Aims

The primary outcome was investigating differences in wear, as measured by femoral head penetration, between cross-linked vitamin E-diffused polyethylene (vE-PE) and cross-linked polyethylene (XLPE) acetabular component liners and between 32 and 36 mm head sizes at the ten-year follow-up. Secondary outcomes included acetabular component migration and patient-reported outcome measures (PROMs) such as the EuroQol five-dimension questionnaire, 36-Item Short-Form Health Survey, Harris Hip Score, and University of California, Los Angeles Activity Scale (UCLA).

Total knee arthroplasty is an excellent operation and the results have been well documented for both cemented and cementless techniques. It is generally accepted that the results for cemented total knee outpace the results for cementless total knees. Despite this there remains great interest in developing systems and techniques that might allow predictable biologic fixation for knee arthroplasty. There is a long list of requirements that must be met to predictably allow bone ingrowth. These include viable bone, optimal pore size, optimal pore depth, optimal porosity, minimal gaps between bone and implant and minimal micromotion. Implant design is critical but it is proposed that operative techniques can help with some of these issues. We will discuss these operative issues during the surgical demo. These technique issues include: replication of normal posterior slope of the tibia, irrigation of all cuts to avoid thermal necrosis, and application of autologous bone chips to interface - “bone slurry”.

These are obviously not all of the issues to consider but we feel they are some of the more important factors related to the cementless technique. The surgeon also has to be mindful of all of the other techniques that are essential to primary total knee arthroplasty. This demo will also utilise an ultracongruent bearing and with Vitamin E polyethylene.

Ultra-high molecular weight polyethylene (UHMWPE) has been the gold standard material of choice for the load-bearing articulating surface in knee joint prostheses. However, the application of joint replacements to younger (aged < 64 years) and more active people plus the general increase in life expectancy results in an urgent need for a longer lasting material with better in-use performance. There are three major material related causes that can lead to joint failure in UHMWPE knee joint replacements: free radical induced chemical degradation; mechanical degradation through wear and delamination; and UHMWPE micron and submicron wear debris induced osteolysis. As a potential solution to these problems, highly crosslinked UHMWPE stabilised with infused antioxidant vitamin E (α-Tocopherol), which is abbreviated as E-Poly, has been of great interest. In the current work, the wear performance and mechanical properties of Vanguard cruciate retaining (CR) E-Poly tibial inserts were assessed and compared with Vanguard CR Arcom tibial inserts. Also E-Poly plates were compared with direct compression moulded UHMWPE wear plates. Both a multi-directional pin-on-plate tester and a six-station Prosim (Manchester, UK) knee wear simulator were used to assess wear properties of E-Poly plates and E-Poly tibial inserts respectively. All E-Poly plates and tibial inserts were sterilised and vacuum packed in the same way as Vanguard implants before wear testing. The wear knee simulator test was conducted in accordance with ISO 14243-3:2004 with the exception that a more aggressive Tibial Rotation and Anterior/Posterior displacement profiles, based on the kinematics of the natural knee were incorporated. Under the same aggressive pre-clinical wear testing condition, compared with Vanguard Arcom CR tibial inserts, Vanguard E-Poly CR tibial inserts experienced an 85% reduction in the mean wear rate. The former had a mean wear rate of 6.51±1.75 mm. 3. per million cycles (MC) and the latter had a mean wear rate of 0.96±0.11 mm. 3. /MC over the 7 million cycle testing period. A similar reduction (80%±8.5) in the mean wear factor was also observed on E-Poly plates compared with a series of direct compression moulded GUR1050 UHMWPE plates processed under a range of manufacturing processing conditions. Wear testing was conducted with a configuration of flat-ended stainless steel indenters multi-directionally sliding against the UHMWPE plates. Mechanical properties on Vanguard Arcom UHMWPE and E-Polys were evaluated using the small punch test. All tests were carried out using an Instron 5565 Universal Testing System at a constant crosshead speed of 0.5mm/min. With regard to work-to-failure, no statistical difference was observed, with the former being 254.2±4.1 mJ and the latter 255.6±28.2 mJ. However, all E-Polys exhibited strain stiffening due to the stretch of crosslinks. This resulted in a ca 12% reduction in elongation to break observed for E-Polys compared with that of Arcom UHMWPE. The former had an elongation to break of 4.1±0.2 mm and the latter of 4.7±0.3 mm. In conclusion, we have found that Vitamin E Stabilised UHMWPE tibial inserts are promising for knee joint prostheses. However, further investigations are needed to address potential issues such as the particle size and size distribution of E-Poly wear debris and the associated reactivity

The three distinct phases of design and development of total knee replacement (TKR) were:. 1969–1985,. 1986–2000 and. 2000 to today and beyond. Hinge designs and early condylar designs highlight the first major period of TKR development from 1969 to 1985. These designs included but were not limited to the Waldius, Shiers, and GUEPAR hinges, Gunston’s Polycentric Knee in 1971, Freeman’s ICLH Knee in 1972, Coventry’s Geomedic Knee in 1972, St. George’s Sled Prosthesis in 1971, Marmor’s Modular Uni in 1971, Townley’s Condylar Design in 1972, Walker and Ranawat’s Duocondylar in 1971, Waugh’s UCI Knee in 1976, Eftekar’s Metal Backing in 1978, Murray and Shaw’s Metal Backed Variable Axis Knee in 1978, Insall and Burstein’s IB-1 Knee in 1978, the Kinematics in 1978, and finally Walker, Ranawat and Insall’s Total Condylar in 1978. The Total Condylar Knee, developed by Walker, Ranawat, and Insall between 1974 and 1978, has been the benchmark for all designs through the 20th century. My personal experience of cemented TKR from 1974–2009 has shown a survivorship of 89%–98% at 15–20 years. Similar data has been presented in several 10+ year follow-up studies. The next major phase of development gave birth to semi-constrained TKR, cruciate saving and substituting PS designs, improved instrumentation and improved cemented fixation. Other guiding principles involved improving alignment, managing soft-tissue balance for varus-valgus deformity, improving kinematics and producing superior polyethylene for reduced wear and oxidation. The advent of rotating platform mobile bearing knees with multiple sizes marked the most recent major advancement in TKR design. With more total knee replacements being performed on younger, more active patients, improved design, better fixation (non-cemented), and more durable articulation are needed. The new standard for ROM will be 125 degrees. Non-cemented fixation, improved poly, such as E-poly, and the rotating platform design will play a major role in increasing the longevity of TKR to over 25 years

Introduction: Two second generation highly crosslinked UHMWPEs have been cleared by the FDA for clinical use in the United States: sequentially crosslinked UHMWPE (X3™ UHMWPE, Stryker Inc., Mahwah, NJ, USA) and α-tocopherol stabilized UHMWPE (E-Poly™ UHMWPE, Biomet, Inc., Warsaw, IN, USA). Both have been shown to be oxidatively stable under standardized aging methods (ASTM F2003); however, these conventional aging methods did not consider the effect of mechanical loading on the oxidative behavior of the materials. By coupling the adverse effects of thermal aging and mechanical stress, we sought to investigate if either material was prone to environmental stress cracking (ESC). We hypothesize that the residual free radicals remaining in sequentially crosslinked PE will lead to oxidative degradation in this adverse test; furthermore, we hypothesized that the α-tocopherol infused in E-Poly™ will continue to protect the highly crosslinked PE even under such unfavorable conditions. Materials and Methods: Three materials were tested:. Conventional: UHMWPE gamma sterilized in inert,. SXL: sequentially irradiated and annealed UHMWPE irradiated to a cumulative dose of 100kGy (33 kGy irradiation + 8 hour annealing in air, repeated 3 times) and gas plasma sterilized, and. E-Poly: UHMWPE irradiated to 100kGy, stabilized with α-tocopherol, and gamma sterilized in inert. Four specimens from each group were subjected to a reciprocating mechanical stress of 10 MPa at a frequency of 0.5 Hz in an environmental chamber maintained at 80°C. Control samples were placed in the chamber but not subjected to cyclic mechanical stress. When a visible crack was observed on a sample’s surface or when a sample fractured, it and its corresponding control sample were analyzed by FTIR to quantify oxidation. Results: All conventional specimens, half (2 of 4) of the SXL specimens, and none of the E-Poly specimens failed prior to the completion of 1,530,000 cycles (5 weeks of testing at 0.5 Hz). Cyclic loading had an adverse effect on the oxidation of the conventional and the SXL groups; the peak oxidation levels were higher in the cyclically loaded samples as compared to the control samples removed at the same time which were not loaded, likely due to an increase in chain scission induced by the mechanical load. The E-Poly specimens did not fail during the 5 weeks of testing, and FTIR did not reveal detectable oxidation in either control or loaded samples. Discusssion and conclusion: Though the sequential processing of SXL creates a material with a lower free radical content compared to once-annealed material, it still yields a material prone to oxidation under extreme conditions, raising questions about its long-term oxidative stability. E-Poly™, protected by α-tocopherol, continues to exhibit high oxidation resistance even under adverse conditions

Vitamin E stabilized highly crosslinked UHMWPE (E-Poly. ™. ) was developed to improve upon the properties of first generation highly crosslinked UHMWPE’s. The post-crosslinking processing for E-Poly. ™. maximizes the strength of the material while at the same time stabilizing residual free radicals that remain after irradiation. E-Poly. ™. is crosslinked with 100 kGy gamma irradiation prior to infusion of vitamin E. The infusion process involves diffusing vitamin E into the crosslinked material at temperatures beneath the melt temperature. Small punch testing (ASTM F2183-02) was completed to evaluate strength of E-Poly. ™. compared to gamma-inert sterilized UHMWPE. The results showed that the E-Poly. ™. material had equivalent or better properties before and after accelerated aging than the gamma-inert sterilized UHMWPE (96–105 N vs. 75–88 N unaged; 100–115 N vs. 42–56 N 2-week aged). Environmental stress crack testing evaluated the resistance to oxidation while the material was subjected to fatigue testing. A constant stress beam was tested for 5 weeks at 80C. Failure was defined as the appearance of cracks or fracture of the specimen. All 4 specimens of gamma sterilized components showed evidence of cracking prior to the completion of the test. 2 of 4 sequentially crosslinked and annealed specimens fractured prior to completion. None of the E-Poly. ™. specimens showed cracks during testing. An examination of the amount of oxidation induced during this testing showed that the addition of fatigue loading increased the oxidation index for UHWMPE’s that had unstabilized free radicals. The surface oxidation index for gamma sterilized UHWMPE increased from ~0.3 to 1.1 and for sequentially crosslinked UHMWPE from ~0.3 to 0.7; the oxidation index for E-Poly. ™. was negligible for all test condition. Hip simulator testing (ISO 14242-1) showed that the volumetric wear rates for E-Poly. ™. were 95–99 % less than that of ArCom. For 28mm head diameters the rates were 53.3 mm3/Mc for ArCom and 0.24 mm3/Mc for E-Poly. ™. Wear particle morphology analysis showed that the E-Poly. ™. wear particles were similar to ArCom. Qualitatively, there appeared to be fewer E-Poly. ™. particles. Knee simulator testing (ISO14243-1) was performed on both cruciate retaining and posterior stabilized Vanguard. ®. knees. The E-Poly. ™. tibial bearing, CR and PS, showed 86% less wear than direct compression molded UHMWPE, the current gold standard. Fatigue testing of the PS post before and after accelerated aging (ASTM F2003) loaded to 1300lbs showed no degradation or failure of the post following 3 million cycles. Vitamin E stabilized highly crosslinked UHMWPE has demonstrated excellent material properties, wear properties, and resistance to oxidation. These properties have been optimized through the combination of cross-linking, processing below the melt temperature subsequent to crosslinking, and the stabilization effect of vitamin E. These properties provide rational support to the utilization of vitamin E stabilized highly crosslinked UHMWPE for hip and knee applications