability in flexural rigidity of various taper designs, with a trend toward trunnions becoming shorter and less rigid with time. CLINICAL RELEVANCE: This temporal trend may partly explain why taper corrosion is being seen with increasing frequency in modern THAs.

PMMA brush-containing two-solution bone cement: preparation, characterization, and influence of composition on cement properties.

Two-solution bone cement consisting of poly (methyl methacrylate) (PMMA) brushes in methyl methacrylate has been developed as an alternative to the traditional two-solution (TSBC) and powder-liquid cements. It was hypothesized that the substitution of brushes, for the entire pre-polymer phase of the cement, would permit a decrease in solution viscosity at higher polymer fractions, and allow for physical entanglements with the cement matrix. Consequently, improved cement exothermal and mechanical properties could be expected with brush addition. PMMA brushes were grafted on the surface of cross-linked PMMA nanospheres following a multi-stage synthetic strategy. Brushes exhibiting optimal molecular weight for preparation of TSBC were used for characterization of cement viscosity, flexural and compressive mechanical properties, exothermal properties and residual monomer content. Interactions between grafts and free polymer formed during free radical polymerization of the cement were evaluated based on molecular weight measurements of the cement matrix and brushes. Brush-containing cements exhibited lower viscosity at significantly higher polymer fractions in comparison to TSBC. Cements with PMMA brushes had significantly lower polymerization temperatures and residual monomer content. Measurements of molecular weight revealed the existence of a dry brush regime when using the brush compositions selected in this study, which led to a reduction in the mechanical properties of some of the compositions tested. The optimal cement viscosity and maintenance of other important cement properties achieved with addition of PMMA brushes is expected to expand the use of the two-solution cements in a range of applications.

Mechanically assisted taper corrosion in modular TKA.

The purpose of this study was to characterize the prevalence of taper damage in modular TKA components. One hundred ninety-eight modular components were revised after 3.9±4.2 years of implantation. Modular components were evaluated for fretting corrosion using a semi-quantitative 4-point scoring system. Design features and patient information were assessed as predictors of fretting corrosion damage. Mild-to-severe fretting corrosion (score ≥2) was observed in 94/101 tapers on the modular femoral components and 90/97 tapers on the modular tibial components. Mixed alloy pairs (p=0.03), taper design (p<0.001), and component type (p=0.02) were associated with taper corrosion. The results from this study supported the hypothesis that there is taper corrosion in TKA. However the clinical implications remain unclear.

Fretting and Fretting Corrosion Behavior of Additively Manufactured Ti-6Al-4V and Ti-Nb-Zr Alloys in Air and Physiological Solutions.

Additive manufacturing (AM) of orthopedic implants has increased in recent years, providing benefits to surgeons, patients, and implant companies. Both traditional and new titanium alloys are under consideration for AM-manufactured implants. However, concerns remain about their wear and corrosion (tribocorrosion) performance. In this study, the effects of fretting corrosion were investigated on AM Ti-29Nb-21Zr (pre-alloyed and admixed) and AM Ti-6Al-4V with 1% nano yttria-stabilized zirconia (nYSZ). Low cycle (100 cycles, 3 Hz, 100 mN) fretting and fretting corrosion (potentiostatic, 0 V vs. Ag/AgCl) methods were used to compare these AM alloys to traditionally manufactured AM Ti-6Al-4V. Alloy and admixture surfaces were subjected to (1) fretting in the air (i.e., small-scale reciprocal sliding) and (2) fretting corrosion in phosphate-buffered saline (PBS) using a single diamond asperity (17 µm radius). Wear track depth measurements, fretting currents and scanning electron microscopy/energy dispersive spectroscopy (SEM/EDS) analysis of oxide debris revealed that pre-alloyed AM Ti-29Nb-21Zr generally had greater wear depths after 100 cycles (4.67 +/- 0.55 µm dry and 5.78 +/- 0.83 µm in solution) and higher fretting currents (0.58 +/- 0.07 µA). A correlation (R2 = 0.67) was found between wear depth and the average fretting currents with different alloys located in different regions of the relationship. No statistically significant differences were observed in wear depth between in-air and in-PBS tests. However, significantly higher amounts of oxygen (measured by oxygen weight % by EDS analysis of the debris) were embedded within the wear track for tests performed in PBS compared to air for all samples except the ad-mixed Ti-29Nb-21Zr (p = 0.21). For traditional and AM Ti-6Al-4V, the wear track depths (dry fretting: 2.90 +/- 0.32 µm vs. 2.51 +/- 0.51 µm, respectively; fretting corrosion: 2.09 +/- 0.59 µm vs. 1.16 +/- 0.79 µm, respectively) and fretting current measurements (0.37 +/- 0.05 µA vs. 0.34 +/- 0.05 µA, respectively) showed no significant differences. The dominant wear deformation process was plastic deformation followed by cyclic extrusion of plate-like wear debris at the end of the stroke, resulting in ribbon-like extruded material for all alloys. While previous work documented improved corrosion resistance of Ti-29Nb-21Zr in simulated inflammatory solutions over Ti-6Al-4V, this work does not show similar improvements in the relative fretting corrosion resistance of these alloys compared to Ti-6Al-4V.

Increasing temperature accelerates Ti-6Al-4V oxide degradation and selective dissolution: An Arrhenius-based analysis.

Ti-6Al-4V selective dissolution occurs in vivo on orthopedic implants as the leading edge of a pitting corrosion attack. A gap persists in our fundamental understanding of selective dissolution and pre-clinical tests fail to reproduce this damage. While CoCrMo clinical use decreases, Ti-6Al-4V and the crevice geometries where corrosion can occur remain ubiquitous in implant design. Additionally, most additively manufactured devices cleared by the FDA use Ti-6Al-4V. Accelerated preclinical testing, therefore, would aid in the evaluation of new titanium devices and biomaterials. In this study, using temperature, we (1) developed an accelerated pre-clinical methodology to rapidly induce dissolution and (2) investigated the structure-property relationship between the dissolving surface and the oxide layer. We hypothesized that solution temperature and H2O2 concentration would accelerate oxide degradation, increase corrosion kinetics and decrease experimental times. To assess this effect, we selected temperatures above (45 °C), below (24 °C), and at (37 °C) physiological levels. Then, we acquired electrochemical impedance spectra during active ß dissolution, showing significant decreases in oxide polarization resistance (Rp) both over time (p = 0.000) and as temperature increased (p = 0.000). Next, using the impedance response as a guide, we quantified the extent of selective dissolution in scanning electron micrographs. As the temperature increased, the corrosion rate increased in an Arrhenius-dependent manner. Last, we identified three surface classes as the oxide properties changed: undissolved, transition and dissolved. These results indicate a concentration and temperature dependent structure-property relationship between the solution, the protective oxide film, and the substrate alloy. Additionally, we show how supraphysiological temperatures induce structurally similar dissolution to tests run at 37 °C in less experimental time. STATEMENT OF SIGNIFICANCE: Within modular taper junctions of total hip replacement systems, retrieval studies document severe corrosion including Ti-6AL-4V selective dissolution. Current pre-clinical tests and ASTM standards fail to reproduce this damage, preventing accurate screening of titanium-based biomaterials and implant designs. In this study, we induce selective dissolution using accelerated temperatures. Building off previous work, we use electrochemical impedance spectroscopy to rapidly monitor the oxide film during dissolution. We elucidate components of the dissolution mechanism, where oxide degradation precedes pit nucleation within the ß phase. Using an Arrhenius approach, we relate these accelerated testing conditions to more physiologically relevant solution concentrations. In total, this study shows the importance of including adverse electrochemical events like cathodic activation and inflammatory species in pre-clinical testing.

Do ceramic femoral heads reduce taper fretting corrosion in hip arthroplasty? A retrieval study.

BACKGROUND: Previous studies regarding modular head-neck taper corrosion were largely based on cobalt chrome (CoCr) alloy femoral heads. Less is known about head-neck taper corrosion with ceramic femoral heads. QUESTIONS/PURPOSES: We asked (1) whether ceramic heads resulted in less taper corrosion than CoCr heads; (2) what device and patient factors influence taper fretting corrosion; and (3) whether the mechanism of taper fretting corrosion in ceramic heads differs from that in CoCr heads. METHODS: One hundred femoral head-stem pairs were analyzed for evidence of fretting and corrosion using a visual scoring technique based on the severity and extent of fretting and corrosion damage observed at the taper. A matched cohort design was used in which 50 ceramic head-stem pairs were matched with 50 CoCr head-stem pairs based on implantation time, lateral offset, stem design, and flexural rigidity. RESULTS: Fretting and corrosion scores were lower for the stems in the ceramic head cohort (p=0.03). Stem alloy (p=0.004) and lower stem flexural rigidity (Spearman's rho=-0.32, p=0.02) predicted stem fretting and corrosion damage in the ceramic head cohort but not in the metal head cohort. The mechanism of mechanically assisted crevice corrosion was similar in both cohorts although in the case of ceramic femoral heads, only one of the two surfaces (the male metal taper) engaged in the oxide abrasion and repassivation process. CONCLUSIONS: The results suggest that by using a ceramic femoral head, CoCr fretting and corrosion from the modular head-neck taper may be mitigated but not eliminated. CLINICAL RELEVANCE: The findings of this study support further study of the role of ceramic heads in potentially reducing femoral taper corrosion.

Is increased modularity associated with increased fretting and corrosion damage in metal-on-metal total hip arthroplasty devices?: a retrieval study.

This retrieval study documents taper damage at modular interfaces in retrieved MOM THA systems and investigates if increased modularity is associated with increased fretting and corrosion. One hundred thirty-four (134) heads and 60 stems (41 modular necks) of 8 different bearing designs (5 manufacturers) were analyzed. Damage at the shell-liner interface of 18 modular CoCr acetabular liners and the corresponding 11 acetabular shells was also evaluated. The results of this study support the hypothesis that fretting and corrosion damage occurs at a variety of modular component interfaces in contemporary MOM THAs. We also found that modularity of the femoral stem was associated with increased damage at the head. An analysis of component and patient variables revealed that dissimilar alloy pairing, larger head sizes, increased medio-lateral offsets and longer neck moment arms were all associated with increased taper damage at the modular interfaces.

Does Taper Angle Clearance Influence Fretting and Corrosion Damage at the Head-Stem Interface? A Matched Cohort Retrieval Study.

Previous studies have speculated that modular taper design may have an effect on the corrosion and material loss at the taper surfaces. We present a novel method to measure taper angle for retrieved head taper and stem trunnions using a roundness machine (Talyrond 585, Taylor Hobson, UK). We also investigated the relationship between taper angle clearance and visual fretting-corrosion score at the taper-trunnion junction using a matched cohort study of 50 ceramic and 50 metal head-stem pairs. In this study, no correlation was observed between the taper angle clearance and the visual fretting-corrosion scores in either the ceramic or the metal cohorts.

Low cycle fretting and fretting corrosion properties of low carbon CoCrMo and additively manufactured CoCrMoW alloys for dental and orthopedic applications.

Additive manufacturing (AM) of CoCrMo metallic implants is growing in the orthopedic and dental fields. This is due to the traditional alloy's excellent corrosion resistance and mechanical properties. AM processes like selective laser melting (SLM) require less time, materials, and waste than casting or subtractive manufacturing complex-geometry structures (bridges, partial dentures, etc.). The objective of this work was to investigate the low cycle tribological and tribocorrosion characteristics of AM CoCrMoW alloys compared to wrought LC CoCrMo (ASTM F-1537) to assess this AM alloy's performance. Fretting and tribocorrosion testing was performed in air (wear only), PBS (wear + corrosion), and PBS with 10 mM H2 O2 (wear + corrosion + inflammation) by a single diamond asperity. No variation between alloys in volume of material removed (p = .12), volume of plastic deformation (p = .13), and scratch depth (p = .84) showed that AM was substantially similar in wear resistance to LC in air and PBS. AM exhibited significantly higher fretting currents (p < .01) at loads up to 100 mN ( I AM PBS = 57 nA and I AM H 2 O 2 = 49 nA) than LC CoCrMo ( I LC PBS = 30 nA) and ( I LC H 2 O 2 = 29 nA). In PBS, wear track depth linearly correlates to fretting current, averaged over 100 cycles. Additionally, fretting currents of both alloys were significantly lower in simulated inflammatory conditions compared to PBS alone. AM alloy has generally similar wear and tribocorrosion resistance to wrought LC CoCrMo and would be ideal for patient specific dentistry or orthopedics where precise, complex geometries are required.

Fretting corrosion testing of acetabular modular tapers for total hip replacements: A comparison of two designs.

Acetabular components (DePuy Pinnacle (A) and Stryker Trident (B), Ti-6Al-4V shells and CoCrMo liners) with varying geometries were assembled under a 4 kN seating load. Liner-displacement was recorded. Cyclic compression to 4 kN, R = 0.01, 9 Hz was applied for three million cycles to evaluate fretting corrosion currents (n = 5). Fretting currents, load-displacement, ion dissolution, and disassembly loads were used to compare device performance. Data were analyzed using ANOVA with Tukey post hoc comparisons (p < 0.05). Liner seating displacements were not significantly different between groups. Fretting currents averaged over the initial 10 h and over three million cycles were 0.17 µA (A) and 0.55 µA (B) and 0.05 µA (A) and 0.17 µA (B), respectively (p = 0.19). No variation in ion averages between A and B (0.23 and 0.45 ppm for Ti [p = 0.21], 0.63 and 0.85 ppm for Co [p = 0.47]) existed. Average push-out forces, -2.41 (A) and -2.42 kN (B), were not significantly different (p = 0.97). SEM and EDS showed some titanium and metal oxide transfer from the shell to the liner in both designs. Overall, both implant designs exhibited very minor MACC in these experiments. This study demonstrates quantitative measures of in vitro fretting corrosion over the course of three million cycles and the minimal degree of acetabular taper damage. Clinical Significance: Retrieval studies show dual mobility acetabular shell-liner tapers with metal-on-metal contacts are susceptible to fretting corrosion in vivo.

Retrieval analysis of the Essure® micro insert female sterilization implant: Methods for metal ion and microscopic analysis.

The Essure® Device is a female sterilization implant comprised of four alloys (Ni-Ti, 316L SS, Pt-Ir and Sn-Ag) and Dacron fibers. As part of the mandated 522 post-market surveillance study, implant retrieval and metal-ion analysis methods were developed separate from patient clinical data, to quantify trace metal ions found in tissue and to assess implant degradation present. Three segments of tissue (proximal implant, distal implant, and tissue distal from the implant) stored in neutral buffered formalin, were retrieved. Tissue was prepared for metal ion analysis using inductively coupled mass spectrometry (ICP-MS). Implant sections from four patients, were analyzed using digital optical microscopy (DOM), scanning electron microscopy (SEM) and energy dispersive spectroscopy (EDS). Image analysis showed Sn-Ag solder corroded and elevated Sn ion levels in tissue proximal to the solder compared to tissues more remote in all cases observed. The 316L SS exhibited signs of degradation with high surface concentrations of molybdenum and chromium and low iron compared to the parent alloy. Evidence of elevated iron, chromium and nickel within the tissues and storage solutions combined with precipitation of an iron-calcium-phosphorous material on some implants indicate evidence of SS corrosion. Ni-Ti, Pt-Ir and Dacron appear to have no major damage. This study includes preliminary results as part of the ongoing 522 study and therefore no final conclusions regarding the device or patient data can be drawn from this present study until the entire 522 study is complete. STATEMENT OF SIGNIFICANCE: The Essure Device is a female sterilization implant that was implanted into approximately 750,000 women. The device is composed of polyethylene terephthalate fibers and 4 metal alloys, 316L stainless steel, Nickel-Titanium, Tin-Silver and Platinum-Iridium. Following an increase in patient reported adverse events, the FDA required a 522-post market surveillance study. As part of this study, implants are retrieved from patients via salpingectomy or hysterectomy. This study focuses on the development of the implant retrieval methods following surgery, with focus on measuring local tissue metal ions, their distribution and assessing the degradation of the implant without correlation to patient clinical condition.

Additively manufactured Ti-29Nb-21Zr shows improved oxide polarization resistance versus Ti-6Al-4V in inflammatory simulating solution.

Retrieval studies in the past two decades show severe corrosion of titanium and its alloys in orthopedic implants. This damage is promoted by mechanically assisted crevice corrosion (MACC), particularly within modular titanium-titanium junctions. During MACC, titanium interfaces may be subject to negative potentials and reactive oxygen species (ROS), generated from cathodic activation and/or inflammation. Additive manufacturing (AM) may be able to produce new, corrosion-resistant titanium alloys and admixtures that are less susceptible to these adverse electrochemical events. In this study, we characterize the impedance and corrosion properties of three new AM titanium materials, including Ti-6Al-4V with added 1% nano-yttria stabilized ZrO2 , admixed Ti-29Nb-21Zr, and pre-alloyed Ti-29Nb-21Zr. We aim to elucidate how these materials perform when subjected to high ROS solutions. We include conventionally and additively manufactured Ti-6Al-4V in our study as comparison groups. A 0.1 M H2 O2 phosphate-buffered saline (PBS) solution, simulating inflammatory conditions, significantly increased biomaterial OCP (-0.14 V vs. Ag/AgCl) compared to PBS only (-0.38 V, p = .000). During anodic polarization, Ti-6Al-4V passive current density more than doubled from 1.28 × 10-7 to 3.81 × 10-7 A/cm2 when exposed to 0.1 M H2 O2 . In contrast, Ti-29Nb-21Zr passive current density remained relatively unchanged, slightly increasing from 7.49 × 10-8 in PBS to 9.31 × 10-8 in 0.1 M H2 O2 . Ti-29Nb-21Zr oxide polarization resistance (Rp ) was not affected by 0.1 M H2 O2 , maintaining a high value (1.09 × 106 vs. 1.89 × 106 Ω cm2 ), while Ti-6Al-4V in 0.1 M H2 O2 solution had significantly diminished Rp (4.38 × 106 in PBS vs. 7.24 × 104 Ω cm2 in H2 O2 ). These results indicate that Ti-29Nb-21Zr has improved corrosion resistance in ROS containing solutions when compared with Ti-6Al-4V based biomaterials.