Osseointegration for limb loss: Can Australia play a key role?

Individuals with limb amputation fitted with conventional socket-suspended prostheses often experience socket related discomfort leading to a significant decrease in quality of life. Most of these concerns can be overcome by surgical techniques enabling bone-anchored prostheses. In this case, the prosthesis is attached directly to the residual skeleton through a percutaneous implant. The aim of this study is to present the current advances in these surgical techniques worldwide with a strong focus on the developments in Australia and Queensland.

Calculation of the speed of walking of individuals with transfemoral amputation fitted with bone-anchored prosthesis

Typically, the walking ability of individuals with a transfemoral amputation (TFA) can be represented by the speed of walking (SofW) obtained in experimental settings. Recent developments in portable kinetic systems allow assessing the level of activity of TFA during actual daily living outside the confined space of a gait lab. Unfortunately, only minimal spatio-temporal characteristics could be extracted from the kinetic data including the cadence and the duration on gait cycles. Therefore, there is a need for a way to use some of these characteristics to assess the instantaneous speed of walking during daily living. The purpose of the study was to compare several methods to determine SofW using minimal spatial gait characteristics.

Description of body posture during Static load bearing exercises for individuals with transfemoral amputation fitted with bone-anchored prosthesis

The rehabilitation programs of bone-anchorage prostheses relying either on the OPRA (Integrum, Sweden) or the ILP (Orthodynamics, Germany) fixation involve some forms of static load bearing exercises (LBE). So far, most of biomechanical studies of these static LBEs focused on the direct measurements of the actual forces and moments applied on the OPRA fixation of individuals with transfemoral amputation (TFA). To date, the proof-of-concept of an apparatus to conduct these kinetic measurements has been presented, along with some preliminary data. The understanding of the kinetic data is essential to improve rehabilitation programs as well as the design of upcoming loading frames. However, kinetic information alone is difficult to interpret without concomitant kinematic data. The purpose of this preliminary study was to introduce a qualitative analysis describing the different body postures during LBE for a group of TFAs.

Load bearing exercises and functional outcome of individuals with transfemoral amputation fitted with OPRA fixation

Individuals with lower limb amputation fitted with an OPRA osseointegrated fixation are facing an extensive rehabilitation program including static load bearing exercises (LBE). The application of a suitable amount of stress stimulates osseointegration and prepares the bone to tolerate the forces and moments that will be incurred during activities of daily living (ADL. At present, the monitoring is typically carried out using a normal bathroom weighing scale. This scale provides information only on the magnitude of the vertical component of the applied force. The moment around the long axis of the fixation when the femur is perpendicular to the ground is not assessed and neither are the components of force and moment generated on the other two axes.

Spatio-temporal characteristics of locomotion and functional outcomes of individuals with transfemoral amputation fitted with OPRA fixation

The conventional method of attachment of prosthesis involves a socket. A new method relying on osseointegrated fixation has emerged in the last decades. It has significant prosthetic benefits. Only a few studies demonstrated the biomechanical benefits. The ultimate aim of this study was to characterise the functional outcome of individuals with lower limb amputation fitted with osseointegrated fixation, which can be assess through temporal and spatial gait characteristics. The specific objective of this study was to present the key temporal and spatial gait characteristics of individuals with transfemoral amputation (TFA).

Temporal and spatial gait characteristics of transfemoral amputees fitted with osseointegrated fixation: preliminary data

The conventional method of attachment of prosthesis involves on a socket. A new method relying on osseointegrated fixation is emerging. It has significant prosthetic benefits. Only a few studies demonstrated the biomechanical benefits. The ultimate aim of this study was to characterise the functional outcome of transfemoral amputees fitted with osseointegrated fixation, which can be assess through temporal and spatial gait characteristics. The specific objective of this preliminary study was to present the key temporal and spatial gait characteristics.

Hip joint stabilization vs. propulsion and resistance in individuals with transfemoral amputation

Joint moments and joint powers are widely used to determine the effects of rehabilitation programs and prosthetic components (e.g., alignments). A complementary analysis of the 3D angle between joint moment and joint angular velocity has been proposed to assess whether the joints are predominantly driven or stabilized.

Spatio-temporal characteristics of locomotion of transfemoral amputees fitted with bone-anchored prosthesis

The conventional method of attachment of prosthesis involves on a socket. A new method relying on osseointegrated fixation is emerging. It has significant prosthetic benefits. Only a few studies demonstrated the biomechanical benefits. The specific objective of this study was to present the key temporal and spatial gait characteristics for unilateral amputation. The ultimate aim of this study was to characterise the functional outcome of the individual with transfemoral lower limb amputation fitted with osseointegrated fixation, which can be assess through temporal and spatial gait characteristics.

Safety of OPRA procedure for individuals with upper limb amputation

Surgical implantations of osseointegrated fixations for bone-anchored prosthesis are developing at an unprecedented pace worldwide while initial skepticism in the orthopedic community is slowly fading away. Clearly, this option is becoming accessible to a wide range of individuals with limb loss. [1-18] The team led by Dr Rickard Branemark has previously published a number of landmark articles focusing on the benefits and safety of the OPRA fixation mainly for individual with lower limb loss, particularly those with transfemoral amputation. [1-3, 19-32] However, similar information is lacking for those with upper limb amputation. This team is once again taking a leading role by sharing a retrospective study focusing on the implant survival, adverse events, implant stability, and bone remodelling for 18 individuals with transhumeral amputation over a 5-year post-operative period. Therefore, a comprehensive analysis of the safety of the procedure is accessible for the first time. In essence, the results showed an implant survival rate of 83% and 80% at 2 and 5 year follow ups, respectively. The most frequent adverse events were superficial skin infections that occurred for 28% (5) participants while the least frequent was deep bone infection that happened only once. More importantly, 38% of complications due to infections were effectively managed with nonoperative treatments (e.g., revision of skin penetration site, local cleaning, antibiotics, restriction of soft tissue mobility). Implant stability and bone remodelling were satisfactory. Clearly, this study provided better understanding of the safety of the OPRA surgical and rehabilitation procedure for individuals with upper limb amputation while establishing standards and benchmark data for future studies. However, strong evidences of the benefits are yet to be demonstrated. However, increase in health related quality of life and functional outcomes (e.g., range of movement) are likely. Altogether, the team of authors are providing further evidence that bone-anchored attachment is definitely a promising alternative to socket prostheses.

Bone-anchored prosthesis: Update in international developments

This symposium will provide hand-on update on the current development of the load sensors measuring the inner prosthetic loading that can strongly contribute the ever increasing demand for evidence-based clinical practice. Surgical implantations of osseointegrated fixations for bone-anchored prosthesis are developing at an unprecedented pace worldwide (e.g., Australia, UK, Sweden, US). This option is becoming accessible to a wide range of individuals with limb loss. With these new developments come new potential challenges and opportunities for all the stakeholders involved in the prosthetic care of these patients. Clearly, there is a need for those stakeholders, particularly those attending the ISPO, to be informed of the current and upcoming international developments in bone-anchored prostheses. The objectives of this symposium will be: • To present an overview of the current growth of the procedures worldwide (e.g., identification of key players, centers of activities, growth trend) with a strong focus on the introduction of the framework to evaluate the availability of the procedure at national level (e.g., number of patients treated, range of the levels of implantation, number of commercial fixations accessible), • To provide first-hand updates on the latest cutting-edge scientific and clinical developments of fixations and rehabilitations programs (e.g., Innovative design of implant, cost-effectiveness, long-terms rehabilitation outcomes for screw-type fixation, current developments in US, comparative analysis for press-fit type of implant, potential moves toward single-stage surgeries).

Additive tissue manufacturing for breast reconstruction: Combining CAD/CAM with adipose tissue engineering

The primary aim of this multidisciplinary project was to develop a new generation of breast implants. Disrupting the currently prevailing paradigm of silicone implants which permanently introduce a foreign body into mastectomy patients, highly porous implants developed as part of this PhD project are biodegradable by the body and augment the growth of natural tissue. Our technology platform leverages computer-assisted-design which allows us to manufacture fully patient-specific implants based on a personalised medicine approach. Multiple animal studies conducted in this project have shown that the polymeric implant slowly degrades within the body harmlessly while the body's own tissue forms concurrently.

The cost and time effectiveness of osseointegration compared to the traditional socket prosthesis

Individuals with limb amputation fitted with conventional socket-suspended prostheses often experience socket related discomfort leading to a significant decrease in quality of life.[1-14] Most of these concerns can be overcome with osseointegration, a direct skeletal fixation method where the prosthetic componentry are directly attached to the fixation, resulting in the redundancy of the traditional socket system. There are two stages of osseointegration; Stage one, a titanium implant is inserted into the marrow space of residual limb bone and Stage two, a titanium extension is attached to the fixture. This surgical procedure is currently blooming worldwide, particularly within Queensland. Whilst providing improvements in quality of life, this new method also has potential to minimise the cost required for an amputee to ambulate during daily living. Thus, the aim of this project was to compare the differences in mean cost of services, cost of componentry and labour hours when using osseointegration compared to traditional socket-based prostheses. Data were extracted from Queensland Artificial Limb Services (QALS) database to determine cost of services, type of services and labour hours required to maintain a prosthetic limb. Five trans-femoral amputee male participants (age 46.4±10.1 yrs; height 175.4±16.3 cm; mass 83.8±14.0 kg; time since second stage 22.0± 8.1 mths) met inclusion criteria which was patient had to be more than 12 months post stage two osseointegration procedure. The socket and osseointegration prosthesis variables examined were the mean hours of labour, mean cost of services and mean cost of prosthetic componentry. Statistical analyses were conducted using an ANOVA. The results identified that there were only significant differences in the number of labour hours (p = 0.005) and cost of services (p = 0.021) when comparing the socket and osseointegration prosthetic type. These results identified that the cost of componentry were comparable between the two methods.

The ultrastructural relationship between osteocytes and dental implants following osseointegration

Background Osteocytes, the most abundant cells in bone, havemultiple functions, including acting as mechanosensors and regulating mineralization. It is clear that osteocytes influence bone remodeling by controlling the differentiation and activity of osteoblasts and osteoclasts. Determining the relationship between titanium implants and osteocytes may therefore benefit our understanding of the process of osseointegration. Purpose The aim of this study was to visualize the ultrastructural relationship between osteocytes and the titanium implant surface following osseointegration in vivo. Materials and Methods Titanium implants were placed in the maxillary molar regions of eight female Sprague Dawley rats, 3 months old. The animals were sacrificed 8 weeks after implantation, and undecalcified tissue sections were prepared. Resin-cast samples were subsequently acid-etched with 37% phosphoric acid prior to examination using scanning electron microscopy. Results Compared with mature bone, where the osteocytes were arranged in an ordered fashion, the osteocytes appeared less organized in the newly formed bone around the titanium implant. Further, a layer of mineralization with few organic components was observed on the implant surface. This study shows for the first time that osteocytes and their dendrites are directly connected with the implant surface. Conclusions: This study shows the direct anchorage of osteocytes via dendritic processes to a titanium implant surface in vivo. This suggests an important regulatory role for osteocytes and their lacunar-canalicular network in maintaining long-term osseointegration.

Development of a method to assess the quality of ankle joint reduction in 3D

This project developed a quantitative method for determining the quality of the surgical alignment of the bone fragments after an ankle fracture. The research examined the feasibility of utilising MRI-based bone models versus the gold standard CT-based bone models in order to reduce the amount of ionising radiation the patient is exposed to. In doing so, the thesis reports that there is potential for MRI to be used instead of CT depending on the scanning parameters used to obtain the medical images, the distance of the implant relative to the joint surface, and the implant material.

Automated fit assessment of intramedullary nail designs during insertion

Modern intramedullary nails, which are utilised for the treatment of bone fractures, need to be designed to fit the anatomy of the patient population. Traditional and recent semi-automated approaches for quantifying the anatomical fit between bones and nail designs suffer from various drawbacks. This thesis proposed an automated comprehensive nail design validation method. The developed software tool was utilised to quantify the anatomical fit of four commercial nail designs. Furthermore, the thesis demonstrated the existence of a bone-nail specific nail entry point. The developed method is of great benefit for the implant manufacturing industry as a nail design validation tool.