Comparison of two pressurisers for cementation of the proximal femur

PURPOSE: To compare pressures generated by 2 different cement pressurisers at various locations in the proximal femur. METHODS: Two groups of 5 synthetic femurs were used, and 6 pressure sensors were placed in the femur at 20-mm intervals proximally to distally. Cement was filled into the femoral canal retrogradely using a cement gun with either the half-moon pressuriser or the femoral canal pressuriser. Maximum pressures and pressure time integrals (cumulative pressure over time) of the 2 pressurisers were compared. RESULTS: At all sensors, the half-moon pressuriser produced higher maximum pressures and pressure time integrals than the femoral canal pressuriser, but the difference was significant only at sensor 1 (proximal femur). This may result in reduced cement interdigitation in the proximal femur. CONCLUSION: The half-moon pressuriser produced higher maximum cementation pressures and pressure time integrals than the femoral canal pressuriser in the proximal femur region, which is critical for rotational stability of the implant and prevention of implant fracture. KEYWORDS: arthroplasty, replacement, hip; bone cements; femur

Can we safely deform a plate to fit every bone? Population-based fit assessment and finite element deformation of a distal tibial plate

Anatomically precontoured plates are commonly used to treat periarticular fractures. A well-fitting plate can be used as a tool for anatomical reduction of the fractured bone. Recent studies highlighted that some plates fit poorly for many patients due to considerable shape variations between bones of the same anatomical site. While it is impossible to design one shape that fits all, it is also burdensome for the manufacturers and hospitals to produce, store and manage multiple plate shapes without the certainty of utilization by a patient population. In this study, we investigated the number of shapes required for maximum fit within a given dataset, and if they could be obtained by manually deforming the original plate. A distal medial tibial plate was automatically positioned on 45 individual tibiae, and the optimal deformation was determined iteratively using finite element analysis simulation. Within the studied dataset, we found that: (i) 89% fit could be achieved with four shapes, (ii) 100% fit was impossible through mechanical deformation, and (iii) the deformations required to obtain the four plate shapes were safe for the stainless steel plate for further clinical use. The proposed framework is easily transferable to other orthopaedic plates.

Clinically-based automatic implant fitting for shape optimization of fracture fixation plates

Complex bone contour and anatomical variations between individual bones complicate the process of deriving an implant shape that fits majority of the population. This thesis proposes an automatic fitting method for anatomically-precontoured plates based on clinical requirements, and investigated if 100% anatomical fit for a group of bone is achievable through manual bending of one plate shape. It was found that, for the plate used, 100% fit is impossible to achieve through manual bending alone. Rather, newly-developed shapes are also required to obtain anatomical fit in areas with more complex bone contour.

Mechanical considerations in fracture fixation

Bone’s capacity to repair following trauma is both unique and astounding. However, fractures sometimes fail to heal. Hence, the goal of fracture treatment is the restoration of bone’s structure, composition and function. Fracture fixation devices should provide a favourable mechanical and biological environment for healing to occur. The use of internal fixation is increasing as these devices may be applied with less invasive techniques. Recent studies suggest however that, internal fixation devices may be overly stiff and suppresses callus formation. The degree of mechanical stability influences the healing outcome. This is determined by the stiffness of the fixation device and the degree of limb loading. This project aims to characterise the fixation stability of an internal plate fixation device and the influence of modifications to its configuration on implant stability. As there are no standardised methods for the determination of fixation stiffness, the first part of this project aims to compares different methodologies and determines the most appropriate method to characterise the stiffness of internal plate fixators. The stiffness of a fixation device also influences the physiological loads experienced by the healing bone. Since bone adapts to this applied load by undergoing changes through a remodelling process, undesirable changes could occur during the period of treatment with an implant. The second part of this project aims to develop a methodology to quantify remodelling changes. This quantification is expected to aid our understanding of the changes in pattern due to implant related remodelling and on the factors driving the remodelling process. Knowledge gained in this project is useful to understand how the configuration of internal fixation devices can promote timely healing and prevent undesirable bone loss.

Influence of plate bending stiffness on mechanical properties of healing fracture, mouse femora

Mechanically well-defined stabilization systems have only recently become available, providing standardized conditions for studying the role of the mechanical environment on mouse bone fracture healing. The aim of this study was to characterize the time course of strength recovery and callus development of mouse femoral osteotomies stabilized with either low or high flexibility (in bending and torsion) internal fixation plates. Animals were euthanized and femora excised at 14, 21, and 28 days post-osteotomy for microCT analysis and torsional strength testing. While a larger mineralized callus was observed in osteotomies under more flexible conditions at all time points, the earlier bridging of the mineralized callus under less flexible conditions by 1 week resulted in an earlier recovery of torsional strength in mice stabilized with low flexibility fixation. Ultimate torque values for these bones were significantly higher at 14 and 21 days post-osteotomy compared to bones with the more flexible stabilization. Our study confirms the high reproducibility of the results that are achieved with this new implant system, therefore making it ideal for studying the influence of the mechanical environment on murine fracture healing under highly standardized conditions.

Mechanical testing and modelling of a bone-implant construct

Finite Element modelling of bone fracture fixation systems allows computational investigation of the deformation response of the bone to load. Once validated, these models can be easily adapted to explore changes in design or configuration of a fixator. The deformation of the tissue within the fracture gap determines its healing and is often summarised as the stiffness of the construct. FE models capable of reproducing this behaviour would provide valuable insight into the healing potential of different fixation systems. Current model validation techniques lack depth in 6D load and deformation measurements. Other aspects of the FE model creation such as the definition of interfaces between components have also not been explored. This project investigated the mechanical testing and FE modelling of a bone– plate construct for the determination of stiffness. In depth 6D measurement and analysis of the generated forces, moments and movements showed large out of plane behaviours which had not previously been characterised. Stiffness calculated from the interfragmentary movement was found to be an unsuitable summary parameter as the error propagation is too large. Current FE modelling techniques were applied in compression and torsion mimicking the experimental setup. Compressive stiffness was well replicated, though torsional stiffness was not. The out of plane behaviours prevalent in the experimental work were not replicated in the model. The interfaces between the components were investigated experimentally and through modification to the FE model. Incorporation of the interface modelling techniques into the full construct models had no effect in compression but did act to reduce torsional stiffness bringing it closer to that of the experiment. The interface definitions had no effect on out of plane behaviours, which were still not replicated. Neither current nor novel FE modelling techniques were able to replicate the out of plane behaviours evident in the experimental work. New techniques for modelling loads and boundary conditions need to be developed to mimic the effects of the entire experimental system.

A novel iterative method for simulating patient-specific optimal deformation and fit of fracture fixation plates

This paper proposes a new iterative method to achieve an optimally fitting plate for preoperative planning purposes. The proposed method involves integration of four commercially available software tools, Matlab, Rapidform2006, SolidWorks and ANSYS, each performing specific tasks to obtain a plate shape that fits optimally for an individual tibia and is mechanically safe. A typical challenge when crossing multiple platforms is to ensure correct data transfer. We present an example of the implementation of the proposed method to demonstrate successful data transfer between the four platforms and the feasibility of the method.

A method for optimal fit of patient-specific fracture fixation plates

Anatomically pre-contoured fracture fixation plates are a treatment option for bone fractures. A well-fitting plate can be used as a tool for anatomical reduction of the fractured bone. However, recent studies showed that some plates fit poorly for many patients due to considerable shape variations between bones of the same anatomical site. Therefore, the plates have to be manually fitted and deformed by surgeons to fit each patient optimally. The process is time-intensive and labor-intensive, and could lead to adverse clinical implications such as wound infection or plate failure. This paper proposes a new iterative method to simulate the patient-specific deformation of an optimally fitting plate for pre-operative planning purposes. We further demonstrate the validation of the method through a case study. The proposed method involves the integration of four commercially available software tools, Matlab, Rapidform2006, SolidWorks, and ANSYS, each performing specific tasks to obtain a plate shape that fits optimally for an individual tibia and is mechanically safe. A typical challenge when crossing multiple platforms is to ensure correct data transfer. We present an example of the implementation of the proposed method to demonstrate successful data transfer between the four platforms and the feasibility of the method.

Status on pre-surgical deformation apparatus for fracture fixation plates

Purpose: This paper reviews the apparatus used for deformation of bone fracture fixation plates during orthopaedic surgeries including surgical irons, pliers and bending press tools. This paper extends the review to various machineries in non-medical industries and adopts their suitability to clinics-related applications and also covers the evolution of orthopaedic bone plates. This review confirms that none of the studied machineries can be implemented for the deformation of bone fracture fixation plates during orthopaedic surgeries. In addition, this paper also presents the novel apparatus that are designed from scratch for this specific purpose. Several conceptual designs have been proposed and evaluated recently. It has been found that Computer Numerical Control (CNC) systems are not the golden solution to this problem and one needs to attempt to design the robotic arm system. A new design of robotic arm that can be used for facilitating orthopaedic surgeries is being completed.

Percutaneous insertion of Dual Growth Rods using a new mobile bearing implant

Growth rods are commonly used for the treatment of scoliosis in the immature spine. Many variations have been proposed but breakage of implants is a common problem. Growth rod insertion commonly involves large exposures at initial insertion followed by multiple smaller procedures for lengthening. We present our early experiences using a percutaneous technique of insertion of a new titanium mobile bearing implant (Medtronic Inc). The implant allows some rotatory motion in the middle of the construct thus reducing construct stresses and thus possibly reducing rod breakage risk. Based on this small initial series with 12 months follow-up, percutaneous insertion of growth rods using the new implant is a safe and reliable technique although the infection rate in our sample was of note. This may be related to the titanium wear and inflammation seen in the soft tissues at time of operation and visualised on histology. No implants have required removal due to infection, and all infections were treated with debridement at next lengthening and suppressive antibiotics. Propionibacterium is one of the commonest infections seen with spinal implants and sometimes does not respond to simple antibiotic suppression. The technique allows preservation of the soft tissues until definitive fusion is needed and may lead to a decrease in hospital stay. The implant is low profile and seems to offer advantages over other systems on the market. Further follow up is needed to look at longer term outcomes with this new implant type.

Effect of bone graft type on fusion rates following endoscopic anterior scoliosis correction

Bone graft is generally considered fundamental in achieving solid fusion in scoliosis correction and pseudarthrosis following instrumentation may predispose to implant failure. In endoscopic anterior-instrumented scoliosis surgery, autologous rib or iliac crest graft has been utilised traditionally but both techniques increase operative duration and cause donor site morbidity. Allograft bone and bone- morphogenetic-protein alternatives may improve fusion rates but this remains controversial. This study's objective was to compare two-year postoperative fusion rates in a series of patients who underwent endoscopic anterior instrumentation for thoracic scoliosis utilising various bone graft types. Significantly better rates of fusion occurred in endoscopic anterior instrumented scoliosis correction using femoral allograft compared to autologous rib-heads and iliac crest graft. This may be partly explained by the difficulty obtaining sufficient quantities of autologous graft. Lower fusion rates in the autologous graft group appeared to predispose to rod fracture although the clinical consequence of implant failure is uncertain.

Simulation of the nutrient supply in fracture healing

The healing process for bone fractures is sensitive to mechanical stability and blood supply at the fracture site. Most currently available mechanobiological algorithms of bone healing are based solely on mechanical stimuli, while the explicit analysis of revascularization and its influences on the healing process have not been thoroughly investigated in the literature. In this paper, revascularization was described by two separate processes: angiogenesis and nutrition supply. The mathematical models for angiogenesis and nutrition supply have been proposed and integrated into an existing fuzzy algorithm of fracture healing. The computational algorithm of fracture healing, consisting of stress analysis, analyses of angiogenesis and nutrient supply, and tissue differentiation, has been tested on and compared with animal experimental results published previously. The simulation results showed that, for a small and medium-sized fracture gap, the nutrient supply is sufficient for bone healing, for a large fracture gap, non-union may be induced either by deficient nutrient supply or inadequate mechanical conditions. The comparisons with experimental results demonstrated that the improved computational algorithm is able to simulate a broad spectrum of fracture healing cases and to predict and explain delayed unions and non-union induced by large gap sizes and different mechanical conditions. The new algorithm will allow the simulation of more realistic clinical fracture healing cases with various fracture gaps and geometries and may be helpful to optimise implants and methods for fracture fixation.

Modelling the effects of bone fragment contact in fracture healing

The fracture healing process is modulated by the mechanical environment created by imposed loads and motion between the bone fragments. Contact between the fragments obviously results in a significantly different stress and strain environment to a uniform fracture gap containing only soft tissue (e.g. haematoma). The assumption of the latter in existing computational models of the healing process will hence exaggerate the inter-fragmentary strain in many clinically-relevant cases. To address this issue, we introduce the concept of a contact zone that represents a variable degree of contact between cortices by the relative proportions of bone and soft tissue present. This is introduced as an initial condition in a two-dimensional iterative finite element model of a healing tibial fracture, in which material properties are defined by the volume fractions of each tissue present. The algorithm governing the formation of cartilage and bone in the fracture callus uses fuzzy logic rules based on strain energy density resulting from axial compression. The model predicts that increasing the degree of initial bone contact reduces the amount of callus formed (periosteal callus thickness 3.1mm without contact, down to 0.5mm with 10% bone in contact zone). This is consistent with the greater effective stiffness in the contact zone and hence, a smaller inter-fragmentary strain. These results demonstrate that the contact zone strategy reasonably simulates the differences in the healing sequence resulting from the closeness of reduction.

Magnitude and variability of loading on the osseointegrated implant of transfemoral amputees during walking

This study directly measured the load acting on the abutment of the osseointegrated implant system of transfemoral amputees during level walking, and studied the variability of the load within and among amputees. Twelve active transfemoral amputees (age: 54±12 years, mass:84.3±16.3 kg, height: 17.8±0.10 m) fitted with an osseointegrated implant for over 1 year participated in the study. The load applied on the abutment was measured during unimpeded, level walking in a straight line using a commercial six-channel transducer mounted between the abutment and the prosthetic knee. The pattern and the magnitude of the three-dimensional forces and moments were revealed. Results showed a low step-to-step variability of each subject, but a high subject-to-subject variability in local extrema of body-weight normalized forces and moments and impulse data. The high subject-to-subject variability suggests that the mechanical design of the implant system should be customized for each individual, or that a fit-all design should take into consideration the highest values of load within a broad range of amputees. It also suggests specific loading regime in rehabilitation training are necessary for a given subject. Thus the loading magnitude and variability demonstrated should be useful in designing an osseointegrated implant system better able to resist mechanical failure and in refining the rehabilitation protocol.