A retrospective multidimensional comparison of microprocessor and mechanical knee users: Analysis of quality of life and satisfaction with the prosthesis.

BACKGROUND: Despite the demonstrated greater efficacy of microprocessor knees (MPK) over mechanical knees (MK), the latter is still widely used by persons with transfemoral amputation. Besides motivations related to local insurance policies, quality of life (QoL) and satisfaction with the prosthesis play a key role in user preference. OBJECTIVE: The aim of this study is to compare QoL and satisfaction in a large sample of MPK and MK users and to assess how these outcomes are explained by clinical and demographic characteristics. STUDY DESIGN: Retrospective study. METHODS: The study was conducted on 75 MPK and 60 MK users. Quality of life was assessed using the EuroQoL Five Dimensions and the EuroQoL Visual Analog Scale questionnaires. Satisfaction was assessed with the Satisfaction with Prosthesis questionnaire. All 3 instruments were self-administered. Univariate and multivariate regression analyses were conducted thereafter. RESULTS: The difference in satisfaction between MPK and MK users was not statistically significant. Significant differences were observed instead for QoL. From the univariate regression analysis, 6 factors were significant predictors of QoL and satisfaction. On multivariate analysis, the number of significant factors was reduced to 3, namely knee type, age at the first prosthesis, and experience with prosthesis. Type of knee and age at the first prosthesis significantly predicted QoL scores, explaining 12% of EuroQoL Five Dimensions and 25% of EuroQoL Visual Analog Scale variances. Age at the first prosthesis and experience with prosthesis predicted Satisfaction with Prosthesis scores in the multivariate model, explaining 25% of the variance. CONCLUSIONS: MPK affects QoL but not satisfaction, which is positively driven by patients' experience with prosthesis and negatively affected by the age at the time of the first prosthesis.

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.

Hierarchical strategy for sEMG classification of the hand/wrist gestures and forces of transradial amputees.

Introduction: The myoelectric control strategy, based on surface electromyographic signals, has long been used for controlling a prosthetic system with multiple degrees of freedom. Several methods classify gestures and force levels but the simultaneous real-time control of hand/wrist gestures and force levels did not yet reach a satisfactory level of effectiveness. Methods: In this work, the hierarchical classification approach, already validated on 31 healthy subjects, was adapted for the real-time control of a multi-DoFs prosthetic system on 15 trans-radial amputees. The effectiveness of the hierarchical classification approach was assessed by evaluating both offline and real-time performance using three algorithms: Logistic Regression (LR), Non-linear Logistic Regression (NLR), and Linear Discriminant Analysis (LDA). Results: The results of this study showed the offline performance of amputees was promising and comparable to healthy subjects, with mean F1 scores of over 90% for the "Hand/wrist gestures classifier" and 95% for the force classifiers, implemented with the three algorithms with features extraction (FE). Another significant finding of this study was the feasibility of using the hierarchical classification strategy for real-time applications, due to its ability to provide a response time of 100 ms while maintaining an average online accuracy of above 90%. Discussion: A possible solution for real-time control of both hand/wrist gestures and force levels is the combined use of the LR algorithm with FE for the "Hand/wrist gestures classifier", and the NLR with FE for the Spherical and Tip force classifiers.

Manipulation Tasks in Hazardous Environments Using a Teleoperated Robot: A Case Study at CERN.

Remote robotic systems are employed in the CERN accelerator complex to perform different tasks, such as the safe handling of cables and their connectors. Without dedicated control, these kinds of actions are difficult and require the operators' intervention, which is subjected to dangerous external agents. In this paper, two novel modules of the CERNTAURO framework are presented to provide a safe and usable solution for managing optical fibres and their connectors. The first module is used to detect touch and slippage, while the second one is used to regulate the grasping force and contrast slippage. The force reference was obtained with a combination of object recognition and a look-up table method. The proposed strategy was validated with tests in the CERN laboratory, and the preliminary experimental results demonstrated statistically significant increases in time-based efficiency and in the overall relative efficiency of the tasks.

Factors influencing the self-perceived mobility of active unilateral lower limb amputees assessed with the Prosthetic Mobility Questionnaire: a brief report.

The Prosthetic Mobility Questionnaire (PMQ 2.0) represents a reliable solution for evaluating amputees' self-perceived mobility. The study aimed to evaluate the perceived mobility of middle-aged users with a traumatic amputation using the PMQ 2.0 and to assess the influence of age, stump and phantom limb pain, amputation level, time since amputation, and prosthesis use on it. Fifty subjects were recruited. The median value of the score was higher than previously published reference values, reflecting the 'active' mobility status of the sample. The hours of prosthesis use per day explained about 21% of the variance of the questionnaire score and was a significant predictor of perceived mobility. Reference values for the recently developed PMQ 2.0 survey and relative to active, traumatic amputees were reported. As prosthesis use was a significant predictor of the amputees' perceived mobility, prolonged use of the artificial limb should be always encouraged in clinical practice.

Current strategies to diagnose and manage positive surgical margins and local recurrence after partial nephrectomy.

Objective: No standard strategy for diagnosis and management of positive surgical margin (PSM) and local recurrence after partial nephrectomy (PN) are reported in literature. This review aims to provide an overview of the current strategies and further perspectives on this patient setting. Methods: A non-systematic review of the literature was completed. The research included the most updated articles (about the last 10 years). Results: Techniques for diagnosing PSMs during PN include intraoperative frozen section, imprinting cytology, and other specific tools. No clear evidence is reported about these methods. Regarding PSM management, active surveillance with a combination of imaging and laboratory evaluation is the first option line followed by surgery. Regarding local recurrence management, surgery is the primary curative approach when possible but it may be technically difficult due to anatomy resultant from previous PN. In this scenario, thermal ablation (TA) may have the potential to circumvent these limitations representing a less invasive alternative. Salvage surgery represents a valid option; six studies analyzed the outcomes of nephrectomy on local recurrence after PN with three of these focused on robotic approach. Overall, complication rates of salvage surgery are higher compared to TA but ablation presents a higher recurrence rate up to 25% of cases that can often be managed with repeat ablation. Conclusion: Controversy still exists surrounding the best strategy for management and diagnosis of patients with PSMs or local recurrence after PN. Active surveillance is likely to be the optimal first-line management option for most patients with PSMs. Ablation and salvage surgery both represent valid options in patients with local recurrence after PN. Conversely, salvage PN and radical nephrectomy have fewer recurrences but are associated with a higher complication rate compared to TA. In this scenario, robotic surgery plays an important role in improving salvage PN and radical nephrectomy outcomes.

Hierarchical Human-Inspired Control Strategies for Prosthetic Hands.

The abilities of the human hand have always fascinated people, and many studies have been devoted to describing and understanding a mechanism so perfect and important for human activities. Hand loss can significantly affect the level of autonomy and the capability of performing the activities of daily life. Although the technological improvements have led to the development of mechanically advanced commercial prostheses, the control strategies are rather simple (proportional or on/off control). The use of these commercial systems is unnatural and not intuitive, and therefore frequently abandoned by amputees. The components of an active prosthetic hand are the mechatronic device, the decoding system of human biological signals into gestures and the control law that translates all the inputs into desired movements. The real challenge is the development of a control law replacing human hand functions. This paper presents a literature review of the control strategies of prosthetics hands with a multiple-layer or hierarchical structure, and points out the main critical aspects of the current solutions, in terms of human's functions replicated with the prosthetic device. The paper finally provides several suggestions for designing a control strategy able to mimic the functions of the human hand.

Laparoscopic sacrocolpopexy versus pelvic organ prolapse suspension for surgical management of pelvic organ prolapse: a retrospective study.

This retrospective surgical clinical study compares clinical and functional effects of laparoscopic sacrocolpopexy (LSC) and laparoscopic pelvic organ prolapse suspension (L-POPS) for anterior and central prolapse correction. Thirty patients enrolled were affected by a symptomatic vaginal central compartment stage 2-3 prolapse and vaginal anterior compartment stage 1-3 prolapse without vaginal posterior compartment prolapse. A successful correction of anterior and central compartments prolapse without relapses were observed in both groups (LSC group versus L-POPS group). In patients who underwent L-POPS, a de novo posterior compartment prolapse was recorded. In this group, 7/15 patients complained more bowel symptoms and underwent vaginal colpoperineoplasty. In 20% (group LSC) and in 13.3% (group L-POPS) of cases, a condition of de novo urinary stress incontinence was described. LSC seems to remain the gold standard for pelvic organ prolapse correction, while further preventive strategies should be carried out in L-POPS to avoid a de novo posterior compartment prolapse.Impact StatementWhat is already known on this subject? Laparoscopic sacrocolpopexy is the gold standard technique for the correction of pelvic organ prolapse; however, laparoscopic pelvic organ prolapse suspension, based on the surgical technique of lateral suspension, is an innovative surgical method for the treatment of POP.What do the results of this study add? L-POPS could be considered a valid alternative to LSC for women with multiple comorbidities because of less operative time and reduced surgical risks. However, in the long follow-up period, some patients underwent L-POPS complained rectal discomfort and dysfunction on quality of life questionnaire and on clinical evaluation from six to twelve months after surgery probably due to the post-operative appearance of posterior compartment prolapse.What are the implications of these findings for clinical practice and/or further research? Considering the retrospective design and the small sample size the major limits of this study, larger, prospective, randomized studies could be encouraged to better compare a modified technique of L-POPS with posterior mesh apposition (preventing the post-operative appearance of posterior compartment prolapse) with the gold standard LSC for the correction of multi-compartment POP.

A parallel classification strategy to simultaneous control elbow, wrist, and hand movements.

BACKGROUND: In the field of myoelectric control systems, pattern recognition (PR) algorithms have become always more interesting for predicting complex electromyography patterns involving movements with more than 2 Degrees of Freedom (DoFs). The majority of classification strategies, used for the prosthetic control, are based on single, hierarchical and parallel linear discriminant analysis (LDA) classifiers able to discriminate up to 19 wrist/hand gestures (in the 3-DoFs case), considering both combined and discrete motions. However, these strategies were introduced to simultaneously classify only 2 DoFs and their use is limited by the lack of online performance measures. This study introduces a novel classification strategy based on the Logistic Regression (LR) algorithm with regularization parameter to provide simultaneous classification of 3 DoFs motion classes. METHODS: The parallel PR-based strategy was tested on 15 healthy subjects, by using only six surface EMG sensors. Twenty-seven discrete and complex elbow, hand and wrist motions were classified by keeping the number of electromyographic (EMG) electrodes to a bare minimum and the classification error rate under 10 %. To this purpose, the parallel classification strategy was implemented by using three classifiers one for each DoF: the "Elbow classifier", the "Wrist classifier", and the "Hand classifier" provided the simultaneous control of the elbow, hand, and wrist joints, respectively. RESULTS: Both the offline and real-time performance metrics were evaluated and compared with the LDA parallel classification results. The real-time recognition results were statistically better with the LR classifier with respect to the LDA classifier, for all motion classes (elbow, hand and wrist). CONCLUSIONS: In this paper, a novel parallel PR-based strategy was proposed for classifying up to 3 DoFs: three joint classifiers were employed simultaneously for classifying 27 motion classes related to the elbow, wrist, and hand and promising results were obtained.

Risk Assessment Model for Complications in Minimally Invasive Hysterectomy: A Pilot Study.

Objective: To estimate the rate of intra-operative and postoperative complications, and to define the risk of 30-day major postoperative complications (Clavien-Dindo > 2) according to the presence of one of 10 different variables of minimally invasive (MI) hysterectomy; and then to create a risk assessment model easily applicable in clinical practice. Methods: A single center single arm retrolective study. Data of consecutive patients who have undergone MI hysterectomy for gynaecologic disorders between May 2018 and April 2021 were analyzed. Perioperative surgical outcomes, occurrence of intra- and postoperative complications, and readmissions within 30 days from surgery were registered. Univariate and multivariable analyses were performed to determine the factors associated with major postoperative complications. Results: Over the study period, 445 patients were included in the study. The majority of patients developed a minor event, while major complications (grade III) were required in 14 patients. None of the patients showed a grade IV or V complication. Univariate analysis was performed on patients who had developed intra- or postoperative complications from those who did not experience complications. Body mass index (BMI) (p-value 0.045) and surgeon's experience (p-value 0.015) were found to be associated with a different surgery time. Regarding major postoperative complications, a statistically significant association was found for the variables: BMI (p-value 0.006), previous abdominal surgery (p-value 0.015), and surgeon's experience (p-value 0.035) in the univariate analysis. Also in the multivariate analysis, the risk of major postoperative complications was higher in these three different variables. BMI, previous surgery, and surgeon's experience were inserted in a reproducible risk assessment model in order to stratify the risk of major postoperative complications. Conclusions: We proposed a risk assessment model including factors not previously considered in the literature: the standardization of the surgical technique, the surgeon's experience, the best MI approach (laparoscopy or robot-assisted), and previous abdominal surgery are crucial tools to consider. Further prospective studies with a larger population sample are needed to validate these preliminary evaluations for patients undergoing MI hysterectomy.

Control Strategies and Performance Assessment of Upper-Limb TMR Prostheses: A Review.

The evolution of technological and surgical techniques has made it possible to obtain an even more intuitive control of multiple joints using advanced prosthetic systems. Targeted Muscle Reinnervation (TMR) is considered to be an innovative and relevant surgical technique for improving the prosthetic control for people with different amputation levels of the limb. Indeed, TMR surgery makes it possible to obtain reinnervated areas that act as biological amplifiers of the motor control. On the technological side, a great deal of research has been conducted in order to evaluate various types of myoelectric prosthetic control strategies, whether direct control or pattern recognition-based control. In the literature, different control performance metrics, which have been evaluated on TMR subjects, have been introduced, but no accepted reference standard defines the better strategy for evaluating the prosthetic control. Indeed, the presence of several evaluation tests that are based on different metrics makes it difficult the definition of standard guidelines for comprehending the potentiality of the proposed control systems. Additionally, there is a lack of evidence about the comparison of different evaluation approaches or the presence of guidelines on the most suitable test to proceed for a TMR patients case study. Thus, this review aims at identifying these limitations by examining the several studies in the literature on TMR subjects, with different amputation levels, and proposing a standard method for evaluating the control performance metrics.

Comparison of absorbable and permanent sutures for laparoscopic sacrocervicopexy: A randomized controlled trial.

INTRODUCTION: Pelvic organ prolapse is a common cause of morbidity and decreased quality of life among women and is treatable by laparoscopic sacrocolpopexy. Recent data suggest that absorbable sutures are a feasible and appealing option for mesh attachment given a potential decreased risk of complications related to mesh erosion. The aim of the present study was to demonstrate the non-inferiority of absorbable sutures to permanent sutures for laparoscopic sacrocervicopexy. MATERIAL AND METHODS: We performed a randomized, single-blinded, non-inferiority trial comparing late-absorbable sutures (group A) to non-absorbable sutures (group B) for anterior and posterior vaginal mesh fixation during laparoscopic sacrocervicopexy at a single center in Italy. The primary outcome was prolapse correction at 12 months after surgery, defined as the absence of a pelvic organ prolapse leading edge reaching or extending below the level of the hymen and the absence of bulge symptoms. Secondary outcomes included intraoperative parameters, postoperative characteristics, and long-term morbidity. Statistical analyses were performed using STATA version 16. RESULTS: A total of 150 patients with pelvic organ prolapse were prospectively randomized 1:1 into two groups (A or B). Baseline characteristics and intraoperative parameters including blood loss, operation time, and intraoperative complications were comparable between groups. The success rate was 100% in both groups and no differences in prolapse correction were observed. The rates of de novo urinary incontinence and persistent urinary incontinence were also similar between groups. The rate of mesh erosion at 12 months was 0% in group A and 4% in group B (P = .24). CONCLUSIONS: Late absorbable sutures are non-inferior to non-absorbable sutures for laparoscopic sacrocervicopexy in terms of procedural success. Moreover we did not see any differences in terms of operative parameters, or intraoperative and postoperative characteristics, although the study was not powered to these outcomes.

Restoring Tactile sensations via neural interfaces for real-time force-and-slippage closed-loop control of bionic hands.

Despite previous studies on the restoration of tactile sensation on the fingers and the hand, there are no examples of use of the routed sensory information to finely control the prosthesis hand in complex grasp and manipulation tasks. Here it is shown that force and slippage sensations can be elicited in an amputee subject by means of biologically-inspired slippage detection and encoding algorithms, supported by a stick-slip model of the performed grasp. A combination of cuff and intraneural electrodes was implanted for eleven weeks in a young woman with hand amputation, and was shown to provide close-to-natural force and slippage sensations, paramount for significantly improving the subject's manipulative skills with the prosthesis. Evidence is provided about the improvement of the subject's grasping and manipulation capabilities over time, thanks to neural feedback. The elicited tactile sensations enabled the successful fulfillment of fine grasp and manipulation tasks with increasing complexity. Grasp performance was quantitatively assessed by means of instrumented objects and a purposely developed metrics. Closed-loop control capabilities enabled by the neural feedback were compared to those achieved without feedback. Further, the work investigates whether the described amelioration of motor performance in dexterous tasks had as central neurophysiological correlates changes in motor cortex plasticity and whether such changes were of purely motor origin, or else the effect of a strong and persistent drive of the sensory feedback.

Simultaneous sEMG Classification of Hand/Wrist Gestures and Forces.

Surface electromyography (sEMG) signals represent a promising approach for decoding the motor intention of amputees to control a multifunctional prosthetic hand in a non-invasive way. Several approaches based on proportional amplitude methods or simple thresholds on sEMG signals have been proposed to control a single degree of freedom at time, without the possibility of increasing the number of controllable multiple DoFs in a natural manner. Myoelectric control based on PR techniques have been introduced to add multiple DoFs by keeping low the number of electrodes and allowing the discrimination of different muscular patterns for each class of motion. However, the use of PR algorithms to simultaneously decode both gestures and forces has never been studied deeply. This paper introduces a hierarchical classification approach with the aim to assess the desired hand/wrist gestures, as well as the desired force levels to exert during grasping tasks. A Finite State Machine was introduced to manage and coordinate three classifiers based on the Non-Linear Logistic Regression algorithm. The classification architecture was evaluated across 31 healthy subjects. The "hand/wrist gestures classifier," introduced for the discrimination of seven hand/wrist gestures, presented a mean classification accuracy of 98.78%, while the "Spherical and Tip force classifier," created for the identification of three force levels, reached an average accuracy of 98.80 and 96.09%, respectively. These results were confirmed by Linear Discriminant Analysis (LDA) with time domain features extraction, considered as ground truth for the final validation of the performed analysis. A Wilcoxon Signed-Rank test was carried out for the statistical analysis of comparison between NLR and LDA and statistical significance was considered at p < 0.05. The comparative analysis reports not statistically significant differences in terms of F1Score performance between NLR and LDA. Thus, this study reveals that the use of non-linear classification algorithm, as NLR, is as much suitable as the benchmark LDA classifier for implementing an EMG pattern recognition system, able both to decode hand/wrist gestures and to associate different performed force levels to grasping actions.