The large diameter mobile polyethylene liner of the dual mobility implant provides increased resistance to hip dislocation. However, a problem specific to the dual mobility system is intra-prosthetic dislocation (IPD), secondary to loss of the retentive rim, causing the inner head to dissociate from the polyethylene liner. We hypothesized that impingement of the polyethylene liner with the surrounding soft-tissue inhibits liner motion, thereby facilitating load transfer from the femoral neck to the liner and leading to loss of retentive rim over time. This mechanism of soft-tissue impingement with the liner was evaluated via cadaver experiments, and retrievals were used to assess polyethylene rim damage. Total hip arthroplasty was performed on 10 cadaver hips using 3D printed dual mobility components. A metal wire was sutured to the posterior surface (underside) of the iliopsoas, and metal wires were embedded into grooves on the outer surface of the liner and inner head to identify these structures under fluoroscopy. Tension was applied to the iliopsoas to move the femur from maximum hyperextension to 90° of flexion for the purpose of visualizing the iliopsoas and capsule interaction with the mobile liner. The interaction of the mobile liner with the iliopsoas was studied using fluoroscopy and direct visual observation. Fifteen retrieved dual mobility liners were assessed for rim edge and rim chamfer damage. Rim edge damage was defined as any evidence of contact, and rim chamfer damage was classified into six categories: impact ribs on the chamfer surface, loss of machining marks, scratching or pitting, rim deformation causing a raised lip, a rounded rim edge, or embedded metal debris.Introduction
Methods
Radiation cross-linked UHMWPEs were developed to address osteolysis-induced joint arthroplasty failure by improving wear resistance and reducing associated particulate debris. Introduced clinically fifteen years ago, they are the primary bearing surface in use with excellent clinical outcomes and wear resistance. First generation materials sought to maintain oxidative stability by reducing or eliminating free radicals through thermal treatments, while second generation aimed to further balance oxidation resistance and improve mechanical properties through sequential irradiation and annealing or the incorporation of an antioxidant. Recent reports have identified lipid absorption and cyclic loading as potential Six types of highly cross-linked UHMWPE hip and knee bearings (Table 1) were surgically-retrieved and collected under IRB approval. Standard material analysis was performed on cross-sections of loaded and unloaded bearing surfaces of the components. Thin sections (150 µm thickness) were extracted in boiling hexanes under reflux for 16 hours followed by vacuum drying for 24 hours. FTIR was used to evaluate oxidation and calculated from post-hexane absorbance spectra by normalizing the area under 1740 cm−1 (1680–1780 cm−1) to the area under 1370 cm−1 (1330–1390 cm−1), per ASTM F2102-13. Gravimetric swelling of regional cross-sectional blocks (1–2 mm3) for 2 hours in 130°C boiling xylenes was used to assess cross-link density, per ASTM 2214.Introduction
Materials & Methods
Four highly cross-linked UHWMPEs except vitamin E-stabilised explants The development of both first and second generation highly cross-linked material focused on stabilizing radiation-induced free radicals as the sole precursor to oxidative degradation; however, secondary in vivo oxidation mechanisms have been identified in both conventional and highly cross-linked UHMWPE, induced by absorbed lipids and cyclic mechanical load. Retrieval studies are reporting in vivo oxidation highly cross-linked retrievals with up to ten year in vivo durations. Preclinical aging tests did not predict these in vivo material changes. With only a decade of these materials in clinical use, retrieval studies are limited to mid-term follow-up. In vitro studies face a challenge in effectively replicating the precise in vivo conditions that lead to this loss of oxidation resistance. In this study, we bypass replicating these in vivo variables by examining surgically-retrieved components, thereby testing material that has been affectively “pre-conditioned” by their in vivo service. After a preliminary post-operative analysis, we subjected retrievals to accelerated aging tests in order to predict the extent to which their oxidative stability had been uniquely compromised in vivo.Summary
Introduction
Sequentially irradiated and annealed UHMWPE hip and knee retrievals showed subsurface Highly cross-linked polyethylene was developed to improve the wear resistance of UHMWPE bearing surfaces in total hip arthroplasty. First generation irradiated and annealed polyethylene showed high oxidation Summary
Introduction
Fifteen irradiated, vitamin E-diffused UHMWPE retrievals with up to three years in vivo service showed no appreciable oxidation, nor change in material properties from a never-implanted liner, and showed a 94% decrease in free radical content. Radiation cross-linking, used to improve wear resistance of ultra-high molecular weight polyethylene (UHMWPE) bearings used in total joint arthroplasty, generates residual free radicals which are the precursors to oxidative embrittlement. First generation materials adopted thermal treatments to eliminate or reduce free radical content, but came with compromises in reduced mechanical properties or insufficient stabilization. A second generation alternative method infuses an antioxidant, vitamin E, into irradiated UHMWPE to stabilise free radicals while maintaining fatigue strength. Summary
Introduction
Vitamin E stabilization of radiation crosslinked UHMWPE is done by (1) blending into the resin powder, consolidating and irradiating or (2) diffusing into already consolidated and irradiated UHMWPE and terminally gamma sterilizing. With blending, a higher radiation dose is required for crosslinking to the same level as virgin UHMWPE. With diffusion, the vitamin E amount used is not limited by the crosslink density, but, vitamin E is exposed to terminal sterilization dose of 25–40 kGy, less than the 100–150 kGy used with blending, which may decrease the grafting of the antioxidant onto the polymer. We investigated the efficiency of grafted vitamin E against squlene-initiated accelerated aging. Medical grade GUR1050 UHMWPE with vitamin E (0.1 wt%) was irradiated to 150 kGy. Tibial knee insert preforms were irradiated to 100 kGy, diffused with vitamin E using a doping and homogenization procedure. This UHMWPE was used either before or after gamma sterilization. One set of machined blocks (10 × 10 × 6 mm; n = 6) were extracted in boiling hexane for 4 days, then dried. The extracted blocks were doped with squalene at 120°C for 2 hours. One block each was analyzed after doping. The rest were accelerated aged at 70°C and 5 atm. of oxygen for 6 (n = 2) and 14 days (n = 3). Thin sections (150 micron thick) were microtomed and analyzed by Fourier Transform Infrared Spectroscopy to determine a vitamin E index (1245–1275 cm−1 normalized to 1850–1985 cm−1) and an oxidation index (1700 cm−1 normalized to 1370 cm−1) after extraction with boiling hexane for 16 hours and drying.Introduction
Methods
Radiation crosslinking decreases the wear of ultra-high molecular weight polyethylene (UHMWPE) and subsequent heating increases its oxidative stability. Clinical trials are showing lower femoral head penetration rate with highly crosslinked vs. conventional UHMWPE liners. Recently, a follow-up report showed a surprising increase in the femoral head penetration rate with a highly crosslinked UHMWPE, prompting us to closely analyze surgically explanted highly crosslinked UHMWPEs. Thirty-four highly crosslinked components, all irradiated (100kGy) and melted, were included in the study. The components were surgically removed from patients for non-polyethylene related reasons. Oxidation was determined at the rim immediately after explantation. After shelf storage in air for 5–77 months, oxidation and crosslink density were measured at the rim and articular surfaces. An additional retrieval (92 mos. in vivo) was tested on the hip simulator; oxidation and crosslink density were determined after simulator testing. All components showed no detectable oxidation immediately after explantation; however, surprisingly oxidation levels increased during shelf storage. Areas with increased oxidation showed a decrease in crosslink density. These changes did not correlate with in vivo duration; however, they correlated strongly with ex vivo duration. The component subjected to hip simulator testing showed no measurable wear and showed no detectable oxidation or marked decrease in crosslink density. Two mechanisms may have reduced the oxidation resistance of highly crosslinked UHMWPE upon exposure to in vivo elements and subsequent exposure to air. One mechanism is based on free radical formation during cyclic loading; the other is based on an oxidation cascade initiated by absorbed lipids. Further studies are necessary to determine the impact of these mechanisms, if any, on the stability of components during in vivo service.
Vitamin E (alpha-tocopherol) is a free-radical stabilizing agent used to maintain oxidative stability in radiation crosslinked UHMWPE for total joint replacements. Diffusion of vitamin E into UHMWPE after irradiation is one method of incorporation, while an alternative is blending vitamin E with UHMWPE resin powder and subsequently irradiating the consolidated mixture. With the latter method, it is possible for the antioxidant properties of Vitamin E to be exhausted in blends during irradiation, leading to oxidation. We report on the relative oxidative resistance of both irradiated (100kGy, 150kGy, 200kGy) vitamin E blends (0.02 wt%, 0.05 wt% and 0.1wt%) and post-irradiation vitamin E-diffused UHMWPE after three years of real-time aging in an aqueous environment at 40°C. Blocks of each type, including irradiated virgin UHMWPE, were also accelerated aged per ASTM F2003. Oxidation was measured with FTIR per ASTM F2102. Oxidation potential was determined through nitric oxide staining of hexane extracted thin sections, FTIR analysis and calculated using the height of the nitrate peak (1630 cm^-1). Our results showed that unstabilized samples exhibited substantial oxidation and oxidation potential throughout the surface and bulk with both types of aging. Post-irradiation diffused UHMWPE showed no detectable oxidation and decreasing oxidation potential with both aging methods. The vitamin E concentration at the surface of the diffused blocks decreased and the initial non-uniform profile with high surface concentration (3.4 wt%) shifted towards a uniform profile, equilibrating at an index of 0.1 or 0.7 wt% vitamin E. Samples showed a reduction in their initial vitamin E content by 47%– 61% over 36 months, but oxidative stability was not compromised. The non-uniform profile presumably created a driving force for elution into the aqueous environment, while the difference in solubility of vitamin E at 40°C, compared to the initial diffusion temperature at 120°C, may have also contributed. After six months of real-time aging, all irradiated blends showed surface oxidation, while 0.02 wt% blends additionally showed subsurface oxidation potential. However, oxidation was not induced by accelerated aging Methods: in any blended, irradiated samples. In conclusion, real-time aging resulted in greater differentiation in the relative oxidative stability of vitamin E-stabilized, radiation crosslinked UHMWPEs than accelerated aging. Irradiated blends with vitamin E concentrations as high as 0.1 wt% showed surface oxidation after 3 years; higher vitamin E concentrations cannot address this shelf oxidation as that will also reduce the crosslinking efficiency and increase wear. Post-irradiation diffused UHMWPE, which was not limited by the amount of incorporated vitamin E, showed oxidative resistance up to 3 years with a reduction in oxidative potential.
