A Novel Technique for Assessing Antioxidant Concentration in Retrieved UHMWPE.

BACKGROUND: Antioxidants added to UHMWPE to prevent in vivo oxidation are important to the long-term performance of hip and knee arthroplasty. Diffused vitamin E antioxidant polyethylene raised questions about potential in vivo elution that could cause inflammatory reactions in periprosthetic tissues and also potentially leave the implant once again prone to oxidation. Currently, there is no information on the elution, if any, of antioxidants from implant polyethylene materials in vivo. QUESTIONS/PURPOSES: (1) Do antioxidants, especially diffused vitamin E, elute from antioxidant polyethylene in vivo? (2) Can extraction of the retrieved antioxidant polyethylene (to remove absorbed species from the in vivo environment near the articular and nonarticular surfaces) improve the identification of antioxidant content? (3) Can actual antioxidant content be estimated from calculated antioxidant indices by accounting for ester content (from absorbed species) near the articular and nonarticular surfaces? METHODS: An institutional review board-approved retrieval laboratory received 39 antioxidant polyethylene hip and knee retrievals at revision from 25 surgeons with in vivo time of 0.02 to 3.6 years (median, 1.3 years). These consecutive antioxidant polyethylene retrievals, received between May 2010 and February 2016, were made from three different antioxidant highly crosslinked polyethylene materials: diffused vitamin E, blended vitamin E, and hindered phenol antioxidant pentaerythritol tetrakis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)] propionate (here and after referred to as PBHP). Retrievals were analyzed using Fourier transform infrared (FTIR) spectroscopy. Absorbed ester index (1725-1740 cm-1 normalized to 1365-1371 cm-1), and vitamin E index (1245-1275 cm-1) and PBHP index (1125-1150 cm-1), normalized to 1850-1985 cm-1, were defined. Microtomed thin sections of PBHP and vitamin E retrievals were hexane-extracted to remove absorbed species from the in vivo environment in an effort to improve identification of antioxidant content. Paired Student's t-tests were used to compare as-retrieved articular antioxidant index with expected antioxidant index (the bulk value for blended antioxidants where constant antioxidant content is expected throughout and the extrapolated original vitamin E concentration at the articular surface based on the as-manufactured vitamin E concentration gradient). Linear regression was used for each of the retrievals to evaluate the correlation of antioxidant index to ester content with the goal of extrapolation to the antioxidant index at zero ester content. RESULTS: On average, vitamin E index at the articular surface (0.04 ± 0.03) was reduced compared with expected vitamin E index (0.09 ± 0.04; 95% confidence interval [CI] of the difference, 0.04-0.07; p < 0.001), and PBHP index at the articular surface (0.06 ± 0.02) was elevated compared with the average PBHP index from the bulk (0.03 ± 0.00; 95% CI of the difference, 0.03-0.05; p < 0.001). Extraction returned the PBHP index at the articular surface (0.03 ± 0.00) to bulk values (95% CI of the difference, -0.001 to 0.004; p = 0.326); diffused vitamin E was removed by extraction. Crossplots of vitamin E index and PBHP index with ester index showed significant (p < 0.001 for 32 of the 35 retrievals with sufficient data) linear trends (r ≥ 0.89) that allowed extrapolation of the articular surface antioxidant indices at zero absorbed ester index. CONCLUSIONS: Absorbed esters from time in vivo caused erroneous values of antioxidant index to be calculated. However, hexane extraction to remove absorbed species also removed diffused vitamin E. Correlating antioxidant indices with ester content, measured by FTIR in unextracted antioxidant retrievals, provides a nonaltered method for estimating actual articular surface vitamin E index and demonstrates that there was no measurable elution in these short-term retrievals. CLINICAL RELEVANCE: Assessing antioxidant content in retrieved polyethylene inserts is important to determine how much of the antioxidant remains in place to prevent oxidation of the polyethylene over time in vivo. Retrieval analyses reporting antioxidant content must account for absorbed species to be valid. Because standard hexane extraction removes both absorbed species and vitamin E from diffused vitamin E retrievals, the correlation method presented in this study is the recommended analysis alternative.

Comparison of Wear and Oxidation in Retrieved Conventional and Highly Cross-Linked UHMWPE Tibial Inserts.

Two groups of retrieved tibial inserts from one manufacturer's knee system were analyzed to evaluate the effect of a highly cross-linked bearing surface on wear and in vivo oxidation. The two groups ((1) conventional gamma-inert sterilized and (2) highly cross-linked, coupled with the same rough (Ra=0.25) Ti-6Al-4V tray) were matched with statistically similar in vivo duration and patient variables. The retrieved inserts were analyzed for ketone oxidation and wear in the form of dimensional change. The difference in oxidation rate between highly cross-linked and conventional gamma-inert sterilized inserts did not reach statistical significance. Observations suggest that the majority of wear can be accounted for by the backside interface with the rough Ti-6Al-4V tray; however, wear measured by thickness-change rate was statistically indistinguishable between the two bearing materials.

Oxidation in Retrieved, Never-Irradiated UHMWPE Bearings: What Can We Learn About in Vivo Oxidation?

BACKGROUND: Published analyses of never-irradiated, ethylene oxide (EtO)-sterilized tibial inserts and EtO- and gas plasma (GP)-sterilized acetabular ultra-high molecular weight polyethylene (UHMWPE) retrievals demonstrated minimal UHMWPE in vivo oxidation, whereas another analysis of EtO-sterilized acetabular liners found elevated oxidation linked with in vivo stresses. This study explored whether never-irradiated UHMWPE bearings are (1) oxidized by the in vivo environment, and (2) more likely to oxidize in higher-stress articulations (knee, ankle, shoulder). METHODS: An institutional review board-approved retrieval archive was queried for never-irradiated, EtO- and GP-sterilized UHMWPE bearings received at revision from 2001 to 2021. A total of 193 EtO-sterilized and 112 GP-sterilized conventional UHMWPE retrievals were analyzed (0 to 25 years in vivo; 133 hip, 144 knee, 18 ankle, and 10 shoulder). Retrieved implants were evaluated for in vivo damage and analyzed for trans-vinylene and ketone content by Fourier transform infrared spectroscopy (FTIR). Twelve never-implanted EtO-sterilized tibial knee inserts, (shelf-aged 5 to 19 years) were non-oxidized controls. Mechanical properties of 3 never-implanted and 3 retrieved tibial inserts were evaluated by ASTM Type-V uniaxial tensile testing. Statistical analyses evaluated correlations between time in vivo and oxidation, and compared mean oxidation rates by articulation. RESULTS: Burnishing was the most common clinical damage for all articulations. Eight retrievals exhibited oxidation-related fatigue damage. All retrievals were validated as never-irradiated (median trans-vinylene index [TVI] = 0.000). Maximum ketone oxidation in retrievals correlated with in vivo time (p < 0.001). Thirty-seven percent of retrievals exhibited UHMWPE (subsurface) oxidation, most frequently ankle, knee, and glenoid inserts. Tensile properties differed between retrieved and never-implanted inserts, changing with oxidation. The oxidation rate differed significantly among the articulations (p < 0.001). CONCLUSIONS: This study cohort confirmed the presence of in vivo oxidation in some non-irradiation-sterilized UHMWPE bearings, with higher-stress articulations (knee, ankle, shoulder) showing evidence of oxidation more frequently and having significantly higher oxidation rates than hips. Mechanical properties degraded by oxidation led to fatigue damage in 8 retrievals after a long duration in vivo. CLINICAL RELEVANCE: Conventional EtO- or GP-sterilized UHMWPE bearings are at minimal risk for fatigue damage secondary to oxidation. However, higher stresses and longer time in vivo (more cycles of use) can lead to increased wear, oxidation, and fatigue damage.

Gamma-irradiation sterilization in an inert environment: a partial solution.

BACKGROUND: In the mid to late 1990 s, to sterilize UHMWPE bearings, manufacturers changed from gamma-irradiation-in-air (gamma-air) sterilization, which initiated oxidation leading to bearing fatigue, to gamma-irradiation sterilization in an inert environment (gamma-inert). The change to gamma-inert sterilization reportedly prevented shelf oxidation before implantation but not in vivo oxidation. QUESTIONS/PURPOSES: We asked: (1) Has the change to gamma-inert sterilization prevented shelf oxidation that led to early in vivo fatigue damage in gamma-air-sterilized tibial inserts? And (2) has the change to gamma-inert sterilization prevented the occurrence of fatigue secondary to in vivo oxidation? METHODS: We rated 183 retrieved gamma-air- and 175 retrieved gamma-inert-sterilized tibial inserts for clinical fatigue damage and analyzed 132 gamma-air- and 174 gamma-inert-sterilized tibial inserts for oxidation by Fourier transform infrared spectroscopy. RESULTS: Oxidation led to decreased mechanical properties in shelf-aged gamma-air-sterilized tibial inserts. Barrier packaging prevented shelf oxidation in gamma-inert-sterilized tibial inserts. Gamma-air- and gamma-inert-sterilized inserts oxidized in vivo. Fatigue damage (delamination) occurred more frequently in inserts retrieved after longer time in vivo. Longer in vivo time correlated with higher oxidation and more accumulated cycles of use. CONCLUSIONS: Published oxidation projections suggest gamma-inert-sterilized tibial inserts would reach the critical oxidation for the onset of fatigue after 11 to 14 years in vivo. These retrievals appear to follow the projected oxidation trends. Frequency of fatigue damage increased with increasing oxidation. CLINICAL RELEVANCE: Fatigue of tibial inserts becomes more likely, especially in active patients, after more than a decade of good clinical performance.

What factors drive polyethylene wear in total knee arthroplasty? : results of a large retrieval series.

AIMS: Wear of the polyethylene (PE) tibial insert of total knee arthroplasty (TKA) increases the risk of revision surgery with a significant cost burden on the healthcare system. This study quantifies wear performance of tibial inserts in a large and diverse series of retrieved TKAs to evaluate the effect of factors related to the patient, knee design, and bearing material on tibial insert wear performance. METHODS: An institutional review board-approved retrieval archive was surveyed for modular PE tibial inserts over a range of in vivo duration (mean 58 months (0 to 290)). Five knee designs, totalling 1,585 devices, were studied. Insert wear was estimated from measured thickness change using a previously published method. Linear regression statistical analyses were used to test association of 12 patient and implant design variables with calculated wear rate. RESULTS: Five patient-specific variables and seven implant-specific variables were evaluated for significant association with lower insert wear rate. Six were significant when controlling for other factors: greater patient age, female sex, shorter duration in vivo, polished tray, highly cross-linked PE (HXLPE), and constrained knee design. CONCLUSION: This study confirmed that knee wear rate increased with duration in vivo. Older patients and females had significantly lower wear rates. Polished modular tibial tray surfaces, HXLPE, and constrained TKA designs were device design factors associated with significantly reduced wear rate. Cite this article: Bone Joint J 2021;103-B(11):1695-1701.

Analysis of Failed Ankle Arthroplasty Components.

BACKGROUND:: Although advances in joint-replacement technology have made total ankle arthroplasty a viable treatment for end-stage arthritis, revision rates for ankle replacements are higher than in hip or knee replacements. The questions asked in this study were what can retrieved ankle devices demonstrate about ankle arthroplasty failures and how can understanding the causes of these failures inform clinical decisions for current and future ankle arthroplasty patients? METHODS:: An IRB-approved retrieval laboratory received retrieved components and surgeon-supplied reason for revision from 70 total-ankles (7 designs, including 5 currently marketed designs) from 2002 to 2018. These retrievals were rated for clinical wear and damage. Metal components were rated by method and effectiveness of fixation. Polyethylene inserts received by the laboratory 6 months or less after retrieval (n = 45) were analyzed for oxidation using Fourier transform infrared spectroscopy. Statistical analysis was performed using IBM SPSS, version 22. RESULTS:: The ankle implants were retrieved most commonly for loosening and polyethylene fracture. Loosening occurred more frequently in fixed-bearing designs (n = 18) than in the mobile-bearing designs (n = 4) and after shorter in vivo time (mean in vivo time to retrieval for loosening: fixed bearing 3.2 ± 2.1 years, mobile bearing 9.7 ± 4.5 years). Gamma-sterilized ankle inserts oxidized at a higher rate than non-gamma (EtO or gas-plasma) sterilized ankle inserts (gamma 0.29 ± 0.22/y, non-gamma 0.07 ± 0.05/y, mean difference=0.215, 95% CI 0.128-0.303, P < .001). The presence of clinical fatigue (cracking and/or delamination) of the polyethylene insert correlated with measured oxidation (Spearman rho = 0.685, P < .001). Nine inserts, all gamma-sterilized, fractured in vivo. CONCLUSIONS:: This study suggests that loosening could be more of a problem in fixed-bearing devices than in mobile bearing devices. Gamma-sterilized polyethylene inserts were found to suffer fatigue damage or fracture in vivo, resulting in the need for revision. Retrieval analysis can provide insight into implant-related reasons for revision, with the goal of understanding the implant-related causes of these failures, informing future ankle design and clinical decisions for current and future ankle arthroplasty patients. LEVEL OF EVIDENCE:: Level III, comparative series.

Effectiveness of anti-oxidant polyethylene: What early retrievals can tell us.

The optimum UHMWPE orthopedic implant bearing surface must balance wear, oxidation, and fatigue resistance. Antioxidant polyethylene addresses free radicals, resulting from irradiation used in cross-linking, that could oxidize and potentially lead to fatigue damage under cycles of in vivo use. This study evaluates what short-term antioxidant UHMWPE retrievals can reveal about: (1) oxidation-resistance and (2) fatigue-resistance of these new materials. Retrievals of three different antioxidant polyethylene materials (n = 25) were analyzed by FTIR and uniaxial tensile tests and compared to conventional (n = 20) and remelted highly cross-linked (n = 30) polyethylene retrievals of similar in vivo duration. Maximum oxidation values differed significantly across material types (p = 0.018). No antioxidant retrieval exhibited a subsurface oxidation peak, in contrast to conventional gamma-sterilized (55%) and highly cross-linked (37%) retrievals that exhibited subsurface oxidation peaks over the same in vivo time. Trans-vinylene index (TVI) correlated positively with nominal irradiation dose (p < 0.001). Tensile toughness correlated negatively with increasing TVI (p < 0.001). The antioxidant materials in this study prevented in vivo oxidation more effectively than remelted HXL polyethylene at least over the in vivo period represented. The comparison of antioxidant retrieval tensile properties can be used as a guide for clinicians in choosing appropriate materials for the applications represented by their patients. © 2017 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 106B: 353-359, 2018.

Rim cracking of the cross-linked longevity polyethylene acetabular liner after total hip arthroplasty.

BACKGROUND: Studies have suggested that cross-linked polyethylene bearings reduce wear rates from 40% to 100% compared with conventional polyethylene. However, the reduced mechanical properties of highly cross-linked polyethylene have the potential to be a limiting factor in device performance. We reviewed a series of retrieved acetabular liners with a fracture of the superior rim to assess the factors that played a role in their failure. METHODS: Four Longevity acetabular bearings, which had been retrieved from two patients after seven to twenty-seven months in vivo, were visually examined for clinical damage, were assessed with use of Fourier transform infrared spectroscopy to determine the level of oxidation, and were analyzed for mechanical properties and fracture surface characterization. Control data were obtained from never-implanted devices and from global reference ultrahigh molecular weight polyethylene bar stock as an industry calibration material. RESULTS: All four retrieved liners demonstrated articular surface wear modes, which in most cases were rated as moderate, and none were rated as severe. All showed cracking or rim failure of the liner at the superior aspect along the groove in the polyethylene that engages the locking ring of the shell. The retrieved liners had no measurable oxidation, and the mechanical properties were comparable with those of never-implanted material. CONCLUSIONS: There was no notable in vivo degradation of the retrieved liners. Important factors related to failure appear to be thin polyethylene at the cup rim, relatively vertical cup alignment, and the material properties of the highly cross-linked polyethylene that are decreased relative to conventional polyethylene. The critical dimension with respect to rim failure in modular liners appears to be the minimum thickness at the equatorial region.

Evaluation of oxidation and fatigue damage of retrieved crossfire polyethylene acetabular cups.

BACKGROUND: Crossfire cross-linked polyethylene is produced differently from other cross-linked polyethylene materials; a below-melt-temperature annealing process is used with the goal of avoiding compromised mechanical properties. The present study was performed to evaluate retrieved Crossfire acetabular cups to determine whether they had oxidized and to what extent oxidation might have influenced their clinical performance. METHODS: Eleven acetabular cups were received at retrieval and a twelfth acetabular cup was received two years post-retrieval over a period of four years. None were retrieved because of polyethylene wear or fatigue. The cups had been in vivo from 0.1 to 5.3 years. Each was examined visually, clinical fatigue damage was rated, and oxidation was measured with use of Fourier transform infrared spectroscopy. RESULTS: The cups exhibited oxidation that varied with its location on the cup: the oxidation value was generally low on the articular surface but more than an order of magnitude higher value on the rim. Maximum rim oxidation correlated significantly with the time in vivo (Spearman rho = 0.734, p = 0.010). Oxidation was identified visually by a white band in thin sections on the rim of seven of the cups and on the articular surface of one of these seven cups. Six of the seven cups also exhibited clinical fatigue damage. Eight of the twelve cups exhibited evidence of impingement or dislocation. CONCLUSIONS: Acetabular cups made of Crossfire polyethylene oxidized to a measurable degree. The oxidation-related reduction of polyethylene mechanical properties was sufficient to allow the fatigue damage seen in these retrieved cups.

Oxidation and other property changes of a remelted highly crosslinked UHMWPE in retrieved tibial bearings.

This study examined retrieved UHMWPE tibial bearings made from a remelted highly crosslinked (HXL) UHMWPE to determine whether the material is chemically stable in vivo. Retrieved tibial components were measured for changes in ketone oxidation and crosslink density. Oxidation increased with in vivo duration, and a significant decrease in crosslink density with increased mean ketone oxidation index was observed. These results suggest that in vivo oxidation is causing material degradation. Furthermore, a subsurface whitened damage region was found below the articular surface of one bearing, indicating the possibility of a clinically relevant decrease in mechanical properties of this component. © 2015 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 105B: 39-45, 2017.

Oxidation and other property changes of retrieved sequentially annealed UHMWPE acetabular and tibial bearings.

This investigation analyzed retrieved sequentially crosslinked and annealed (SXL) ultra-high molecular weight polyethylene bearings to determine whether the material is chemically stable in vivo. A series of retrieved tibial and acetabular components were analyzed for changes in ketone oxidation, crosslink density, and free radical concentration. Oxidation was observed to increase with in vivo duration, and the rate of oxidation in tibial inserts was significantly greater than in acetabular liners. SXL acetabular bearings oxidized at a rate comparable to gamma-sterilized liners, while SXL tibial inserts oxidized at a significantly faster rate than their gamma-sterilized counterparts. A significant decrease in crosslink density with increased mean ketone oxidation index was observed, suggesting that in vivo oxidation may be causing material degradation. Furthermore, a subsurface whitened damage region was also found in a subset of the bearings, indicating the possibility of a clinically relevant decrease in mechanical properties of these components.

Rapid polyethylene failure of unicondylar tibial components sterilized with gamma irradiation in air and implanted after a long shelf life.

BACKGROUND: The mechanical toughness of polyethylene that has been sterilized by gamma irradiation in air decreases after a long shelf life. The purpose of the present study is to report the high failure rate after unicondylar knee replacements performed with polyethylene bearings that had been sterilized with gamma irradiation in air and implanted after a shelf life of < or = 4.4 years. METHODS: Between December 1997 and January 2000, seventy-five unicondylar knee replacements were performed in sixty-two patients. All patients were followed both clinically and radiographically. A revision operation was offered when the patient had pain, swelling, and radiographic evidence of rapid polyethylene wear. The effect of aging of the polyethylene during storage was evaluated by dividing the knees into three groups on the basis of shelf life and comparing them with regard to the rate of revision and the observed wear of the polyethylene. Four retrieved components were examined for the presence of oxidation. RESULTS: At a mean of eighteen months after the arthroplasty, thirty knees had been revised and seven were scheduled for revision. The rate of polyethylene wear increased as the shelf life increased. There was a significant inverse linear correlation between the shelf life of the polyethylene and the time to revision (p < 0.01, r (2) = 0.64). All retrieved components had greater-than-expected wear with pitting and delamination of the surface. Seven components had fractured, and ten had both fractured and fragmented. Analysis of four components confirmed severe oxidation of the polyethylene. CONCLUSION: The present study demonstrated early, severe wear of tibial polyethylene bearings that had been sterilized by gamma irradiation in air and stored for < or = 4.4 years. This risk can be minimized by ensuring that implants have not been sterilized with gamma irradiation in air and stored for several years.

Crosslink density, oxidation and chain scission in retrieved, highly cross-linked UHMWPE tibial bearings.

Irradiated, thermally stabilized, highly cross-linked UHMWPE bearings have demonstrated superior wear performance and improved in vitro oxidation resistance compared with terminally gamma-sterilized bearings, yet retrieval analysis reveals unanticipated in vivo oxidation in these materials despite fewer or no measurable free radicals. There has been little evidence to date that the oxidation mechanism in thermally stabilized materials is the same as that in conventional materials, and so it is unknown whether oxidation in these materials is leading to chain scission and a degradation of mechanical properties, molecular weight, and crosslink density. The aim of this study was to determine whether measured in vivo oxidation in retrieved, highly cross-linked tibial bearings corresponds with a decreasing crosslink density. Analysis of three tibial bearing materials revealed that crosslink density decreased following in vivo duration, and that the change in crosslink density was strongly correlated with oxidation. The results suggest that oxidation in highly cross-linked materials is causing chain scissions that may, in time, impact the material properties. If in vivo oxidation continues over longer durations, there is potential for a clinically significant degradation of mechanical properties.

Evaluating the suitability of highly cross-linked and remelted materials for use in posterior stabilized knees.

Posterior stabilized (PS) knee designs are a popular choice for cruciate sacrificing knee arthroplasty procedures. The introduction of PS inserts fabricated from highly cross-linked and remelted Ultra High Molecular Weight Polyethylene (UHMWPE) has recently generated concern as these materials have been shown to possess reduced mechanical properties. This study investigated whether highly cross-linked and remelted UHMWPE material (referred to as XRP) can be expected to perform similarly to historical gamma-air polyethylene, which has suffered few reported incidences of tibial post failure. Never-implanted gamma-air PS tibial inserts shelf-aged 14 years were examined and compared to XRP materials. Evaluation of oxidation levels, impact toughness, and fatigue strength demonstrated never-implanted gamma-air PS tibial inserts to possess nonuniform mechanical properties. Despite severe oxidation along the exterior of gamma-air tibial posts, comparatively low oxidation levels at the center of the tibial posts corresponded to sufficiently high mechanical properties. XRP material (75 kGy) showed superior impact toughness over shelf aged gamma-air material; however, tibial post fatigue testing demonstrated XRP material (100 kGy) to be less resistant to fatigue failure than historical gamma-air material. Results from this study indicate that XRP materials (100 kGy) may demonstrate an inferior resistance to tibial post failure than historical polyethylene.

Unilateral tibial polyethylene liner failure in bilateral total knee arthroplasty--bilateral retrieval analysis at 8 years.

This is a report of a unique case of bilateral simultaneous total knee arthroplasties in which one tibial liner failed dramatically, whereas the other liner showed minimal evidence of wear. This unique case allows isolation of component factors as the primary contributing etiology to failure. The differentiating characteristic was the method of sterilization and the shelf life of the polyethylene liner. The insert that showed minimal wear was sterilized with gamma radiation in a barrier package and had a shelf life of less than 1 year, whereas the insert that failed dramatically was sterilized in air and had a shelf life of more than 5 years. This case provides a dramatic example of the potential detrimental effects of manufacturing details on the performance of orthopedic implants, particularly polyethylene inserts.

In vivo oxidation of gamma-barrier-sterilized ultra-high-molecular-weight polyethylene bearings.

gamma-Barrier packaging is shown to be effective in preventing oxidation of polyethylene during shelf storage and in addressing the problem of early fatigue failure seen in gamma-air-sterilized bearings with long shelf-storage before implantation. The series of gamma-barrier retrievals studied suggests that oxidation occurs in the body via the same mechanism as seen in gamma-air-sterilized bearings. A critical oxidation level is identified above which polyethylene bearings are susceptible to fatigue damage after sufficient cycles of use. Although critical oxidation was not reached in the majority of the retrieved gamma-barrier bearings studied, in vivo oxidation appears to follow an exponential increase with time. The result of in vivo oxidation is expected to be loss of mechanical properties, and susceptibility of polyethylene bearings to eventual fatigue failure.

Comparison of cross-linked polyethylene materials for orthopaedic applications.

Cross-linked polyethylenes are being marketed by orthopaedic manufacturers to address the problem of osteolysis caused by polyethylene particulate wear debris. Wear testing of these cross-linked polyethylenes in hip simulators has shown dramatic reduction in wear rate compared with standard ultrahigh molecular weight polyethylene, either gamma irradiated in air or nitrogen - or ethylene oxide-sterilized. However, this reduction in wear rate is not without cost. The cross-linking processes can result in materials with lower mechanical properties than standard ultrahigh molecular weight polyethylene. To evaluate the effect of the various cross-linking processes on physical and mechanical properties of ultrahigh molecular weight polyethylene, commercially available cross-linked polyethylenes from six orthopaedic manufacturers were tested. This study was the culmination of collaboration with these manufacturers, who provided cross-linked polyethylene for this study, wear characteristics of the material they provided, and review of the physical and mechanical properties measure for their polyethylene. Cross-linked materials were evaluated as received and after an accelerated aging protocol. Free radical identity and concentration, oxidation, crystallinity, melt temperature, ultimate tensile strength, elongation at break, tensile stress at yield, and toughness are reported for each material. By comparing these physical and mechanical properties, surgeons can evaluate the trade-off that results from developing materials with substantially lower wear rates.