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Osseointegration implant has attracted significant attention as an alternative treatment for transfemoral amputees. It has been shown to improve patients' sitting and walking comfort and control of the artificial limb, compared to the conventional socket device. However, the patients treated with osseointegration implants require a long rehabilitation period to establish sufficient femur–implant connection, allowing the full body weight on the prosthesis stem. Hence, a robust assessment method on the osseointegration process is essential to shorten the rehabilitation period and identify the degree of osseointegration prior to the connection of an artificial limb. This paper investigates the capability of a vibration-related index (E-index) on detecting the degree of simulated osseointegration process with three lengths of the residual femur (152, 190 and 228 mm). The adhesive epoxy with a setting time of 5 min was applied at the femur–implant interface to represent the stiffness change during the osseointegration process. The cross-spectrum and colormap of the normalised magnitude demonstrated significant changes during the cure time, showing that application of these plots could improve the accuracy of the currently available diagnostic techniques. Furthermore, the E-index exhibited a clear trend with a noticeable average increase of 53% against the cure time for all three residual length conditions. These findings highlight that the E-index can be employed as a quantitative justification to assess the degree of osseointegration process without selecting and tracing the resonant frequency based on the geometry of the residual femur. [ABSTRACT FROM AUTHOR]

Osseointegrated prostheses are widely used following transfemoral amputation. However, this technique requires sufficient implant stability before and during the rehabilitation period to mitigate the risk of implant breakage and loosening. Hence, reliable assessment methods for the osseointegration process are essential to ensure initial and long–term implant stability. This paper researches the feasibility of a vibration analysis technique for the osseointegration (OI) process by investigating the change in the dynamic response of the residual femur with a novel implant design during a simulated OI process. The paper also proposes a concept of an energy index (the E–index), which is formulated based on the normalized magnitude. To illustrate the potential of the E–index, this paper reports on changes in the vibrational behaviors of a 133 mm long amputated artificial femur model and implant system, with epoxy adhesives applied at the interface to simulate the OI process. The results show a significant variation in the magnitude of the colormap against curing time. The study also shows that the E–index was sensitive to the interface stiffness change, especially during the early curing process. These findings highlight the feasibility of using the vibration analysis technique and the E–index to quantitatively monitor the osseointegration process for future improvement on the efficiency of human health monitoring and patient rehabilitation. [ABSTRACT FROM AUTHOR]

Reliable and quantitative assessments of bone quality and fracture healing prompt well-optimised patient healthcare management and earlier surgical intervention prior to complications of nonunion and malunion. This study presents a clinical investigation on modal frequencies associations with musculoskeletal components of human legs by using a prototype device based on a vibration analysis method. The findings indicated that the first out-of-plane and coupled modes in the frequency range from 60 to 110 Hz are associated with the femur length, suggesting these modes are suitable quantitative measures for bone evaluation. Furthermore, higher-order modes are shown to be associated with the muscle and fat mass of the leg. In addition, mathematical models are formulated via a stepwise regression approach to determine the modal frequencies using the measured leg components as variables. The optimal models of the first modes consist of only femur length as the independent variable and explain approximately 43% of the variation of the modal frequencies. The subsequent findings provide insights for further development on utilising vibration-based methods for practical bone and fracture healing monitoring. [ABSTRACT FROM AUTHOR]

The lack of a quantitative method to adequately assess fractured bone healing that has undergone fixation limits prognostic capabilities on patients' optimal return to work. This paper addresses the use of vibrational analysis to monitor the state of healing of a plate-screw fixated femur and supplement the current clinical radiographic assessment. This experimental study involves an osteotomised composite femur specimen enclosed by modelling clay to simulate the damping effect of overlying soft tissues. Epoxy adhesives are applied to the fractured region and to simulate the healing process. With the instrumentation described, the cross-spectrum and coherence are obtained and analysed in the frequency domain over a period of time. The results suggest that it is crucial to analyse the cross-spectrum and proposed healing index to quantitatively assess the stages of healing. The results also show that the mass loading effect due to modelling clay did not influence the proposed healing assessment technique. The findings indicate a potential non-intrusive technique to evaluate the healing of fractured femur by utilising the vibrational responses. [ABSTRACT FROM AUTHOR]

Quantitative and reliable monitoring of osseointegration will help further evaluate the integrity of the orthopaedic construct to promote novel prosthesis design and allow early mobilisation. Quantitative assessment of the degree or the lack of osseointegration is important for the clinical management with the introduction of prosthetic implants to amputees. Acousto-ultrasonic wave propagation has been used in structural health monitoring as well as human health monitoring but so far has not extended to osseointegrated implants or prostheses. This paper presents an ultrasonic guided wave approach to assess the osseointegration of a novel implant. This study explores the potential of integrating structural health monitoring concepts into a new osseointegrated implant. The aim is to demonstrate the extension of acousto-ultrasonic techniques, which have been widely reported for the structural health monitoring of engineering structures, to assess the state of osseointegration of a bone and implant. To illustrate this potential, this paper will report on the experimental findings which investigated the unification of an aluminium implant and bone-like geometry surrogate. The core of the test specimen is filled with silicone and wrapped with plasticine to simulate the highly damped cancellous bone and soft tissue, respectively. To simulate the osseointegration process, a 2-h adhesive epoxy is used to bond the surrogate implant and a bone-like structure. A series of piezoelectric elements are bonded onto the surrogate implant to serve as actuators and sensors. The actuating piezoelectric element on an extramedullary strut is excited with a 1 MHz pulse signal. The reception of the ultrasonic wave by the sensing elements located on the adjacent and furthest struts is used to assess the integration of this implant to the parent bone structure. The study shows an Osseointegration Index can be formulated by using engineering and acousto-ultrasonic methods to measure the unification of a bone and implant. This also highlights a potential quantitative evaluation technique regardless of bone-implant geometry and soft tissue damping. [ABSTRACT FROM AUTHOR]