Abstract. Objectives. Ultra-High Molecular Weight Polyethylene (UHMWPE) can be made radiopaque through the diffusion of an oil-based contrast agent (Lipiodol Ultra-fluid). A similar process is used for Vitamin E incorporated polyethylene, which has a well-established clinical history. This study aimed to quantify the leaching of Lipiodol and compare to vitamin E polyethylene. Method. GUR 1050 polyethylene (4 mm thickness) was cut into squares, 10 mm. 2. Samples (n=5) were immersed in 25 ml Lipiodol (Guerbet, France), or 15 ml Vitamin E (L-atocopherol, Sigma-Aldrich, UK). To facilitate diffusion, samples were held at 105°C for 18 hours. After treatment, all samples were immersed in DMEM (Sigma-Aldrich, UK) with Penicillin Streptomycin (Sigma-Aldrich, Kent, UK) at 4%v/v and held at 37°C in an incubator. Untreated polyethylene samples were included as controls. Leaching was quantified gravimetrically at weeks 2, 4 and 8. The radiopacity of the Lipiodol-diffused samples was investigated from µCT images (162kV, resolution 0.2 mm, X Tec, XT H 225 ST, Nikon Metrology, UK). Results. The leaching of Lipiodol and Vitamin E followed the same trend and reached a steady state after week 2. At this point there was a 20% decrease in the Hounsfield Unit and droplets of radiopaque oil were visible in the DMEM solution; these were not evident in subsequent scans. Over 8 weeks of 20% Lipiodol leached out of the polyethylene, which was greater than of 10% Vitamin E. Conclusion. After 8 weeks the radiopaque polyethylene was still identifiable in CT scan images, even though 20% of leaching occurred. The leaching of Lipiodol may be mitigated through cross-linking, which has been shown to reduce leaching of Vitamin E; this will be investigated as future work. Declaration of Interest. (b) declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research reported:I declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research project

Ultra-high molecular weight polyethylene (UHMWPE) is a commonly used as bearing material in joint replacement devices. UHMWPE implants can be hard to see on a standard X-ray because UHMWPE does not readily attenuate X-rays. Radiopaque UHMWPE would enable direct imaging of the bearing both during and after surgery, providing in vivo assessment of bearing position, dislocation or fracture, and potentially a direct measure of wear. The X-ray attenuation of UHMWPE was increased by diffusing an FDA approved contrast agent (Lipiodol) into UHMWPE parts (Zaribaf et al, 2018). The aim of this study was to evaluate the optimal level of radiopacity for a UHMWPE bearing. Samples of un-irradiated medical grade UHMWPE (GUR 1050) were machined into 4mm standard medium Oxford Unicompartmental bearings. Samples were immersed in Lipiodol Ultra Fluid (Guerbert, France) at elevated temperatures (85 °C, 95 °C and 105 °C) for 24 h to achieve three different levels of radiopacity. A phantom set-up was used for X-ray imaging; the phantom contained two perspex rods to represent bone, with the metallic tibial tray and polyethylene bearing fixed to the end of one rod and the metallic femoral component fixed to the other rod. Radiographs of the samples were taken (n=5) with the components positioned in full extension. To ensure consistency, the images of all the samples were taken simultaneously alongside an untreated part. The results of our ongoing study demonstrate that the radiopacity of UHMWPE can be enhanced using Lipiodol and the parts are visible in a clinical radiographs. The identification of the optimal treatment from a clinical perspective is ongoing; we are currently running a survey with clinicians to find the consensus on the optimal radiopacity taking into account the metallic components and alignment. Future work will involve a RSA study to assess the feasibility of measuring wear directly from the bearing

INTRODUCTION. Growth-guidance constructs are an alternative to growing rods for the surgical treatment of early onset scoliosis (EOS). In growth-guidance systems, free-sliding anchors preserve longitudinal spinal growth, thereby eliminating the need for surgical lengthening procedures. Non-segmental constructs containing ultra-high molecular weight polyethylene (UHMWPE) sublaminar wires have been proposed as an improvement to the traditional Luque trolley. In such a construct, UHMWPE sublaminar wires, secured by means of a knot, serve as sliding anchors at the proximal and distal ends of a construct, while pedicle screws at the apex prevent rod migration and enable curve derotation. Ideally, a construct with the optimal UHMWPE sublaminar wire density, offering the best balance between providing adequate spinal fixation and minimizing surgical exposure, is designed preoperatively for each individual patient. In a previous study, we developed a parametric finite element (FE) model that potentially enables preoperative patient-specific planning of this type of spinal surgery. The objective of this study is to investigate if this model can capture the decrease in range of motion (ROM) after spinal fixation as measured in an experimental study. MATERIALS AND METHODS. In a previous in vitro study, the ROM of an 8-segment porcine spine was measured before and after instrumentation, using different instrumentation constructs with a sequentally decreasing number of wire fixation points. In the current study, the parametric FE model of the thoracolumbar spine was first validated relative to ROM values reported in the literature. The rods, screws, and sublaminar wires were implemented, and the model was subsequently used to replicate the in vitro tests. The experimental and simulated ROM”s for the different instrumentation conditions were compared. RESULTS. Good agreement between in vitro biomechanical tests and FE simulations was observed in terms of the decrease in ROM for the complete construct with wires at each level. The stepwise increase in total ROM with decreasing number of wires at the construct ends was less prominent in silico in comparison to in vitro. CONCLUSION. Important first steps in the implementation and validation of a growth-guidance construct for EOS patients in a patient-specific FE model of the spine have been made in this study. The parametric nature of the FE model allows for rapid personalization. Although further improvements to the model will be necessary to better distinguish between different spinal instrumentation constructs, we conclude that the model can well capture essential aspects of spinal motion and the overall effect of instrumentation

Although bovine serum is the lubricant recommended by several international standards for the wear testing of orthopedic biomaterials there are issues over its use. The inherent batch variation in protein content means that two bovine serum lubricants can give different wear rates. Due to degradation, the lubricant needs to be changed regularly, so that any third body wear particles are removed, thus potentially influencing wear regimes. There are also cost and safety issues with the use of bovine serum. For these reasons, alternative lubricants were investigated. A 50-station wear test rig was used, which applied multi-directional motion to each ultra-high molecular weight polyethylene (UHMWPE) test pin. Each pin articulated against a cobalt chrome plate polished to better than 0.05 microns Ra. The following lubricants were used: 50% dilute bovine serum; soy protein; olive oil; wheatgerm oil; soya oil; albumin and globulin (AG) mix; albumin, globulin and chondroitin sulphate (AGC) mix; whole milk; Channel Island milk; 11 mg/ml protein egg white; 20 mg/ml egg white; and 40 mg/ml egg white. A minimum of 6 UHMWPE pins per lubricant were wear tested and the tests ran to 2.5 million cycles. Gravimetric measurements were taken throughout the test to determine the volume of wear and at the end of the test the samples were examined using a SEM. The lubricants giving the closest results to bovine serum were 20 and 40 mg/ml egg white, with mean UHMWPE total wear volumes of 17.4 mm3 and 17.8 mm3 compared to bovine serum which gave 20.7 mm3. Surface topographies showed similar features too. The 11 mg/ml egg white lubricant and the AG and AGC lubricants were next closest in terms of wear. An UV absorbance assay found that all the protein based lubricants suffered from a high degradation rate, and the rate increased with increasing protein content. Egg white may offer a less expensive alternative to dilute bovine serum as a test lubricant although it is likely that it too would need to be changed as regularly as bovine serum

Summary. Low energy irradiation of vitamin E blended UHMWPE is feasible to fabricate total joint implants with high wear resistance and impact strength. Introduction. Irradiated ultra-high molecular weight polyethylene (UHMWPE), used in the fabrication of joint implants, has increased wear resistance. But, increased crosslinking decreases the mechanical strength of the polymer, thus limiting the crosslinking to the surface is desirable. Here, we used electron beam irradiation with low energy electrons to limit the penetration of the radiation exposure and achieve surface cross-linking. Methods. Medical grade 0.1wt% vitamin E blended UHMWPE (GUR1050) was consolidated and irradiated using an electron beam at 0.8 and 3 MeV to 150 kGy. Fourier Transform Infrared Spectroscopy (FTIR) was used from the surface along the depth at an average of 32 scans and a resolution of 4 cm. −1. A transvinylene index (TVI) was calculated by normalizing the absorbance at 965 cm. −1. (950–980cm. −1. ) against 1895 cm. −1. (1850 – 1985 cm. −1. ). TVI in irradiated UHMWPE is linearly correlated with the radiation received [3]. Vitamin E indices were calculated as the ratio of the area under 1265 cm. −1. (1245–1275 cm. −1. ) normalized by the same. Pin-on-disc (POD) wear testing was conducted on cylindrical pins (9 mm dia., 13 mm length, n=3) as previously described at 2 Hz [4] for 1.2 million cycles (MC). Wear rate was measured as the linear regression of gravimetric weight change vs. number of cycles from 0.5 to 1.2 MC. Double notched IZOD impact testing was performed (63.5 × 12.7 × 6.35mm) in accordance with ASTM F648. Cubes (1 cm) from 0.1wt% blended and 150 kGy irradiated pucks (0.8 MeV) were soaked in vitamin E at 110°C for 1 hour followed by homogenization at 130°C for 48 hours. Results. The penetration of the electron beam for cross-linking was limited at low beam energy and cross-linking of the surface 2 mm was achieved. The wear rate of samples irradiated at 0.8 and 3 MeV was 1.12±0.15, and 0.98±0.11, respectively (p»0.5). In addition, the wear rate of the surface (0.8 MeV) irradiated UHMWPE was 0.33±0.02 mg/MC 1 mm below the surface. The impact strength of UHMWPE irradiated at 0.8 MeV was 73 kJ/m. 2. and 54.2 kJ/m. 2. for that irradiated at 3 MeV (p=0.001). Doping with vitamin E and homogenization increased the surface vitamin E concentration from undetectable levels to 0.11±0.01. Discussion. The wear rate of this surface cross-linked UHMWPE was comparable to uniformly cross-linked UHMWPEs irradiated at higher electron beam energies. Even lower wear rate subsurface suggested the feasibility of machining 1 mm from the surface in implant fabrication. Limiting cross-linking to the surface resulted in higher impact strength compared to a uniformly cross-linked UHMWPE. Vitamin E was optionally replenished by additional doping after cross-linking; an advantage of this method may be increased oxidation resistance

Summary. 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. Introduction. 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. In vitro studies predict excellent oxidation and wear resistance in vitamin E-stabilised bearings, but the long-term in vivo oxidation behavior, influenced by lipid absorption and cyclic loading, remains largely unknown. Our aim was to investigate in vivo changes in UHMWPE surgically-retrieved explants that were radiation cross-linked and stabilised by vitamin E. Patients & Methods. Fifteen surgically-retrieved irradiated, vitamin E-diffused and inert-gamma sterilised bearings (E1™, Biomet, Inc., Warsaw IN) with in vivo durations ranging from 3 days to 36.6 months were analyzed at unloaded rim/eminence and the articular surface along with one never-implanted component. Total lifetime of components was summed as shelf storage prior to implantation, in vivo duration and ex vivo duration in air. Fourier Transform Infrared Spectroscopy (FTIR) was used to measure carbonyl index (CI; per ASTM F2102-01ε1) both before and after 16 hour hexane extraction to. Extracted thin films were also reacted with nitric oxide to quantify hydroperoxides, an intermediate oxidation product associated with oxidation potential. Cross-link density was calculated from gravimetric swelling analysis per ASTM F2214. Crystallinity measurements were performed regionally using differential scanning calorimetry (DSC). Free radical content was measured by electron spin resonance (Memphis, TN). Results. Irradiated and vitamin E-diffused retrievals showed scratching at the articular surface, but retained machining marks up to three years in vivo, indicative of no measurable wear. Retrievals showed no significant oxidation at the time of surgical removal with maximum post-hexane carbonyl indices in the barely detectable range (MCI=0.029–0.154), located at the surface of retrievals. Ex vivo oxidation was not observed after 18 months of aging in air at room temperature. There was no increase in hydroperoxides (never-implanted HI=0.62±0.04; retrieval HI= 0.62±0.04), nor change in cross-link density (never-implanted: 0.275±0.015 mol/dm. 3. ; retrieval: 0.295±0.016 mol/dm. 3. ) or crystallinity (never-implanted: 58.3±1.4%; retrievals: 60.0±3.5%). Lipid penetration increased with time, showing a higher rate of diffusion in loaded regions. Free radical content was observed to decay with increasing in vivo duration (R. 2. =0.44; p<0.05), and by one order of magnitude (94%) by 36.6 months. A stronger negative correlation (R. 2. =0.65) was observed between the total lifetime of the liner and free radical content. Discussion/Conclusion. The free-radical scavenging activity of the vitamin E appears to successfully prevent both in vivo and ex vivo oxidation for short durations. Without an increase in hydroperoxides, the oxidation cascade initiated by radiation-induced and lipid-derived free radicals appears to have been halted. Retrievals also gave no indication of wear in this timeframe, similar to improved wear resistance seen in first generation materials. Continued monitoring will be necessary at longer implant durations

Objectives

All-suture anchors are increasingly used in rotator cuff repair procedures. Potential benefits include decreased bone damage. However, there is limited published evidence for the relative strength of fixation for all-suture anchors compared with traditional anchors.

Malrotation of the femoral component is a cause of patellofemoral maltracking after total knee arthroplasty. Its precise effect on the patellofemoral mechanics has not been well quantified. We have developed an in vitro method to measure the influence of patellar maltracking on contact. Maltracking was induced by progressively rotating the femoral component either internally or externally. The contact mechanics were analysed using Tekscan. The results showed that excessive malrotation of the femoral component, both internally and externally, had a significant influence on the mechanics of contact. The contact area decreased with progressive maltracking, with a concomitant increase in contact pressure. The amount of contact area that carries more than the yield stress of ultra-high molecular weight polyethylene significantly increases with progressive maltracking. It is likely that the elevated pressures noted in malrotation could cause accelerated and excessive wear of the patellar button.

Nanometre-sized particles of ultra-high molecular weight polyethylene have been identified in the lubricants retrieved from hip simulators. Tissue samples were taken from seven failed Charnley total hip replacements, digested using strong alkali and analysed using high-resolution field emission gun-scanning electron microscopy to determine whether nanometre-sized particles of polyethylene debris were generated in vivo. A randomised method of analysis was used to quantify and characterise all the polyethylene particles isolated.

We isolated nanometre-sized particles from the retrieved tissue samples. The smallest identified was 30 nm and the majority were in the 0.1 μm to 0.99 μm size range. Particles in the 1.0 μm to 9.99 μm size range represented the highest proportion of the wear volume of the tissue samples, with 35% to 98% of the total wear volume comprised of particles of this size. The number of nanometre-sized particles isolated from the tissues accounted for only a small proportion of the total wear volume. Further work is required to assess the biological response to nanometre-sized polyethylene particles.