Recent findings about UHMWPE oxidation from in vivo stresses lead to the need of a better understanding of which anti-oxidant additivation method is the best option for the use in orthopaedic field. A GUR 1050 crosslinked Vitamin E - blended UHMWPE has been investigated, to provide an accurate outline of its properties. DSC and FTIR measurements, together with ageing and tensile tests were performed on compression moulded blocks, as well as biocompatibility tests, including implantation on rabbits. Moreover, wear simulations on finished components (Delta acetabular liners) have been completed. All the test procedures have been repeated for a reference material, a GUR 1050 crosslinked and remelted standard UHMWPE (commercial name UHMWPE X-Lima), and the outcomes have been compared to the crosslinked Vitamin E - blended UHMWPE ones. On the additivated UHMWPE, we found a ultimate tensile strength of 43 MPa, a yield strength value of 25 MPa, and an elongation to breakage equal to 320%. The degree of cristallinity was 45 ± 2%, and no signal of creation of oxidation products was detected up to 2000 h of permanence in oxidant ambient after the ageing test. The reference material showed comparable mechanical resistance values (∗ = 40 MPa, y = 20 MPa, 350% elongation), a cristallinity of 46 ± 2%, and the creation of oxidation products starting from 700 h in oxidant ambient. The biocompatibility tests indicate that the additivated material is biocompatible, as the reference X-Lima UHMWPE. Wear tests gave a wear rate of 5,09 mg/million cycles against 6,13 mg/million cycles of the reference material, and no sign of run in wear rate. Our results indicate that there is no change in mechanical properties in respect to the reference material. This is confirmed by DSC measurements, that show no change in cristallinity. The blend between polymer and additive assures an uniform concentration of Vitamin E across the whole thickness of the moulded block, and ageing test results on additivated UHMWPE have shown that the material possess a superior resistance to degradation phenomena. Biocompatibility assess that the presence of Vitamin E is not detrimental for the in vivo use of the material, and wear results indicate a better wear resistance of the material, especially in the first stages of the wear process. From these considerations, it can be concluded that the material, in respect to the standard UHMWPE, is highly resistant to oxidation phenomena, therefore it is expected to have superior in vivo endurance performance

INTRODUCTION. Surgical correction of spinal deformities in the growing child can be applied with or without fusion. Sublaminar wiring, first described by Luque, allows continuation of growth of the non-fused spine after correction of the deformity. Neurological complications and wire breakage are the main clinical problems during the introduction and removal of currently used sublaminar wires. In this pilot study a posterior hybrid construction with the use of a medical-grade UHMWPE (Dyneema Purity®) sublaminar wire was assessed in an ovine model. We hypothesized that such a hybrid construction can safely replace current titanium laminar wires, while providing sufficient stability of the non-fused spinal column with preservation of growth. MATERIALS AND METHODS. This study included 6 Tesselaar sheep, age 7±2months. Two pedicle screws (Legacy system, Medtronic) were placed at lumbar level. Four consecutive laminae were attached to two titanium bars (4.5 mm) using 3 mm diameter UHMWPE (Dyneema Purity®) on the left side and 5 mm diameter on the right side. The sublaminar wires were fixed with a double loop sliding knot and tightened with a tensioning device. As a control, in one animal titanium sublaminar wires (Atlas cable, Medtronic) were applied. After sacrifice the spine of the animals was harvested. Radiographs were taken and CT scans were performed. The vertebrae were dissected and placed in formaldehyde for macroscopic and histological evaluation. RESULTS. The animals were sacrificed after a (minimal) postoperative period of 15 weeks. One animal developed a wire fistula and one animal died the first postoperative day due to complications of the anesthesia. None of the 3 or 5 mm knots loosened and no neurological complications occurred. An average of 8.7 mm growth was seen over the segment operated on. Computed tomography confirmed the preserved stability. Even though no decortication was performed, variable bone bridges with fused levels were seen on CT. Macroscopic and histological analysis showed no inflammation at lamina and dura levels containing Dyneema Purity®, with the exception of the case with the fistula where it was observed locally. DISCUSSION. This pilot animal model study shows that the UHMWPE laminar wire made by Dyneema Purity® has good handling and tensioning properties and can provide sufficient stability in fusionless spinal instrumentation while allowing substantial growth. The examined model showed to be a feasible spinal study model, without occurrence of neurological problems. Reactive periostal bone formation with fusion levels led to some restrictions in this model. In the future it will be necessary to test the described construction in a large animal scoliosis model

INTRODUCTION. The lifetime of UHMWPE implants may be limited by wear and oxidative degeneration. Wear produced particles are in general biologically active, and may induce osteolysis. As threshold of PE wear rate below which osteolysis is rarely observed is postulated to be less tahn 0.1 mm per year. Moreover, PE delamination and breakage are consequences of the embrittlement of the PE due to oxidation. Both demonstrate, that improving the clinical behaviour of UHMWPE means reduction of wear particles. The first can be achieved by cross-linking the second by the anti-oxidative stabiliser vitamin E. The highly cross-linked PE vitamys ® used for the isoelastic monobloc cup RM Pressfit (Mathys AG Bettlach, Bettlach, Switzerland) is mixed with 0.1% of synthetic vitamin E and is the first and only highly cross-linked PE used in total hip replacement that meets all requirements for the best grade UHMWPE in yield strength, ultimate tensile strength and elongation at break. METHODS AND MATERIAL. With the first implantation of RM Pressfit vitamys® a prospective multicentre study was started. So far 256 cases in 7 clinics from Europe and New Zealand are included. This report presents the first clinical experiences of one Swiss clinic from the multicentre study. Prospective data collection includes Harris Hip score (HHS), patient satisfaction and radiographic analysis. Clinical and radiographic follow-up is done after 6 weeks, 6, 12 and 24 months, and thereafter for long-term results. Standardized documentation of surgery and postoperative course is performed. RESULTS. 81 patients were included in the study. Mean age at implantation is 69 years. The indication was primary OA in 57% and secondary OA in 36%, the others were treated either for necrosis, fracture or hip dysplasia. 68% of the patients received a 36mm femoral head, 31% a 32mm and 1% a 28mm. Intraoperatively two minor complications occurred, one femur and one trochanter fissure. No complications occurred during implantation of the cup. Most of the cups (59%) were implanted with an inclination of 40°-50°, 30% with 35°-40°. There were no signs of early loosening and a good Harris Hip Score was achieved. DISCUSSION. The principals of this monobloc cup with its isoelastic property and the thin titanium coating is a proven concept. Ihle et al. (JBJS 2008) reported 91% survival rate with revision for aseptic loosening as endpoint after 20 years. They found an increase of cup revisions after 14 to 16 years after implantation due to osteolysis probably due to PE wear. At short term, we haven't encountered any problems related to the implantation of this cup. So far one patient in the entire multicentre study needed a stem revision after periprosthetic femur fracture. To prove the durability of this novel material a follow-up of 14 years and more will be required

INTRODUCTION. Cementless Total Hip Replacement surgery is a well established procedure for relative young patients with severe hip disease. Excellent long term clinical results have been published on the performance of the femoral component. With growing clinical experience, our concern focused on excessive wear of the Ultra High Molecular Weight Polyethylene (UHMWPE) ringloc liner of the Mallory Head cementless Total Hip Prosthesis. After its introduction in our clinic in 1997, this implant is still in use without any modification. We were concerned that due to premature liner wear, the performance of this implant would not be compliant with the international guideline on implant survival (NICE guidelines: at 10 year follow up, 90% of all implants should still be in situ). Our objective was to establish the amount of liner wear in our first 200 MH implants. METHODS. Our first 200 patients consecutively treated with Mallory Head prostheses were followed up to obtain a recent digital image. Follow up was complete for 181 (90.5%) of our 200 patients. Ten had died and nine were not able or willing to come for follow up. The mean duration of follow up was 8.3 years (range: 8–13). The 181 recent digital images were classified as either excessive wear or no excessive wear by two independent orthopedic surgeons. Next, liner wear was measured in the 2D frontal plane using PolyWare Pro/3D Digital Version Rev 5.1 software (Draftware Developers, Conway, USA). A threshold for excessive liner wear was set at 0.2mm/year, according to literature. RESULTS. Using software for measuring PE wear, 46.7% of all patients had excessive UHMWPE wear (> 0.2mm/yr). There was no relation between the amount of wear and BMI, gender, component size or the acetabular inclination angle. Thirteen patients (6.5%) were revised. Nine of these revisions were for excessive liner wear or aseptic loosening (4.5%). For now, our series of cementless Mallory Head prostheses is compliant with the NICE guideline on implant survival. However, with the measured amount of wear we expect to see a significant increase in the number of revisions for liner wear in the near future. DISCUSSION. Our clinical observation of premature UHMWPE wear proved correct. The measured amount of UHMWPE wear is consistent with the few other studies published on this subject. Although we present a retrospective study, limiting the strength of our results, we have included a large group of patients with acceptable loss to follow up. It is unclear if the observed wear will lead to a sharp increase in the number of revisions within the next few years. Possibly, future revisions will be complicated by loss of acetabular bone stock following the pathofysiological reaction to wear particles. Our results can probably be generalised for any district hospital

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. Methods. 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. Results. After extraction, 92% of the original vitamin E was removed from diffused and sterilized UHMWPE and 99% of the vitamin E was removed from the diffused and unsterilized UHMWPE. Vitamin E content of the blended, irradiated UHMWPEs could not be detected. As a result of accelerated aging in the presence of squalene, all extracted vitamin E-stabilized UHMWPEs showed increased oxidation except diffused, sterilized UHMWPE. The small amount grafted vitamin E in these samples (8%, ∼0.02 wt%) protected irradiated UHMWPE under these conditions. All vitamin E-stabilized, extracted UHMWPEs showed higher oxidative stability than irradiated and melted virgin UHMWPE in the presence of squalene. In the blended, irradiated UHMWPE, there was less effective vitamin E compared to the diffused, sterilized UHMWPE due to the high dose irradiation. Conclusions. Radiation grafting of vitamin E onto UHMWPE was effective against squalene initiated oxidation in accelerated aging. Vitamin E-diffused, sterilized UHMWPE showed no oxidation and diffused, unsterilized UHMWPE and blended, irradiated UHMWPE showed higher oxidative resistance than irradiated/melted UHMWPE

Introduction. Cobalt chrome on polyethylene remains a widely used bearing combination in total joint replacement. However wear induced osteolysis, bulk material property degradation of highly cross-linked polyethylene (HXLPE) [1], and oxidation after implantation (thought to be as a result of lipid absorption or cyclic loading [2]) remains a concern. ECIMA is a cold-irradiated, mechanically annealed, vitamin E blended next generation HXLPE developed to maintain mechanical properties, minimise wear and to improve the oxidation resistance in the long-term. The aim of this study was to compare the in-vitro wear rate and mechanical properties of three different acetabular liners; conventional UHMWPE, HXLPE and ECIMA. Methods. Twelve liners (Corin, UK) underwent a 3 million cycle (mc) hip simulation. Three conventional UHMWPE liners (GUR1050, Ø32 mm, 30 kGy sterilised in Nitrogen), three HXLPE liners (GUR1020, Ø40 mm, 75 kGy cross-linking and EtO sterilised) and six ECIMA liners (0.1 wt% vitamin E GUR1020, Ø40 mm, 120 kGy cross-linking, mechanically deformed and annealed, and EtO sterilised) articulated against CoCrMo alloy femoral heads to ASTM F75 (Corin, UK). Wear testing was performed in accordance with ISO 14242 parts 1 and 2, with a maximum force of 3.0 kN and at a frequency of 1 Hz. The test lubricant used was calf serum with a protein content of 30 g/l and 1% (v/v) patricin added as an antibacterial agent. Volumetric wear rate was determined gravimetrically after the first 0.5 mc and every 1 mc thereafter. ASTM D638 type V specimens (3.2 mm thick) were machined from ECIMA material for uniaxial tension testing to ASTM D638. Ultimate tensile strength (UTS), yield strength and elongation values were measured. These values were compared to mechanical data available for the other material types. Results. There was a 94% and a 68% reduction in the wear rate for the ECIMA liners compared to the conventional UHMWPE and HXLPE liners respectively. There was an increase in UTS, yield strength and elongation of 11%, 11% and 15% respectively, for ECIMA compared to HXLPE. Discussion. The wear results reported in this study indicate that ECIMA is a very low wearing material which has the potential to reduce wear related osteolysis in-vivo. Importantly, the mechanical properties were generally maintained unlike the degradation found in many modified polyethylene materials and were more comparable to conventional UHMWPE than HXLPE. The reduced wear rate during in-vitro hip simulation of ECIMA compared to conventional UHMWPE, coupled with improved mechanical properties in comparison to HXLPE, makes ECIMA a promising next generation, advanced bearing material

Introduction. A tibial insert with choices in size, thickness, and posterior slope is proposed to improve ligament balancing in total knee arthroplasty. However, increasing posterior slope, or the angle between the distal and proximal insert surfaces, will redistribute ultra-high molecular weight polyethylene (UHMWPE) thickness in the sagittal plane, potentially affecting wear. This study used in-vitro testing to compare wear for a standard cruciate-retaining tibial insert (STD) and a corresponding 6° sloped insert (SLP), both manufactured from direct-compression molded (DCM) UHMWPE. Our hypothesis was slope variation would have no significant effect on wear. Methods. Two of each insert (STD and SLP) were tested on an Instron-Stanmore knee simulator with a force-control regime. The gait cycle and other settings followed ISO 14243-1 and -2, except for reference positions. The STD insert was tilted 6° more than the SLP insert to level the articular surfaces. Wear was gravimetrically measured at intervals according to strict protocol. Results. No statistical difference (p=0.36) in wear rates was found for the STD (9.5 ±1.8 mg/Mc)) and SLP (11.4 ±0.5 mg/Mc) inserts. Discussion. The overall wear rate measured was higher than previously published rates for implants similar to the STD inserts. This may result from increased shear loads due to the shift in reference position and 6° slope. This is the first time the effect of tibial insert slope on wear has been evaluated in-vitro. For inserts made from DCM UHMWPE with a slope limited to 6°, this test suggests altering tibial insert slope has an insignificant effect on wear

Periprosthetic osteolysis depends on the biological activity of wear particles, but there is little known about the distribution of polyethylene wear particles (PE) in the surrounding joint tissue. The purpose of this study was to examine the localisation of wear particles of six different PEs, including four crosslinked polyethylenes (XPE), as well as their biological activity in the murine knee. Material and Methods. Wear particles of 4 XPE- and 2 UHMWPE-inserts were isolated (knee joint simulator). For all groups the particles were similar in size and shape (mean diameter 0.3–05μm; 20nm-nucleopore-filter; ISO; n = 100.000).56 female Balb/c mice were randomly assigned to six treatment groups and one control group: control (PBS), XPE1 (3×30 kGy Gamma, annealed/sequential irradiated), XPE2 (95 kGy E-beam, remelted), XPE3 (65 kGy E-beam, remelted), XPE 4 (50 kGy Gamma, remelted), UHMWPE 1, UHMWPE 2. 50 μl of each particle suspension [(0.1% vol/vol (particle volume/PBS volume) after removal of endotoxin] were injected into the left knee joint. After 1 week the mice were killed and a histological and immunhistochemical analysis of the knee joints was done (IL-1, TNF-, ICAM-1). For the immunhistochemistry the articular cartilage, the bone marrow and the synovial membrane were evaluated semiquantitatively (Kruskal-Wallis test; all pairwise multiple comparison procedure; Bonferoni correction; significance level: p<0.05). Results. All groups showed a thickened synovial layer with an increased cellular infiltration. The particles of XPE 1 and 2 were localised in the bone marrow as well as in the joint space. In contrast, the particles of XPE 3 and 4 were distributed in the synovial layer and in the bone marrow as well, but not in the joint space. The UHMWPE1 particles were mainly located in the bone marrow and joint space while the UHMWPE2 particles were mainly found in the bone marrow and the synovial layer. For all PE groups there was a higher cytokine expression compaired to control (p<0.0024) without any differences between the groups (bone marrow/synovial layer). The chondrocytes in the groups with XPE 1- and XPE 2-particles expressed more TNF- than in the control group and the other treatment groups (p = 0.000). Conclusion. XPEs lead to a similar inflammatory reaction in vivo compared to conventional polyethylenes. The high TNF- expression in the articular cartilage (groups XPE 1 and 2) might be explained by the localisation of the wear particles in the joint space in direct contact with the chondrocytes. Long-term studies are necessary to analyse the effects of different wear particle distributions in the joint surrounding tissue after knee and hip replacement. Furthermore it has to be investigated, whether their distribution in the joint space or their transport into the bone marrow is responsible for the level of the chronic inflammatory reaction

The use of external fixation in the management of long bone fractures has long been recognised. The aim of this study was to compare 3 differing constructs of Hoffman-2 and Hoffman-3 External Fixator systems to assess which potentially withstood the greatest load. Three different constructs (2, 3 and 4-bar) of Hoffman 2 and 3 External Fixation systems were tested. A UHMWPE tube was utilised as a bone substitute to construct a biomechanically reproducible model which could be tested on an MTS testing jig. Each construct was loaded to 3, 5, 8, 12 and 15mm of displacement at the fracture gap. Each construct was cyclically loaded 200 times for each test and repeated 5 times. The results demonstrate that the Hoffman-3 configurations withstood a load of at least twice that of the Hoffman 2 configurations across all displacements. Using a 2-way ANOVA test at all displacements the 2-bar configuration withstood greater load than the 3 bar (P<0.0001). With Hoffman 2 the 2-bar configuration withstood a greater load than the 4 bar diamond configuration. These results demonstrate that Hoffman-3 External Fixation Device has a greater axial loading capacity than its Hoffman-2 predecessor

Osteolysis induced by UHMWPE debris has historically been one of the major causes of long term failure of TJR. An increase in concentration of polyethylene particles in the peri-prostheic tissue has been linked to an increased incidence of osteolysis. The dual mobility hip bearing concept mates a femoral head into a polyethylene liner which has an unconstrained articulation into a metal shell. The wear mechanism of the dual mobility hip bearing is distinct from a constrained single articulation design, which may result in a difference in wear debris particles. The aim of this study is to evaluate wear debris generated from a dual mobility hip and compare it to a conventional single articulation design when both are manufactured from sequentially crosslinked and annealed polyethylene. The dual mobility hip (Restoration ADM) incorporated a 28mm CoCr femoral head into a polyethylene liner that articulates against a metal shell (48mm ID). The conventional hip (Trident®) mated a 28mm CoCr femoral head against a polyethylene liner. The polyethylene for all liners was sequentially crosslinked and annealed (X3). A hip joint simulator was used for testing at a rate of 1 Hz with cyclic Paul curve physiologic loading. A serum sample from each testing group was collected. Serum samples were protein digested following the published process by Scott et al. The digested serum was then filtered through a series of polycarbonate filter papers of decreasing size and sputter coated with gold for analysis using SEM. Image fields were randomized and wear debris was compared in terms of its length, width, aspect ration, and equivalent circular diameter (ECD). A total of 149 conventional hip particles and 114 dual mobility hip particles were imaged. Results show a majority of particles are of spherical nature and images do not indicate the presence of fibrillar or larger elongated polyethylene debris. Particle length between designs is not statistically different, while all other comparisons show statistical significance (p<0.05). It is hypothesized that the dual mobility hip system reduces the total amount of cross-shear motion on any one articulation, which aids in the reduction in wear. This design feature may be responsible for the slight difference in morphology of dual mobility wear debris when compared to the constrained hip design. The length of the particles was similar, simply indicating a different shape rather than a marked reduction in overall size. The debris generated is this study was from highly crosslinked polyethylene in two different designs, which produced a very significant decrease in quantity of particles when compared to the quantity of debris from conventional polyethylene. The wear debris was of similar length in both designs and so we do not expect any difference in biological response to debris from either device. The dual mobility design has also shown no effect of cup abduction angle on wear demonstrating forgiveness to implant positioning. This advantage, combined with the low wear rate and similar length wear particles, should lead to good clinical performance of dual mobility cups with sequentially irradiated and annealed polyethylene