Primary stability in cementless total hip replacement: measurement techniques and aided-surgery

Primary stability of stems in cementless total hip replacements is recognized to play a critical role for long-term survival and thus for the success of the overall surgical procedure. In Literature, several studies addressed this important issue. Different approaches have been explored aiming to evaluate the extent of stability achieved during surgery. Some of these are in-vitro protocols while other tools are coinceived for the post-operative assessment of prosthesis migration relative to the host bone. In vitro protocols reported in the literature are not exportable to the operating room. Anyway most of them show a good overall accuracy. The RSA, EBRA and the radiographic analysis are currently used to check the healing process of the implanted femur at different follow-ups, evaluating implant migration, occurance of bone resorption or osteolysis at the interface. These methods are important for follow up and clinical study but do not assist the surgeon during implantation. At the time I started my Ph.D Study in Bioengineering, only one study had been undertaken to measure stability intra-operatively. No follow-up was presented to describe further results obtained with that device. In this scenario, it was believed that an instrument that could measure intra-operatively the stability achieved by an implanted stem would consistently improve the rate of success. This instrument should be accurate and should give to the surgeon during implantation a quick answer concerning the stability of the implanted stem. With this aim, an intra-operative device was designed, developed and validated. The device is meant to help the surgeon to decide how much to press-fit the implant. It is essentially made of a torsional load cell, able to measure the extent of torque applied by the surgeon to test primary stability, an angular sensor that measure the relative angular displacement between stem and femur, a rigid connector that enable connecting the device to the stem, and all the electronics for signals conditioning. The device was successfully validated in-vitro, showing a good overall accuracy in discriminating stable from unstable implants. Repeatability tests showed that the device was reliable. A calibration procedure was then performed in order to convert the angular readout into a linear displacement measurement, which is an information clinically relevant and simple to read in real-time by the surgeon. The second study reported in my thesis, concerns the evaluation of the possibility to have predictive information regarding the primary stability of a cementless stem, by measuring the micromotion of the last rasp used by the surgeon to prepare the femoral canal. This information would be really useful to the surgeon, who could check prior to the implantation process if the planned stem size can achieve a sufficient degree of primary stability, under optimal press fitting conditions. An intra-operative tool was developed to this aim. It was derived from a previously validated device, which was adapted for the specific purpose. The device is able to measure the relative micromotion between the femur and the rasp, when a torsional load is applied. An in-vitro protocol was developed and validated on both composite and cadaveric specimens. High correlation was observed between one of the parameters extracted form the acquisitions made on the rasp and the stability of the corresponding stem, when optimally press-fitted by the surgeon. After tuning in-vitro the protocol as in a closed loop, verification was made on two hip patients, confirming the results obtained in-vitro and highlighting the independence of the rasp indicator from the bone quality, anatomy and preserving conditions of the tested specimens, and from the sharpening of the rasp blades. The third study is related to an approach that have been recently explored in the orthopaedic community, but that was already in use in other scientific fields. It is based on the vibration analysis technique. This method has been successfully used to investigate the mechanical properties of the bone and its application to evaluate the extent of fixation of dental implants has been explored, even if its validity in this field is still under discussion. Several studies have been published recently on the stability assessment of hip implants by vibration analysis. The aim of the reported study was to develop and validate a prototype device based on the vibration analysis technique to measure intra-operatively the extent of implant stability. The expected advantages of a vibration-based device are easier clinical use, smaller dimensions and minor overall cost with respect to other devices based on direct micromotion measurement. The prototype developed consists of a piezoelectric exciter connected to the stem and an accelerometer attached to the femur. Preliminary tests were performed on four composite femurs implanted with a conventional stem. The results showed that the input signal was repeatable and the output could be recorded accurately. The fourth study concerns the application of the device based on the vibration analysis technique to several cases, considering both composite and cadaveric specimens. Different degrees of bone quality were tested, as well as different femur anatomies and several levels of press-fitting were considered. The aim of the study was to verify if it is possible to discriminate between stable and quasi-stable implants, because this is the most challenging detection for the surgeon in the operation room. Moreover, it was possible to validate the measurement protocol by comparing the results of the acquisitions made with the vibration-based tool to two reference measurements made by means of a validated technique, and a validated device. The results highlighted that the most sensitive parameter to stability is the shift in resonance frequency of the stem-bone system, showing high correlation with residual micromotion on all the tested specimens. Thus, it seems possible to discriminate between many levels of stability, from the grossly loosened implant, through the quasi-stable implants, to the definitely stable one. Finally, an additional study was performed on a different type of hip prosthesis, which has recently gained great interest thus becoming fairly popular in some countries in the last few years: the hip resurfacing prosthesis. The study was motivated by the following rationale: although bone-prosthesis micromotion is known to influence the stability of total hip replacement, its effect on the outcome of resurfacing implants has not been investigated in-vitro yet, but only clinically. Thus the work was aimed at verifying if it was possible to apply to the resurfacing prosthesis one of the intraoperative devices just validated for the measurement of the micromotion in the resurfacing implants. To do that, a preliminary study was performed in order to evaluate the extent of migration and the typical elastic movement for an epiphyseal prosthesis. An in-vitro procedure was developed to measure micromotions of resurfacing implants. This included a set of in-vitro loading scenarios that covers the range of directions covered by hip resultant forces in the most typical motor-tasks. The applicability of the protocol was assessed on two different commercial designs and on different head sizes. The repeatability and reproducibility were excellent (comparable to the best previously published protocols for standard cemented hip stems). Results showed that the procedure is accurate enough to detect micromotions of the order of few microns. The protocol proposed was thus completely validated. The results of the study demonstrated that the application of an intra-operative device to the resurfacing implants is not necessary, as the typical micromovement associated to this type of prosthesis could be considered negligible and thus not critical for the stabilization process. Concluding, four intra-operative tools have been developed and fully validated during these three years of research activity. The use in the clinical setting was tested for one of the devices, which could be used right now by the surgeon to evaluate the degree of stability achieved through the press-fitting procedure. The tool adapted to be used on the rasp was a good predictor of the stability of the stem. Thus it could be useful for the surgeon while checking if the pre-operative planning was correct. The device based on the vibration technique showed great accuracy, small dimensions, and thus has a great potential to become an instrument appreciated by the surgeon. It still need a clinical evaluation, and must be industrialized as well. The in-vitro tool worked very well, and can be applied for assessing resurfacing implants pre-clinically.

Intraoperative kinematic evaluation with navigation system and postoperative kinematic evaluation with dynamic RSA of total knee arthroplasty

Restoring a correct implant kinematics and providing a good ligament balance and patellar tracking is mandatory to improve clinical and functional outcome after a Total Knee Replacement. Surgical navigation systems are a reliable and accurate tool to help the surgeon in achieving these goals. The aim of the present study was to use navigation system with an intra-operative surgical protocol to evaluate and determine an optimal implant kinematics during a Total Knee Replacement.

Valutazione del rilascio ionico in pazienti portatori di protesi di rivestimento d'anca BHR: confronto a lungo termine con artroplastica totale d'anca metallo-metallo

Lo scopo di questo studio è stato quello di determinare se a lungo termine le concentrazioni sieriche di ioni nei pazienti con protesi di rivestimento d’anca metallo-metallo (MOM-HR, metal-on-metal hip resurfacing) fossero differenti da quelle valutate nei pazienti con protesi totale d’anca metallo-metallo e testa del diametro di 28 mm (MOM-THA, metal-on-metal total hip arthroplasty); inoltre è stato valutato se le concentrazioni ioniche fossero al di sopra dei valori di riferimento e se fosse possibile stabilire l’esistenza di una relazione tra sesso e concentrazioni di ioni con riferimento al tipo di impianto. Il gruppo MOM-HR era costituito da 25 pazienti mentre il gruppo MOM-THA era di 16 pazienti. Per poter ricavare i valori di riferimento sono stati reclutati 48 donatori sani. La misurazione delle concentrazioni degli ioni cobalto (Co), cromo (Cr), nickel (Ni) e molibdeno (Mo) è stata effettuata utilizzando la spettrofotometria ad assorbimento atomico su fornace di grafite. A parte il Ni, le concentrazioni di ioni nei pazienti con MOM-HR erano più elevate rispetto ai controlli. Il rilascio di ioni Cr e Co nei pazienti con MOM-HR è risultato superiore rispetto ai soggetti con MOM-THA. Da un’analisi basata sul sesso, è emerso che nelle femmine con MOM-HR i livelli di ioni Cr e Co sono risultati significativamente aumentati rispetto alle femmine con MOM-THA. Indipendentemente dal tipo di impianto, gli accoppiamenti metallo-metallo (MOM) producono concentrazioni di ioni metallici significativamente più alte a follow-up a lungo termine rispetto a quelle osservate nei soggetti sani. Un fattore che deve essere attentamente considerato nella scelta dell’impianto, e in particolar modo nei soggetti giovani, è il cospicuo rilascio di ioni Cr e Co nella popolazione femminile con MOM-HR.

Timeliness, efficiency and public procurement in hip surgery in Italy

Considering different perspectives, the scope of this thesis is to investigate how to improve healthcare resources allocation and the provision efficiency for hip surgeries, a resource-intensive operation, among the most frequently performed on the elderly, with a trend in volume that is increasing in years due to population aging. Firstly, the effect of Time-To-Surgery (TTS) on mortality for hip fracture patients is investigated. The analysis attempts to account for TTS endogeneity due to the inability to fully control for variables affecting patient delay – e.g. patient severity. Exploiting an instrumental variable model, where being admitted on Friday or Saturday predicts longer TTS, findings show exogenous TTS does not have a significant effect on mortality. Thus suggesting surgeons prioritize patients effectively, neutralizing the adverse impact of longer TTS. Then, the volume-outcome relation for total hip replacement surgery is analyzed, seeking to account for selective referral, which may be present in elective surgery context, and induce reverse causality issue in the volume-outcome relation. The analysis employs a conditional choice model where patient travel distance from all regions' hospitals is used as a hospital choice predictor. Findings show the exogenous hospital volume significantly decreases adverse outcomes probability, especially in the short run. Finally, the change in public procurement design enforced in the Romagna LHA (Italy) is exploited to assess its impact on hip prostheses cost, surgeons' implant choice, and patient health outcomes. Hip prostheses are the major cost-driver of hip replacement surgeries, hence it is crucial to design the public tender such that implant prices are minimized, but cost-containment policies have to be weighted with patient well-being. Evidence shows that a cost reduction occurred without a significant surgeons’ choices impact. Positive or no effect of surgeons specialization is found on patients outcomes after the new procurement introduction.

Physical activity as a tool to improve the quality of life for individuals with hip or knee osteoarthritis

Total hip and knee replacements (THR/TKR) are considered the gold standard surgical treatments for end-stage osteoarthritis (OA), effectively alleviating pain, enhancing joint mobility and quality of life (QoL). Maintaining an active lifestyle and regular physical activity (PA) is crucial for these patients, as it can increase bone density and stability of joint prosthesis. This thesis aims to: (1) systematically review recommendations from healthcare professionals; (2) explore interventions promoting an active lifestyle post-THR and TKR; (3) investigate the primary causes of stiffness post-TKR; (4) design an exercise protocol to enhance QoL post-THR and TKR; (5) evaluate orthopedic surgeons' attitudes toward PA for patients post-THR/TKR; and (6) assess changes in QoL after a specifically designed PA intervention. The initial review revealed consensus on permissible sports activities post-surgery, but few studies addressed interventions targeting PA behaviors. Subsequently, findings highlighted key factors contributing to post-TKR stiffness, including mispositioned components, psychological distress, and obesity. Building on these insights, a PA intervention was implemented, followed by a survey investigating orthopedic surgeons' attitudes towards PA, which demonstrated a general positive attitude. Lastly, a pilot randomized controlled trial demonstrated significant enhancements in QoL, physical function, and clinical outcomes following a three-month adapted PA intervention. Future research should focus on raising awareness among individuals and healthcare professionals, fostering engagement in PA programs, and promoting active lifestyles. PA represents a valuable strategy for mitigating the burden of chronic diseases on society.

New functional and biomechanical assessments for the improvement of the surgical navigation systems for joint replacement in the human lower limb

In case of severe osteoarthritis at the knee causing pain, deformity, and loss of stability and mobility, the clinicians consider that the substitution of these surfaces by means of joint prostheses. The objectives to be pursued by this surgery are: complete pain elimination, restoration of the normal physiological mobility and joint stability, correction of all deformities and, thus, of limping. The knee surgical navigation systems have bee developed in computer-aided surgery in order to improve the surgical final outcome in total knee arthroplasty. These systems provide the surgeon with quantitative and real-time information about each surgical action, like bone cut executions and prosthesis component alignment, by mean of tracking tools rigidly fixed onto the femur and the tibia. Nevertheless, there is still a margin of error due to the incorrect surgical procedures and to the still limited number of kinematic information provided by the current systems. Particularly, patello-femoral joint kinematics is not considered in knee surgical navigation. It is also unclear and, thus, a source of misunderstanding, what the most appropriate methodology is to study the patellar motion. In addition, also the knee ligamentous apparatus is superficially considered in navigated total knee arthroplasty, without taking into account how their physiological behavior is altered by this surgery. The aim of the present research work was to provide new functional and biomechanical assessments for the improvement of the surgical navigation systems for joint replacement in the human lower limb. This was mainly realized by means of the identification and development of new techniques that allow a thorough comprehension of the functioning of the knee joint, with particular attention to the patello-femoral joint and to the main knee soft tissues. A knee surgical navigation system with active markers was used in all research activities presented in this research work. Particularly, preliminary test were performed in order to assess the system accuracy and the robustness of a number of navigation procedures. Four studies were performed in-vivo on patients requiring total knee arthroplasty and randomly implanted by means of traditional and navigated procedures in order to check for the real efficacy of the latter with respect to the former. In order to cope with assessment of patello-femoral joint kinematics in the intact and replaced knees, twenty in-vitro tests were performed by using a prototypal tracking tool also for the patella. In addition to standard anatomical and articular recommendations, original proposals for defining the patellar anatomical-based reference frame and for studying the patello-femoral joint kinematics were reported and used in these tests. These definitions were applied to two further in-vitro tests in which, for the first time, also the implant of patellar component insert was fully navigated. In addition, an original technique to analyze the main knee soft tissues by means of anatomical-based fiber mappings was also reported and used in the same tests. The preliminary instrumental tests revealed a system accuracy within the millimeter and a good inter- and intra-observer repeatability in defining all anatomical reference frames. In in-vivo studies, the general alignments of femoral and tibial prosthesis components and of the lower limb mechanical axis, as measured on radiographs, was more satisfactory, i.e. within ±3°, in those patient in which total knee arthroplasty was performed by navigated procedures. As for in-vitro tests, consistent patello-femoral joint kinematic patterns were observed over specimens throughout the knee flexion arc. Generally, the physiological intact knee patellar motion was not restored after the implant. This restoration was successfully achieved in the two further tests where all component implants, included the patellar insert, were fully navigated, i.e. by means of intra-operative assessment of also patellar component positioning and general tibio-femoral and patello-femoral joint assessment. The tests for assessing the behavior of the main knee ligaments revealed the complexity of the latter and the different functional roles played by the several sub-bundles compounding each ligament. Also in this case, total knee arthroplasty altered the physiological behavior of these knee soft tissues. These results reveal in-vitro the relevance and the feasibility of the applications of new techniques for accurate knee soft tissues monitoring, patellar tracking assessment and navigated patellar resurfacing intra-operatively in the contest of the most modern operative techniques. This present research work gives a contribution to the much controversial knowledge on the normal and replaced of knee kinematics by testing the reported new methodologies. The consistence of these results provides fundamental information for the comprehension and improvements of knee orthopedic treatments. In the future, the reported new techniques can be safely applied in-vivo and also adopted in other joint replacements.

Sviluppo, implementazione e valutazione funzionale di un nuovo modello protesico di caviglia

Total ankle arthroplasty (TAA) is still not as satisfactory as total hip and total knee arthroplasty. For the TAA to be considered a valuable alternative to ankle arthrodesis, an effective range of ankle mobility must be recovered. The disappointing clinical results of the current generation of TAA are mostly related to poor understanding of the structures guiding ankle joint mobility. A new design (BOX Ankle) has been developed, uniquely able to restore physiologic ankle mobility and a natural relationship between the implanted components and the retained ligaments. For the first time the shapes of the tibial and talar components in the sagittal plane were designed to be compatible with the demonstrated ligament isometric rotation. This resulted in an unique motion at the replaced ankle where natural sliding as well as rolling motion occurs while at the same time full conformity is maintained between the three components throughout the flexion arc. According to prior research, the design features a spherical convex tibial component, a talar component with radius of curvature in the sagittal plane longer than that of the natural talus, and a fully conforming meniscal component. After computer-based modelling and preliminary observations in several trial implantation in specimens, 126 patients were implanted in the period July 2003 – December 2008. 75 patients with at least 6 months follow-up are here reported. Mean age was 62,6 years (range 22 – 80), mean follow-up 20,2 months. The AOFAS clinical score systems were used to assess patient outcome. Radiographs at maximal dorsiflexion and maximal plantar flexion confirmed the meniscalbearing component moves anteriorly during dorsiflexion and posteriorly during plantarflexion. Frontal and lateral radiographs in the patients, show good alignment of the components, and no signs of radiolucency or loosening. The mean AOFAS score was observed to go from 41 pre-op to 74,6 at 6 month follow-up, with further improvement at the following follow-up. These early results reveal satisfactory clinical scores, with good recovery of range of motion and reduction of pain. Radiographic assessment reveals good osteointegration. All these preliminary results confirm biomechanical studies and the validity of this novel ligamentcompatible prosthesis design. Surely it will be important to re-evaluate these patients later.

Efficacia delle griglie in titanio con osso particolato nella ricostruzione dei difetti alveolari tridimensionali dei mascellari

Questa tesi valuta l’efficacia della tecnica delle griglie in titanio con osso particolato nella ricostruzione dei difetti alveolari tridimensionali ai fini della riabilitazione dentale implanto-protesica. Il primo studio ha considerato la metodica in termini di complicanze post-operatorie e di risultati implanto-protesici. Sono stati considerati 24 pazienti con difetti tridimensionali trattati con l’applicazione di 34 griglie di titanio e osso particolato e riabilitati protesicamente dopo circa 8-9 mesi. 4 su 34 griglie sono state rimosse prima dell’inserimento implantare (11.76% di fallimento totale); 20 su 34 griglie si sono esposte per deiscenza dei tessuti molli (58.82% di complicanze): 4 (11.77%) prima e 16 (47.05%) dopo le prime 4-6 settimane dall’intervento; in nessun caso il piano di trattamento implanto-protesico ha subito variazioni. Dopo un follow-up medio di 20 (3-48) mesi dal carico protesico, nessuno degli 88 impianti ha perso la propria osteo-integrazione (100% di sopravvivenza implantare), con un valore complessivo di successo implantare di 82.9%. Il secondo studio ha calcolato in termini volumetrici la ricostruzione ossea ottenuta con griglie e la sua corre-lazione con l’estensione dell’esposizione e la tempistica del suo verificarsi. Sono stati valutati 12 pazienti con 15 difetti alveolari. Per ciascun sito sono state studiate le immagini TC con un software dedicato per misurare i volumi in tre dimensioni: il volume di osso non formatosi rispetto a quanto pianificato, lacking bone volume (LBV), è stato calcolato sottraendo il volume di osso ricostruito, reconstructed bone volume (RBV) in fase di ri-entro chirurgico dal volume di osso pianificato pre-operativamente, planned bone volume (PBV). LBV è risultato direttamente proporzionale all’area di esposizione della griglia, con un valore del 16.3% di LBV per ogni cm2 di griglia esposta. Si sono evidenziate, inoltre, correlazioni positive tra LBV , la tempistica precoce di esposizione e il valore di PBV.

Biomimetica per l'ingegneria tissutale dell'osso

Reconstruction of bone is needed for high bone loss due to congenital deformities, trauma or neoplastic diseases. Commonly, orthopaedic surgical treatments are autologus or allogenic bone implant or prosthetic implant. A choice to the traditional approaches could be represented by tissue engineering that use cells (and/or their products) and innovative biomaterials to perform bone substitutes biologically active as an alternative to artificial devices. In the last years, there was a wide improvement in biology on stem cells potential research and in biomedical engineering through development of new biomaterials designed to resemble the physiological tissues. Tissue engineering strategies and smart materials aim together to stimulate in vivo bone regeneration. This approaches drive at restore not only structure integrity and/or function of the original tissue, but also to induce new tissue deposition in situ. An intelligent bone substitute is now designed like not only a scaffold but also as carrier of regeneration biomolecular signals. Biomimetics has helped to project new tissue engineered devices to simulate the physiological substrates architecture, such extracellular matrix (ECM), and molecular signals that drive the integration at the interface between pre-existing tissue and scaffold. Biomimetic strategies want to increase the material surface biological activity with physical modifications (topography) o chemical ones (adhesive peptides), to improve cell adhesion to material surface and possibly scaffold colonization. This study evaluated the effects of biomimetic modifications of surgical materials surface, as poly-caprolattone (PCL) and titanium on bone stem cells behaviour in a marrow experimental model in vitro. Two biomimetic strategies were analyzed; ione beam irradiation, that changes the surface roughness at the nanoscale, and surface functionalization with specific adhesive peptides or Self Assembled Monolayers (SAMs). These new concept could be a mean to improve the early (cell adhesion, spreading..) and late phases (osteoblast differentiation) of cell/substrate interactions.

Riabilitazione del mascellare posteriore atrofico mediante impianti corti (6-8 mm) o rialzo di seno con contestuale inserimento di impianti di lunghezza standard: studio retrospettivo con follow up a 3 anni

Background: sebbene la letteratura recente abbia suggerito che l’utilizzo degli impianti corti possa rappresentare una alternative preferibile alle procedure di rigenerazione ossea nelle aree posteriori atrofiche, perché è un trattamento più semplice e con meno complicazioni, esistono solo pochi studi a medio e lungo termine che abbiano comparato queste tecniche. Scopo: lo scopo di questo studio retrospettivo è quello di valutare se gli impianti corti (6-8 mm) (gruppo impianti corti) possano presentare percentuali di sopravvivenza e valori di riassorbimento osseo marginali simili a impianti di dimensioni standard (≥11 mm) inseriti contemporaneamente ad una grande rialzo di seno mascellare. Materiali e Metodi: in totale, 101 pazienti sono stati inclusi: 48 nel gruppo impianti corti e 53 nel gruppo seno. In ciascun paziente da 1 a 3 impianti sono stati inseriti e tenuti sommersi per 4-6 mesi. I parametri clinici e radiografici valutati sono: i fallimenti implantari, le complicazioni, lo stato dei tessuti molli, e il riassorbimento osseo marginale. Tutti i pazienti sono stati seguiti per almeno 3 anni dal posizionamento implantare. Risultati: il periodo di osservazione medio è stato di 43.47 ± 6.1 mesi per il gruppo impianti corti e 47.03 ± 7.46 mesi per il gruppo seno. Due su 101 impianti corti e 6 su 108 impianti standard sono falliti. Al follow-up finale, si è riscontrato un riassorbimento osseo medio di 0.47 ± 0.48 mm nel gruppo impianti corti versus 0.64 ± 0.58 mm nel gruppo seno. Non sono presenti differenze statisticamente significative fra i gruppi in termini di fallimenti implantari, complicazioni protesiche, tessuti molli, e riassorbimento osseo. Il gruppo seno ha presentato, invece, un maggior numero di complicazioni chirurgiche. Conclusioni: entrambe le tecniche hanno dimostrato un simile tasso di successo clinico e radiografico, ma gli impianti corti hanno ridotto il numero di complicazioni chirurgiche.

Nuovi metodi di diagnosi precoce dei fallimenti di protesi d'anca con accoppiamento articolare ceramica-ceramica

L’accoppiamento articolare in ceramica è sempre più utilizzato in chirurgia protesica dell’anca per le sue eccellenti proprietà tribologiche. Tuttavia la fragilità della ceramica è causa di fallimenti meccanici. Abbiamo quindi condotto una serie di studi al fine di individuare un metodo efficace di diagnosi precoce del fallimento della ceramica. Abbiamo analizzato delle componenti ceramiche espiantate e abbiamo trovato un pattern di usura pre-frattura che faceva supporre una dispersione di particelle di ceramica nello spazio articolare. Per la diagnosi precoce abbiamo validato una metodica basata sulla microanalisi del liquido sinoviale. Per validare la metodica abbiamo eseguito un agoaspirato in 12 protesi ben funzionanti (bianchi) e confrontato i risultati di 39 protesi con segni di rottura con quelli di 7 senza segni di rottura. Per individuare i pazienti a rischio rottura i dati demografici di 26 pazienti con ceramica rotta sono stati confrontati con 49 controlli comparabili in termini demografici, tipo di ceramica e tipo di protesi. Infine è stata condotta una revisione sistematica della letteratura sulla diagnosi della rottura della ceramica. Nell’aspirato la presenza di almeno 11 particelle ceramiche di dimensioni inferiori a 3 micron o di una maggiore di 3 micron per ogni campo di osservazione sono segno di rottura della ceramica. La metodica con agoaspirato ha 100% di sensibilità e 88 % di specificità nel predire rotture della ceramica. Nel gruppo delle ceramiche rotte è stato trovato un maggior numero di malposizionamenti della protesi rispetto ai controlli (p=0,001). Il rumore in protesi con ceramica dovrebbe sollevare il sospetto di fallimento ed indurre ad eseguire una TC e un agoaspirato. Dal confronto con la letteratura la nostra metodica risulta essere la più efficace.

Sindrome da insensitività completa agli androgeni e massa ossea. Valutazione basale e longitudinale dopo oltre 12 mesi di terapia estrogenica

L’osso è un tessuto target per estrogeni ed androgeni ma l’azione singola e la sinergia tra i due non sono compresi interamente. Le donne affette da Sindrome da Insensititvità Completa agli Androgeni (CAIS) hanno un cariotipo 46XY ma presentano una completa inattività del recettore degli androgeni. Nello studio abbiamo valutato la densità minerale ossea (BMD) in un gruppo di donne adulte CAIS sottoposte a gonadectomia al momento della prima visita e dopo almeno 12 mesi di terapia estrogenica. Il principale obiettivo è stato di valutare se, nelle donne CAIS, una ottimale estrogenizzazione fosse sufficiente a mantenere/ripristinare una adeguata BMD. 24 donne CAIS sono state sottoposte a DXA lombare e femorale all'arruolamento nello studio (t1), dopo terapia estrogenica di 12mesi(t2) e oltre (t>2). Sono state valutate: BMD(g/cm2) e Zscore lombare e femorale (a t1,t2 e t>2) E’ stato considerato se fossero rilevanti l’essere (gruppo1) o meno (gruppo 2) in terapia ormonale al t1 e l’età della gonadectomia. Risultati: Al t1 BMD e Zscore lombari e femorale erano significativamente ridotti rispetto alla popolazione controllo nel campione totale (lombare 0,900+0,12; -1,976+0,07, femorale 0,831 + 0,14; -1,385+0,98), nel gruppo 1 (lombare 0,918+0,116;-1,924+0,79, femorale 0,824+0,13;-1,40+1,00) e nel gruppo 2 (lombare 0.845+0,11 -2,13+1,15, femorale 0,857+0,17;-1,348+1,05) Al t2 e t>2 la BMD lombare è risultata significativamente aumentata (p=0,05 e p=0,02). Zscore lombare, BMD e Zscore femorale non hanno dimostrato variazioni significative. L’aver effettuato la gonadectomia in età post puberale è associato a Zscore lombare e femorale più elevati al t1. Nelle donne CAIS la terapia estrogenica è indispensabile per prevenire un'ulteriore perdita di BMD ma, da sola, non sembra in grado di ripristinare normali valori di BMD.I risultati del nostro studio supportano la tesi che gli androgeni, mediante l’azione recettoriale, abbiano un' azione diretta nel raggiungere e mantenere la BMD.