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.

Dislocation after total hip replacement: there is no such thing as a safe zone for socket placement with the posterior approach

Introduction Malorientation of the socket contributes to instability after hip arthroplasty but the optimal orientation of the cup in relation to the pelvis has not been unequivocally described. Large radiological studies are few and problems occur with film standardisation, measurement methodology used and alternative definitions of describing acetabular orientation. Methods A cohort of 1,578 patients from a single institution is studied where all patient data was collected prospectively. Risk factors for patients undergoing surgery are analysed. Radiological data was compared between a series of non-dislocating hips and dislocating cases matched 2:1 by operation type, age and diagnosis. Results The overall dislocation rate for all 1,578 cases was 3.23% but the rate varied according to the type of surgery performed. The rate in uncomplicated primary cases was 2.4% which increased to 9.3% for second stage implantation for a two stage procedure for infection. There was no significant difference in the variability of the dislocating and non-dislocating groups for either inclination (p = 0.393) or anteversion (p = 0.661). Conclusions A “safe zone” for socket orientation to avoid dislocation could not be defined. The cause of dislocation is multifactorial, re-establishing the anatomic centre of rotation, balancing soft tissues and avoidance of impingement around the hip are important considerations.

Using coloured petri nets to simulate DoS-resistant protocols

In this work, we examine unbalanced computation between an initiator and a responder that leads to resource exhaustion attacks in key exchange protocols. We construct models for two cryp-tographic protocols; one is the well-known Internet protocol named Secure Socket Layer (SSL) protocol, and the other one is the Host Identity Protocol (HIP) which has built-in DoS-resistant mechanisms. To examine such protocols, we develop a formal framework based on Timed Coloured Petri Nets (Timed CPNs) and use a simulation approach provided in CPN Tools to achieve a formal analysis. By adopting the key idea of Meadows' cost-based framework and re¯ning the de¯nition of operational costs during the protocol execution, our simulation provides an accurate cost estimate of protocol execution compar- ing among principals, as well as the percentage of successful connections from legitimate users, under four di®erent strategies of DoS attack.

Functional outcome of transfemoral amputees fitted with an osseointegrated fixation : temporal gait characteristics

The purpose of this study was to characterise the functional outcome of 12 transfemoral amputees fitted with osseointegrated fixation using temporal gait characteristics. The objectives were (A) to present the cadence, duration of gait cycle, support and swing phases with an emphasis on the stride-to-stride and participant-to-participant variability, and (B) to compare these temporal variables with normative data extracted from the literature focusing on transfemoral amputees fitted with a socket and able-bodied participants. The temporal variables were extracted from the load applied on the residuum during straight level walking, which was collected at 200 Hz by a transducer. A total of 613 strides were assessed. The cadence (46±4 strides/min), the duration of the gait cycle (1.29±0.11 s), support (0.73±0.07 s, 57±3% of CG) and swing (0.56±0.07 s, 43±3% of GC) phases of the participants were 2% quicker, 3%, 6% shorter and 1% longer than transfemoral amputees using a socket as well as 11% slower, 9%, 6% and 13% longer than able-bodied, respectively. All combined, the results indicated that the fitting of an osseointegrated fixation has enabled this group of amputees to restore their locomotion with a highly functional level. Further longitudinal and cross-sectional studies would be required to confirm these outcomes. Nonetheless, the data presented can be used as benchmark for future comparisons. It can also be used as input in generic algorithms using templates of patterns of loading to recognise activities of daily living and to detect falls.

A modified cementing technique using BoneSource to augment fixation of the acetabulum in a sheep model

Background and purpose Our aim was to prove in an animal model that the use of HA paste at the cement-bone interface in the acetabulum would improve fixation. We examined, in sheep, the effect of interposing a layer of hydroxyapatite cement around the periphery of a polyethylene socket prior to fixing it using polymethylemethacrylate (PMMA). Methods We made a randomized study involving 22 sheep to test whether the application of BoneSource hydroxyapatite material to the surface of the ovine acetabulum prior to cementing a polyethylene cup at hip arthroplasty improved the fixation and the nature of the interface. We studied the gross radiographical appearance of the implant-bone interface and the histological appearance at the interface. Results There were more radiolucencies evident in the control group. Histologically, only sheep randomized into the BoneSource group exhibited a fully osseointegrated interface. Use of the hydroxyapatite material did not confer any detrimental effects. In some cases the material appeared to have been fully resorbed. When the material was evident on histological section, it was incorporated into an osseointegrated interface. There was no giant cell reaction present in any case. There was no evidence of migration of BoneSource to the articulation. Interpretation The application of HA material prior to cementation of a socket produced an improved interface. The technique may be useful in man with to extend the longevity of the cemented implant by protecting the socket interface from the effect of hydrodynamic fluid flow and particulate debris.

The feasibility of vibration analysis as a technique to detect osseointegration of transfemoral implants

One of the main causes of above knee or transfemoral amputation (TFA) in the developed world is trauma to the limb. The number of people undergoing TFA due to limb trauma, particularly due to war injuries, has been increasing. Typically the trauma amputee population, including war-related amputees, are otherwise healthy, active and desire to return to employment and their usual lifestyle. Consequently there is a growing need to restore long-term mobility and limb function to this population. Traditionally transfemoral amputees are provided with an artificial or prosthetic leg that consists of a fabricated socket, knee joint mechanism and a prosthetic foot. Amputees have reported several problems related to the socket of their prosthetic limb. These include pain in the residual limb, poor socket fit, discomfort and poor mobility. Removing the socket from the prosthetic limb could eliminate or reduce these problems. A solution to this is the direct attachment of the prosthesis to the residual bone (femur) inside the residual limb. This technique has been used on a small population of transfemoral amputees since 1990. A threaded titanium implant is screwed in to the shaft of the femur and a second component connects between the implant and the prosthesis. A period of time is required to allow the implant to become fully attached to the bone, called osseointegration (OI), and be able to withstand applied load; then the prosthesis can be attached. The advantages of transfemoral osseointegration (TFOI) over conventional prosthetic sockets include better hip mobility, sitting comfort and prosthetic retention and fewer skin problems on the residual limb. However, due to the length of time required for OI to progress and to complete the rehabilitation exercises, it can take up to twelve months after implant insertion for an amputee to be able to load bear and to walk unaided. The long rehabilitation time is a significant disadvantage of TFOI and may be impeding the wider adoption of the technique. There is a need for a non-invasive method of assessing the degree of osseointegration between the bone and the implant. If such a method was capable of determining the progression of TFOI and assessing when the implant was able to withstand physiological load it could reduce the overall rehabilitation time. Vibration analysis has been suggested as a potential technique: it is a non destructive method of assessing the dynamic properties of a structure. Changes in the physical properties of a structure can be identified from changes in its dynamic properties. Consequently vibration analysis, both experimental and computational, has been used to assess bone fracture healing, prosthetic hip loosening and dental implant OI with varying degrees of success. More recently experimental vibration analysis has been used in TFOI. However further work is needed to assess the potential of the technique and fully characterise the femur-implant system. The overall aim of this study was to develop physical and computational models of the TFOI femur-implant system and use these models to investigate the feasibility of vibration analysis to detect the process of OI. Femur-implant physical models were developed and manufactured using synthetic materials to represent four key stages of OI development (identified from a physiological model), simulated using different interface conditions between the implant and femur. Experimental vibration analysis (modal analysis) was then conducted using the physical models. The femur-implant models, representing stage one to stage four of OI development, were excited and the modal parameters obtained over the range 0-5kHz. The results indicated the technique had limited capability in distinguishing between different interface conditions. The fundamental bending mode did not alter with interfacial changes. However higher modes were able to track chronological changes in interface condition by the change in natural frequency, although no one modal parameter could uniquely distinguish between each interface condition. The importance of the model boundary condition (how the model is constrained) was the key finding; variations in the boundary condition altered the modal parameters obtained. Therefore the boundary conditions need to be held constant between tests in order for the detected modal parameter changes to be attributed to interface condition changes. A three dimensional Finite Element (FE) model of the femur-implant model was then developed and used to explore the sensitivity of the modal parameters to more subtle interfacial and boundary condition changes. The FE model was created using the synthetic femur geometry and an approximation of the implant geometry. The natural frequencies of the FE model were found to match the experimental frequencies within 20% and the FE and experimental mode shapes were similar. Therefore the FE model was shown to successfully capture the dynamic response of the physical system. As was found with the experimental modal analysis, the fundamental bending mode of the FE model did not alter due to changes in interface elastic modulus. Axial and torsional modes were identified by the FE model that were not detected experimentally; the torsional mode exhibited the largest frequency change due to interfacial changes (103% between the lower and upper limits of the interface modulus range). Therefore the FE model provided additional information on the dynamic response of the system and was complementary to the experimental model. The small changes in natural frequency over a large range of interface region elastic moduli indicated the method may only be able to distinguish between early and late OI progression. The boundary conditions applied to the FE model influenced the modal parameters to a far greater extent than the interface condition variations. Therefore the FE model, as well as the experimental modal analysis, indicated that the boundary conditions need to be held constant between tests in order for the detected changes in modal parameters to be attributed to interface condition changes alone. The results of this study suggest that in a clinical setting it is unlikely that the in vivo boundary conditions of the amputated femur could be adequately controlled or replicated over time and consequently it is unlikely that any longitudinal change in frequency detected by the modal analysis technique could be attributed exclusively to changes at the femur-implant interface. Therefore further development of the modal analysis technique would require significant consideration of the clinical boundary conditions and investigation of modes other than the bending modes.

Benefits of using modern cementing techniques in the acetabulum : the rim cutter

Purpose. To compare radiological records of 90 consecutive patients who underwent cemented total hip arthroplasty (THA) with or without use of the Rim Cutter to prepare the acetabulum. Methods. The acetabulum of 45 patients was prepared using the Rim Cutter, whereas the device was not used in the other 45 patients. Postoperative radiographs were evaluated using a digital templating system to measure (1) the positions of the operated hips with respect to the normal, contralateral hips (the centre of rotation of the socket, the height of the centre of rotation from the teardrop, and lateralisation of the centre of rotation from the teardrop) and (2) the uniformity and width of the cement mantle in the 3 DeLee Charnley acetabular zones, and the number of radiolucencies in these zones. Results. The study group showed improved radiological parameters and were closer to the anatomic centre of rotation both vertically (1.5 vs. 3.7 mm, p<0.001) and horizontally (1.8 vs. 4.4 mm, p<0.001) and had consistently thicker and more uniform cement mantles (p<0.001). There were 2 radiolucent lines in the control group but none in the study group. Conclusion. The Rim Cutter resulted in more accurate placement of the centre of rotation of a cemented prosthetic socket, and produced a thicker, more congruent cement mantle with fewer radiolucent lines.

The results of acetabular impaction grafting in 129 primary cemented total hip arthroplasties

Between 1995 and 2003, 129 cemented primary THRs were performed using full acetabular impaction grafting to reconstruct acetabular deficiencies. These were classified as cavitary in 74 and segmental in 55 hips. Eighty-one patients were reviewed at mean 9.1 (6.2-14.3) years post-operatively. There were seven acetabular component revisions due to aseptic loosening, and a further 11 cases that had migrated >5mm or tilted >5° on radiological review - ten of which reported no symptoms. Kaplan-Meier analysis of revisions for aseptic loosening demonstrates 100% survival at nine years for cavitary defects compared to 82.6% for segmental defects. Our results suggest that the medium-term survival of this technique is excellent when used for purely cavitary defects but less predictable when used with large rim meshes in segmental defects.

Cryptographic techniques for managing computational effort

Availability has become a primary goal of information security and is as significant as other goals, in particular, confidentiality and integrity. Maintaining availability of essential services on the public Internet is an increasingly difficult task in the presence of sophisticated attackers. Attackers may abuse limited computational resources of a service provider and thus managing computational costs is a key strategy for achieving the goal of availability. In this thesis we focus on cryptographic approaches for managing computational costs, in particular computational effort. We focus on two cryptographic techniques: computational puzzles in cryptographic protocols and secure outsourcing of cryptographic computations. This thesis contributes to the area of cryptographic protocols in the following ways. First we propose the most efficient puzzle scheme based on modular exponentiations which, unlike previous schemes of the same type, involves only a few modular multiplications for solution verification; our scheme is provably secure. We then introduce a new efficient gradual authentication protocol by integrating a puzzle into a specific signature scheme. Our software implementation results for the new authentication protocol show that our approach is more efficient and effective than the traditional RSA signature-based one and improves the DoSresilience of Secure Socket Layer (SSL) protocol, the most widely used security protocol on the Internet. Our next contributions are related to capturing a specific property that enables secure outsourcing of cryptographic tasks in partial-decryption. We formally define the property of (non-trivial) public verifiability for general encryption schemes, key encapsulation mechanisms (KEMs), and hybrid encryption schemes, encompassing public-key, identity-based, and tag-based encryption avors. We show that some generic transformations and concrete constructions enjoy this property and then present a new public-key encryption (PKE) scheme having this property and proof of security under the standard assumptions. Finally, we combine puzzles with PKE schemes for enabling delayed decryption in applications such as e-auctions and e-voting. For this we first introduce the notion of effort-release PKE (ER-PKE), encompassing the well-known timedrelease encryption and encapsulated key escrow techniques. We then present a security model for ER-PKE and a generic construction of ER-PKE complying with our security notion.

Results using Trabecular Metal™ augments in combination with acetabular impaction bone grafting in deficient acetabula

We examined whether the use of trabecular metal wedges to fill segmental defects is an effective method of socket reconstruction when used in combination with impaction grafting and implantation of a cemented socket. Fifteen hips in 14 patients underwent impaction grafting in combination with a TM wedge with a minimum of 2 years follow-up. All patients had their defects assessed using the Paprosky classification. Patients were reviewed with x-rays and migration of the implant was measured. Outcome scores were also collected. Mean follow-up was 39 months (25-83). The mean age at surgery was 67.8 (49-85) years. Seven of the patients had previously undergone impaction grafting with the use of a stainless steel rim mesh to constrain the graft. None of the patients had failed either clinically or radiologically.

Revascularization and tissue regeneration of an empty root canal space is enhanced by a direct blood supply and stem cells

Background Regenerative endodontics is an innovative treatment concept aiming to regenerate pulp, dentin and root structures. In the diseased or necrotic tooth, the limitation in vascular supply renders successful tissue regeneration/generation in a whole tooth challenging. The aim of this study is to evaluate the ability of vascularized tissue to develop within a pulpless tooth using tissue engineering techniques. Materials and methods A pulpless tooth chamber, filled with collagen I gel containing isolated rat dental pulp cells (DPC) and angiogenic growth factors, was placed into a hole created in the femoral cortex or into its own tooth socket, respectively. The gross, histological and biochemical characteristics of the de novo tissue were evaluated at 4 and 8weeks post-transplantation. Results Tooth revascularization and tissue generation was observed only in the femur group, confirming the important role of vascular supply in tissue regeneration. The addition of cells and growth factors significantly promoted connective tissue production in the tooth chamber. Conclusion Successful revascularization and tissue regeneration in this model demonstrate the importance of a direct vascular supply and the advantages of a stem cell approach. © 2012 John Wiley & Sons A/S.

Formal analysis of card-based payment systems in mobile devices

To provide card holder authentication while they are conducting an electronic transaction using mobile devices, VISA and MasterCard independently proposed two electronic payment protocols: Visa 3D Secure and MasterCard Secure Code. The protocols use pre-registered passwords to provide card holder authentication and Secure Socket Layer/ Transport Layer Security (SSL/TLS) for data confidentiality over wired networks and Wireless Transport Layer Security (WTLS) between a wireless device and a Wireless Application Protocol (WAP) gateway. The paper presents our analysis of security properties in the proposed protocols using formal method tools: Casper and FDR2. We also highlight issues concerning payment security in the proposed protocols.

Are bone-anchored prostheses about to revolutionise the world of prosthetics?

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 primary aim of this study is to present the current advances in these surgical techniques worldwide with a strong focus on the developments in Australia. The secondary aim is to provide an overview of the possible critical changes that may occurred in the world of prosthetic following these developments in bone-anchored prostheses.

Repeatability of static load bearing exercises during rehabilitation of individuals with transfemoral amputation fitted with osseointegrated implant

Bone-anchored prostheses, relying on implants to attach the prosthesis directly to the residual skeleton, are the ultimate resort for patients with transfemoral amputations (TFA) experiencing severe socket discomfort. The first patient receiving a bone-anchored prosthesis underwent the surgery in 1990 in the Sahlgrenska University Hospital (Sweden). To date, there are two commercially available implants: OPRA (Integrum, Sweden) and ILP (Orthodynamics, Germany). The key to success to this technique is a firm bone-implant bonding, depending on increasing mechanical stress applied daily during load bearing exercises (LBE). The loading data could be analysed through different biomechanical variables. The intra-tester reliability of these exercises will be presented here. Moreover the effect of increase of loading, axes of application of the load and body weight as well as the difference between force and moment variables will be discussed.