Search

It is well known that the biomechanical and tribological performance of articular cartilage is inextricably linked to its extracellular matrix (ECM) structure and zonal heterogeneity. Furthermore, it is understood that the presence of native ECM components, such as collagen II and aggrecan, promote healthy homeostasis in the resident chondrocytes. What is less frequently discussed is how chondrocyte metabolism is related to the extracellular mechanical environment, at both the macro and microscale. The chondrocyte is in immediate contact with the pericellular matrix of the chondron, which acts as a mechanocoupler, transmitting external applied loads from the ECM to the chondrocyte. Therefore, components of the pericellular matrix also play essential roles in chondrocyte mechanotransduction and metabolism. Recreating the biomechanical environment through tuning material properties of a scaffold and/or the use of external cyclic loading can induce biosynthetic responses in chondrocytes. Decellularized scaffolds, which retain the native tissue macro- and microstructure also represent an effective means of recapitulating such an environment. The use of such techniques in tissue engineering applications can ensure the regeneration of skeletally mature articular cartilage with appropriate biomechanical and tribological properties to restore joint function. Despite the pivotal role in graft maturation and performance, biomechanical and tribological properties of such interventions is often underrepresented. This review outlines the role of biomechanics in relation to native cartilage performance and chondrocyte metabolism, and how application of this theory can enhance the future development and successful translation of biomechanically relevant tissue engineering interventions. Impact statement Physiological cartilage function is a key criterion in the success of a cartilage tissue engineering solution. The

International audience; Ceramic-on-ceramic bearings in total hip replacement have shown the potential to provide low wear solutions in hip replacement. Assessing the tribological performance of these materials is important to predict their long-term performance in patients. In this study, a methodology was devised to assess the tribological in vitro behaviour of composite ceramics under combined adverse edge loading conditions and accelerated ageing. Two commercial ceramic composites were considered, namely Alumina-Toughened Zirconia (ATZ, ceramys®) and Zirconia-Toughened Alumina (ZTA, symarec®). The bearing couples were studied using the Leeds Mark II hip joint simulator for a total of eight million cycles, the first two million under normal gait (no edge loading) and the following six million cycles with the addition of edge loading conditions driven by medial-lateral separation. The bearing couples underwent hydrothermal ageing using an accelerated protocol in autoclave every million cycles. The influence of edge loading combined with ageing was significant for ATZ bearings, resulting in a slower overall ageing kinetics over the wear stripe than on the control heads. During the autoclave ageing steps, the monoclinic fraction increased more over the wear stripe area than over the unworn area. Both results thus indicated that the monoclinic phase was removed during shocks induced by edge loading. The wear performance of the two materials were similar exhibiting relatively low wear rates and low level of microstructural damage for these clinically relevant adverse conditions.

Objectives Bone void fillers are increasingly being used for dead space management in arthroplasty revision surgery. The aim of this study was to investigate the influence of calcium sulphate bone void filler (CS-BVF) on the damage and wear of total knee arthroplasty using experimental wear simulation. Methods A total of 18 fixed-bearing U2 total knee arthroplasty system implants (United Orthopedic Corp., Hsinchu, Taiwan) were used. Implants challenged with CS-BVF were compared with new implants (negative controls) and those intentionally scratched with a diamond stylus (positive controls) representative of severe surface damage (n = 6 for each experimental group). Three million cycles (MC) of experimental simulation were carried out to simulate a walking gait cycle. Wear of the ultra-high-molecular-weight polyethylene (UHMWPE) tibial inserts was measured gravimetrically, and damage to articulating surfaces was assessed using profilometry. Results There was no significant difference (p > 0.05) between the wear rate of implants challenged with CS-BVF (3.3 mm3/MC (95% confidence interval (CI) 1.8 to 4.8)) and the wear rate of those not challenged (2.8 mm3/MC (95% CI 1.3 to 4.3)). However, scratching the cobalt-chrome (CoCr) significantly (p < 0.001) increased the wear rate (20.6 mm3/MC (95% CI 15.5 to 25.7)). The mean surface roughness of implants challenged with CS-BVF was equivalent to negative controls both after damage simulation (p = 0.98) and at the conclusion of the study (p = 0.28). Conclusion When used close to articulating surfaces, a low-hardness, high-purity CS-BVF had no influence on wear. When trapped between the articulating surfaces of a total knee arthroplasty, CS-BVF did not scratch the surface of CoCr femoral components, nor did it increase the wear of UHMWPE tibial inserts compared with undamaged negative controls. Cite this article: R. M. Cowie, S. S. Aiken, J. J. Cooper, L. M. Jennings. The influence of a calcium sulphate bone void filler on the third-body damage and polyethylene wear of total knee arthroplasty. Bone Joint Res 2019;8:65–72. DOI: 10.1302/2046-3758.82.BJR-2018-0146.R1.

There is a clinical need for novel graft materials for the repair of peripheral nerve defects. A decellularisation process has been developed for porcine peripheral nerves, yielding a material with potentially significant advantages over other devices currently being used clinically (such as autografts and nerve guidance conduits). Grafts derived from xenogeneic tissues should undergo sterilisation prior to clinical use. It has been reported that sterilisation methods may adversely affect the properties of decellularised tissues, and therefore potentially negatively impact on the ability to promote tissue regeneration. In this study, decellularised nerves were produced and sterilised by treatment with 0.1% (v/v) PAA, gamma radiation (25–28 kGy) or E Beam (33–37 kGy). The effect of sterilisation on the decellularised nerves was determined by cytotoxicity testing, histological staining, hydroxyproline assays, uniaxial tensile testing, antibody labelling for collagen type IV, laminin and fibronectin in the basal lamina, and differential scanning calorimetry. This study concluded that decellularised nerves retained biocompatibility following sterilisation. However, sterilisation affected the mechanical properties (PAA, gamma radiation), endoneurial structure and basement membrane composition (PAA) of decellularised nerves. No such alterations were observed following E Beam treatment, suggesting that this method may be preferable for the sterilisation of decellularised porcine peripheral nerves.

A range of surgical techniques and osteochondral interventions have been developed for early stage chondral/osteochondral repair interventions in the knee however, methods for functional, pre-clinical assessment of these therapies are limited. In this study, a method for simulating physiological loading and motion in the porcine patellofemoral joint was developed using a 6-axis simulator. As an example of how the method can be used, the influence of surgical positioning of osteochondral allografts in the patella on cartilage wear, deformation and damage and graft stability was investigated in this porcine patellofemoral joint model. The functional performance of allografts implanted either optimally (flush with the cartilage surface) or 1 mm proud of the cartilage surface was compared to a positive control (stainless steel pin implanted 1 mm proud of the cartilage surface), a negative control (no intervention) and a defect model. Allografts implanted flush with the surrounding cartilage could restore the articulating surface of the patella resulting in low wear, damage and deformation of the opposing cartilage surface, similar to that of the negative control group. Implanting the graft proud of the patella surface resulted in cartilage lesions on the femoral trochlea (ICRS grade 2) and a cartilage volume difference of 2.0 ± 3.9 mm3; the positive controls resulted in more severe lesions, a higher volume difference (14.2 ± 7.4 mm3) which in some cases exposed subchondral bone (ICRS grade 4). Defects in the patella caused deformation of the opposing cartilage surface. All grafts implanted in the patella subsided over the duration of the study. This study demonstrated a method that can be used to evaluate osteochondral repair strategies in the patellofemoral joint applying physiological loading and motions.

A human cadaveric specimen-specific knee model with appropriate soft tissue constraints was developed to appropriately simulate the biomechanical environment in the human knee, in order to pre-clinically evaluate the biomechanical and tribological performance of soft tissue interventions. Four human cadaveric knees were studied in a natural knee simulator under force control conditions in the anterior posterior (AP) and tibial rotation (TR) axes, using virtual springs to replicate the function of soft tissues. The most appropriate spring constraints for each knee were determined by comparing the kinematic outputs in terms of AP displacement and TR angle of the human knee with all the soft tissues intact, to the same knee with all the soft tissues resected and replaced with virtual spring constraints (spring rate and free length/degree). The virtual spring conditions that showed the least difference in the AP displacement and TR angle outputs compared to the intact knee were considered to be the most appropriate spring conditions for each knee. The resulting AP displacement and TR angle profiles under the appropriate virtual spring conditions all showed similar shapes to the individual intact knee for each donor. This indicated that the application of the combination of virtual AP and TR springs with appropriate free lengths/degrees was successful in simulating the natural human knee soft tissue function. Each human knee joint had different kinematics as a result of variations in anatomy and soft tissue laxity. The most appropriate AP spring rate for the four human knees varied from 20 to 55 N/mm and the TR spring rate varied from 0.3 to 1.0 Nm/°. Consequently, the most appropriate spring condition for each knee was unique and required specific combinations of spring rate and free length/degree in each of the two axes.

This study investigated the fixation of a cemented PEEK femoral TKA component. PEEK and CoCr implants were subjected to a walking gait cycle for 10 million cycles (MC), 100,000 cycles or 0 cycles (unloaded control). A method was developed to assess the fixation at the cement&ndash, implant interface, which exposed the implants to a fluorescent penetrant dye solution. The lateral condyles of the implants were then sectioned and viewed under fluorescence to investigate bonding at the cement&ndash, implant interface and cracking of the cement mantle. When tested for 100,000 cycles, debonding of the cement&ndash, implant interface occurred in both PEEK (61%) and CoCr (13%) implants. When the duration of testing was extended (10 MC), the percentage debonding was further increased for both materials to 88% and 61% for PEEK and CoCr, respectively. The unloaded PEEK specimens were 79% debonded, which suggests that, when PEEK femoral components are cemented, complete bonding may never occur. Analysis of cracks in the cement mantle showed an absence of full-thickness cracks in the unloaded control group. For the 100,000-cycle samples, on average, 1.3 and 0.7 cracks were observed for PEEK and CoCr specimens, respectively. After 10 MC, these increased to 24 for PEEK and 19 for CoCr. This was a preliminary study with a limited number of samples investigated, but shows that, after 10 MC under a walking gait, substantial debonding was visible for both PEEK and CoCr implants at the cement&ndash, implant interface and no significant difference in the number of cement cracks was found between the two materials.

PEEK-OPTIMA&trade, is being considered as an alternative to cobalt chrome (CoCr) in the femoral component of total knee replacements. To date, investigations of ultra-high molecular weight polyethylene (UHMWPE)-on-PEEK have shown an equivalent wear rate to conventional implant materials under standard conditions. In this study, the third body wear performance of UHMWPE-on-PEEK was directly compared to UHMWPE-on-CoCr in a series of pin-on-plate studies using two approaches for third body damage. Damage simulation with particles of bone cement showed a significant (p &lt, 0.001), four-fold increase in the mean surface roughness of PEEK plates compared to CoCr. However, wear simulation against the damaged plates showed no significant difference in the wear of UHMWPE pins against the different materials (p = 0.59), and a polishing effect by the pin against the PEEK plates was observed. Scratching PEEK and CoCr counterfaces with a diamond stylus to create scratches representative of severe third body damage (4 &micro, m lip height) resulted in a significantly higher (p = 0.01) wear of UHMWPE against CoCr compared to PEEK and again, against PEEK plates, polishing by the UHMWPE pin led to a reduction in scratch lip height. This study shows that in terms of its wear performance under third body wear/damage conditions, UHMWPE-on-PEEK differs from conventional knee replacement materials.

Osteochondral grafts are used clinically to repair cartilage and bone defects and to restore the congruent articulating surfaces of the knee joint following cartilage damage or injury. The clinical success of such osteochondral grafts is heavily reliant on the biomechanical and tribological properties of the surgical repair; however, a limited number of studies have investigated these factors. The aim of this study was to evaluate the influence of graft harvesting and implantation technique as well as bone properties on the primary stability of press-fit implanted osteochondral grafts using a series of uniaxial experimental push-in and push-out tests. Animal (porcine and bovine) knees were used to deliver models of different bone properties (elastic modulus and yield stress). The study showed the graft harvesting method using either a chisel or drill-aided trephine to have no influence on primary graft stability; however, the preparation technique for the graft recipient site was shown to influence the force required to push the graft into the host tissue. For example, when the length of the graft was equal to the recipient site (bottomed), the graft was more stable and dilation of the recipient site was shown to reduce short-term graft stability especially in immature or less dense bone tissue. The push-out tests which compared tissue of different skeletal maturities demonstrated that the maturity of both the graft and host bone tissue to influence the stability of the graft. A higher force was required to push out more skeletally mature grafts from mature bone tissue. The study demonstrates the importance of surgical technique and bone quality/properties on the primary stability and ultimately, the success of osteochondral grafts in the knee.

The aims of this study were to develop a biological large diameter vascular graft by decellularisation of native human aorta to remove the immunogenic cells whilst retaining the essential biomechanical, and biochemical properties for the ultimate benefit of patients with infected synthetic grafts. Donor aortas (n = 6) were subjected to an adaptation of a propriety decellularisation process to remove the cells and acellularity assessed by histological analysis and extraction and quantification of total DNA. The biocompatibility of the acellular aortas was determined using standard contact cytotoxicity tests. Collagen and denatured collagen content of aortas was determined and immunohistochemistry was used to determine the presence of specific extracellular matrix proteins. Donor aortas (n = 6) were divided into two, with one half subject to decellularisation and the other half retained as native tissue. The native and decellularised aorta sections were then subject to uniaxial tensile testing to failure [axial and circumferential directions] and suture retention testing. The data was compared using a paired t-test. Histological evaluation showed an absence of cells in the treated aortas and retention of histoarchitecture including elastin content. The decellularised aortas had less than 15 ng mg¯¹ total DNA per dry weight (mean 94% reduction) and were biocompatible as determined by in vitro contact cytotoxicity tests. There were no gross changes in the histoarchitecture [elastin and collagen matrix] of the acellular aortas compared to native controls. The decellularisation process also reduced calcium deposits within the tissue. The uniaxial tensile and suture retention testing revealed no significant differences in the material properties (p > 0.05) of decellularised aorta. The decellularisation procedure resulted in minimal changes to the biological and biomechanical properties of the donor aortas. Acellular donor aorta has excellent potential for use as a large diameter vascular graft.

A robust and stratified pre-clinical natural knee model, which has the capability to more appropriately simulate the biomechanical environment in vivo, will deliver more efficient and reliable assessment of soft tissue interventions before clinical studies. In order to simulate the biomechanical function of the natural knee without the natural ligaments in place, there is a requirement to develop appropriate spring constraints for the natural knee model. Therefore, this study was to investigate the effect of spring constraints on the function and output of the natural porcine knee model, and determine the spring constraint which most closely replicated the function of the natural ligaments. Two linear compression springs with stiffnesses of 9 N/mm (spring-9) and 20 N/mm (spring-20) were set at different free lengths in the anterior-posterior (A/P) axis in a natural knee simulator. The kinematic (A/P displacement) and tribological properties (shear force) output of the simulator were compared at different spring settings. The most appropriate spring setting was determined by comparing the A/P displacement and shear force output at different spring settings with those of the all ligaments model. Spring-9 with a free length of 4 mm showed the minimal difference (-0.03±0.68 mm) in A/P displacement output and spring-20 with a free length of 5 mm showed the minimal difference (-0.10±0.73 mm) in A/P displacement output compared to the all ligament control. There was no statistical difference between the two minimal differences either in A/P displacement or in shear force (paired t-test, p = 0.58, and p = 0.68 respectively) when both spring settings matched most closely to the A/P kinematics of the intact knee. This indicated that both conditions were appropriate spring constraints settings in the A/P direction for the natural porcine knee model.

PEEK-OPTIMA™ (Invibio Ltd, UK) has been considered as an alternative joint arthroplasty bearing material due to its favourable mechanical properties and the biocompatibility of its wear debris. In this study, the potential to use injection moulded PEEK-OPTIMA™ as an alternative to cobalt chrome in the femoral component of a total knee replacement was investigated in terms of its wear performance. Experimental wear simulation of three cobalt chrome and three PEEK-OPTIMA™ femoral components articulating against all-polyethylene tibial components was carried out under two kinematic conditions: 3 million cycles under intermediate kinematics (maximum anterior-posterior displacement of 5 mm) followed by 3 million cycles under high kinematic conditions (anterior-posterior displacement 10 mm). The wear of the GUR1020 ultra-high-molecular-weight polyethylene tibial components was assessed by gravimetric analysis; for both material combinations under each kinematic condition, the mean wear rates were low, that is, below 5 mm3/million cycles. Specifically, under intermediate kinematic conditions, the wear rate of the ultra-high-molecular-weight polyethylene tibial components was 0.96 ± 2.26 mm3/million cycles and 2.44 ± 0.78 mm3/million cycle against cobalt chrome and PEEK-OPTIMA™ implants, respectively (p = 0.06); under high kinematic conditions, the wear rates were 2.23 ± 1.85 mm3/million cycles and 4.44 ± 2.35 mm3/million cycles, respectively (p = 0.03). Following wear simulation, scratches were apparent on the surface of the PEEK-OPTIMA™ femoral components. The surface topography of the femoral components was assessed using contacting profilometry and showed a statistically significant increase in measured surface roughness of the PEEK-OPTIMA™ femoral components compared to the cobalt chrome implants. However, this did not appear to influence the wear rate, which remained linear over the duration of the study. These preliminary findings showed that PEEK-OPTIMA™ gives promise as an alternative bearing material to cobalt chrome alloy in the femoral component of a total knee replacement with respect to wear performance.

Hip joint simulators are used extensively for preclinical testing of hip replacements. The variation in simulator design and test conditions used worldwide can affect the tribological performance of polyethylene. The aim of this study was to assess the effects of simulator mechanics and design on the wear and creep of ultra-high-molecular-weight polyethylene. In the first part of this study, an electromechanical simulator and pneumatic simulator were used to compare the wear and creep of metal-on-polyethylene components under the same standard gait conditions. In the second part of the study, the same electromechanical hip joint simulator was used to investigate the influence of kinematics on wear. Higher wear rates and penetration depths were observed from the electromechanical simulator compared with the pneumatic simulator. When adduction/abduction was introduced to the gait cycle, there was no significant difference in wear with that obtained under the gait cycle condition without adduction/abduction. This study confirmed the influence of hip simulator design and loading conditions on the wear of polyethylene, and therefore direct comparisons of absolute wear rates between different hip joint simulators should be avoided. This study also confirmed that the resulting wear path was the governing factor in obtaining clinically relevant wear rates, and this can be achieved with either two axes or three axes of rotations. However, three axes of rotation (with the inclusion of adduction/abduction) more closely replicate clinical conditions and should therefore be the design approach for newly developed hip joint simulators used for preclinical testing.

Ceramic composites have performed very well under adverse edge loading conditions when used in like-on-like configurations, where the femoral head and acetabular cup are of the same material. The aim of this study was to determine the wear of pure alumina (Al2 O3 ), alumina toughened zirconia (ATZ) and zirconia toughened alumina (ZTA) when used in mixed bearing combinations, under edge loading conditions due to translational mal-positioning. The head-on-cup configurations of three ceramic materials were ATZ-on-ZTA, ZTA-on-ATZ, Al2 O3 -on-ATZ, ATZ-on-Al2 O3 , Al2 O3 -on-ZTA, and ZTA-on-Al2 O3 . They were tested on the Leeds II hip simulator under microseparation conditions. The bedding in and steady state wear rates of ATZ-on-ZTA were 1.16mm3 /million cycles and 0.18mm3 /million, respectively, and for ATZ-on-Al2 O3 were 0.66 mm3 /million cycles and 0.20 mm3 /million, respectively. The wear rates of the other bearing combinations under these adverse microseparation conditions, Al2 O3 -on-ATZ, Al2 O3 -on-ZTA, ZTA-on-ATZ and ZTA-on-Al2 O3 were very low with no clear bedding in and steady state phases, and with steady state wear rates lower than 0.11 mm3 /million. The mixed material combinations tested in this study have shown slightly higher wear rates when compared to ATZ in like-on-like configuration reported previously, but superior wear resistance when compared to alumina-on-alumina bearings tested previously under the same adverse microseparation conditions. © 2016 The Authors Journal of Biomedical Materials Research Part B: Applied Biomaterials Published by Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 105B: 1361-1368, 2017.

The successful development of cartilage repair treatments for the knee requires understanding of the biomechanical environment within the joint. Computational finite element models play an important role in non-invasively understanding knee mechanics, but it is important to compare model findings to experimental data. The purpose of this study was to develop a methodology for generating subject-specific finite element models of porcine tibiofemoral joints that was robust and valid over multiple different constraint scenarios. Computational model predictions of two knees were compared to experimental studies on corresponding specimens loaded under several different constraint scenarios using a custom designed experimental rig, with variations made to the femoral flexion angle and level of tibial freedom. For both in vitro specimens, changing the femoral flexion angle had a marked effect on the contact distribution observed experimentally. With the tibia fixed, the majority of the contact region shifted to the medial plateau as flexion was increased. This did not occur when the tibia was free to displace and rotate in response to applied load. These trends in contact distribution across the medial and lateral plateaus were replicated in the computational models. In an additional model with the meniscus removed, contact pressures were elevated by a similar magnitude to the increase seen when the meniscus was removed experimentally. Overall, the models were able to capture specimen-specific trends in contact distribution under a variety of different loads, providing the potential to investigate subject-specific outcomes for knee interventions.

A review of research undertaken to evaluate the biomechanical stability and biotribological behaviour of osteochondral grafts in the knee joint and a brief discussion of areas requiring further improvement in future studies are presented. The review takes into consideration osteochondral autografts, allografts, tissue engineered constructs and synthetic and biological scaffolds.

The successful development of early-stage cartilage and meniscus repair interventions in the knee requires biomechanical and biotribological understanding of the design of the therapeutic interventions and their tribological function in the natural joint. The aim of this study was to develop and validate a porcine knee model using a whole joint knee simulator for investigation of the tribological function and biomechanical properties of the natural knee, which could then be used to pre-clinically assess the tribological performance of cartilage and meniscal repair interventions prior to in vivo studies. The tribological performance of standard artificial bearings in terms of anterior–posterior (A/P) shear force was determined in a newly developed six degrees of freedom tribological joint simulator. The porcine knee model was then developed and the tribological properties in terms of shear force measurements were determined for the first time for three levels of biomechanical constraints including A/P constrained, spring force semi-constrained and A/P unconstrained conditions. The shear force measurements showed higher values under the A/P constrained condition (predominantly sliding motion) compared to the A/P unconstrained condition (predominantly rolling motion). This indicated that the shear force simulation model was able to differentiate between tribological behaviours when the femoral and tibial bearing was constrained to slide or/and roll. Therefore, this porcine knee model showed the potential capability to investigate the effect of knee structural, biomechanical and kinematic changes, as well as different cartilage substitution therapies on the tribological function of natural knee joints.

Wear of total knee replacement continues to be a significant factor influencing the clinical longevity of implants. Historically, failure due to delamination and fatigue directed design towards more conforming inserts to reduce contact stress. As new generations of more oxidatively stable polyethylene have been developed, more flexibility in bearing design has been introduced. The aim of this study was to investigate the effect of insert conformity on the wear performance of a fixed bearing total knee replacement through experimental simulation. Two geometries of insert were studied under standard gait conditions. There was a significant reduction in wear with reducing implant conformity. This study has demonstrated that bearing conformity has a significant impact on the wear performance of a fixed bearing total knee replacement, providing opportunities to improve clinical performance through enhanced material and design selection.

The aim of this study was to adapt a proprietary decellularisation process for human dermis for use with porcine skin. Porcine skin was subject to: sodium chloride (1 M) to detach the epidermis, trypsin paste to remove hair follicles, peracetic acid (0.1% v/v) disinfection, washed in hypotonic buffer and 0.1% (w/v) sodium dodecyl sulphate in the presence of proteinase inhibitors followed by nuclease treatment. Cellular porcine skin, decellularised porcine and human dermis were compared using histology, immunohistochemistry, GSL-1 lectin (alpha-gal epitope) staining, biochemical assays, uniaxial tensile and in vitro cytotoxicity tests. There was no microscopic evidence of cells in decellularised porcine dermis. DNA content was reduced by 98.2% compared to cellular porcine skin. There were no significant differences in the biomechanical parameters studied or evidence of cytotoxicity. The decellularised porcine dermis retained residual alpha-gal epitope. Basement membrane collagen IV immunostaining was lost following decellularisation; however, laminin staining was retained.

Complications of patellofemoral arthroplasty often occur soon after implantation and, as well as other factors, can be due to the design of the implant or its surgical positioning. A number of studies have previously considered the wear of ultra-high-molecular-weight polyethylene patellae following suboptimal implantation; however, studies have primarily been carried out under a limited number of degrees of freedom. The aim of this study was to develop a protocol to assess the wear of patellae under a malaligned condition in a six-axis patellofemoral joint simulator. The malalignment protocol hindered the tracking of the patella centrally in the trochlear groove and imparted a constant 5° external rotation (tilt) on the patella button. Following 3 million cycles of wear simulation, this condition had no influence on the wear of ultra-high-molecular-weight polyethylene patellae aged for 4 years compared to well-positioned non-aged implants (p > 0.05). However, under the malaligned condition, ultra-high-molecular-weight polyethylene patellae aged 8–10 years after unpacking (following sterilisation by gamma irradiation in an inert atmosphere) and worn ultra-high-molecular-weight polyethylene components also aged 4 years after unpacking (following the same sterilisation process) exhibited a high rate of wear. Fatigue failure due to elevated contact stress led to delamination of the ultra-high-molecular-weight polyethylene and in some cases complete failure of the patellae. The results suggest that suboptimal tracking of the patella in the trochlear groove and tilt of the patella button could have a significant effect on the wear of ultra-high-molecular-weight polyethylene and could lead to implant failure.

The clinical use of decellularized cardiac valve allografts is increasing. Long‐term data will be required to determine whether they outperform conventional cryopreserved allografts. Valves decellularized using different processes may show varied long‐term outcomes. It is therefore important to understand the effects of specific decellularization technologies on the characteristics of donor heart valves. Human cryopreserved aortic and pulmonary valved conduits were decellularized using hypotonic buffer, 0.1% (w/v) sodium dodecyl sulfate and nuclease digestion. The decellularized tissues were compared to cellular cryopreserved valve tissues using histology, immunohistochemistry, quantitation of total deoxyribose nucleic acid, collagen and glycosaminoglycan content, in vitro cytotoxicity assays, uniaxial tensile testing and subcutaneous implantation in mice. The decellularized tissues showed no histological evidence of cells or cell remnants and >97% deoxyribose nucleic acid removal in all regions (arterial wall, muscle, leaflet and junction). The decellularized tissues retained collagen IV and von Willebrand factor staining with some loss of fibronectin, laminin and chondroitin sulfate staining. There was an absence of major histocompatibility complex Class I staining in decellularized pulmonary valve tissues, with only residual staining in isolated areas of decellularized aortic valve tissues. The collagen content of the tissues was not decreased following decellularization however the glycosaminoglycan content was reduced. Only moderate changes in the maximum load to failure of the tissues were recorded postdecellularization. The decellularized tissues were noncytotoxic in vitro, and were biocompatible in vivo in a mouse subcutaneous implant model. The decellularization process will now be translated into a good manufacturing practices‐compatible process for donor cryopreserved valves with a view to future clinical use. Copyright © 2016 The Authors Tissue Engineering and Regenerative Medicine published by John Wiley & Sons, Ltd.

New bearing materials for total joint replacement have been explored as the need to improve longevity and enhance performance is driven by the changing demands of the patient demographic. Carbon-reinforced PEEK has demonstrated good wear characteristics in experimental wear simulation in both simple geometry pin-on-plate studies and in total hip joint replacement. Carbon reinforced PEEK CFR-PEEK has the potential to reduce tibial insert thickness and preserve bone in the knee. This study investigated the wear performance of PEEK and CFR-PEEK in a low conformity total knee replacement configuration. Custom-made flat inserts were tested against cobalt-chromium femoral bearings in a knee wear simulation for a period of three million cycles. Wear was assessed gravimetrically at intervals throughout the study. The wear rates of both PEEK and CFR-PEEK were very high and almost two orders of magnitude higher than the wear rate of UHMWPE under comparable conditions. Evidence of mechanical failure of the materials, including surface cracking and delamination was observed in both materials. This study highlights that these materials may not be suitable alternatives for UHMWPE in low-conformity designs., Highlights • Study investigated wear of PEEK and CFR-PEEK as alternative to PE in TKR. • Very high wear rates observed for both PEEK and CFR-PEEK. • Wear rates two orders of magnitude higher than UHWMPE under same conditions. • Evidence of mechanical failure of PEEK and CFR-PEEK materials.

As life expectancy and activity levels of patients increase so does the demand on total knee replacements (TKRs). Abnormal mechanics and wear of TKRs can lead to implant loosening and revision. Component alignment after surgery varies due to the presurgical alignment, the accuracy of the surgical instrumentation and due to patient factors, such as the soft tissue balance.\ud \ud This study experimentally investigated the effect of variation in component alignment and the soft tissue conditions on the kinematics and wear of a fixed bearing TKR. DePuy Sigma fixed bearing TKRs with moderately cross-linked UHMWPE were used. Different alignment conditions were simulated in the coronal, sagittal and transverse planes in an ISO force-controlled simulation system. Three different soft tissue conditions were simulated using virtual springs to represent a stiff knee, a preserved PCL and a resected PCL.\ud \ud Four different alignment conditions were studied; ideal alignment, 4° tibial and femoral varus joint line, 14° rotational mismatch and 10° posterior tibial slope. The varus joint line alignment resulted in similar kinematics and lower wear rate compared to ideal alignment. The rotational mismatch alignment resulted in significantly higher tibial rotation and abduction-adduction as well as a significantly higher wear rate than ideal alignment. The posterior tibial slope alignment resulted in significantly higher wear than the ideal alignment and dislocated under the lower tension soft tissue conditions.\ud \ud Component alignment and the soft tissue conditions had a significant effect on the kinematics and wear of the TKR investigated in this study. The surgical alignment of the TKR is an important factor in the clinical outcome of the joint as factors such as increased tibial rotation can lead to anterior knee pain and instability and increased wear can lead to aseptic loosening and early failure resulting in revision.

Total joint replacement is a successful surgical intervention for the treatment of the degeneration of many joints, particularly the hip and knee. As the demand for joint replacement grows, and the life expectancy of the population increases, the performance requirements of these implants also changes. New materials, to improve longevity and enhance performance have been explored including PEEK and CFR-PEEK. \ud \ud \ud This study investigated whether CFR-PEEK and PEEK were appropriate materials for total joint replacement by examining wear performance in simple configuration studies articulating against cobalt chrome under a range of cross-shear and contact pressure conditions. Simple geometry pin on plate studies were conducted for one million cycles for each test condition, with the contact pressure and cross-shear conditions representing a range in which the material may need to operate in-vivo. \ud \ud \ud The wear factor for PEEK was significantly higher than CFR-PEEK and conventional polyethylene under all test conditions. Both PEEK and CFR-PEEK wear were influenced by contact pressure, with the highest wear factors for both materials measured at the highest pressure conditions. PEEK appeared to have a cross-shear dependent wear response, but this was not observed for the CFR-PEEK material. \ud \ud \ud This study has further characterised the wear performance of two materials that are gaining interest for total joint replacement. The wear performance of the PEEK material showed poorer wear performance compared to polyethylene when articulating with a metal counterface, but the performance of the CFR-PEEK material suggested it may provide a suitable alternative to polyethylene in some applications. The wear performance of CFRPEEK was poorer than polyethylene when it was used as the plate, when there was translation of the contact zone over the surface of the CFR-PEEK plate. This has implications for applications in low conforming contacts, such as lower conformity knee replacement.

PEEK-OPTIMA™ (Invibio Ltd, UK) has been considered as an alternative joint arthroplasty bearing material due to its favourable mechanical properties and the biocompatibility of its wear debris. In this study, the potential to use injection moulded PEEK-OPTIMA™ as an alternative to cobalt chrome in the femoral component of a total knee replacement was investigated in terms of its wear performance. Experimental wear simulation of three cobalt chrome and three PEEK-OPTIMA™ femoral components articulating against all-polyethylene tibial components was carried out under two kinematic conditions: 3 million cycles under intermediate kinematics (maximum anterior-posterior displacement of 5 mm) followed by 3 million cycles under high kinematic conditions (anterior-posterior displacement 10 mm). The wear of the GUR1020 ultra-high-molecular-weight polyethylene tibial components was assessed by gravimetric analysis; for both material combinations under each kinematic condition, the mean wear rates were low, that is, below 5 mm3/million cycles. Specifically, under intermediate kinematic conditions, the wear rate of the ultra-high-molecular-weight polyethylene tibial components was 0.96 ± 2.26 mm3/million cycles and 2.44 ± 0.78 mm3/million cycle against cobalt chrome and PEEK-OPTIMA™ implants, respectively (p = 0.06); under high kinematic conditions, the wear rates were 2.23 ± 1.85 mm3/million cycles and 4.44 ± 2.35 mm3/million cycles, respectively (p = 0.03). Following wear simulation, scratches were apparent on the surface of the PEEK-OPTIMA™ femoral components. The surface topography of the femoral components was assessed using contacting profilometry and showed a statistically significant increase in measured surface roughness of the PEEK-OPTIMA™ femoral components compared to the cobalt chrome implants. However, this did not appear to influence the wear rate, which remained linear over the duration of the study. These preliminary findings showed that PEEK-OPTIMA™ gives promise as an alternative bearing material to cobalt chrome alloy in the femoral component of a total knee replacement with respect to wear performance.

Metal-on-metal (MoM) bearings have shown low-wear rates under standard hip simulator conditions; however, retrieval studies have shown large variations in wear rates and mechanisms. High-wear in vivo has caused catastrophic complications and has been associated with steep cup-inclination angle (rotational malpositioning). However, increasing the cup-inclination angle in vitro has not replicated the increases in wear to the same extent as those observed in retrievals. Clinically relevant wear rates, patterns, and particles were observed in vitro for ceramic-on-ceramic bearings when microseparation (translational malpositioning) conditions were introduced into the gait cycle. In the present study, 28 and 36-mm MoM bearings were investigated under adverse conditions. Increasing the cup angle from 45° to 65° resulted in a significant increase in the wear rate of the 28 mm bearings. However, for the 36 mm bearings, head-rim contact did not occur under the steep cup-angle condition, and the wear rate did not increase. The introduction of microseparation to the gait cycle significantly increased the wear rate of the MoM bearings. Cup angle and head size did not influence the wear rate under microseparation conditions. This study indicated that high-in vivo wear rates were associated with edge loading due to rotational malpositioning such as high-cup-inclination angle and translational malpositioning that could occur due to several surgical factors. Translational malpositioning had a more dominant effect on the wear rate. Preclinical simulation testing should be undertaken with translational and rotational malpositioning conditions as well as standard walking cycle conditions defined by the ISO standard. © 2012 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 2013.

Polyethylene wear is a great concern in total joint replacement. It is now considered a major limiting factor to the long life of such prostheses. Cross-linking has been introduced to reduce the wear of ultra-high-molecular-weight polyethylene (UHMWPE). Computational models have been used extensively for wear prediction and optimization of artificial knee designs. However, in order to be independent and have general applicability and predictability, computational wear models should be based on inputs from independent experimentally determined wear parameters (wear factors or wear coefficients). The objective of this study was to investigate moderately cross-linked UHMWPE, using a multidirectional pin-on-plate wear test machine, under a wide range of applied nominal contact pressure (from 1 to 11 MPa) and under five different kinematic inputs, varying from a purely linear track to a maximum rotation of ±55°. A computational model, based on a direct simulation of the multidirectional pin-on-plate wear tester, was developed to quantify the degree of cross-shear (CS) of the polyethylene pins articulating against the metallic plates. The moderately cross-linked UHMWPE showed wear factors less than half of that reported in the literature for the conventional UHMWPE, under the same loading and kinematic inputs. In addition, under high applied nominal contact stress, the moderately cross-linked UHMWPE wear showed lower dependence on the degree of CS compared to that under low applied nominal contact stress. The calculated wear coefficients were found to be independent of the applied nominal contact stress, in contrast to the wear factors that were shown to be highly pressure dependent. This study provided independent wear data for inputs into computational models for moderately cross-linked polyethylene and supported the application of wear coefficient–based computational wear models.

A new Stratified Approach For Enhanced Reliability (SAFER) pre-clinical simulation testing of joint prostheses has been described in a preceding paper in this volume. The application of SAFER in vitro simulation and testing to metal-on-metal bearings is described in this review paper. The review aims to provide further understanding of the reasons for, and causes of, increased wear in metal-on-metal hips in a proportion of patients. Variation in positioning (mal-positioning) of the head and cup in hip prostheses results in the head contacting the rim of the cup and producing increased wear. Variation in both translational and rotational positioning has been investigated. Variation in translational positioning of the centres of the head and cup, which is not detected on radiographs, is a frequent occurrence clinically and can result in a substantial increase in wear rate. The variation in translational positioning acts synergistically with variation in rotational positioning to produce substantial increases in wear. These recent findings are consistent with the wear mechanisms and formation of stripe wear reported for ceramic-on-ceramic bearings over a decade ago, and provide insight into the reasons for the variation and increases in the wear rate found clinically in metal-on-metal hips in specific patients, which may cause premature failure.

Polyethylene wear is considered a threat to the long term survival of total knee replacements. The aim of this study was to investigate the contribution that resurfacing the patella makes to wear debris-induced osteolysis following total knee replacement. Ultra-high molecular-weight polyethylene wear particles were isolated from simulator lubricant. Particle shape, size, and volume distributions were recorded allowing the osteolytic potential of the wear debris produced in the patellofemoral joint to be estimated using the concept of specific biological activity and functional biological activity. Values were compared with those reported for the tibiofemoral joint. Specific biological activity for the patellofemoral joint was not significantly different from the values for the tibiofemoral joint of total knee replacement devices, and therefore, has a similar potential to stimulate osteolytic cytokine release from macrophages. Functional biological activity was significantly lower for the patellofemoral joint compared with the tibiofemoral joint. Functional biological activity was significantly lower for the patellofemoral joint compared with the fixed bearing and rotating platform total knee replacement devices. However, as patellar resurfacing is commonly fitted as part of a total knee replacement system, this results in a 20% increase in overall functional biological activity for the system. Therefore, implanting a patellar resurfacing will increase the potential for osteolysis in the knee.

The wear and creep characteristics of highly crosslinked ultrahigh-molecular-weight polyethylene (UHMWPE) articulating against large-diameter (36 mm) ceramic and cobalt chrome femoral heads have been investigated in a physiological anatomical hip joint simulator for 10 million cycles. The crosslinked UHMWPE/ceramic combination showed higher volume deformation due to creep plus wear during the first 2 million cycles, and a steady-state wear rate 40 per cent lower than that of the crosslinked UHMWPE/cobalt chrome combination. Wear particles were isolated and characterized from the hip simulator lubricants. The wear particles were similar in size and morphology for both head materials. The particle isolation methodology used could not detect a statistically significant difference between the particles produced by the cobalt chrome and alumina ceramic femoral heads.

Orthopedic hip implants are one of the most successful forms of arthroplasty with survivorships of over 20–30 years, however there are still reported cases of failure within 10 years of surgery. There is a continuous demand to develop lower wearing, safer and more reliable hip implants to reduce failure rates of these devices in vivo and to provide long lifetimes to younger and more active patients receiving implants. Ultra-high molecular weight polyethylene (UHMWPE) is used in the majority of hip prostheses. There is increasing expectation that these implants will function continuously without intervention for the life expectancy of the patient. The factors that determine the success of hip implants can be separated into three main categories: (1) biomechanical, (2) biological, and (3) biomaterial factors. The implant design, surgical method, and patient variation can all contribute to the success or failure of an implant following surgery.

In vivo fluoroscopic studies of patients with total knee replacements (TKRs) have shown lift-off of the femoral condyles from the tibial insert. This study investigated the influence of femoral condylar lift-off on the ultra-high molecular weight polyethylene (UHMWPE) wear of fixed bearing (FB) and rotating platform mobile bearing (RP MB) total knee replacements, using a physiological knee joint simulator. In the absence of lift-off, the RP MB knees exhibited a lower wear rate of 5.2;;2.2 mm3 per million cycles (mm3/MC) compared with 8.8;;4.8 mm3/MC for the FB knees. The presence of femoral condylar lift-off was found to accelerate the wear of the FB and RP MB knees tested in this study to 16.4;;2.9 and 16.9;;2.9 mm3/MC respectively. For the RP MB knees the increase in wear rate was more marked, resulting in a similar wear rate for both designs of knee under lift-off conditions. In both cases the medial condyle displayed more wear damage. This study has shown that a small amount of abduction/adduction lift-off and medial-lateral shift increases wear and that the increase in wear is design dependent. In this simulator test, lift-off was simulated on every cycle, whereas the amount of wear and effect of lift-off clinically would depend on the frequency of occurrence of lift-off in vivo.

Advancements in knee replacement design, material and sterilisation processes have provided improved clinical results. However, surface wear of the polyethylene leading to osteolysis is still considered the longer-term risk factor. Experimental wear simulation is an established method for evaluating the wear performance of total joint replacements. The aim of this study was to investigate the influence of simulation input conditions, specifically input kinematic magnitudes, waveforms and directions of motion and position of the femoral centre of rotation, on the wear performance of a fixed-bearing total knee replacement through a combined experimental and computational approach. Studies were completed using conventional and moderately cross-linked polyethylene to determine whether the influence of these simulation input conditions varied with material. The position of the femoral centre of rotation and the input kinematics were shown to have a significant influence on the wear rates. Similar trends were shown for both the conventional and moderately cross-linked polyethylene materials, although lower wear rates were found for the moderately cross-linked polyethylene due to the higher level of cross-linking. The most important factor influencing the wear was the position of the relative contact point at the femoral component and tibial insert interface. This was dependent on the combination of input displacement magnitudes, waveforms, direction of motion and femoral centre of rotation. This study provides further evidence that in order to study variables such as design and material in total knee replacement, it is important to carefully control knee simulation conditions. This can be more effectively achieved through the use of displacement control simulation.

Current international standards require pre-clinical testing of joint replacements under a standard walking cycle, with a standard patient, and with correctly positioned prostheses. These conditions do not replicate the wide variation in wear rates found with a wider range of conditions clinically. In this paper the effect of rotational and translational mal-positioning of the components of ceramic-on-ceramic and metal-on-metal hip prostheses on wear is reported. An elevated level of wear was found with translational mal-positioning and microseparation in ceramic-on-ceramic bearings, while a substantially elevated level of wear was found with both translational and rotational mal-positioning in metal-on-metal bearings.

The mean average life is increasing; therefore, there is a need to increase the lifetime of the prostheses. To fulfil this requirement, new prosthetic designs and materials are being introduced. Two of the design parameters that may affect wear of total knee replacements, and hence the expected lifetime, are the insert conformity and material. Computational models have been used extensively for wear prediction and optimisation of artificial knee designs. The objective of the present study was to use a previously validated non-dimensional wear coefficient-based computational wear model to investigate the effect of insert conformity and material on the predicted wear in total knee replacements. Four different inserts (curved, lipped, partial flat and custom flat), with different conformity levels, were tested against the same femoral and under two different kinematic inputs (intermediate and high), with different levels of cross-shear. The insert bearing materials were either conventional or moderately cross-linked ultra-high molecular weight polyethylene (UHMWPE). Wear predictions were validated against the experimental data from Leeds knee simulation tests. The predicted wear rates for the curved insert (most conformed) were more than three times those for the flat insert (least conformed). In addition, the computationally predicted average volumetric wear rates for moderately cross-linked UHMWPE bearings were less than half of their corresponding conventional UHMWPE bearings. Moreover, the wear of the moderately cross-linked UHMWPE was shown to be less dependent on the degree of cross-shear, compared to conventional UHMWPE. These results along with supporting experimental studies provide insight into the design variables, which may reduce wear in knee replacements.

Ceramic-on-ceramic bearings have become of great interest due to the substantial improvements in the manufacturing techniques and material properties and due to polyethylene wear debris–induced osteolysis and the issues with metal wear debris and ion release by metal-on-metal bearings. Edge loading conditions due to translational malpositioning (microseparation conditions) have been shown to replicate clinically relevant wear mechanisms and increase the wear of ceramic-on-ceramic bearings; thus, it was necessary to test new bearing materials and designs under these adverse conditions. The aim of this study was to assess the effect of increasing head size on the wear of BIOLOX® delta ceramic-on-ceramic bearings under edge loading conditions due to rotational (steep cup inclination angle) and translational (microseparation) malpositioning. In this study, six 36-mm ceramic-on-ceramic bearings (BIOLOX delta, CeramTec, Germany) were tested under standard and edge loading conditions using the Leeds II hip simulator and compared to the 28-mm bearings tested and published previously under identical conditions. The mean wear rate under standard gait conditions was below 0.1 mm3/million cycles for both the 28-mm and the 36-mm ceramic-on-ceramic bearings, and increasing the inclination angle did not affect the wear rates. The introduction of microseparation to the gait cycle increased the wear rate of ceramic-on-ceramic bearing and resulted in stripe wear on the femoral heads. Under microseparation conditions, the wear rate of size 36-mm bearings (0.22 mm3/million cycles) was significantly higher ( p = 0.004) than that for size 28-mm bearings (0.13 mm3/million cycles). This was due to the larger contact area for the larger bearings and deprived lubrication under edge loading conditions. The wear rate of BIOLOX delta ceramic-on-ceramic bearings under microseparation conditions was still very low ( 3/million cycles) compared to earlier generation ceramic-on-ceramic bearings (BIOLOX forte, 1.84 mm3/million cycles) and other bearing materials such as metal-on-metal bearings (2–8 mm3/million cycles).

Cross-linked polyethylene has been introduced into total joint replacement to improve wear resistance. Although the performance of highly cross-linked polyethylene is well documented clinically and experimentally for total hip replacements, the reduction in mechanical properties with increasing irradiation is of concern for application to total knee replacement. The aim of this study was to investigate the wear performance of a moderately cross-linked polyethylene material in a fixed-bearing total knee replacement. The study was conducted using two femoral geometries, a conventional cruciate-retaining femoral and a high-flexion femoral geometry. The femoral geometry appeared to have no effect on the wear of the knee replacement under standard gait conditions. A significant reduction in wear volume was measured with the moderately cross-linked polyethylene compared with the conventional polyethylene over a six-million-cycle wear study. This study indicates the use of a moderately cross-linked polyethylene in a fixed-bearing total knee replacement may provide a low wearing option for total knee replacement.

Further development of ceramic materials for total hip replacement aim to increase fracture toughness and further reduce the incidence of bearing fracture. Edge loading due to translational mal positioning (microseparation) has replicated stripe wear, wear rates, and bimodal wear debris observed on retrievals. This method has replicated the fracture of early zirconia ceramic-on-ceramic bearings. This has shown the necessity of introducing microseparation conditions to the gait cycle when assessing the tribological performance of new hip replacement bearings. Two novel ceramic matrix composite materials, zirconia-toughened alumina (ZTA) and alumina-toughened zirconia (ATZ), were developed by Mathys Orthopadie GmbH. In this study, ATZ-on-ATZ and ZTA-on-ZTA bearing combinations were tested and compared with alumina-on-alumina (Al2O3-on-Al2O3) bearings under adverse microseparation and edge loading conditions using the Leeds II physiological anatomical hip joint simulator. The wear rate (±95% confidence limit) of ZTA-on-ZTA was 0.14 ± 0.10 mm3/million cycles and that of ATZ-on-ATZ was 0.06 ± 0.004 mm3/million cycles compared with a wear rate of 0.74 ± 1.73 mm3/million cycles for Al2O3-on-Al2O3 bearings. Stripe wear was evident on all bearing combinations; however, the stripe formed on the ATZ and ZTA femoral heads was thinner and shallower that that formed on the Al2O3 heads. Posttest phase composition measurements for both ATZ and ZTA materials showed no significant change in the monoclinic zirconia content. ATZ-on-ATZ and ZTA-on-ZTA showed superior wear resistance properties when compared with Al2O3-on-Al2O3 under adverse edge loading conditions. © 2013 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 101B: 1456–1462, 2013.