Are Corrosion and Material Loss a Threat for Titanium-Titanium Tapers in Total Hip Arthroplasty Modular Acetabular Components?

BACKGROUND: Extensive research has reported on fretting corrosion and material loss for a variety of metal taper interfaces in orthopedic devices. For modular acetabular shell-liner constructs, the interfaces studied thus far have consisted of mixed-metal pairings, and the risk of fretting corrosion and material loss for the all-titanium (Ti) shell-liner taper junction in one ceramic-on-ceramic (COC) design remains poorly understood. We asked: do Ti shell-liner taper interfaces in COC total hip arthroplasty devices show in vivo evidence of (1) fretting and/or corrosion, and (2) quantifiable potential material loss? METHODS: We examined 22 shell-liner pairs and 22 single liners from retrieved COC components. The taper interface surfaces were assessed for fretting corrosion using a semiquantitative scoring method and imaged with scanning electron microscopy. A subcohort of components was measured with a coordinate measuring machine, and volumetric material loss and maximum wear depth were calculated. RESULTS: Fretting corrosion at the taper interfaces was minimal to mild for 95% of liners and 100% of shells. Imaging revealed fretting marks within a band of corrosion on some implants and evidence of corrosion not in the proximity of mechanical damage. Estimated material loss ranged from 0.2 to 1.3 mm3 for liners, and 0.5 to 1.1 mm3 for shells. Maximum wear depth for all components was 0.03 mm or less. CONCLUSIONS: Our results indicate that, compared to other taper junctions in total joint arthroplasty, the risk of corrosion and material loss may be minimal for Ti shell-liner interfaces.

Long-term fretting corrosion performance of modular head-neck junctions with self-reinforced composite gaskets from PEEK and UHMWPE.

Soft gasket-like polymer films may provide multiple advantages in inhibiting fretting corrosion between metal-hard surfaces in total joint implants. Self-reinforced composites (SRC's) made from either poly(ether ether ketone), SRC-PEEK, or ultra high molecular weight polyethylene, SRC-PE, were fabricated and tested to investigate their ability to limit or prevent mechanically assisted corrosion in modular taper devices. Hot compaction was used to create nominally 100 µm thick unidirectional composite gaskets. These gaskets were placed on the trunnions of modular head-neck tapers and seated with 4000 N. One million cycle potentiostatic fretting corrosion tests (3000 N, R = 0.1, 15 Hz, -0.05 V) were employed to assess the ability of these SRCs to reduce or prevent fretting corrosion damage in the modular taper junction. Fretting currents and head-neck micromotion were evaluated. The results of testing, along with pull-off tests and optical and scanning electron microscopic analysis showed that SRC gaskets reduced or eliminated fretting corrosion currents, with the SRC-PEEK performing better than the SRC-PE. Fretting currents were low for SRC's compared to metal-metal tapers. No wear through of the gaskets was noted and minimal wear damage was seen in the SRC-PEEK gaskets. SRC-PE gaskets demonstrated greater deformation and damage compared to the SRC-PEEK gaskets. Pull-off loads for the SRC-PEEK were higher than SRC-PE and not statistically different than the control metal-metal junctions. There was evidence of fatigue cracks forming at the high stress concentration junctions for the SRC-PEEK at the thread form corners of the trunnion, but no loss of integrity was observed. SRC-PEEK gaskets show promise as a method to eliminate modular taper fretting corrosion.

Self-reinforced poly(ether ether ketone) and polyethylene composite gaskets for prevention of mechanically-assisted corrosion in modular taper junctions: Seating, micromotion and short-term fretting corrosion.

Mechanically-assisted crevice corrosion (MACC) is a phenomenon known to cause complications in modular orthopedic implants, particularly at metal-metal taper junctions. Previous studies of the properties and corrosion performance of an interfacial polymeric self-reinforced composite (SRC) gaskets have shown its capability as a high-strength, insulating barrier against oxide abrasion and metal degradation of metal-metal (or metal-hard) contacts in MACC conditions. This study characterizes the short-term tribocorrosion performance of poly (ether ether ketone) SRCs (SRC-PEEK) and polyethylene SRC (SRC-PE) films under in vitro test conditions for head-neck modular junction designs in hip replacement devices. SRC films composed of SRC-PEEK and SRC-PE were seated between 9/10 femoral head bores and stem tapers as thin interfacial gaskets and tested against metal-metal controls under short-term cyclic loading conditions in a custom in vitro test setup. Head-neck seating mechanics were measured, followed by incremental cyclic fretting corrosion testing with monitoring of fretting current, force, and relative micromotion between head and neck components during cyclic loading. SRC-PEEK tapers had a seating subsidence that was approximately three times that of the SRC-PE tapers and nine times that of controls. SRC-PE tapers, likely due to low friction, partially failed to lock during seating resulting in a pushing up of the head on the taper. Average fretting currents were significantly lower for both SRC groups (less than 0.3 µA at 4000 N) compared to control tapers experiencing fretting corrosion currents between 1.7 µA and 32 µA, (p < 0.05). SRC-PEEK gaskets exhibited similar subsidence and micromotion performance as controls while SRC-PE tapers experienced over 240 µm of subsidence during seating and loading conditions. The SRC-PE low-friction properties likely caused insufficient taper locking, which may increase the risk of improper head seating or head disassociation. These results show that SRC-PEEK gaskets, unlike SRC-PE gaskets, can maintain adequate frictional locking at the taper junction and prevent the onset of MACC. SRC-PEEK gaskets improve the performance of modular taper junctions and could be considered as a potential solution to mitigate fretting corrosion.

Fretting Corrosion, Third-Body Polyethylene Damage, and Cup Positioning in Primary vs Revision Dual Mobility Total Hip Arthroplasty.

BACKGROUND: Dual mobility (DM) articulations were introduced for total hip arthroplasty to reduce the risk of instability for patients who have a high risk of dislocation. The use of DM constructs in both primary and revision total hip arthroplasty has been steadily increasing, leading to concerns regarding potential risks of fretting corrosion, polyethylene wear, metal release, and failure due to component positioning. METHODS: A total of 56 retrieved DM constructs were collected. The inner and outer polyethylene liner surfaces were assessed for 7 damage mechanisms, and fretting corrosion was evaluated for the femoral stem, head, and modular liner. Three polyethylene liners with the greatest amounts of embedded debris were examined using scanning electron microscopy. Energy-dispersive X-ray spectroscopy was used to determine the elemental content of the debris. Acetabular cup orientation was analyzed radiographically using the EBRA (Einzel-Bild-Roentgen-Analyse) method. RESULTS: The devices were revised most frequently for infection (36%), loosening (21%), and instability/dislocation (18%). The most common polyethylene damage mechanisms were scratching, pitting, burnishing, and embedded debris, and no difference in total damage was found between primary and revision cases. Scanning electron microscopy/energy-dispersive X-ray spectroscopy revealed that debris morphology and composition were consistent with porous titanium coating, resulting from cup loosening or broken screws and augments. A total of 71% and 50% of the constructs were determined to be within the Lewinnek safe zone for inclination and anteversion, respectively. CONCLUSION: The most notable mechanisms of surface damage were due to third-body debris, especially for the polyethylene surfaces which articulate against cobalt-chromium femoral heads and acetabular liners. Scratching of the femoral head and the metal liner from this debris may support the clinical use of ceramic for DM bearing surfaces in the future.

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.

The seating mechanics of head-neck modular tapers in vitro: Load-displacement measurements, moisture, and rate effects.

The mechanically assisted crevice corrosion performance of head-neck modular tapers is a significant concern in orthopedic biomaterials. Fretting crevice corrosion processes in modular tapers are thought to be influenced by a wide array of factors including seating mechanics of the junction, hence there is a need for in vitro test methods that can assess their performance. This study presented a test method to directly measure the load-displacement seating mechanics of modular tapers and used this method to compare the seating mechanics for different tapers, moisture, seating loads and seating rates. Seating mechanics were explored whereby the instantaneous load-displacement behavior of the head seating onto the neck is captured and used to define the mechanics of seating. Two distinct taper design/material combinations were assembled wet or dry using axially applied loads (500, 1,000, 2,000, and 4,000 N) at two loading rates of 100 and 104 N/s (n = 5 for each condition) using a servohydraulic test frame. The results showed that pull-off strength scaled with seating load and ranged between 43% and 68% of seating load depending on sample and wetness. Tapers seated wet had higher pull-off strengths (2,200 ± 300 N) than those seated dry (1,800 ± 200 N, p < 0.05). Seating mechanics (load-displacement plots) varied due to sample type and due to wetness with differences in seating energy, seating stiffness, and seating displacement. These results show the detailed mechanics of seating during assembly and provide significant insight into the complex interplay of factors associated with even "ideal" seating (axial, quasistatic) loading. © 2017 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 36:1164-1172, 2018.

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.