Aldo Toni

Mechanical validation of whole bone composite femur models.

Composite synthetic models of the human femur have recently become commercially available as substitutes for cadaveric specimens. Their quick diffusion was justified by the advantages they offer as a substitute for real femurs. The present investigation concentrated on an extensive experimental validation of the mechanical behaviour of the whole bone composite model, compared to human fresh-frozen and dried-rehydrated specimens for different loading conditions. First, the viscoelastic behaviour of the models was investigated under simulated single leg stance loading, showing that the little time dependent phenomena observed tend to extinguish within a few minutes of the load application. The behaviour under axial loading was then studied by comparing the vertical displacement of the head as well as the axial strains, by application of a parametric descriptive model of the strain distribution. Finally, a four point bending test and a torsional test were performed to characterize the whole bone stiffness of the femur. In all these tests, the composite femurs were shown to fall well within the range for cadaveric specimens, with no significant differences being detected between the synthetic femurs and the two groups of cadaveric femurs. Moreover, the interfemur variability for the composite femurs was 20-200 times lower than that for the cadaveric specimens, thus allowing smaller differences to be characterized as significant using the same simple size, if the composite femurs are employed.

Long‐term results in 144 localized Ewing's sarcoma patients treated with combined therapy

The results of 144 previously untreated cases of primary Ewings sarcoma of bone are reported with a minimum follow‐up of 5 years. This series was treated between 1972 and 1982 at Istituto Ortopedico Rizzoli with a combined therapy. The local control of the disease consisted of amputation (ten cases), resection followed by radiation therapy (35‐45 Gy) (48 cases) and radiation therapy alone (40‐60 Gy) (86 cases). Adjuvant chemotherapy, rigorously standardized, was performed according two different protocols: the first (85 cases treated in the period 1972–1978) consisted of vincristine (VCR) Adriamycin (doxorubicin) (ADM), and cyclophosphamide (EDX); the second (59 cases treated in the period 1979‐1982) of VCR, ADM, EDX and dactinomycin (DACT). At a follow‐up of 5 to 16 years (median, 9), 59 patients (41%) are continuously disease‐free (CDF), 81 (56%) developed metastatic disease and/or local recurrence, and four (3%) had a second malignancy. Three factors seem to be correlated to prognosis: the site of the initial lesion (only 23% of the pelvic lesions are represented in the CDF group versus 46% of the other locations); the chemotherapy protocol (32% of the cases in the first protocol are CDF versus 54% in the second); the type of local treatment (60% of the patients treated with amputation or resection plus radiotherapy versus 28% of those treated with radiation therapy alone are CDF). A local recurrence was observed in 24% of the patients (8% in the group locally treated with surgery or surgery plus radiation therapy versus 36% in the group treated with radiation therapy alone). These data suggest that even though adjuvant chemotherapy can improve the long‐term results in localized Ewings sarcoma patients, this disease still represents, in a high percentage of cases, a lethal process whose final prognosis widely depends on the local control of the lesion. Due to the questionable effect of the radiation therapy alone in controlling the primary lesion and its important side effects, the role of surgery in treating Ewings sarcoma of bone should be extended.

Finite element and experimental models of cemented hip joint reconstructions can produce similar bone and cement strains in pre-clinical tests

Finite element (FE) models could be used for pre-clinical testing of cemented hip replacement implants against the damage accumulation failure scenario. To accurately predict mechanical failure, the models should accurately predict stresses and strains. This should be the case for various implants. In the current study, two FE models of composite hip reconstructions with two different implants were validated relative to experimental bone and cement strains. The objective was an overall agreement within 10% between experimental and FE strains. Two stem types with different clinical results were analyzed: the Lubinus SPII and the Mueller Curved with loosening rates of 4% and 16% after 10 yr, respectively (Prognosis of total hip replacement. 63rd Annual Meeting of the American Academy of orthopaedic surgeons, Atlanta, USA). For both implant types, six stems were implanted in composite femurs. All specimens were subjected to bending. The Mueller Curved specimens were additionally subjected to torsion. Bone strains were recorded at 10 locations on the cortex and cement strains at three locations within the cement mantle. An FE model was built for both stem types and the experiments were simulated. Bone and cement strains were calculated at the experimental gauge locations. Most FE bone strains corresponded to the mean experimental strains within two standard deviations; most FE cement strains within one standard deviation. Linear regression between the FE and mean experimental strains produced slopes between 0.82 and 1.03, and R(2) values above 0.98. Particularly for the Mueller Curved, agreement improved considerably when FE strains were compared to the strains from the experimental specimen used to build the FE model. The objective of overall agreement within 10% was achieved, indicating that both FE models were successfully validated. This prerequisite for accurately predicting long-term failure has been satisfied.

Early diagnosis of ceramic liner fracture. guidelines based on a twelve-year clinical experience

Osteolytic lesions due to wear debris are the major long-term problem associated with total hip replacement1. To avoid wear debris, hard-bearing-surface total hip prostheses with improved tribological properties have been introduced into surgical practice. Ceramic surfaces have had some promising long-term results2, and modern metal-backed alumina cups have been associated with very good clinical results3-5. Alumina has excellent tribological properties and a very high Youngs modulus that leads to very good compression strength, but it has poor bending strength: it has no way to deform6. This means that ceramic can break without warning. Under normal physiologic conditions, modern ceramics never reach their fatigue limit, so ceramic head fractures are rare (a rate of 0.004%7 in one study). In contrast, ceramic liner fractures are not well recognized, and their frequency could be underestimated (Fig. 1). In addition, it is difficult to identify patients who are at risk because liner fractures can be due to multiple causes: dislocation, impingement, malpositioning, and microseparation8,9. Fig. 1 A ceramic liner fracture. The diagnosis is often difficult to make on the basis of standard radiographs. A fragment of ceramic is visible near the calcar (arrow). The liner was found to be fractured (arrow) at revision surgery. While many efforts have been made to improve the ceramic manufacturing process and the surgical technique for inserting ceramic components10, little has been reported regarding the early diagnosis of ceramic fracture. When a ceramic fracture involves the liner and is the consequence of repeated microtrauma, the diagnosis is rarely made early, except when ceramic fragments are visible on radiographs. Moreover, decision-making regarding revision surgery after a ceramic-on-ceramic prosthesis has failed is difficult: the ceramic fragments that have spread into the periarticular space are abrasive and …

Comparative in vitro study on the long term performance of cemented hip stems: Validation of a protocol to discriminate between "good" and "bad" designs

The long-term clinical success of cemented hip stems is influenced both by the implant design, and by the surgical procedure. A methodology is proposed for discriminating between implant designs with different clinical outcomes. The protocol was designed with industrial pre-clinical validation in mind. Two cemented stem types were tested, one (Lubinus SPII) having good and the other (Müller Curved) having poor clinical outcomes. Three implants for each type were subjected to a mechanical in vitro test of one million loading cycles. Each cycle reproduced the load components of stair climbing. Interface shear micromotion was measured during the test in the direction of rotation and along the stem axis. The stem roughness before and after the test was compared. After the test, the cement mantles were retrieved and inspected through dye penetrants to detect evidences of micro-damage. For each specimen, the events of the loosening process were examined, based on the in vitro data available, so as to analyze the whole failure mechanism. The protocol developed was sensitive to the implant design, with significantly different results being found for the two stem types, both in terms of stem-cement micromotions, surface roughness alteration, and cement mantle damage. The information yielded by the three different investigation techniques was consistent for each of the two groups of specimens tested, allowing a better understanding of the failure process. In vitro inducible micromotion and permanent migration measurements, together with cement-stem interface fretting damage and cement fatigue damage, can help predicting the clinical performance of cemented stems.

Design-related fretting wear in modular neck hip prosthesis.

An accelerated cyclic loading corrosion test was used to determine the corrosion behavior of a commercial (GSP) and a prototype titanium hip prosthesis each with a modular neck. Four GSP and four prototype stems were subjected to a 2-Hz cyclic load ranging between 200 and 2,100 N for 1,000,000 cycles. Three stems were tested in an environment of FeCl3 solution, three stems were tested in Ringers solution, and two stems were tested in air. After cyclic loading, the specimens were carefully examined with optical and scanning electron microscopy (SEM). None of them showed macroscopic or microscopic signs of corrosion, regardless of the environment to which the specimens were subjected. However, macroscopic evidence of mechanical fretting was present at the neck-stem modular junction, primarily concentrated at the medial contact point between stem and neck, especially for the prototype stems. SEM analysis confirmed these observations. The appreciable differences observed between the two designs suggest that the problem can be minimized or eliminated with an accurately designed taper fitting.

Relationship between bone-prosthesis bonding and load transfer in total hip reconstruction

The effect of bone-prosthesis bonding on proximal load transfer is investigated using a coupled experimental and finite element analysis on a synthetic femur. Three-dimensional finite element models for an intact femur and a femur implanted with a cementless prosthesis were constructed from the experimental models used, and the proximal femoral strains recorded for two loading conditions approximating a one-legged stance. The approach was used to investigate a press-fitted and a fully bonded bone-prosthesis structure to identify the stem-bone behaviour for both interface conditions and their implications for proximal bone load transfer. Regression slopes close to unity indicated that the finite element predictions were an accurate estimate of the experimental measurements. Physiological surface strains were recorded only when the abductor force was included in the loading. Meanwhile, experimental measurements and numerical predictions showed that a different load transfer pattern is to be expected for normally press-fitted and glued press-fitted stems. The finite element model for the treated femur, modelling both interface conditions correlated very well with the experimental model. These finite element models subsequently modified and used to analyse the effect of different interface conditions predicted a significant increase in the load transfer to the proximal calcar bone when only proximal bonding is achieved. This study suggests that information obtained for the assessment and prediction of total hip arthroplasty longevity by numerical and experimental techniques used together and in parallel is of greater value than either technique used alone. The employment of a femur analogue as featured in this study is also shown to be a suitable alternative to cadaveric specimens in such an analysis.

Influence of thigh muscles on the axial strains in a proximal femur during early stance in gait

This work is focused on the in vitro simulation of the loads occurring in the femur during early stance in gait, for hip prosthesis stress shielding test purposes. Ten thigh muscles (the three gluteal muscles, the three vasti, rectus femoris, adductor longus and magnus, biceps femoris), simulated by nylon straps, were tested in order to establish their influence on the strains in the proximal femur. Axial and hoop strains were recorded from 16 strain gauges for the effect of each muscle and compared to the strains recorded as a result of the hip joint reaction force only (i.e. without muscle simulation). It appears that the three glutei are the principal muscles in determining the vertical strains, however the rectus femoris, biceps femoris and the adductors were also seen to significantly affect the strain pattern. The inadequacy of increasing the adduction angle and applying the resultant force at the hip joint to simulate the abductors was also confirmed.

CT-based surgical planning software improves the accuracy of total hip replacement preoperative planning

The present study is aimed to compare accuracy and the repeatability in planning total hip replacements with the conventional templates on radiographs to that attainable on the same clinical cases when using CT-based planning software. The sizes of the cementless components planned with new computer aided preoperative planning system called Hip-Op and with standard templates were compared to those effectively implanted. The study group intentionally included only difficult clinical cases. The most common aetiology was congenital dysplasia of hip (65.6%). The Hip-Op planning system allowed the surgeons to obtain a preoperative planning more accurate than with templates, especially for the socket. Assuming correct a size planned one calliper above or below that implanted the accuracy increased from 83% for the stem and 69% for the socket when using templates to 86% for the stem and 93% for the socket when using the Hip-Op system. The repeatability of the Hip-Op system was found comparable to that of the template procedure, which is much more familiar to the surgeons. Furthermore, the repeatability of the preoperative planning with the Hip-Op system was consistent between surgeons, independently from their major or minor experience. The study clearly shows the advantages of a three-dimensional computer-based preoperative planning over the traditional template planning, especially when deformed anatomies are involved. The surgical planning performed with the Hip-Op system is accurate and repeatable, especially for the socket and for less experienced surgeons.

Cytotoxicity testing of cyanoacrylates using direct contact assay on cell cultures

The use of a tissue adhesive for surgical procedures has prompted a large number of clinical and experimental studies. Alkyl-2-cyanoacrylate esters constitute a family of adhesives with good mechanical properties but their biological compatibility has to be assessed. In this study the cytotoxicity of three commercially available cyanoacrylates and one of unknown composition has been determined. The first part of the study deals with direct contact testing procedures using L 929 cells challenged with drops of adhesives: cell morphology, cell growth and bacterial growth inhibition were assayed. Testing methods included cell viability assay using vital dyes, cell growth measurement using crystal violet staining uptake and bacterial growth assay using S. aureus growth inhibition. All the cyanoacrylate adhesives tested were found to be cytotoxic and to inhibit cell proliferation: differences between the cyanoacrylates were found.