In vitro biomechanical testing of the stability of primary and revision hip acetabular implants

Hip acetabular stability is the capability of acetabular implants to resist to the forces acting in the acetabulum during patient activities after surgery. If implant motions are sufficiently low, primary stability is achieved and the osteointegration process between the implant and the surrounding bone may occur. In this context, measuring implant motions is essential to predict the implant failure. In clinical practise, these measurements are limited to implant migration, while elastic motions and periacetabular strains are not monitored. So far, to obtain a complete set of stability measurements in vitro testing is the most reliable option. Despite the importance of the experimental analysis, a general consensus about the application of biomechanical tools to solve clinical problems is still missing. The aim of my Ph.D project was to develop and apply reliable in vitro methods to assess the hip acetabular stability in case of primary and revision reconstructions. First, two methodological studies were conducted (1) to define and implement a robust reference frame for the human hemipelvis based on a morphological analysis of this anatomical district and (2) to create a robust procedure to measure the implant motions and the periacetabular strains with the Digital Image Correlation technique. Secondly, I applied these methods to answer the following clinical questions: 1. How do changes in the motor task affect the cup stability and the periacetabular strains? 2. Does the cup medialization affect implant stability? 3. Which is the effect on cup stability of defect reconstructions with an innovative synthetic bone substitute or with human bone graft in revision surgery? All these clinical questions were answered in three experimental studies. In conclusion, this project provided a reliable set of in vitro methods to perform biomechanical testing on human hemipelvis and to assess the stability of acetabular reconstructions by mean of Digital Image Correlation

Exploring the EMG transient: the muscular activation sequences used as novel time-domain features for hand gestures classification

IntroductionMuscular activation sequences have been shown to be suitable time-domain features for classification of motion gestures. However, their clinical application in myoelectric prosthesis control was never investigated so far. The aim of the paper is to evaluate the robustness of these features extracted from the EMG signal in transient state, on the forearm, for classifying common hand tasks.MethodsThe signal associated to four hand gestures and the rest condition were acquired from ten healthy people and two persons with trans-radial amputation. A feature extraction algorithm allowed for encoding the EMG signals into muscular activation sequences, which were used to train four commonly used classifiers, namely Linear Discriminant Analysis (LDA), Support Vector Machine (SVM), Non-linear Logistic Regression (NLR) and Artificial Neural Network (ANN). The offline performances were assessed with the entire sample of recruited people. The online performances were assessed with the amputee subjects. Moreover, a comparison of the proposed method with approaches based on the signal envelope in the transient state and in the steady state was conducted.ResultsThe highest performance were obtained with the NLR classifier. Using the sequences, the offline classification accuracy was higher than 93% for healthy and amputee subjects and always higher than the approach with the signal envelope in transient state. As regards the comparison with the steady state, the performances obtained with the proposed method are slightly lower (<4%), but the classification occurred at least 200 ms earlier. In the online application, the motion completion rate reached up to 85% of the total classification attempts, with a motion selection time that never exceeded 218 ms.DiscussionMuscular activation sequences are suitable alternatives to the time-domain features commonly used in classification problems belonging to the sole EMG transient state and could be potentially exploited in control strategies of myoelectric prosthesis hands

A method to assess primary stability of acetabular components in association with bone defects

The objectives of this study were to develop a simplified acetabular bone defect model based on a representative clinical case, derive four bone defect increments from the simplified defect to establish a step‐wise testing procedure, and analyze the impact of bone defect and bone defect filling on primary stability of a press‐fit cup in the smallest defined bone defect increment. The original bone defect was approximated with nine reaming procedures and by exclusion of specific procedures, four defect increments were derived. The smallest increment was used in an artificial acetabular test model to test primary stability of a press‐fit cup in combination with bone graft substitute (BGS). A primary acetabular test model and a defect model without filling were used as reference. Load was applied in direction of level walking in sinusoidal waveform with an incrementally increasing maximum load (300 N/1000 cycles from 600 to 3000 N). Relative motions (inducible displacement, migration, and total motion) between cup and test model were assessed with an optical measurement system. Original and simplified bone defect volume showed a conformity of 99%. Maximum total motion in the primary setup at 600 N (45.7 ± 5.6 µm) was in a range comparable to tests in human donor specimens (36.0 ± 16.8 µm). Primary stability was reduced by the bone defect, but could mostly be reestablished by BGS‐filling. The presented method could be used as platform to test and compare different treatment strategies for increasing bone defect severity in a standardized way

A Workflow for Studying the Stump-Socket Interface in Persons with Transtibial Amputation through 3D Thermographic Mapping

The design and fitting of prosthetic sockets can significantly affect the acceptance of an artificial limb by persons with lower limb amputations. Clinical fitting is typically an iterative process, which requires patients' feedback and professional assessment. When feedback is unreliable due to the patient's physical or psychological conditions, quantitative measures can support decision-making. Specifically, monitoring the skin temperature of the residual limb can provide valuable information regarding unwanted mechanical stresses and reduced vascularization, which can lead to inflammation, skin sores and ulcerations. Multiple 2D images to examine a real-life 3D limb can be cumbersome and might only offer a partial assessment of critical areas. To overcome these issues, we developed a workflow for integrating thermographic information on the 3D scan of a residual limb, with intrinsic reconstruction quality measures. Specifically, workflow allows us to calculate a 3D thermal map of the skin of the stump at rest and after walking, and summarize this information with a single 3D differential map. The workflow was tested on a person with transtibial amputation, with a reconstruction accuracy lower than 3 mm, which is adequate for socket adaptation. We expect the workflow to improve socket acceptance and patients' quality of life

Development of in vitro methods to test acetabular prosthetic reconstructions (messa a punto di metodi in vitro per la caratterizzazione biomeccanica di ricostruzioni acetabolari)

The revision hip arthroplasty is a surgical procedure, consisting in the reconstruction of the hip joint through the replacement of the damaged hip prosthesis. Several factors may give raise to the failure of the artificial device: aseptic loosening, infection and dislocation represent the principal causes of failure worldwide. The main effect is the raise of bone defects in the region closest to the prosthesis that weaken the bone structure for the biological fixation of the new artificial hip. For this reason bone reconstruction is necessary before the surgical revision operation. This work is born by the necessity to test the effects of bone reconstruction due to particular bone defects in the acetabulum, after the hip prosthesis revision. In order to perform biomechanical in vitro tests on hip prosthesis implanted in human pelvis or hemipelvis a practical definition of a reference frame for these kind of bone specimens is required. The aim of the current study is to create a repeatable protocol to align hemipelvic samples in the testing machine, that relies on a reference system based on anatomical landmarks on the human pelvis. In chapter 1 a general overview of the human pelvic bone is presented: anatomy, bone structure, loads and the principal devices for hip joint replacement. The purpose of chapters 2 is to identify the most common causes of the revision hip arthroplasty, analysing data from the most reliable orthopaedic registries in the world. Chapter 3 presents an overview of the most used classifications for acetabular bone defects and fractures and the most common techniques for acetabular and bone reconstruction. After a critical review of the scientific literature about reference frames for human pelvis, in chapter 4, the definition of a new reference frame is proposed. Based on this reference frame, the alignment protocol for the human hemipelvis is presented as well as the statistical analysis that confirm the good repeatability of the method

Il ruolo del verde indocianina per la valutazione del linfonodo sentinella

Obiettivo: dimostrare l'equivalenza tra la sensibilità del Verde Indocianina e quella del Tecnezio radioattivo nella detezione del linfonodo sentinella(LS), nei pazienti affetti da carcinoma mammario allo stadio iniziale. Metodi: linfoscintigrafia con Tc99m-marcato, attraverso Gammacamera e con Verde Indocianina, attraverso Photo Dinamic Eye, per la detezione del LS. Utilizzo della sonda Gamma Probe per la discriminazione dei linfonodi radioattivi da quelli non radioattivi. Analisi statistica dei dati. Risultati: sono stati studiati 200 pazienti per un totale di 387 linfonodi asportati; la sensibilità del ICG risulta essere del 98,09%. Studi statistici hanno confermato la non significatività dei parametri di BMI, taglia mammaria, dose iniettata, tempo iniezione-incisione per il rintracciamento del numero corretto di linfonodi (al massimo 2). Conclusioni: l'elevata sensibilità del ICG permette di affermare l'equivalenza tra la capacità di detezione dei LS con le due sostanze(Tc e ICG). A livello operativo la tecnica con ICG facilita l'asportazione del LS. Data la non significatività della dose di ICG iniettata per la detezione del numero corretto di linfonodi, clinicamente conviene iniettare sempre la dose minima di farmaco

A reliable in vitro approach to assess the stability of acetabular implants using digital image correlation

The main cause of failure of the hip acetabular component is aseptic loosen- ing. Preclinical test methods currently used to assess the stability of hip acetabular implants rely on crude simplifications. Normally, either one com- ponent of motion or bone strains are measured. We developed a test method to measure implant 3D translations and rotations and bone strains using digital image correlation. Hemipelvises were aligned and potted to allow consistent testing. A force was applied in the direction of the load peak during level walking. The force was applied in 100\u2010cycle packages, each load package being 20% larger than the previous one. A digital image correlation system allowed measuring the cup\u2010bone relative 3D displacements (permanent migra- tions and inducible micromotions) and the strain distribution in the periacetabular bone. To assess the test repeatability, the protocol was applied to six composite hemipelvises implanted with very stable cups. To assess the suitability of the method to detect mobilisation, six loose implants were tested. The method was repeatable: the interspecimen variability was 16 \u3bcm for the bone/cup relative translations, 0.04\ub0 for the rotations. The method was capa- ble of tracking extremely loose implants (translations up to 4.5 mm; rotations up to 30\ub0). The strain distribution in the bone was measured, showing the areas of highest strain. We have shown that it is possible to measure the 3D relative translations and rotations of an acetabular cup inside the pelvis and simultaneously to measure the full\u2010field strain distribution in the bone sur- face. This will allow better preclinical testing of the stability of acetabular implants

Effect of different motor tasks on hip cup primary stability and on the strains in the periacetabular bone: An in vitro study

Background: Excessive prosthesis/bone motions and the bone strains around the acetabulum may prevent osteointegration and lead to cup loosening. These two factors depend on post-operative joint loading. We investigated how Walking (which is often simulated) and Standing-Up from seated (possibly more critical) influence the cup primary stability and periacetabular strains. METHODS: Twelve composite hemipelvises were used in two test campaigns. Simplified loading conditions were adopted to simulate Walking and Standing-Up. For each motor task, a single-direction force was applied in load packages of increasing amplitude. Stable and unstable uncemented cups were implanted. Digital image correlation was used to measure implant/bone motions (three-dimensional translations and rotations, both permanent and inducible), and the strain distribution around the acetabulum. FINDINGS: When stable implants were tested, higher permanent cranial translations were found during Walking (however the resultant migrations were comparable with Standing-Up); higher rotations were found for Standing-Up. When unstable implants were tested, motions were 1-2 order of magnitude higher. Strains increased significantly from stable to unstable implants. The peak strains were in the superior aspect of the acetabulum during Walking and in the superior-posterior aspect of the acetabulum and at the bottom of the posterior column during Standing-Up. INTERPRETATION: Different cup migration trends were caused by simulated Walking and Standing-Up, both similar to those observed clinically. The cup mobilization pattern depended on the different simulated motor tasks. Pre-clinical testing of new uncemented cups could include simulation of both motor tasks. Our study could also translate to indication of what tasks should be avoided