Does cyclic stress play a role in highly crosslinked polyethylene oxidation?

BACKGROUND: Minimizing the impact of oxidation on ultrahigh-molecular-weight polyethylene components is important for preserving their mechanical integrity while in vivo. Among the strategies to reduce oxidation in modern first-generation highly crosslinked polyethylenes (HXLPEs), postirradiation remelting was considered to afford the greatest stability. However, recent studies have documented measurable oxidation in remelted HXLPE retrievals. Biologic prooxidants and physiologic loading have been proposed as potential mechanisms. QUESTIONS/PURPOSES: In our pilot study, we asked: (1) Does cyclic stress induced by wear or (2) by cyclic compression loading increase oxidation and crystallinity of remelted HXLPE? (3) Does oxidative aging reduce the wear resistance of remelted HXLPE? METHODS: Remelted and annealed HXLPE prisms (n = 1 per test condition) were tested in a wear simulator for 500,000 cycles. After wear testing, some samples were subjected to accelerated aging and then wear-tested again. Wear track volumes were characterized by confocal microscopy. Thin films (200-µm thick) were microtomed from wear prisms and then used for Fourier transform infrared spectroscopy oxidation and crystallinity assessments. Remelted HXLPE compression cylinders (n = 1 per test condition) were subjected to fatigue experiments and similar oxidation characterization. RESULTS: Remelted HXLPE qualitatively showed low oxidation indices (≤ 1) when subjected either to cyclic loading or aging alone. However, oxidation levels almost doubled in near-surface regions when remelted HXLPE samples underwent consecutive cyclic loading, artificial aging, and cyclic loading steps. The type of loading (wear versus compression fatigue) appeared to not affect the oxidation behavior in the studied conditions. Annealed HXLPE showed higher oxidation (oxidation index > 3) than remelted HXLPE and delamination wear. No delamination wear was observed in remelted HXLPE in agreement with its comparatively low oxidation levels (oxidation index < 3). CONCLUSIONS: With the numbers available in our pilot study, the findings suggest that cyclic stress arising from a wear process or from cyclic compression may trigger the loss of oxidative stability of remelted HXLPE and contribute to synergistically accelerate its progression. Further studies of the effect of cyclic stress on oxidation of remelted HXLPE are needed. CLINICAL RELEVANCE: Retrieval studies are warranted to determine the natural history of the in vivo oxidation and wear behavior of first-generation, remelted HXLPE.

European Database of Explanted UHMWPE Liners from Total Joint Replacements: Correlations among Polymer Modifications, Structure, Oxidation, Mechanical Properties and Lifetime In Vivo.

This contribution lays the foundation for the European database of explanted UHMWPE liners from total joint replacements. Three EU countries (Czech Republic, Italy and Spain) have joined their datasets containing anonymized patient data (such as age and BMI), manufacturer data (such as information on UHMWPE crosslinking, thermal treatment and sterilization), orthopedic evaluation (such as total duration of the implant in vivo and reasons for its revision) and material characterization (such as oxidative degradation and micromechanical properties). The joined database contains more than 500 entries, exhibiting gradual growth, and it is beginning to show interesting trends, which are discussed in our contribution, including (i) strong correlations between UHMWPE oxidative degradation, degree of crystallinity and microhardness; (ii) statistically significant differences between UHMWPE liners with different types of sterilization; (iii) realistic correlations between the extent of oxidative degradation and the observed reasons for total joint replacement failures. Our final objective and task for the future is to continuously expand the database, involving researchers from other European countries, in order to create a robust tool that will contribute to the better understanding of structure-properties-performance relationships in the field of arthroplasty implants.

In vivo oxidation contributes to delamination but not pitting in polyethylene components for total knee arthroplasty.

The aim of this study was to better understand how in vivo oxidation contributes to fatigue damage in total knee arthroplasty (TKA). A total of 119 tibial inserts were consecutively collected after revision surgery. Of the 119 polyethylene retrievals, 29 were gamma sterilized in air (historical), whereas the remaining 90 were gamma sterilized in nitrogen (conventional). Surface damage assessment and characterization of oxidation were performed on all the retrievals. Delamination was significantly more prevalent and extensive in the longer-term, highly oxidized, historical tibial inserts. Pitting damage, in contrast, seemed to be equally prevalent between both retrieval groups and was not correlated with in vivo oxidation. Our findings support our hypothesis that in vivo oxidation is a contributing factor to delamination, but not pitting, in TKA. Despite the lower oxidation displayed by conventional retrievals, this study provides strong evidence that delamination secondary to in vivo oxidation may occur during the second decade of implantation.

Post damage in contemporary posterior-stabilized tibial inserts: influence of implant design and clinical relevance.

The mechanisms of damage at the polyethylene post in 3 contemporary tibial insert designs were evaluated and compared with a historical standard (Insall-Burstein II; Zimmer, Warsaw, Ind). One hundred five gamma sterilized posterior-stabilized tibial inserts were revised after an average of 4.7 years (0.05-13.6 years). Retrievals were classified according to their designs: Insall-Burstein II (n = 28); PFC (Johnson & Johnson, Raynham, Mass; n = 30); NexGen (Zimmer; n = 32); and Scorpio (Stryker Orthopaedics, Mahwah, NJ; n = 15). Reasons for revision and patient details were available. Surface damage scoring and photogrammetry were performed on all the retrieved tibial inserts. Oxidation analysis was carried out for traceable historical, gamma air-sterilized and conventional, gamma inert-sterilized tibial inserts (n = 61) with the use of infrared spectroscopy. The posts for all 3 contemporary designs exhibited damage similar to the historical controls. Articular, post, and backside damage scores significantly increased with implantation time. Post damage was insensitive to design and patient factors but was exacerbated by oxidation. An association between damage at the post and articular surface was also confirmed. Logistic models suggested an interaction between post damage, backside surface damage, and implant loosening.

Mechanical properties, oxidation, and clinical performance of retrieved highly cross-linked Crossfire liners after intermediate-term implantation.

Sixty Crossfire (Stryker Orthopaedics, Mahwah, NJ) liners were consecutively revised after an average of 2.9 years (range, 0.01-8.0 years) for reasons unrelated to wear or mechanical performance of the polyethylene. Femoral head penetration was measured directly from 42 retrievals implanted for more than 1 year. Penetration rate results (0.04 mm/y, on average; range, 0.00-0.13 mm/y) confirmed decreasing wear rates with longer in vivo times. Overall, we observed oxidation levels at the bearing surface of the 60 liners (0.5, on average; range, 0.1-1.7) comparable to those of nonimplanted liners (0.5, on average; range, 0.3-1.1) and preservation of mechanical properties. We also measured elevated oxidation of the rim (3.4, on average; range, 0.2-8.8) that was correlated with implantation time. Rim surface damage, however, was observed in only 3 (5%) of 60 cases. Retrieval analysis of the 3 rim-damaged liners did not reveal an association between surface damage and the reasons for revision.

Reasons for revision of first-generation highly cross-linked polyethylenes.

Over a 10-year period, we prospectively evaluated the reasons for revision of contemporary and highly cross-linked polyethylene formulations in amulticenter retrieval program. Two hundred twelve consecutive retrievals were classified as conventional gamma inert sterilized (n = 37), annealed (Cross fire,[Stryker Orthopedics, Mahwah, NJ] n = 72), or remelted (Longevity [Zimmer ,Warsaw, Ind], XLPE[Smith and Nephew, Memphis, Tenn], Durasul [Zimmer,Warsaw, Ind] n = 103) liners. The most frequent reasons for revision were loosening (35%), instability(28%), and infection (21%) and were not related to polyethylene formulation (P = .17). Annealed and remelted liners had comparable linear penetration rates(0.03 and 0.04 mm/y, respectively, on average), and these were significantly lower than the rate in conventional retrievals (0.11 mm/y, P ≤ .0005). This retrieval study including first-generation highly cross linked liners demonstrated lower wear than conventional polyethylene. Although loosening remained as the most prevalent reason for revision, we could not demonstrate a relationship between wear and loosening.The long-term clinical performance of first-generation highly cross-linked liners remains promising based on the midterm outcomes of the components documented in this study [corrected].

Clinical, surface damage and oxidative performance of poly II tibial inserts after long-term implantation.

Carbon fiber-reinforced ultra-high molecular weight polyethylene (Poly II) was clinically introduced in the 1970s, but catastrophic short-term outcomes were reported in case studies. Clinical use of Poly II persisted into the 1980s until it was eventually abandoned. To date, no studies have documented its long-term clinical and material performance. Forty Poly II tibial inserts of the Total Condylar, Insall-Burstein I, and Miller-Galante I designs were retrieved at revision surgery. Twenty-six historical unreinforced polyethylene knee retrievals of similar designs (Miller-Galante I and II, and Insall-Burstein II) served as the control group. The average in vivo durations of both retrieval groups were similar (11.1 and 11.6 years, respectively), although Poly II had a wider implantation range (3.7-32.8 years) than historical polyethylene (4.4-17.0 years). Surface damage on all the retrievals, as well as oxidation and mechanical strength when possible, were characterized. Poly II tibial inserts had long-term clinical survivability and material performance comparable to unreinforced polyethylene bearings. Poly II retrievals exhibited less surface damage at all the regions than historical components, and they were less sensitive to pitting and delamination, but more susceptible to abrasion and embedded debris. Both Poly II and historical retrievals were found to oxidize in vivo and exhibited similar mechanical strength. This study provides improved understanding of well-consolidated Poly II long-term retrievals and also motivation to revisit carbon fiber-reinforced polymeric bearings for joint replacement in the twenty-first century.

Comparative fatigue behavior and toughness of remelted and annealed highly crosslinked polyethylenes.

Highly cross-linked polyethylenes (HXLPEs) have been incorporated into the hip replacement armamentarium based on their improved wear resistance. However, two different methods of thermal treatment separate the orthopedic community as strategies to control potential long-term oxidation, and controversy remains with problems in the long-term use of acetabular liners (long-term oxidation, rim fracture after impingement, etc.). Meanwhile, the mechanical properties of HXLPEs that may alleviate these problems are still unclear. On the other hand, HXLPEs are scarcely used in knee replacements, as there exists concern about the probably reduced fatigue and fracture performances of these materials. Thus, our aim was to compare the effects of both thermal treatment regimes on mechanical properties and to associate these findings with the material microstructure. The fatigue behavior of annealed and remelted HXLPEs was characterized using short-term cyclic stress-strain, long-term fatigue, and fatigue crack propagation tests. On the other hand, impact tests, tensile experiments, and the J-integral multispecimen method allowed us to assess toughness. Microstructure features such as crosslink density, crystallinity percentage, and lamellar thickness were investigated by swelling measurements, differential scanning calorimetry, and transmission electron microscopy, respectively. This study confirms that annealing preserves mechanical properties better than remelting from both fatigue and fracture resistance points of view, and it remarks that a suitable selection of irradiation and stabilization conditions is needed to achieve optimal mechanical performances of ultra high molecular weight polyethylenes for each specific total joint replacement.

Bacterial adherence to separated modular components in joint prosthesis: a clinical study.

Bacterial adherence on total joint replacement implants may lead to biofilm formation and implant-related osteoarticular infection. It is unclear if different biomaterials in the prosthetic components are more prone to facilitate this bacterial adherence, although ultrahigh molecular weight polyethylene (UHMWPE) component exchange in modular systems has been clinically utilized in the early management of these infections. To clarify if the amount of clinically adhered microorganisms was related to the material or the component, we investigated retrieved implants from infected joint replacements. Thirty-two patients were revised after confirmed implant-related infection through positive cultures. Eighty-seven total joint components (hip and knee) were obtained and separately sonicated following a previously published protocol. Cultures were quantified, and detected colony forming units (CFU) were adjusted according to the component surface and compared based on the component material and location. Variable adherence of bacteria to chrome cobalt alloys, UHMWPE, hydroxyapatite coated components, and titanium alloys. The commonest isolated organisms were Staphylococcus epidermidis (23 of 87 components) and Staphylococcus aureus (10 of 87). Twelve components did not show any microorganism adhered despite location in an infected joint, with positive cultures in other components. A mixed linear model adjusted for random effects (the random effect being the infected patient) obtained convergence for the CFU/mm(2) variable, but could not confirm a significantly higher adherence to a particular component or to a particular biomaterial. Therefore, the bacterial adherence primarily depends on the infective microorganism and the response of each individual patient, rather than materials or components.

Polyethylene oxidation in total hip arthroplasty: evolution and new advances.

Ultra-high molecular weight polyethylene (UHMWPE) remains the gold standard acetabular bearing material for hip arthroplasty. Its successful performance has shown consistent results and survivorship in total hip replacement (THR) above 85% after 15 years, with different patients, surgeons, or designs. As THR results have been challenged by wear, oxidation, and liner fracture, relevant research on the material properties in the past decade has led to the development and clinical introduction of highly crosslinked polyethylenes (HXLPE). More stress on the bearing (more active, overweighted, younger patients), and more variability in the implantation technique in different small and large Hospitals may further compromise the clinical performance for many patients. The long-term in vivo performance of these materials remains to be proven. Clinical and retrieval studies after more than 5 years of in vivo use with HXLPE in THR are reviewed and consistently show a substantial decrease in wear rate. Moreover, a second generation of improved polyethylenes is backed by in vitro data and awaits more clinical experience to confirm the experimental improvements. Also, new antioxidant, free radical scavengers, candidates and the reinforcement of polyethylene through composites are currently under basic research.Oxidation of polyethylene is today significantly reduced by present formulations, and this forgiving, affordable, and wellknown material is still reliable to meet today's higher requirements in total hip replacement.

On the assessment of oxidative and microstructural changes after in vivo degradation of historical UHMWPE knee components by means of vibrational spectroscopies and nanoindentation.

This study reports on the suitability of different experimental techniques to evaluate chemical, microstructural, and mechanical changes associated with in vivo oxidation encountered in historical polyethylene components. To accomplish this aim, eight traceable tibial inserts were analyzed after revision surgery. The knee bearings were gamma sterilized in air and implanted for an average of 11.5 years after a shelf life of no longer than 1 year. Characterization of oxidation and transvinylene indexes, crystallinity, amorphous, and intermediate phase fractions, along with hardness and surface modulus, were performed in transverse sections of each bearing using Fourier transform infrared spectroscopy, Raman spectroscopy, and nanoindentation, respectively. Generally, subsurface maxima in the crystallinity, oxidation index, and hardness were observed at a depth of about 1 mm in all of the bearings. The superior surfaces and anterior-posterior faces of the inserts exhibited significantly higher oxidation and greater crystallinity than the inferior side. These observations suggest that the metallic tray may limit the access of molecular oxygen to the backside of the tibial inserts. We conclude that chemical, physical, and mechanical properties data confirm the occurrence of in vivo degradation in the long-term implanted knee components following gamma irradiation in air. Furthermore, infrared spectroscopy alone appeared to provide excellent insight into the oxidation and crystallization state of the in vivo oxidized polyethylene.

Gamma inert sterilization: a solution to polyethylene oxidation?

BACKGROUND: In the 1990s, oxidation was found to occur in ultra-high molecular weight polyethylene total joint replacement components following gamma irradiation and prolonged shelf aging in air. Orthopaedic manufacturers developed barrier packaging to reduce oxidation during and after radiation sterilization. The present study explores the hypothesis that polyethylene components sterilized in a low-oxygen environment undergo similar in vivo oxidative mechanisms as inserts sterilized in air. In addition, the potential influence of the different sterilization processes on the wear performance of the polyethylene components was examined. METHODS: An analysis of oxidation, wear, and surface damage was performed for forty-eight acetabular liners and 123 tibial inserts. The mean implantation time was 12.3+/-3.7 years for thirty-one acetabular liners that had been gamma sterilized in air and 4.0+/-2.5 years for the seventeen acetabular liners that had been gamma sterilized in inert gas. The mean implantation time was 11.0+/-3.2 years for the twenty-six tibial inserts that had been sterilized in air and 2.8+/-2.2 years for the ninety-seven tibial inserts that had been gamma sterilized in inert gas. Oxidation and hydroperoxide levels were characterized in loaded and unloaded regions of the inserts. RESULTS: Measurable oxidation and oxidation potential were observed in all cohorts. The oxidation and hydroperoxide levels were regional. Surfaces with access to body fluids were more heavily oxidized than protected bearing surfaces were. This variation appeared to be greater in historical (gamma-in-air-sterilized) components. Regarding wear performance, historical and conventional acetabular liners showed similar wear penetration rates, whereas a low incidence of delamination was confirmed for the conventional tibial inserts in the first decade of implantation. CONCLUSIONS: The present study explores the impact of industry-wide changes in sterilization practices for polyethylene. We found lower oxidation and oxidation potential in the conventional acetabular liners and tibial inserts that had been gamma sterilized in inert gas as compared with the historical components that had been gamma sterilized in air. However, we also found strong evidence that conventional components undergo mechanisms of in vivo oxidation similar to those observed following gamma irradiation in air. In addition, gamma sterilization in inert gas did not provide polyethylene with a significant improvement in terms of wear resistance as compared with gamma sterilization in air, except for a lower incidence of delamination in the first decade of implantation for tibial inserts.