Femoral Head Penetration Rates and Oxidation of Highly Cross-Linked Polyethylene Hip Liners Implanted More Than 10 Years.

BACKGROUND: Highly cross-linked polyethylene (HXLPE) was introduced to improve wear in total hip arthroplasty, with manufacturers implementing different thermal treatments to reduce oxidation. It is important to understand how long-term time in vivo affects the wear of these materials. The purpose of this study was to investigate the wear and oxidative performance of first-generation HXLPE hip inserts implanted for greater than 10 years and compare annealed and remelted HXLPE formulations. METHODS: There were 49 total hip arthroplasty liners retrieved during routine revision surgery as part of an institutional review board-approved implant retrieval program. Penetration rates for the liners were calculated as the difference between the thickness of the unloaded and loaded regions divided by implantation time. Oxidation indices for the rim, locking mechanism, articulating surface, and backside regions were measured using Fourier-transform infrared spectroscopy according to American Society for Testing and Materials 2102. Mann-Whitney U tests were used to determine the statistical difference between annealed and remelted components. RESULTS: The cohort had an average implantation time of 13.1 ± 2.6 years for annealed and 12.1 ± 1.7 years for remelted components. The components were revised most often for polyethylene wear, instability, and loosening. The penetration rate averaged 0.0177 ± 0.014 mm/year for annealed components and 0.015 ± 0.022 mm/year for remelted components. Penetration rates did not differ between the remelted and annealed cohorts (P = .28). Oxidation indices were found to be significantly higher in the annealed cohort for all regions of interest (P < .001). CONCLUSIONS: Oxidation was found to be higher in the annealed HXLPE; however, this does not seem to be associated with greater wear as we found the average penetration rates for the cohorts were low, and the penetration rates were similar between the annealed and remelted cohorts.

Oxidation and Damage Mechanisms of 2nd Generation Highly Cross-Linked Polyethylene Tibial Inserts.

INTRODUCTION: After clinical introduction in 2005, sequentially annealed, highly crosslinked polyethylene (SA HXLPE) was studied for retrievals with short implantation times; however, long-term follow-ups are lacking. The objective of this study was to examine and compare the revision reasons, damage mechanisms, and oxidation indices (OI) of SA HXLPE and conventional gamma-inert sterilized (Gamma Inert) ultra-high molecular weight polyethylene tibial inserts implanted for > 5 years. METHODS: There were 74 total knee arthroplasty (TKA) tibial inserts (46 SA HXLPEs, 28 Gamma Inerts) implanted for > 5 years (mean 7 ± 2 years) retrieved as part of a multicenter retrieval program. Cruciate-retaining implants comprised 44% of the SA HXLPEs and 14% of the Gamma Inerts. Patient factors and revision reasons were collected from revision operating notes. A semi-quantitative scoring method was used to assess surface damage mechanisms. Oxidation was measured using Fourier transform infrared microscopy according to American Society for Testing and Materials (ASTM) 2102. Differences between cohorts were assessed with Mann-Whitney U-Tests. RESULTS: Loosening (Gamma Inert: 17 of 28, SA HXLPE: 15 of 46) and instability (Gamma Inert: 6 of 28, SA HXLPE: 15 of 46) were the most common revision reasons for both cohorts. The most prevalent surface damage mechanisms were burnishing, pitting, and scratching, with burnishing of the condyles being higher in Gamma Inert components (P = 0.022). Mean oxidation was higher in the SA HXLPE inserts at the articulating surface (P = 0.002) and anterior-posterior (AP) faces (P = 0.023). No difference was observed at the backside surface (P = 0.060). CONCLUSIONS: Revision reasons and surface damage mechanisms were comparable in the Gamma Inert and SA cohorts. Further studies are needed to continue to assess the in vivo damage and clinical relevance, if any, of oxidation in SA HXLPE over longer implantation times, particularly for implants implanted for more than 10 years.

Short-Term Surface Damage Mechanisms of Retrieved Highly Cross-Linked Polyethylene Patellar Components.

BACKGROUND: Previous retrieval studies of patellar components for total knee arthroplasty focused on historical designs and polyethylene materials that are no longer clinically relevant. Therefore, this study aimed to compare revision reasons and surface damage mechanisms of conventional, gamma inert sterilized polyethylene and highly cross-linked polyethylene (HXLPE) patellar components in contemporary designs from a single manufacturer. METHODS: A total of 114 gamma inert and 76 HXLPE patellar components were gathered in a multicenter orthopaedic implant retrieval program. Patient age and body mass index were similar between cohorts (P = .27 and P = .42, respectively); however, the gamma inert cohort was implanted longer (µdifference = 3.1 years; P = .005). A matched subset was created based on the total knee arthroplasty design, patellar shape, and implantation time. Revision reasons were gathered from revision operating notes, and surface damage was examined via the Hood scoring method. Differences between HXLPE and gamma inert cohorts were evaluated using Mann-Whitney U-tests. RESULTS: The most common revision reasons were infection, loosening, and instability, with the most common patellar complication resulting in revision being patellar loosening for both cohorts with similar incidences for both (chi-square; P = .60, P = .59). The most common surface damage modes were burnishing, scratching, and pitting in both cohorts. Total surface damage was significantly higher in the gamma inert components (P = .02), but not in the matched subset (P = .46). CONCLUSION: Overall, the clinical performance of HXLPE was similar to that of conventional polyethylene for patellar components with short implantation times. While this study provides much needed information on the performance of HXLPE patellae in short-term retrievals, long-term studies are still needed.

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.

Quantitative ultrahigh-molecular-weight polyethylene wear in total elbow retrievals.

BACKGROUND: The purpose of this study was to evaluate ultrahigh-molecular-weight polyethylene (UHMWPE) wear and damage from retrieved total elbow arthroplasty components and compare in vivo wear with wear produced in vitro. METHODS: Explanted total elbow components were collected at revision surgery. UHMWPE damage was characterized visually, whereas penetration and wear were quantified using micro-computed tomography and gas pycnometry. Volumetric wear rates were compared with historical hip data, and wear data were compared with reported in vitro wear test data. RESULTS: Humeral bushing damage primarily occurred in the form of burnishing, scratching, and pitting at the articular face in the region of contact with the ulnar component. Wear of the ulnar bushings was concentrated on the edge of the component at the point of contact with the axis pin. Pitting and embedded debris were dominant damage modes, in addition to burnishing and delamination. Backside wear was negligible. The median linear penetration rates of the lateral, medial, and ulnar bushings were 0.14 mm/yr (range, 0.01-0.78 mm/yr), 0.12 mm/yr (range, 0.03-0.55 mm/yr), and 0.11 mm/yr (range, 0.01-0.69 mm/yr), respectively. The volumetric wear rates of the lateral, medial, and ulnar bushings were 5.5 mm3/yr (range, 0.7-37.2 mm3/yr), 5.9 mm3/yr (range, 0.6-25.5 mm3/yr), and 5.5 mm3/yr (range, 1.2-51.2 mm3/yr), respectively. CONCLUSIONS: The observed wear rates were similar to those reported in well-functioning total hip replacement patients with conventional UHMWPE bearings. We found limitations in reported in vitro testing resulting in wear that was not consistent with our retrieval data. We recommend further investigation to clinically validate in vitro simulation to provide appropriate loading protocols for elbow wear simulation.

Retrieval Analysis of Cruciate-Retaining and Posterior-Stabilized Total Knee Arthroplasty and Correlations to Laxity and Wear.

BACKGROUND: Total knee arthroplasty (TKA) with posterior-stabilized (PS) or posterior cruciate-retaining (CR) implants has high success rates and survivorship. However, it is uncertain how laxity and constraint are associated with long-term polyethylene wear under physiological conditions. METHODS: To answer this question, we measured the laxity patterns of 47 harvested cadaver specimens with primary TKAs in a custom knee-testing machine at full extension and at 30°, 60°, and 90° of flexion. The wear patterns of the tibial inserts were assessed using a semiquantitative method which is a modified approach of that proposed by Hood et al in 1983. RESULTS: Statistical analysis found that the PS TKA cohort had a statistically significant increase in varus laxity at 60° and 90° of flexion, as well as total coronal laxity at 60° of flexion when compared to the CR cohort. Furthermore, analysis demonstrated a significant correlation between increased PS coronal laxity and increased tibial wear, a trend that was not seen in the CR specimens. CONCLUSION: Our findings suggest that greater laxity in flexion after primary TKA may increase the wear realized over time and that PS TKAs may be more susceptible due to the loss of support the PCL affords to the flexion space. Whether a CR or PS TKA is used, surgeons need to avoid the pitfalls that may create greater flexion laxity during the procedure to optimize long-term polyethylene wear.

Reasons for Revision, Oxidation, and Damage Mechanisms of Retrieved Vitamin E-Stabilized Highly Crosslinked Polyethylene in Total Knee Arthroplasty.

BACKGROUND: In order to improve oxidation resistance, antioxidants such as vitamin-E are added to polyethylene used in the bearing surfaces of orthopedic components. Currently, little is known about the efficacy of this treatment in vivo. This study therefore reports on the reasons for revision, surface damage mechanisms, and oxidation of retrieved vitamin E-stabilized highly crosslinked polyethylene (HXLPE) for total knee arthroplasty. METHODS: We examined 103 retrieved knee inserts fabricated from vitamin E (VE)-stabilized HXLPE and 67 fabricated from remelted HXLPE as a control. The implantation times were 1.2 ± 1.3 and 1.5 ± 1.3 years for the VE and control cohorts, respectively. The inserts were evaluated for 7 surface damage mechanisms using a semiquantitative scoring method and analyzed for oxidation using Fourier-transform infrared spectroscopy. Reasons for revision were also assessed using operative notes created at time of retrieval. RESULTS: Both groups were revised primarily for instability, infection, and loosening. Burnishing, pitting, and scratching were the most common damage mechanisms observed, with the VE cohort demonstrating less surface damage than the control. Measured oxidation for the cohort was low, with a median oxidation index of 0.09 ± .05 for the articulating surface, 0.05 ± 0.06 for the backside, 0.08 ± 0.06 for the anterior/posterior surfaces, and 0.08 ± 0.05 for the stabilizing post. As compared to the control cohort, oxidation tended to be less for the VE group at the articulating (P < .001) and backside (P = .003) surfaces, although the median differences were minimal and may not be clinically significant. CONCLUSION: The results indicate positive fatigue damage resistance and oxidation resistance for the retrieved VE-stabilized total knee arthroplasty inserts.

Structure-Property Relationships for 3D printed PEEK Intervertebral Lumbar Cages Produced using Fused Filament Fabrication.

Recent advances in additive manufacturing technology now enable fused filament fabrication (FFF) of Polyetheretherketone (PEEK). A standardized lumbar fusion cage design was 3D printed with different speeds of the print head nozzle to investigate whether 3D printed PEEK cages exhibit sufficient material properties for lumbar fusion applications. It was observed that the compressive and shear strength of the 3D printed cages were 63-71% of the machined cages, whereas the torsion strength was 92%. Printing speed is an important printing parameter for 3D printed PEEK, which resulted in up to 20% porosity at the highest speed of 3000 mm/min, leading to reduced cage strength. Printing speeds below 1500 mm/min can be chosen as the optimal printing speed for this printer to reduce the printing time while maintaining strength. The crystallinity of printed PEEK did not differ significantly from as-machined PEEK cages from extruded rods, indicating that the processing provides similar microstructure.

Oxidation, Damage Mechanisms, and Reasons for Revision of Sequentially Annealed Highly Crosslinked Polyethylene in Total Knee Arthroplasty.

BACKGROUND: Sequentially annealed, highly crosslinked polyethylene (HXLPE) has been used clinically in total knee arthroplasty (TKA) for over a decade. However, little is known about the revision reasons; its surface damage mechanisms; or its in vivo oxidative stability relative to conventional polyethylene. We asked whether retrieved HLXPE tibial inserts exhibited: (1) similar revision reasons; (2) improved resistance to surface damage; and (3) improved oxidative stability, when compared with conventional gamma inert sterilized polyethylene inserts. METHODS: A total of 456 revised tibial inserts were collected in a multicenter retrieval program between 2000 and 2016. The implantation time for the HXLPE components was 1.8 ± 1.8 years, and for the control inserts it was 3.4 ± 2.7 years. Revision reasons were assessed based on medical records, radiographs, and examinations of the retrieved components. Surface damage was assessed using a semi-quantitative scoring method. Oxidation was measured using Fourier transform infrared spectroscopy. RESULTS: The tibial inserts in both cohorts were revised most frequently for loosening, infection, and instability. The most commonly observed surface damage modes were burnishing, pitting, and scratching. Oxidation of the HXLPE inserts was, on average, low and similar to the control inserts at the bearing surface and the stabilizing post. CONCLUSIONS: We observed evidence of in vivo oxidation in both HXLPE and control tibial inserts. We found no association between the levels of oxidation and the clinical performance of the HXLPE tibial components. The findings of this study document the revision reasons, surface damage modes, and oxidative behavior of sequentially annealed HXLPE for TKA.

What Is the Incidence of Cobalt-Chromium Damage Modes on the Bearing Surface of Contemporary Femoral Component Designs for Total Knee Arthroplasty?

BACKGROUND: The purpose of this study was to determine the incidence of metal release in contemporary total knee arthroplasty and the patient-related factors associated with this release. METHODS: In total, 256 retrieved cobalt-chromium femoral components were collected through a multi-institutional orthopedic implant retrieval program (implanted: 1-15 years). Implants were mainly revised for loosening (84/256), instability (62/256), and infection (46/256). Third-body damage was assessed using a semiquantitative scoring method. Microscale electro-corrosion damage (MECD) was evaluated using digital optical microscopy. Radii of curvature were measured from representative components to calculate anterior-posterior and medial-lateral ratios. Femoral component surface roughness was measured using a white light interferometer. Using a multivariable linear model, associations between damage score, implant, and patient factors were tested. Spearman's ρ correlation tests were performed to determine the association between roughness measurements and damage score. RESULTS: Mild to severe damage was observed in 52% (134/256) of the components. In the multivariable linear model, anterior-posterior ratio (ß = -8.07; P < .001), loosening (ß = -0.52; P = .006), and patient weight (ß = 0.01; P = .007) were associated with damage score. Suspected MECD damage was observed in 82% (209/256) of components. The Ra value (ρ = 0.196; P = .002) and Rq value (ρ = 0.157; P = .012) increased as the damage score increased. CONCLUSION: The findings of this retrieval study support that similar damage mechanisms exist in contemporary and long-term total knee arthroplasty devices. Additionally, we observed associations between loosening, anterior-posterior conformity, and patient weight with increased surface damage.

Fretting and Corrosion Damage in Taper Adapter Sleeves for Ceramic Heads: A Retrieval Study.

BACKGROUND: During revision surgery with a well-fixed stem, a titanium sleeve can be used in conjunction with a ceramic head to achieve better stress distribution across the taper surface. In vitro testing suggests that corrosion is not a concern in sleeved ceramic heads; however, little is known about the in vivo fretting corrosion of the sleeves. The purpose of this study was to investigate fretting corrosion in sleeved ceramic heads in retrieved total hip arthroplasties. METHODS: Thirty-seven sleeved ceramic heads were collected during revision. The femoral heads and sleeves were implanted 0.0-3.3 years. The implants were revised predominantly for instability, infection, and loosening. Fifty percent of the retrievals were implanted during a primary surgery. Fretting corrosion was assessed using the Goldberg-Higgs semiquantitative scoring system. RESULTS: Mild-to-moderate fretting corrosion scores (score = 2-3) were observed in 92% of internal tapers, 19% of external tapers, and 78% of the stems. Severe fretting corrosion was observed in 1 stem trunnion that was previously retained during revision surgery and none of the retrieved sleeves. There was no difference in corrosion damage of sleeves used in primary or revision surgery. CONCLUSION: The fretting corrosion scores in this study were predominantly mild and lower than reported fretting scores of cobalt-chrome heads in metal-on-polyethylene bearings. Although intended for use in revisions, we found that the short-term in vivo corrosion behavior of the sleeves was similar in both primary and revision surgery applications. From an in vivo corrosion perspective, sleeves are a reasonable solution for restoring the stem taper during revision surgery.

Do Stem Taper Microgrooves Influence Taper Corrosion in Total Hip Arthroplasty? A Matched Cohort Retrieval Study.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

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.

Retrieval analysis of sequentially annealed highly crosslinked polyethylene used in total hip arthroplasty.

BACKGROUND: First-generation annealed and second-generation sequentially annealed, highly crosslinked polyethylenes (HXLPEs) have documented reduced clinical wear rates in their first decade of clinical use compared with conventional gamma inert-sterilized polyethylene. However, for both types of annealed HXLPE formulations, little is known about their reasons for revision, their in vivo oxidative stability, and their resistance to mechanical degradation. QUESTIONS/PURPOSES: We asked whether retrieved sequentially annealed HLXPE acetabular liners exhibited: (1) similar reasons for revision; (2) lower oxidation; (3) improved resistance to wear and degradation of mechanical properties; and (4) improved resistance to macroscopic evidence of rim damage when compared with acetabular liners fabricated from single-dose annealed HXLPE. METHODS: One hundred eighty-five revised acetabular liners in two cohorts (annealed and sequentially annealed) were collected in a multicenter retrieval program between 2000 and 2013. We controlled for implantation time between the two cohorts by excluding annealed liners with a greater implantation time than the longest term sequentially annealed retrieval (5 years); the mean implantation time (± SD) for the annealed components was 2.2 ± 1.4 years, and for the sequentially annealed liners, it was 1.2 ± 1.2 years. Reasons for revision were assessed based on medical records, radiographs, and examinations of the retrieved components. Oxidation was measured at the bearing surface, the backside surface, the locking mechanism, and the rim using Fourier transform infrared spectroscopy (ASTM F2102). Penetration was measured directly using a micrometer (accuracy: 0.001 mm). Mechanical behavior (ultimate load) was measured at the superior and inferior bearing surfaces using the small punch test (ASTM F2183). We used nonparametric statistical testing to analyze for differences in oxidation, penetration rates, and ultimate load when adjusting for HXLPE formulation as a function of implantation time. RESULTS: The acetabular liners in both cohorts were revised most frequently for instability, loosening, and infection. Oxidation indices (OIs) of the sequentially annealed liners were lower than annealed liners at the bearing surface (mean OI difference = 0.3; p < 0.001), the backside surface (mean OI difference = 0.2; p < 0.001), and the rim (mean OI difference = 2.6; p < 0.001). No differences were detected in linear penetration rates between the cohorts (p = 0.10). Ultimate strength at the bearing surface of the HLXPE was not different between sequentially annealed and annealed cohorts (p = 0.72). CONCLUSIONS: We observed evidence of in vivo oxidation in retrieved annealed and, to a lesser extent, retrieved sequentially annealed acetabular liners. However, we observed no association between the levels of oxidation and clinical performance of the liners. CLINICAL RELEVANCE: The findings of this study document the oxidative and mechanical behavior of sequentially annealed HXLPE. The reduced oxidation levels in sequentially annealed liners support the hypothesis that annealing in sequential steps eliminates more free radicals. However, as a result of the short-term followup, analysis of longer-term retrievals is warranted.

UHMWPE wear debris and tissue reactions are reduced for contemporary designs of lumbar total disc replacements.

BACKGROUND: Lumbar total disc replacement (L-TDR) is a procedure used to relieve back pain and maintain mobility. Contemporary metal-on-polyethylene (MoP) L-TDRs were developed to address wear performance concerns about historical designs, but wear debris generation and periprosthetic tissue reactions for these newer implants have not been determined. QUESTIONS/PURPOSES: The purpose of this study was to determine (1) whether periprosthetic ultrahigh-molecular-weight polyethylene (UHMWPE) wear debris and biological responses were present in tissues from revised contemporary MoP L-TDRs that contain conventional cores fabricated from γ-inert-sterilized UHMWPE; (2) how fixed- versus mobile-bearing design affected UHMWPE wear particle number, shape, and size; and (3) how these wear particle characteristics compare with historical MoP L-TDRs that contain cores fabricated from γ-air-sterilized UHMWPE. METHODS: We evaluated periprosthetic tissues from 11 patients who received eight fixed-bearing ProDisc-L and four mobile-bearing CHARITÉ contemporary L-TDRs with a mean implantation time of 4.1 and 2.7 years, respectively. Histologic analysis of tissues was performed to assess biological responses and polarized light microscopy was used to quantify number and size/shape characteristics of UHMWPE wear particles from the fixed- and mobile-bearing devices. Comparisons were made to previously reported particle data for historical L-TDRs. RESULTS: Five of seven (71%) fixed-bearing and one of four mobile-bearing L-TDR patient tissues contained at least 4 particles/mm(2) wear with associated macrophage infiltration. Tissues with wear debris were highly vascularized, whereas those without debris were more necrotic. Given the samples available, the tissue around mobile-bearing L-TDR was observed to contain 87% more, 11% rounder, and 11% less-elongated wear debris compared with tissues around fixed-bearing devices; however, there were no significant differences. Compared with historical L-TDRs, UHMWPE particle number and circularity for contemporary L-TDRs were 99% less (p = 0.003) and 50% rounder (p = 0.003). CONCLUSIONS: In this preliminary study, short-term results suggest there was no significant influence of fixed- or mobile-bearing designs on wear particle characteristics of contemporary L-TDRs, but conventional UHMWPE has notably improved the wear resistance of these devices compared with historical UHMWPE.

Is there material loss at the backside taper in modular CoCr acetabular liners?

BACKGROUND: Metal wear and corrosion products generated by hip replacements have been linked to adverse local tissue reactions. Recent investigations of the stem/head taper junction have identified this modular interface as another possible source of metal debris; however, little is known regarding other modular metallic interfaces, their ability to produce metal debris, and possibly to provide insight in the mechanisms that produce metal debris. QUESTIONS/PURPOSES: We asked three questions: (1) can we develop a reliable method to estimate volumetric material loss from the backside taper of modular metal-on-metal liners, (2) do backside tapers of modular metal-on-metal liners show a quantifiable volumetric material loss, and, if so, (3) how do regions of quantitatively identified material loss correspond to visual and microscopic investigations of surface damage? METHODS: Twenty-one cobalt-chromium (CoCr) liners of one design and manufacturer were collected through an institutional review board-approved retrieval program. All liners were collected during revision surgeries, where the primary revision reason was loosening (n=11). A roundness machine measured 144 axial profiles equally spaced about the circumference of the taper region near the rim to estimate volume and depth of material loss. Sensitivity and repeatability analyses were performed. Additionally, visual and scanning electron microscopy investigations were done for three liners. RESULTS: Our measurement method was found to be reproducible. The sensitivity (how dependent measurement results are on experimental parameters) and repeatability (how consistent results are between measurements) analyses confirmed that component alignment had no apparent effect (weak correlation, R2=0.04) on estimated volumetric material loss calculations. Liners were shown to have a quantifiable material loss (maximum=1.7 mm3). Visual investigations of the liner surface could identify pristine surfaces as as-manufactured regions, but could misidentify discoloration as a possible region of material loss. Scanning electron microscopy more accurately distinguished between as-manufactured and damaged regions of the taper. CONCLUSIONS: The roundness machine has been used to develop a repeatable method for characterizing material loss; future work comparing a gravimetric standard with estimations of material loss determined from the roundness machine may show the accuracy and effectiveness of this method. Liners show rates of material loss that compare with those reported for other taper junctions. Visual inspection alone may misidentify as-manufactured regions as regions of material loss. CLINICAL RELEVANCE: This study identifies the acetabular liner/shell interface in modular metal-on-metal devices as a potential source of metal wear or corrosion products. The relation between metal debris and clinical performance, regardless of the type of bearing couple, is a concern for clinicians. Therefore, it is important to characterize every type of modular junction to understand the quantity, location, and mechanism(s) of material loss.

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.

Retrieval analysis of PEEK rods for posterior fusion and motion preservation.

INTRODUCTION: The purpose of this study was to analyze explanted PEEK rod spinal systems in the context of their clinical indications. We evaluated damage to the implant and histological changes in explanted periprosthetic tissues. METHODS: 12 patients implanted with 23 PEEK rods were revised between 2008 and 2012. PEEK rods were of the same design (CD Horizon Legacy, Medtronic, Memphis TN, USA). Retrieved components were assessed for surface damage mechanisms, including plastic deformation, scratching, burnishing, and fracture. Patient history and indications for PEEK rod implantation were obtained from analysis of the medical records. RESULTS: 11/12 PEEK rod systems were employed for fusion at one level, and motion preservation at the adjacent level. Surgical complications in the PEEK cohort included a small dural tear in one case that was immediately repaired. There were no cases of PEEK rod fracture or pedicle screw fracture. Retrieved PEEK rods exhibited scratching, as well as impressions from the set screws and pedicle screw saddles. PEEK debris was observed in two patient tissues, which were located adjacent to PEEK rods with evidence of scratching and burnishing. CONCLUSION: This study documents the surface changes and tissue reactions for retrieved PEEK rod stabilization systems. Permanent indentations by the set screws and pedicle screws were the most prevalent observations on the surface of explanted PEEK rods.