Biomedical subjects

M Baleani

Publications and source records attributed to M Baleani.

At least 19 recordsLinked to original sources

PubMed2006

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.

Absorptiometry, Photon↗

PubMed2004

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.

Bone Cements↗

PubMed2003

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.

Anatomy, Cross-Sectional↗

PubMed2003

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.

Anti-Bacterial Agents↗

PubMed2003

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.

Arthroplasty, Replacement, Hip↗

PubMed2001

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.

Alloys↗

PubMed2001

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.

Acetabulum↗

PubMed2001

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.

Arthroplasty, Replacement↗

PubMed2001

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.

Compressive Strength↗

PubMed2000

Initial stability of a new hybrid fixation hip stem: experimental measurement of implant-bone micromotion under torsional load in comparison with cemented and cementless stems.

A new hybrid fixation stem, named cemented-locked uncemented (CLU), for total hip arthroplasty was developed to achieve good initial stability. Primary stability is guaranteed by the cement which is injected into two pockets in the lateral area. This leaves a large surface available for long-term biologic fixation (direct bone attachment on implant). This study evaluates in vitro the initial stability of the CLU prototype under torsional load, in comparison with cemented and cementless stems. The results show that the CLU stem is very stable in simulated stair climbing. Its micromotions are comparable to those of a cemented prosthesis, and significantly less (80-90% lower) than those for a cementless stem. These findings confirm the optimal initial stability expected from the CLU prototype. This new design, which employs hybrid fixation, should improve bone formation on the implant and reduce the risk of stem loosening.

Arthroplasty, Replacement, Hip↗

PubMed2000

Large-sliding contact elements accurately predict levels of bone-implant micromotion relevant to osseointegration.

Primary stability is recognised as an important determinant in the aseptic loosening failure process of cementless implants. An accurate evaluation of the bone-implant relative micromotion is becoming important both in pre-clinical and clinical studies. If the biological threshold for micro-movements is in the range 100-200 micrometer then, in order to be discriminative, any method used to evaluate the primary stability should have an accuracy of 10-20 micrometer or better. Additionally, such method should also be able to report the relative micromotion at each point of the interface. None of the available experimental methods satisfies both requirements. Aim of the present study is to verify if any of the current finite element modelling techniques is sufficiently accurate in predicting the primary stability of a cementless prosthesis to be used to decide whether the micromotion may or may not jeopardise the implant osseointegration. The primary stability of an anatomic cementless stem, as measured in vitro, was used as a benchmark problem to comparatively evaluate different contact modelling techniques. Frictionless contact, frictional contact and press-fitted frictional contact conditions were modelled using alternatively node-to-node, node-to-face and face-to-face contact elements. The model based on face-to-face contact elements accounting for frictional contact and initial press-fit was able to predict the micromotion measured experimentally with an average (RMS) error of 10 micrometer and a peak error of 14 micrometer. All the other models presented errors higher than 20 micrometer assumed in the present study as an accuracy threshold.

Bone and Bones↗

PubMed2000

The effect of sandblasting treatment on endurance properties of titanium alloy hip prostheses.

Sandblasting is a procedure of increasing surface roughness. This treatment is common in the orthopedic field. An increased roughness may affect the endurance limit of the material. This study investigates the effect on the endurance limit of the Ti6Al4V due to two different sandblasting treatments: fine sandblasting and coarse sandblasting. Twenty hip stems, 10 finely sandblasted and 10 coarsely sandblasted, were tested under sinusoidal fluctuating bending. The staircase method was used to estimate the endurance limit of the material. The results show an important reduction in the endurance properties up to 40% for the coarsely sandblasted specimens. The failures of the sandblasted specimens were not due to material defects. Rather, the decreased endurance strength of the sandblasted stems was caused by surface defects, which act as crack initiators. By modulating the roughness with an appropriate sandblasting treatment, it is possible to limit the reduction in the endurance limit of the alloy.

Alloys↗

PubMed1999

Endurance testing of hip prostheses: a comparison between the load fixed in ISO 7206 standard and the physiological loads.

BACKGROUND: Pre-clinical endurance validation of innovative hip prostheses femoral components are carried out following the ISO 7206 standard. The in vitro fatigue test must simulate accurately the physiological load to correctly define the section of the stem. OBJECTIVE: This study investigates if the loads defined in the ISO 7206 standard simulate correctly the physiological load that occur in vivo. DESIGN: Simulation of the damage induced by in vitro test and in vivo loads is performed. Different designs of the stem are examined. Materials with different fatigue limit are considered. For the in vivo loads, different body weights are modelled. METHODS: The minimal stem dimensions required to stand 20years of patient use and to pass the fatigue test are calculated based on linear damage accumulation. RESULTS: The results show that the ISO load simulates reasonably well the physiological load that is likely to occur in active patients with a low or normal body weight. Conversely, the ISO test underestimates the physiological load that heavy and active patients are likely to apply to the implant. CONCLUSIONS: Different minimum requirements for endurance strength should be fixed for hip prostheses designed for patients of different weight. This solution would reduce the risk of undersizing or oversizing the stem. RELEVANCE: The introduction of a classification of the hip prostheses, fixing different minimum requirements for endurance strength, will lead to correctly size stems made of new materials or coated using new surface treatments, reducing the risk of implant failure of innovative prostheses.

Hip Prosthesis↗

PubMed1997

Fretting wear in a modular neck hip prosthesis.

In vitro cyclic load fretting tests were conducted on a prototype of a cementless, modular neck, hip prosthesis. The study had three major objectives: to determine the amount of fretted material in the tapered-neck joint under various load cycle amplitudes, to determine the fretting damage evolution, and to determine the effect of different-sized stem bodies on the production of debris. All the tests produced some fretting microdamage on the tapered surface although the extent was quite different among test groups. The amount of abraded material increased almost linearly with the applied load magnitude but not with the number of load cycles. The amount of weight loss was higher in the large stem bodies than in the small ones. Weight loss ranged from 0.28 +/- 0.10 mg for small stem bodies loaded 5.5 million times up to 2300N to 2.54 +/- 0.53 mg for large stem bodies located 20 million times up to 3300N. Considering the large-size stem results, and assuming one million load cycles between 300N and 3300N to be the average yearly load history, the modular neck tapered joint would produce 0.6 mg/year of metal debris. The clinical impact of this observation is unknown; however, some of the literature on the presence of metal in patient tissues and fluids supports the hypothesis that a normal and stable prosthesis is likely to produce less than 10 mg/year of metal debris. Thus, a further production of 0.6 mg/year due to the modular neck should not have any significant effect.

Alloys↗

PubMedDate not supplied

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.

Biomechanical Phenomena↗

PubMedDate not supplied

An FEA-based protocol for the pre-clinical validation of custom-made hip implants.

Custom-made prostheses are successfully used to treat particular pathologies such as congenital hip dysplasia. The new EC rules on medical devices require a complete technical dossier for each produced custom-made device counter signed by the surgeon who 'prescribes' the custom-made device. Thus, a specific pre-clinical validation protocol must be developed, considering the economical and temporal constraints imposed by the device type. As a first step, in the present study a protocol based on finite element analysis (FEA) was developed and validated, to verify each custom-made hip stem in terms of mechanical strength. The study was carried out on 12 custom-made cementless hip stem designs already produced and implanted, for which the 3D solid model was available. Two of the selected designs were used for the method validation, comparing strain gauges measurements with the stresses predicted by the finite element (FE) model. Once the proposed methodology was verified, all the remaining stem designs were analysed. The developed protocol made possible a complete analysis in less than 4 h; its accuracy (7-8% on the strain gauge measurements) was considered acceptable for the specific application.

Alloys↗

PubMedDate not supplied

Experimental study on the cement mantle in hip arthroplasty: effect of defects on the property of the materials used.

The study simulated implantation of a hip prosthesis stem in the femur. The cement mantle produced in vitro was observed under an optic microscope. A higher concentration of porosity in the cement mantle at the stem-cement interface was observed. By heating the stem to 45 degrees C and 55 degrees C the authors observed a reduction in porosity in the three surfaces examined: stem-cement interface, internal surface, and cement-pseudofemur interface. Heating of the stem causes a reduction in polymerization time and an increase in maximum temperature achieved during the polymerization process. A reduction in porosity at the stem-cement interface influenced bending strength of the specimens extracted from the mantle. A significant difference between resistance to flexion in the specimens produced with the stem at 55 degrees, and in those with the stem at 23 degrees C was observed.

Arthroplasty, Replacement, Hip↗

PubMedDate not supplied

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.

Animals↗