A novel apparatus to assess the mechanical properties of Ankle-Foot Orthoses: Stiffness analysis of the Codivilla spring.

Ankle-Foot Orthoses (AFOs) are the most common devices prescribed to support the ankle and restore a quasi-normal gait pattern in drop-foot patients. AFO stiffness is possibly the main mechanical property affecting foot and ankle biomechanics. A variety of methods to evaluate this property have been reported, however no standard procedure has been validated and widely used. This study is reporting the repeatability of a novel apparatus to measure AFO stiffness in ideal frictionless conditions. The apparatus is based on a servo-hydraulic testing machine and allows to apply a displacement-controlled rotation of the AFO shell, simulating the physiological ankle dorsi/plantarflexion movement. The repeatability of the apparatus in measuring AFO stiffness in dorsiflexion and plantarflexion was assessed intra- and inter-session in a sample of standard polypropylene AFOs of different sizes (Codivilla spring). The repeatability of the apparatus in measuring the AFO stiffness was high. The Intra- and Inter-session Coefficient of Variation ranged between 0.02 ÷ 1.3 % and 1.3 ÷ 5 %, respectively. The Intra Class Correlation Coefficient ranged between 0.999 ÷ 1 intra- and 0.993 ÷ 0.997 inter-session. AFOs stiffness was observed to increase with the AFO size. The setup is easy to replicate and can be implemented with any torsion-controlled servo-hydraulic testing machine and has resulted simple to use and flexible enough to adapt to AFOs with different sizes. The frictionless contacts characterizing the apparatus make it possible to measure the ideal AFO stiffness by excluding the effect of the fixation methods to the leg and help to improve the repeatability of measurements.

The effect of vacuum mixing and pre-heating the femoral component on the mechanical properties of the cement mantle.

We investigated the effect of pre-heating a femoral component on the porosity and strength of bone cement, with or without vacuum mixing used for total hip replacement. Cement mantles were moulded in a manner simulating clinical practice for cemented hip replacement. During polymerisation, the temperature was monitored. Specimens of cement extracted from the mantles underwent bending or fatigue tests, and were examined for porosity. Pre-heating the stem alone significantly increased the mean temperature values measured within the mantle (+14.2 degrees C) (p < 0.001) and reduced the mean curing time (-1.5 min) (p < 0.001). The addition of vacuum mixing modulated the mean rise in the temperature of polymerisation to 11 degrees C and reduced the mean duration of the process by one minute and 50 seconds (p = 0.01 and p < 0.001, respectively). In all cases, the maximum temperature values measured in the mould simulating the femur were < 50 degrees C. The mixing technique and pre-heating the stem slightly increased the static mechanical strength of bone cement. However, the fatigue life of the cement was improved by both vacuum mixing and pre-heating the stem, but was most marked (+ 280 degrees C) when these methods were combined. Pre-heating the stem appears to be an effective way of improving the quality of the cement mantle, which might enhance the long-term performance of bone cement, especially when combined with vacuum mixing.

Microindentation on cortical human bone: effects of tissue condition and indentation location on hardness values.

The hardness of cortical human bone has been measured on osteons in different conditions. However, no data are reported in the literature regarding the effect of cortical tissue condition and indentation location on the measured hardness values. This study aimed to investigate whether the hardness of the human cortical bone evaluated by micro-indentation is influenced, first, by the tissue condition and, second, by the distance of the indentation from the edge of the Haversian canal. Two femura were collected from a subject without musculoskeletal disease. The Vickers hardness was measured by means of microindentation (applied load, 100 gf) on osteons with a cross-section greater than 200 microm. The tests were performed on wet and embedded tissue at different distances from the Haversian canal edge (30-150 microm). No significant differences were found in hardness values between the two contralateral femura. Embedded tissue was significantly harder (12 per cent) than wet tissue. No significant differences were found in hardness values measured at different distances from the Haversian canal edge except for those closer than 60 microm. Therefore, indentations cannot be performed on osteons small in cross-section, since the distance from the closer pore has to be controlled. They should be performed on wet tissue, to avoid an offset in the measured hardness.

Effect of stem preheating on the fatigue behaviour of bone cement around hip prostheses.

Tensile fatigue behaviour of bone cement specimens obtained from cement mantles moulded in vitro, simulating the surgical scenario, was investigated. The effect of stem preheating, before its insertion into the cement dough, on specimen fatigue life was studied. A commercial bone cement was selected for this study. Bone cement mixing was conducted in air, following the manufacturer's instructions, and injected simulating the clinical practice. Two conditions were considered: stem maintained at the surgical room temperature (23 degrees C), and stem preheated to 45 degrees C. Four repetitions of the whole procedure were performed for each condition obtaining a total of 32 specimens. All specimens underwent fatigue testing (stress ratio, 0; maximum tensile stress, 15 MPa) until failure. Both two-parameter and three-parameter Weibull distributions were initially used to analyse the fatigue life data set. However, the two-parameter distribution was chosen for both groups on the basis of the coefficient of determination used to test the goodness of fit. Stem preheating seems to have a negligible effect on fatigue behaviour of the studied bone cement in the low range of fatigue lives (up to 10(4)). However, above this number of cycles, stem preheating seems to reduce the probability of failure. These findings are discussed in the text.

Composición corporal femenina en un equipo de gimnasia artística de alta competencia / Female body composition in high performance artistic gymnastics

El objetivo del trabajo es evaluar la composición corporal femenina en un grupo de gimnasia artística. Esta se caracteriza por el predominio de ejercicios basados en "fuerza-velocidad" con destreza, lográndose por lo general en gimnastas de escaso peso y altura.

Fracture properties of an acrylic bone cement.

This study investigated experimentally the fracture properties, i.e., the fatigue strength, the resistance to crack propagation and the fracture toughness, of an acrylic bone cement (Cemex RX). The mean endurance limit was determined following the staircase method. The endurance limit was estimated at 9.2 MPa. The fatigue crack propagation rate was measured according to the ASTM E647 standard. The equation of the line fitting the crack growth per cycle (da/dN) versus the stress-intensity factor range (delta K), in a log-log graph, was used to calculate the empirical constants of Paris' law for the selected bone cement: da/dN (m/cycle) = 3.56 x 10(-7) x delta K (MPa x m1/2)5.79. This power-law relationship described well (R2 = 0.96) the growth rate in the stable crack growth region, i.e., in the mid delta K range. The fracture toughness K(IC) of the bone cement was determined according to the ASTM E399 standard. The K(IC) mean value was 1.38 MPa x m1/2. These experimental results provide the set of necessary inputs for numerical studies aimed to investigate the damage accumulation process in the mantle fixing cemented prostheses.

Dependence of mechanical compressive strength on local variations in microarchitecture in cancellous bone of proximal human femur.

Human cancellous bone is a heterogeneous material. Despite this, most of the published studies report correlations between mechanical properties and morphometric parameters averaged on the whole specimen. This work investigated whether local variations in morphometric parameters were linked to the localized failure regions of cancellous bone. Additionally, it was examined whether local values of morphometric parameters can predict the ultimate stress better than the average bone volume fraction (BV/TV). Cylindrical cancellous bone specimens extracted along the primary compressive group of human femoral heads were studied. These were microCT-imaged to assess the morphometric parameters, compressed to determine the ultimate stress, and rescanned by microCT to visualize the failure region. Failure involved slightly less than half of the free height of the specimens. Significant differences were found in the morphometric parameters calculated in the failure and in the non-failure regions. The cross-sections containing minimum BV/TV values were those most often located inside the failure region (83%, p<0.001). Regression analysis confirmed that variations in BV/TV best describe variations in ultimate stress (R2=0.84) out of the averaged morphometric parameters. The prediction of ultimate stress increased when minimum or maximum values of the morphometric parameters were taken, with the highest prediction found by considering the minimum BV/TV (R2=0.95). In conclusion, due to the heterogeneity of cancellous bone, there may exist regions characterized by a different microarchitecture, where the bone is weaker and consequently is more likely to fail. These regions mostly contain minimum values in BV/TV, which were found to predict ultimate stress better than average BV/TV.

Structural parameters and mechanical strength of cancellous bone in the femoral head in osteoarthritis do not depend on age.

For normal bone, aging has been associated with a decrease of both density and failure strength, and with the development of pathologies such as osteoporosis. Conversely, it has been reported that another common disease, osteoarthritis, may alter these age-related changes in cancellous bone, suggesting that it may have a protective role against osteoporosis and the correspondent fracture risk. It was reported that in the principal compressive region of the femoral head in osteoarthritis the bone density does not depend on age. However, it is not clear if this independence on age of the cancellous bone density corresponds also to a reduced dependence on age of the strength to failure. The present work examined cancellous bone from the principal compressive region of the femoral head of 37 patients having severe osteoarthritis. The aim was (1) to investigate the dependence on age of both the structural parameters and the ultimate stress and (2) to investigate the relationships between the ultimate stress and the structural parameters. Using X-ray microcomputed tomography, three-dimensional structural parameters, such as bone volume fraction, direct trabecular thickness and structure model index were calculated. Then the specimens were compressed to failure to determine the ultimate stress. It was found that none of the investigated structural parameters did depend on age, and also the ultimate stress did not depend on age (p>0.05 for all regressions on age). In addition, the ultimate stress was significantly correlated with the structural parameters, primary with the minimum bone volume fraction and the average bone volume fraction (R(2)=0.95 and R(2)=0.84, respectively). These findings show that severe osteoarthritis or a related factor may change the age dependences of both the structural parameters and the mechanical properties usually reported for normal cancellous bone. These results suggest for this pathology to have a protective role against the age-related decrease in density, the age-related deterioration of the microarchitecture and the age-related decrease of the failure strength for the cancellous bone in the principal compressive region of the human femoral head.

Radiopacity of tantalum-loaded acrylic bone cement.

Radiopacifying agents are commonly added to bone cements to enhance the visibility of the cement in radiography. The radiopacifiers usually employed may, however, have undesired effects on the mechanical properties of the cement. A potentially new radiopacifier is tantalum, which in the present work was evaluated in terms of radiopacity. Bone cements containing different percentages of tantalum were compared with plain bone cement as well as with formulations containing different percentages of the commonly used radiopacifier barium sulphate. The radiopacity was assessed quantitatively and qualitatively, by measuring with a digital densitometer the optical density of the cement on X-ray films, and consulting the expertise of ten orthopaedic surgeons. It was found that tantalum does present radiopacity, but not as high as barium sulphate under the specific conditions applied to this study.

Comparative and experimental study on different tendinous grasping techniques in rotator cuff repair: a new reinforced stitch.

Arthroscopic repair of wide rotator cuff ruptures is burdened by a percentage of recurrences that is greater than the repair carried out when an open technique is used. One of the main reasons for this difference can be searched for in the minor hold of stitching on the tendinous aspect obtained with arthroscopic repair. In fact, when an open technique is used, good hold can be guaranteed by using reinforced stitches such as the modified Mason-Allen. Thus, arthroscopic repair technique on the tendinous aspect, particularly in wide and massive injuries, must be improved. It was the purpose of this study to compare a new reinforced stitch that can easily be obtained in arthroscopy (simple stitch that orthogonally crosses a horizontal stitch previously knotted on the tendon: SS-HL), with traditional stitches (simple stitch, mattress-stitch and modified Mason-Allen stitch). Tests were carried out on sheep infraspinatus tendons in order to evaluate the resistance of pull-out. The SS-HL stitch showed resistance to loading that was similar to that when the modified Mason-Allen was used, but it was greater than that shown by the simple stitch (+48%) and the mattress stitch (+35%).

A procedure and criterion for bone cement fracture toughness tests.

Nowadays, two procedures, based on the recommendation of two American standards (ASTM E399 and ASTM D5045), are used to determine the fracture toughness, KIc, of bone cement. However, there is a lack of knowledge about the equivalence of the two testing methods applied to bone cement. Additionally, in spite of the recommendation of several authors to introduce a rejection criterion for specimens based on the size of defects found in the fracture surface, no data are available about the effect of porosity within the material on the KIc of bone cement. The aims of this study were to verify whether the KIc values calculated for bone cement using the two procedures are comparable and whether macroporosity within the tested samples affects the KIc value of bone cement, and, if so, to establish a rejection criterion for specimen selection. Samples of pure polymethyl methacrylate (PMMA) were tested by both procedures. Additionally, samples showing defects (macroporosity) of different sizes and located in different positions within the specimen were tested. The KIc value determined following the ASTM E399 procedure was 13 per cent lower than that calculated following the ASTM D5045 procedure. In the first series a lower data scatter was observed. Also, the presence of macroporosity on the fracture surface of the specimen affected the KIc value of bone cement. Therefore, the mechanical behaviour of samples was affected by defects within the material. Since it is possible to mould specimens without macroporosity, it seems recommendable to reject specimens with macroporosity on the fracture surface before calculating the KIc value of bone cement.

The influence of stem insertion rate on the porosity of the cement mantle of hip joint replacements.

This study investigates the effect of stem insertion rate on the porosity of the cement mantle. An experimental protocol was developed to simulate the surgical technique of cementing a prosthetic stem into the medullary canal of the femur. Cement mantle specimens were produced for three different stem insertion rates. The presence of porosity in the cement mantle was investigated. Additionally, the mechanical strength of the bone cement was assessed. Increasing the stem insertion rate did not have a significant effect on the porosity distribution within the bulk cement mantle. However, for all stem insertion rates investigated, the porosity concentration increased significantly moving from the cement/pseudofemur interface through to the stem/cement interface. In all cases, the presence of porosity significantly decreased the mechanical behaviour of the bone cement. High porosity concentration at the stem/cement interface seems to be attributed also to the rheology of the cement during implant insertion. Nevertheless, the surgeon cannot influence the formation of porosity by changing the stem insertion rate.

The muscle standardized femur: a step forward in the replication of numerical studies in biomechanics.

The standardized femur is the computer aided design (CAD) solid model of a synthetic human femur, commonly used in experiments in vitro, available in the public domain through the International Society of Biomechanics Finite Element Mesh Repository. Currently used by hundreds of researchers, it was made available to simplify the experimental cross-validation of numerical studies as well as their replication by other researchers. One aspect that the standardized femur left uncovered is the definition of muscles and ligaments. In particular, for a variety of simulations it would be extremely useful to map on to the femoral surface the insertion of the principal muscles. The aim of the present study was to create a new solid model, called the muscle standardized femur, where the femoral insertion of each muscle is mapped on to the surface of the femur. Published data on muscle insertion morphometry were registered to the model by applying an affine scaling defined on bone landmarks. Good agreement was found with another similar study in which only the insertion centres were defined. The new model will be made available in the public domain for no-profit uses. When combined with published data on the direction and intensity of muscular forces this model is expected to make a useful contribution to the steadily growing library of models and data sets made available to the biomechanical community.

Fatigue strength of PMMA bone cement mixed with gentamicin and barium sulphate vs pure PMMA.

Barium sulphate is added to polymethylmethacrylate (PMMA) bone cement as a radiopacifier. Gentamicin is an antibiotic added to bone cement to treat or prevent infection in arthroplasty. This study investigated the combined effect of barium sulphate and gentamicin sulphate on the fatigue strength of PMMA bone cement. Three different formulations were studied: pure PMMA, PMMA with barium sulphate added and PMMA with barium sulphate and gentamicin sulphate added. Before testing all specimens were stored in water at 37 degrees C for at least 15 days to season the PMMA and to elute the antibiotic. Fatigue tests were performed following a previously validated procedure. The slope part of the Wöhler diagram was obtained and a rough endurance limit was estimated for all three formulations. The experimental data showed that the addition of barium sulphate to PMMA bone cement affected the fatigue strength of the material, whereas addition of gentamicin sulphate to the radiopaque PMMA had no effect on the fatigue properties of the bone cement. While PMMA with barium sulphate added was confirmed to have a reduced fatigue strength when compared with plain PMMA, no detrimental effect was found for the addition of gentamicin sulphate to radiopaque PMMA.

Initial stability of a cementless acetabular cup design: experimental investigation on the effect of adding fins to the rim of the cup.

Different design solutions have been suggested for improvement of the initial stability of cementless acetabular cups, such as adding threads, spikes, or pegs to the hemispherical geometry, the pore structure of the surface; and screw fixation. This experimental study investigated the effect of fins on the initial stability of the acetabular cup. Three designs were studied, with none, 2, and 12 fins, respectively. The cups were press fit into cavities reamed in 2 different polyurethane foams, used to simulate 2 qualities of cancellous bone. Two millimeter press-fit and exact-fit conditions were investigated. The results show that the type of substrate and the interference value are important in determining the initial stability of the cup. The addition of fins on the cup rim enhances in vitro the initial stability, especially in cases of a poor press fit with a good substrate. This preclinical investigation suggests that the use of a cup design with fins may be beneficial in all cases in which press fit of the cup cannot be assured. However, further clinical studies are required to validate in vivo the efficacy of the fins as additional fixation devices.

Pre-clinical validation of a new partially cemented femoral prosthesis by synergetic use of numerical and experimental methods.

The present work reports the pre-clinical validation of an innovative partially cemented femoral prosthesis called cement-locked uncemented (CLU) prosthesis. The inventors of the device under investigation claimed that, when compared to a comparable fully cemented stem, the new stem would present various advantages. Two previous experimental studies confirmed that primary stability and stress shielding were comparable to those of cemented stems. Aim of the present study was to investigate if the remaining claims were confirmed as well. A complete finite element model of the bone-implant complex was created from CT data. The model was validated against in vitro measurements of bone surface strains as well as against primary stability measurements. The peak stresses predicted in the CLU cement mantle were not found significantly lower than those reported in other studies on fully cemented stems. However, once the cement inlet geometry is optimised and the associated stress risers are eliminated, the CLU cement mantle should be subjected to much lower stresses. The stress induced in the stems by both load cases was well below the fatigue limit of the Ti6Al4V alloy. Finite element models predicted for all load cases relative motion between cement and metal lower than 60 microm. This amplitude may be fully accommodated by elastic deformations of the cement micro-ridges. The experimental and numerical results showed the validity of the new fixation concept, although a further optimisation of the geometry of the cement pockets is needed in order to further reduce the stresses in the cement.

The effect on the fatigue strength of bone cement of adding sodium fluoride.

New bone cements that include several additives are currently being investigated and tested. One such additive is sodium fluoride (NaF), which promotes bone formation, facilitating implant integration and success. The influence of NaF on the fatigue performance of the cement as used in biomedical applications was tested in this paper. In fact fatigue failure of the cement mantle is a major factor limiting the longevity of a cemented implant. An experimental bone cement with added NaF (12 wt%) was investigated. The fatigue strength of the novel bone cement was evaluated in comparison with the cement without additives; fatigue tests were conducted according to current standards. The load levels were arranged based on a validated, statistically based optimization algorithm. The curve of stress against number of load cycles and the endurance limit were obtained and compared for both formulations. The results showed that the addition of NaF (12 wt%) to polymethylmethacrylate (PMMA) bone cement does not affect the fatigue resistance of the material. Sodium fluoride can safely be added to the bone cement without altering the fatigue performance of the PMMA bone cement.

Temperature and ageing condition effects on the characterization of acrylic bone cement.

This study investigates the effect of the environmental temperature and ageing condition on the characterization of acrylic bone cement. The tests were performed according to ISO 5833. The testing parameters were allowed to vary within the limits defined by the standard, in order to assess their effect on the results of the test. In certain cases the tests were also performed under conditions which the standard does not provide for but which are likely to occur clinically. This investigation showed that the cement behaviour may also change in the temperature range specified in the standard. Therefore, it is deemed appropriate to correlate the curing parameters of the bone cement to the environmental temperature, performing the test at different temperatures. In this way the effect of temperature on the duration of the phases in the cement curing could be assessed. The resultant graphical representation of the effect of temperature on the duration of the phases in cement curing has direct clinical relevance. Furthermore, this study showed that the ageing conditions of the mechanically tested specimens affected the results. Hence, it is deemed advisable to modify the ageing conditions of the specimens, fixing them closer to the in vivo conditions.

Experimental study on rotator cuff repair.

It was the purpose of the experimental study to use laboratory experience to verify the effectiveness of different methods used to repair the rotator cuff. The sheep was used as an animal model because its infraspinous tendon is the most similar to that in the human. Three static trials were conducted using Instron machines, comparing the repair systems used most by the same authors in their clinical work, the hold of the suturing wires with two different threading procedures in the bone tunnels and two types of knotting, and the breakage loading of the suturing wires in the two different miniplate systems. The authors conclude that tendinous anchoring must be entrusted to reinforced suturing systems (modified SCOI and Mason Allen), the threading of wires in pairs in a single bone tunnel makes surgery easier and shortens the amount of time required, with threading of wires similar to or better than threading with a single wire. There are no differences in breakage loading of the wire at the level of the holes in the two miniplates considered in this study.

Selection of the best element type in the finite element analysis of hip prostheses.

Hip prostheses have to fulfil biomedical, anatomical and strength requirements. In the initial design phase it is convenient to carry out contact analyses that simulate standardized fatigue tests using automatically generated finite element meshes of the implant design. While parabolic tetrahedrons are known to be more accurate, they usually cannot be used in contact analyses. In the present study, a prototype design was analysed using automatically generated tetrahedral meshes under linearly equivalent boundary conditions. Results of convergence analyses show that linear tetrahedral elements, even with rotational degrees of freedom, should be avoided, especially when modelling regions with a high stress gradient.