Summary Statement. In young, active patients cementless THR demonstrates excellent prosthetic stability by RSA and outstanding clinical outcomes at 5 years using a tapered titanium femoral stem, crosslinked polyethylene liners and either titanium or tantalum shells. Introduction. Early femoral implant stability is essential to long-term success in total hip replacement. Radiostereometric analysis (RSA) provides precise measurements of micromotion of the stem relative to the femur that are otherwise not detectable by routine radiographs. This study characterised micromotion of a tapered, cementless femoral stem and tantalum porous-coated vs. titanium acetabular shells in combination with highly cross-linked UHMWPE or conventional polyethylene liners using radiostereometric analysis (RSA) for 5 years following THR. Patients and Methods. This IRB-approved, prospective, double randomised, blinded study, involved 46 patients receiving a primary THR by a single surgeon. Each patient was randomised to receive a titanium (23) (Trilogy, Zimmer) or tantalum (23) (Modular Tantalum shell, Zimmer) uncemented hemispheric shell and either a highly-crosslinked or conventional polyethylene liner. Tantalum RSA markers were implanted in each patient. All patients had a Dorr A or B femoral canal and received a cementless, porous-coated titanium tapered stem (M/L Taper, Zimmer). All final femoral broaches were stable to rotational and longitudinal stress. RSA examinations, Harris Hip, UCLA, WOMAC, SF-12 scores were obtained at 10 days, 6 months, and annually through 5 years. Results. All patients demonstrated statistically significant improvement in Harris Hip, WOMAC, and SF-12 PCS scores post-operatively. Evaluation of polyethylene wear demonstrated that median penetration measurements were significantly greater in the conventional compared to the HXPLE liner cohorts at 1 year through 5 years follow-up (p<0.003). At 5 years, conventional liners showed 0.38 ± 0.05mm vertical wear whereas HXLPE liners showed 0.08 ± 0.02mm (p<0.003). Evaluation of the femoral stems demonstrated that the rate of subsidence was highest in the first 6 months (0.09mm/yr), with no other detectable motion through 5 years. Two outlying patients had significantly higher stem subsidence values at 6 months (0.7 mm and 1.0mm). One stem stabilised without further subsidence after 6 months (0.7mm), and the other stem stabilised at 1 year (1.5mm). Neither patient has clinical evidence of loosening. Evaluation of acetabular shells demonstrated less median vertical translation in tantalum than titanium shells at each time-point except at 3-years follow-up, however due to large standard errors, there was no significant difference between the two designs (p>0.05). These large standard errors were predominantly caused by two outliers, neither of which had clinical evidence of loosening. Discussion/Conclusion. In this RSA study of young THR patients, cementless tapered femoral stems, highly crosslinked polyethylene liners, and tantalum or titanium acetabular shells all demonstrated excellent performance through 5 years follow-up. Highly crosslinked polyethylene liners demonstrated significantly less wear than conventional liners. The femoral stem showed excellent stability through 5 years, with no clinical or radiologic episodes of failure. The small amount of micromotion seen is less than that previously reported for similar tapered, cementless stems and approaches the accuracy of RSA (0.05mm). Both acetabular shells demonstrated excellent stability with minimal micromotion at 5 years without significant differences in migration. All patients demonstrated significant clinical improvement in pain and function and additional RSA evaluation of these patients is planned

Summary Statement. This study assesses oxidation, mechanical behavior and revision reasons of 2. nd. generation HXLPE used in total hip and knee arthroplasty. While oxidation was low for both X3 and E1 HXLPEs, oxidative regional variations were detected in the sequentially annealed cohort. Introduction. First generation highly crosslinked polyethylenes (HXPLEs) have proven successful in lowering both penetration and osteolysis rates. However, 1. st. generation annealing and remelting thermal stabilization have been associated with in vivo oxidation or reduced mechanical properties. Thus, 2. nd. generation HXLPEs were developed to improve oxidative stability while still maintaining material properties. Little is known about the in vivo clinical failure modes of these 2. nd. generation HLXPEs. The purpose of this study was to assess the revision reasons, wear, oxidative stability, and mechanical behavior of retrieved sequentially annealed Vitamin E diffused HXLPE in THA and TKA. Methods. 251 2. nd. Generation HXLPE hip and knee components were consecutively retrieved during revision surgeries and continuously analyzed in a prospective, IRB approved, multicenter study. 123 acetabular liners (Implanted 1.2y; Range 0–5.0y) and 117 tibial inserts (Implanted 1.6y; Range 0–5.8y) were highly crosslinked and annealed in 3 sequential steps (X3). Five acetabular liners (Implanted 0.6y; Range 0–2.0y) and six tibial inserts (Implanted 1.3y; Range 0.5–1.8y) were diffused with Vitamin E (E1). Patient information was collected from medical records. Linear penetration of liners was measured using a calibrated digital micrometer (accuracy: 0.001 mm). Surface damage of tibial components was assessed using the Hood method. Thin sections were taken from the acetabular liners (along the superior/inferior axis) and the tibial components (along the medial condyle and central spine) for oxidation analysis and analyzed according to ASTM 2102. Mechanical behavior was assessed via the small punch test (ASTM 2183). Results. The liners and tibial components fabricated from both HXLPEs were revised predominantly for loosening, instability, and infection. The average penetration rate for the Sequentially Annealed group was low (PR=0.045mm/yr). Pitting, scratching and burnishing were the predominant damage mechanisms of the tibial inserts within both material groups, with no evidence of delamination. Oxidation indices were low (Mean OI≤0.3) and similar between liners and inserts of the Sequentially Annealed components at the bearing and backside surface (p≥0.15). Oxidation was positively correlated with implantation time at the bearing surface of the Sequentially Annealed groups (Rho>0.29, p<0.005). The Ultimate Load of the Sequentially Annealed acetabular liners was statistically higher than the tibial components (p<0.001), however the mean difference was minimal (∼6N). Discussion. This study evaluated the properties of 2. nd. generation HXLPEs used in THA and TKA. Sequentially Annealed liners had penetration rates comparable with 1. st. generation HXLPEs. While oxidation was low for both sequentially annealed and Vitamin E HXLPEs, we were able to detect regional variations in the oxidative in the sequentially annealed cohort. Longer-term retrievals are necessary to fully assess the oxidative stability of Vitamin E diffused HXLPE used in TKA and THA