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MM421: Finite Element Analysis - Continuous Assessment Project 13/12/10

Table of contents

1. ABSTRACT.........................................................................................................................................................2 2. INTRODUCTION................................................................................................................................................2 3. LITERATURE REVIEW.....................................................................................................................................3 4. EXPERIMENTAL METHODOLOGY...............................................................................................................8 5. DETAILS OF FINITE ELEMENT MODEL.......................................................................................................8 6. RESULTS: OVERVIEW OF FE RESULTS AND COMPARISON WITH EXPERIMENTS........................14 FIGURE 22: MAXIMUM STRESS VS. FORCE FOR DIFFERENT NUMERICAL MODELS.......................23 7. DISCUSSION: A CRITICAL EVALUATION OF YOUR RESULTS............................................................25 8. CONCLUSIONS................................................................................................................................................28 9. REFERENCES ..................................................................................................................................................29 APPENDIX:..........................................................................................................................................................31

1. Abstract

The purpose of this project is to verify that finite element analysis can reasonably be used to predict the behaviour of a fracture fixation plate under bending. Finite element analysis is a much cheaper approach to developing products than repeated prototyping and thus speeds up the development of new medical orthopaedic implants. However if the implant has significantly different properties after construction than originally modelled, it could cost millions in redeveloping the model, or worse, failure of the plate after being implanted. For this analysis, three finite element models were created, of varying degrees of detail, to be compared with experimental results, as well as mechanics of materials theory and finite element theory. Theoretical calculation can also be used to predict material behaviour, but is less useful as the scenario becomes more complicated. Finite element software is far more efficient in terms of accuracy, cost and scope. It is noted through the results that the ANSYS finite element program predicts material behaviour to a better degree than theoretical calculations. It can also be witnessed that increasing the level of precision of the model in simulating the real life plate in bending greatly decreases the variation between experimental and numerical data.

2. Introduction

Internal fracture fixation plates are at the forefront of biomedical engineering research. Despite the fact that they have been in development for over a century and have received criticism in the past due to apparent risk of infection, research into the application of internal fixation plates is on-going and still reaching new advancements. It is important to carefully analyse and test any implant that is designed to reside inside the human body for the duration of its application. For this analysis; a

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4.5mm, 10-hole Smyth & Nephew Periloc fracture fixation plate is analysed experimentally and numerically. The plate used in this analysis is a locking plate. This is a particular type of internal fixation device in which the screws are locked at a ninety degree angle to the plate. It protects the bone against shear damage in axial loading. In a regular fixation plate; a large axial load could cause the plate to slide along the bone. This would then cause the screws to rotate and shear the bone away while also offsetting the axis of the screw, causing instability in the system. As the screws are locked at ninety degrees in a locking plate and hence cannot rotate to allow the plate to slide along the bone, shear damage can be avoided. This locking mechanism is achieved by a number of different methods. For the plate used in this analysis there is a thread on the head of the screw hole. The screws used to lock these plates into place have a double thread of the same pitch on the head of the screw. This thread locks the screw at a rigid ninety degree angle to the plate (Figure 1) [1].

Figure 1- Diagram of locking screw (A) with double thread on screw head (B) [1].

The focal point of the analysis is a three point bend test. This test emulates the maximum stress concentrations that would be expected in the plate due to neck fractures in the tibial or femoral shaft which would be the expected application of such a fixation plate. A bend test was carried out to obtain experimental data and a finite element analysis (FEA) was carried out using ANSYS finite element software in order to verify experimental findings with numerical theory. Before the practical, theoretical and numerical portions of this study were carried out, literature was consulted on the topics of internal fixation plates and the ethical considerations attached to their use as well as finite element methods of representing a 3-point bend test.

3. Literature Review

Metallic implants are increasingly becoming more popular for fixation of fractures which occur in the Epiphyseal and Diaphyseal of the human long bones. In the leg these are the Femur (Thigh bone), Tibia (Shin bone) and the Fibula (the Smaller of the two lower leg bones) and in the arm, being the humeri, radii, and ulnas. They are used where traditional external healing methods such as casting will not be effective [2]. The metallic implants are put in place on fractures by a method of open reduction and internal fixation (ORIF). Open reduction involves opening up of the limb to set a bone and internal fixation is the process of using plates and screws to rigidly fix the fractured bone.

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The reason in many cases why casting of the limb is not sufficient to set a fractured bone is that there may be indications that the neurovascular structure or skin could be damaged. Also it could be evident that misalignment will result, or even that the fracture is a comminuted one due to severe trauma (see figure 2) [3].

Figure 2: A. Comminution Fracture of the femur. B. Use of a plate to assist reduction of the bone with screw placement in both Epiphyseal and Diaphyseal [3].

3.1. Plate Geometry The use of locking plates as a means of internal fracture fixation offers significant advantages over conventional compression plates, including improved healing of osteoporotic bone [4]. The first of these advantages is that conventional compression plates have an associated need to contour them to exactly fit the bone that they will be applied to. Due to the fact that locking compression plates (LCP) are perfectly rigid beams that can be kept elevated from the bone, the need for the same level of contouring is not present. Here then, can an indirect reduction approach be used, this technique is known as minimally invasive plate osteosynthesis (MIPO), see figure 3. [2]. In MIPO, the plate is tunnelled extraperiostally through a small skin incision and is fixed either side of the site of fracture with locking head screws [5]. It has been written in a review journal by D. Miller and T. Goswami that the chances of successful and uneventful recovery of patients become higher when MIPO techniques are employed [2]. Baumgaertel et al. have also shown that MIPO techniques, when used together with LCP, improve callus formation, leading to faster healing times [6].

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Figure 3: Images of MIPO to repair a fracture with visible holes for screw insertion [5].

Esenkaya et al. carried out an evaluation of different stainless steel fixation plates in a study to determine which plate geometry was best suited to carrying an axial load. During this study they concluded that all the samples used were undamaged up to an axial load of at least 5.6 kN. This axial load corresponds with the axial compressive load in the knee of an adult during single leg stance position while walking at a fast pace [7]. Bending in a fixation plate applied to a tibial shaft neck fracture loaded axially would occur if the compressive force applied to the bone was offset from the neutral axis of the bone. The magnitude of the bending moment would be determined by the magnitude of the angular offset and hence the magnitude of the resultant transverse force. A 2mm thick stainless steel reversed "L" plate yielded in bending due to a 7963 N axial compressive force [7]. This was due to shifting of the bone in axial compression as the fracture was not normal to the neutral axis of the bone. For the analysis discussed in this report; only elastic deformation of the plate is considered. From the literature studied, and considering that the fracture plate used in this analysis was 2.25 times thicker than the one seen in literature, a maximum bending load of 750-1250 N is hypothesised for the practical analysis.

3.2. Plate length and Screw placement These parameters are also crucial when designing a successful locking plate as they can dictate whether or not the plate shall hold up to its intended lifespan. The design of locking plates, as specified already, enables it to transfer a vertical axial force into that of a compressive stress on a fracture once the locking screws are secured. Due to this, a bending stress can result over the site of fracture. This stress is directly affected by the plate length and screw placement. A shorter working length can induce stress concentrations, which when combined with fatigue from movement can cause dangerously high stress levels on the LCP above the site of fracture [8].

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Figure 4: a) A short working length of implant produces high stress and strain over a small area of implant. b) Longer working length produces less stress and strain reducing risk of implant failure [8].

For Diaphyseal fractures, P. Cronier has indicated that the quality of the fixation is higher when longer plates are used [1]. This elasticity of the whole system can then be increased by leaving out consecutive screws. Wagner M. et al suggests that three or four holes should be left empty if it is felt that it wont affect the fracture stability [9]. This elasticity provided by longer plates is a necessity as a fully rigid system can lead to catastrophic failure of the plate in certain cases, (Figure 5). It can be easily mistaken that by using a shorter plate, further chance of tissue damage will be reduced, but with the use of MIPO techniques explained above, no large tissue incisions are needed [2].

Figure 5: Catastrophic failure of a locking plate due to stiffness caused by fatigue and a short working length [8].

3.3. Materials The choice of materials to be used for the manufacture of internal fixators is of critical importance. Miller and Goswami in their review paper list titanium alloys and stainless steel as the two major materials suitable for locking compression plates [2]. Along with these, the alloy Cobalt-chromiummolybdenum (used primarily in Hip prosthesis manufacture) has a Youngs modulus akin to stainless steel and so is used as another source of comparison. It was noted in this paper that the fracture Gap size can cause the von mises stress between stainless steel and Titanium to vary greatly. When the fracture gap size is large (~6mm) the stress levels dont tend to differ, but as fracture gap size decreases it was found that stainless steel, because of its higher youngs modulus and thus, higher stiffness comes under a higher stress than the titanium [2]. Table 1 below, constructed from a paper by Wood [10], gives a good indication of the materials properties, and their advantages, uses and disadvantages in relation to biological implant manufacture.

Metals

Titanium

Stainless Steel

Chemical Composition

Ti6Al4V

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E (Young's Modulus)

110GPa

200GPa

~190GPa

Advantages

Relatively strong and cheap Excellent resistance to stress compared to Titanium. A Greater Yield strength (y) corrosion cracking, fatiguing and is biocompatible material, when Stronger than stainless steel. annealed can be cold worked as than Stainless steel. it is relatively ductile so as to form plates Cement-less joint replacements (total knee arthroplasty); Fracture fixation devices. Total joint arthroplasty (usually fixed Rarely used in new designs in with cement); Used with cement as joint replacement; Fracture yielding of adjacent bones can occur fixation devices from the hardness of the material.

Uses

Disadvantages

Excessively corrosive in some cases. Susceptible to fatigue Poor wear Characteristics. Co, Cr, Mo known to be toxic in cracking. Very high modulus *varies with smooth or ionic form; High modulus. *varies PMMA cement may cause porous surface with smooth or porous surface fracture or tissue reaction problems.

3.4. FEA Modelling For information on generating a finite element model of a 3-points bend test, a journal by A. Arriaga et al. was consulted. In the consulted text, a 3-point bend test of a thermoplastic polymer was modelled in ANSYS. A full 3D model was generated using solid elements, a refined mesh and contact conditions between the metal supports, load applicator and plastic test piece. Good correlation was seen between the experimental results and the numerical results obtained in the consulted text. This verified the hypothesised method for this analysis was tested and should produce accurate results. Due to the 4.5mm thickness of the plate being analysed in this study being significant in comparison to the other dimensions of the plate; it was decided that solid elements would be the best choice to accurately simulate the experimental data, as shell elements require that the thickness dimension be insignificant or very small in comparison to other dimensions [11]. It was also found in a journal by F. Mujika that the effects of Shear and local deformation at force application and support points can have an effect on the results of a 3-point bend test if the span-to-depth ratio is not large. As the spanto-depth ratio for the bend test carried out in this study was greater than 20:1 it was assumed that

A journal by S.J. Ferguson, U.P Wyss and D.R. Pichora highlighted a number of ethical issues associated with internal fixation plates which will be discussed in a later section of this report. It also depicted the difficulty in modelling a full finite element model of a fixation plate on bone system. Bone is a non-homogeneous, anisotropic, non-linear material which has time dependent viscoelastic properties [13]. For this reason it was decided that a simpler model involving a 3-point bend test of the plate alone would be sufficient to form an understanding of the stress system in a plate applied to bone. Though the fixation plate analysed in the journal referred to above was geometrically different to the one analysed in this study, it was observed that the model constructed had a refined mesh around the screw holes in the plate. This acknowledged for the present study as a stress concentration would be expected around the holes and a refined mesh would be necessary to accurately detect this stress concentration.

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Further information on ethical issues involved in the use of internal fixation plates as well as general information on locking plates and their application was discussed in a journal by P. Cronier et al [1]

4. Experimental Methodology

Plate Dimensions: 0.192m x 0.015m x 0.0045m Force: Ramped from 0N to 1420N Force is equally distributed between supports.

1. The tibia fixing plate was mounted between the supports and the loading point as in the diagram. 2. The top support (marked as force) was moved downwards at a uniform speed, deflecting the plate. 3. The restoring force acting on the force applicator from the plate was recorded relative to the deflection of the plate. 4. A system of gauges and computational programs was used to record the force versus deflection graph as a live video. 5. Points were taken from this graph to plot against the theoretical and finite elements method solutions.

5.1. Environment

Element Types The element types used were solid-185 and solid-186.

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Solid-185 is essentially a cuboid shape with nodes at each corner. It allows for 3-D modelling as it has a degree of freedom in the x, y, and z plane, allows rotation of nodes for bending, and have the relevant structural material properties included. This element work great in linear or bending test where it has a uniform structured mesh. There are a few disadvantages to solid-185. The element does not allow for much flexibility when fitting into complex geometry, and reacts poorly to being skewed or elongated. In skewed situations the element may be forced to assume a prism of tetrahedral shape, however it performs poorly in these shapes (especially tetrahedral). Solid-186 is the same basic shape but has 20 nodes which allow for more complex element shapes and curvature of the element edges. This also gives more defined node values at the expense of longer computational times. It works better than solid-185 in these situations, however for a well structure mesh, it was found to have negligible difference. All models are modelled in solid-186 unless otherwise specified. Material Properties Material properties match those of the theory section for steel-316L. A Poissons ratio of 0.3 was decided upon as it is an average values for mild steel.

5.2.

Modelling:

3 separate finite element models were built and tested, as a means to understand the different features of the real life plate and to understand the effects of de-featuring in models. 1.1.1. Creating Geometry Benchmark A benchmark test was performed to be compared with classical mechanical theory. A 192mm x 15mm x 4.5mm block was created and meshed without any mounting holes or other discontinuities; the model was completely de-featured. This was to show that simulation values could be validated through theory, proving finite element analysis as a legitimate test in this situation. Results for the benchmark are in the results section. Adding Holes In order to allow a uniform mesh around the holes, the 6mm radius cylindrical cuts were removed from blocks of dimensions 13mm square extruded 4.5mm with the subtract operation. This aided in splitting each cuboid/cylinder combination into uniform simple shapes to aid in meshing.

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Splitting geometry The workplane was offset 7.5mm, or half of the block above. The divide volume by workplane command was used to divide the volume in half, and then the workplane was rotated 900 to further divide the volume into quarters. The workplane was then aligned by keypoints, for example 5, 7, and 3 in the above picture, to set the workplane at a 450 degree angle. The volume was segmented into 8 volumes using this method. The volume could also have been split using areas drawn through the model. 1.1.2. Copying geometry Pattern The VGEN command was used to copy the meshed volume in a pattern of 10, with every alternate volume offset by 2mm in the positive y dimension. This laid out the correct position of the holes. The fill volumes were created with a repeating pattern of horizontal and vertical blocks, to create a complete singular structure with the same general dimensions as used in the experiment.

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In the interest of reducing possible problems related to coinciding areas and lines, as well as to make future modifications simpler, the glue operation was used to force the program to share coinciding feature between mated parts. This second model was meshed and processed, separate from the final model, to see the effect of various levels of defeaturing on the quality of the results. Semi-cylindrical cuts A final model was built which included semi-cylindrical cuts made in the bar (as seen in the figure below). The assumption was that less material would affect the moment of inertia value, therefore increasing the deflection. As the plate would be allowed to deflect more, this should have the consequence of lower stress. This however may be offset by the fact that the cuts are discontinuities and therefore are themselves stress raisers.

This geometry was used as the final model tested, and is the closest to the actual plate used in the experiments. 5.3. Meshing:

1.1.3. Size Controls The block/hole combination was originally meshed as below, as this would give very accurate results in the context of the simulated model. However, the nodes limits for the ANSYS education version 12.1 is 32,000. As there are 10 holes, if this segmented volume was patterned 10 times the node limits would be exceeded. The mesh had to be simplified to reduce the node number.

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The mesh density was reduced in areas on expected unimportance, namely the ends of the plate. The areas of expected highest deformation and stress, the holes and cuts in the centre of the plate, have a higher density mesh. The overall intention was to make as many elements as possible out of cube shapes, particularly those of high importance, have a much more refined mesh at areas of importance, while reducing sizing ratio (difference between largest and smallest elements in the model) to fewer than 10 and having fewer nodes than 32,000. The final node count was just over 28,000.

The spacing ratios were set up to favour elements near the circle; known to be a stress raiser, and to favour the extremities along the z axis; as it will undergo a bending test acting in the z direction and through engineering understanding it is known that max values for tensile and compressive stress are found at points furthest away from the neutral axis. The model lines were sized to prevent ANSYS from using any tetrahedral elements in the mesh, as hexahedral elements produce better results for the element types described and do not work well in conjunction with tetrahedral elements. Each segment of the block/hole shapes were individually line sized, or had the line size copied from another segment. This was considered the best way to have a uniform mesh while increasing mesh density at points of concern. The fill areas were meshed with volume sweeping, in which the program used the meshed areas of the block/hole shape in contact with the shape to be mesh and sweeping this mesh to the other side of the volume. This was to ensure the mesh lined up internally at the joining areas.

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5.4.

Loading:

Coupling nodes Nodes were coupled at the point of the application of the load using the coupled node option (CP). The nodes coupled were those that fell exactly on the line x=0.096, z=0.0045. This was to spread the application of the load equally over nodes in the y-direction. In this way the model would not shown a stress increase at the point of the load. Force applied to node One of the coupled nodes was loaded with incremental loads of 250,500,750 and 1000N in the negative z direction, as described in the experiment. Displacement load on sides The bar is constrained from movement at points 50mm to either side of the site of the load. The volumes were divided at x-coordinates 0.046mm and 0.146mm and these volumes were re-meshed, the intention being to force nodes to fall on the lines x: 0.046mm & 0.146mm, z: 0; the point at which the model is constrained. In meshes where it was feasible, the mesh size was chosen deliberately to have nodes fall on these lines. Another option would be to manually add nodes to these points. The x=0.046mm, z=0 nodes were constrained in the x and z direction, and the x=0.146, z=0 nodes were constrained in the z-direction. This created reactions to the applied force at these lines which would allow the shape to rotate but not to travel through the supports. The plate would also be allowed to compress in the x direction, which it would be imagined would happen under real life situations unless the plate was clamped. It would have been more precise with the experiment to model the supports, constrain the supports in all directions and create contact elements at the points where the plate and the supports would come into contact. This would allow the reaction forces to be spread out over an increasingly larger area, reducing stress generated in the z-direction. Application of contact loads are outside the scope of the syllabus. 5.5. Solution and Post-processing:

After the creation of geometry, meshing of the geometry, and correct application of loads and boundary conditions, the solution was run. Upon completion some processing was done to measure results. Finding Resulting Extremes of Deflection and Stress Deflection was recorded in the z-direction, as it was in the experimental and theory sections. The total displacement of the nodes was ignored because, as stated prior, the plate was allowed to move along the x-axis at one side, which would skew results. Another output recorded was Von-Mises Stress, a criterion used to predict stress by computing distortion energy. In this way the stress tensor can be achieved at exact points, rather than computed in singular directions by considering the force and the area it imparts upon. Average Stress As the final model has varying sections causing stress raising, the maximum stress recorded by ANSYS was noticed to only be acting on an infinitesimally small volume. In real applications this would lead to micro cracking and stress relieving, rather than the immediate complete fracture of the component. To compare with stress found through theory, the average stress was found over a series of nodes on the lower face of the model, between the 4 and 6 cylindrical-sector cut, which meant about 31mm shared on both sides of the x-axis on the surface to the plate.

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The list option from the utility menu was used to show the von-Mises stress of the selected nodes. The table of values was input into excel and the average function was used to show the average stress at the surface. 5.6. Convergence Testing:

Always with ANSYS it is a concern that the mesh density is too low to accurately record results. As a convergence test, the element type was changed to solid-185 and the plate remeshed. This has the outcome of having only 40% of the nodes. The solution for a load of 1000N was reworked. Another technique used was to refine the mesh at the centre cut and the centre holes. The solution was solved again at a load of 1000N. Upon comparing results, it was noticed that the stress values did not differ by more than 2% for either of the convergence tests.

Prior to any actual finite element analysis being undertaken, the plate was assumed to be a simple beam and a number of assumptions were made about the model. A simple numerical analysis was performed to get indicative values for the max bending stress and beam deflection. For the matter of simplification of the mathematical equations used, the effects of local deformation and flexural rotation at the points of loading shall be ignored. It was assumed that the beam did not contain any holes and also that it was a static load applied to the midpoint

FL 48EI

(1)

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F = applied force l = beam length E = elastic modulus I = second area moment Calculating I:

I= bh 3 12 I= 0.015x0.00 45 3 = 1.139x10 12

10

m4

(2)

where; b = sample width h = sample height Substituting Equation (2) into (1) to calculate the beam deflection at Max load:

FL 3 = 48EI

10

= 9.48x10

m = 0.948mm

The Max bending stress at the outer thickness of the sample is found from simple beam theory with: = My I (3)

Where; M = Bending moment at the point of loading y = distance from the neutral axis to outer surface of the beam I = Second moment of area The bending moment at the point of loading can be found using equation 4.

M=

Giving;

(4)

1000N

Node 1 Node 3

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R1

Node 2

R2

[Ke]=

(5)

Where; Element length l = 0.05m And completing the matrix with element lengths; (6)

= 175840

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(7)

Using the global energy equation [14], the max displacements can be found. This is: [Ktotal]{U} = {F} (8)

Where V1, 1 = displacement and slope at node 1. P1, M1 = external transverse loads and moment at node 1. V2, 2 = displacement and slope at node 2. P1, M2 = external transverse loads and moment at node 2. V3, 3 = displacement and slope at node 3. P1, M3 = external transverse loads and moment at node 3. Giving:

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Due to the boundary conditions, (zero displacement at nodes 1 and 3) certain rows and columns can be crossed out to minimise the number of equations [14].

By means of Gaussian elimination, the value of v2 (the vertical nodal deflection), 1, 2, 3. (The rotation/slopes) can be found. Although the slope is not needed for the purpose of this investigation it is left for completeness. 1 = v2 = 2 = 3= -0.0284349 = -1.69 -0.000947831 M = 0.948mm 4.50415e-19 (~ 0) 0.0284349 = 1.69

6.3. Finite element results 1.1.4. Benchmark Test Model A preliminary model was constructed in order to form a benchmark for stress and deflection from which to move forward to a more complex model.

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Figure 15: This benchmark model of the three point bend test was run initially in order to test the Finite Element method intended for use in further models. Deflection at maximum load.

Figure 16: The benchmark stress at maximum load was also noted in order to get an estimation of the stress without stress raisers present.

1.1.5. Model without semi-cylindrical cuts An analysis was run on the de-featured model in order to investigate how the semicylindrical cuts affected stress concentrations in the plate.

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Figure 17: Deflection in z-direction for the full finite element model loaded up to 500N.

Figure 18: At maximum load, the middle section of the plate is seen to exhibit stress concentrations at the edges of the holes only. Stress is spread across bottom surface of the plate.

1.1.6. Final Model The main analysis for the purpose of comparing methods was run on a model with the minimum amount of de-featuring. All semi-cylindrical cuts were included and the mesh was further refined at points expected to be stress concentrations.

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Figure 19: Deflection at maximum load for final model with cuts on bottom surface included.

Figure 20: Stress concentration, at apex of cut at 750N load, in final model.

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6.4. Comparison of results 1.1.7. Comparison of Numerical models The results obtained for max stress and plate deflection for each model at different loads have been graphed in order to depict the convergence of the model in simulating the experimental scenario.

1.8 1.6 1.4 1.2

-d ) m ( n o t c e r i

1

Final Model

0.8 0.6

Z n o i t c l f e D

0.4 0.2 0 0 200 400 600 F e (N) orc 800 1000 1200

Figure 21: Plate deflection vs. force for different numerical models.

1400 1200 1000 800

Final Model

600

) P M ( i a c n o C s e r t S

400 200 0 0 200 400 600 F e (N) orc 800 1000 1200

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Figure 22: Maximum stress vs. force for different numerical models

1.1.8. Comparison of methods In this analysis, three methods were employed to find the deformation of the beam or locking plate. The following graph compares the methods used in terms of obtained value of deflection in the zdirection at different loads.

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Figure 24: Graph of stress vs. load for final model average stress

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The following sub-sections will discuss the outcome of the analysis under headings relating to the results seen in the last section. 7.1. Discussion of theoretical results Two mathematical benchmark tests were performed initially to create a reference point on which to base the initial finite element benchmark model. In each of these cases the plate was considered to be a rectangular prism without any holes. A value for the deflection was calculated using both basic beam theory and element stiffness matrix methods. These results were found to correlate perfectly; indicating that the benchmark model was verified as a viable start point for the finite element analysis 7.2. Discussion of numerical results 1.1.9. Benchmark Model The benchmark model was created to verify our intended finite element method moving forward. As the theory had obtained a convergent value for deflection, it was now possible to re-create the theoretical conditions in a finite element model. The resultant deflection and stress observed in the benchmark model correlated very closely with that obtained in both theoretical methods, (Figure 14). The maximum stress is observed at the edges of the plate on either side of the force application point. This is the expected result as there are no stress raisers present Stress (MPa) Theoretical Benchmark Finite Element Benchmark 494 490 Deflection (mm) 0.948 0.953

Successful simulation of the theory verified that a detailed FE analysis could now be order to gain further information about the system in bending.

employed in

1.1.10. Feature inclusive model and mapped mesh Once the benchmark model had been tested and verified; a fully three dimensional model of the locking plate was created. The resultant finite element model accounted for the holes through the plate. Once this had been completed; a further model was generated containing further detail in the form of semi-cylindrical cuts on the bottom surface of the plate which had originally been omitted during de-featuring. There is a difference seen in deflection between each of the models (Figure 21). This is due to the inclusion of the holes and finally the semi-cylindrical cuts in models following the benchmark. The reduction in material leads to a reduced stiffness in the plate by reducing the second moment of area. A greater change is seen in deflection on addition of the cuts along the bottom of the plate compared

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to the holes. This is assumed to be due to the material being removed transversely in the case of the cuts as opposed to normally for the holes. A significant difference in max stress is observed between the de-featured benchmark model and the other two models. This is due to the inclusion of the holes and cuts, as both of these features are stress raisers. However, there is very little difference seen in max stress on addition of the cuts to the model already containing holes. This is due to the mesh refinement remaining constant between these models. The mesh around the holes was refined enough to detect the stress concentrations forming at the top and bottom of each hole, (Figure R4). The observed stress concentrations at maximum loading are seen to be above one Gigapascal (Figure 21) and are far above the upper tensile strength of 558 MPa for 316L stainless steel. As there are no damage conditions included in this model, these stress concentrations would reflect micro-cracks forming and are artificial in magnitude. It is hypothesised that micro-cracks would be seen slightly earlier in the model with cuts to the bottom surface included. However, the difference is seen to be insignificant; a damage model would be required to analyse the failure conditions more accurately. As mentioned in section five, an average stress was summed over a section of bottom surface of the plate in order to find a value that might correlate more closely with theory. The values for the average stress through the bar was much closer to theoretically calculated and benchmark values; indicating that, without focusing on stress raisers, the more complex geometry in the final model correlates well with beam theory when the average stress is considered, (Figure 23). 7.3. Comparison of methods

The final aspect of the results that will be discussed is a general comparison of the available methods used to analyses the fracture fixation plate. Different methods are employed in all scientific investigations in order to gain further knowledge of a scenario and also to verify that which has already been analysed. In this analysis, experimental data was initially collected. This data was then compared to theoretical and numerical data based on the same experiment. The comparison of methods with regard the value obtained for deflection of the plate is seen in Figure 22. From this graph it can be seen that the deflection is considerably higher in the experimental procedure compared to FEA and theory. The theoretical model deflects less due defeaturing; however the FEA model containing holes and cuts deflects considerably less than the experimentally measured deflection for higher loading. The deflection is lower in the FEA analysis for two main reasons; firstly there are still features of the plate unaccounted for, such as the side radii. Any extra material in the FEA model that is not present in actual plate serves to stiffen the model artificially. This error can be reduced by emulating the plate geometry more closely and not de-featuring the model. The second reason for the discrepancy observed in deflections at increasing loads is due to exclusion of contact conditions and damage simulation. The effects of local deformation at the site of loading as well as micro-cracks induced at stress concentrations above the tensile strength of the material are omitted from this type of analysis. Further analysis of the experiment would likely show that beyond 550N loading, the plate had begun to yield in bending. Yielding would lead to a non-linear relationship between stress and load, (Figure 22) and ultimately a non-linear relationship between stress and strain due to plastic deformation. As plastic deformation is not part of the FE model and would not be possible to analyse in a static analysis, the results for deflection diverge. All FEA models have been tested for convergence and a linear result has been obtained for all models. It is assumed that a well-placed plate would be designed to withstand all axial loads due to weight and

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walking as well as slight impacts and resultant transverse loading. None of these loading conditions should approach the yield stress for the plate and hence an elastic analysis should be sufficient. If high trauma was to be considered, a damage model with time steps would be necessary.

7.4. Ethical Considerations As with any engineering analysis; particularly one performed in the field of medical devices, there are a number of ethical considerations which must be kept in mind when discussing fracture fixation plates and their application.

7.4.1. Stress shielding Stress shielding is a phenomenon that occurs when two or more components made of materials with different moduli form one mechanical system. The component with the higher Modulus bears more of the applied load and protects the weaker component [13]. Such is the case with rigid fixation devices such as a locking plate attached to a bone. Though it would seem that this is an important part of how a fixation plate works; it in fact creates problems in the later stages of healing. As bone begins to reform at fracture point, the fact that it is supporting less than the load it was used to carrying can lead to a weakened bone and may cause refracture due to osteoporosis [13]. In order to promote bone union with an aim towards biological synthesis it is necessary to leave 1-2 screw holes empty on either side of the fracture point. This increases elasticity in the system and allows a certain amount of the load to be carried by the healing bone while also leaving the weakened are of the bone free from screw holes [1]. 7.4.2. Locking screw removal Screw holes in the bone are a common cause of refracture on plate removal as stress concentrations around screw holes are found to be approximately 3.5 times the nominal stress [13]. This also avoids a high stress concentration in a small part of the plate at the centre of the plate which could lead to yielding or failure. Another issue that can arise when discussing the use of internal locking plates is the possibility of "jamming" of the locking screws. In up to 17% of cases for 5mm screws and up to 8.6% of cases for 3.5mm screws "jamming" of the screw head locking mechanism can occur [1]. The plate must then be cut to be removed or the screw heads must be drilled. This creates further risk of foreign bodies remaining in the body and causing infection. These are an example of the kind of considerations that must be kept in mind during the design and application of medical devices. This is naturally due to the extreme trauma involved in fixing a faulty plate. The level of standards set by the Food and Drug Administration (FDA) for medical devices is very high and must be met by any manufacturer that wishes to compete, or even exist in the medical device industry.

Page 27

7.5. Sources of Error During the 3-point bend test it would be ideal to test both experimentally and numerically for numerous different span lengths. This would test for the fact that depending on the application, the plate may need to be tested as supported from different sets of holes. It is rare and usually not advised to fill all screw holes as this is in effect doing further damage to the bone. 3-4 screws are usually enough.

Simplification of the FEA model could lead to inaccuracies. In this study, no contact elements were used to simulate the exact effect of the bending conditions on the surface of the plate.

The experimental bending test was only carried out at one speed. This made it more difficult to analyse the straining rate and hence keep the analysis in the elastic deformation region.

8. Conclusions

When considering a simple loading scenario without any complex geometry a theoretical approach yields accurate results and is the fastest and most efficient method. As a loading scenario becomes more complex and the geometry in question also increases in complexity, the adopted method must change to either experimental or numerical methods.

Numerical methods can be used in conjunction with software packages such as ANSYS to accurately simulate a loading scenario. This simulation gives an approximate estimation of the displacement at a certain point. From which, deflection at other points or Von Mises stress can be then estimated. FEA is used only to support and investigate experimental conditions and cannot be considered as accurate as experimental procedure. The varying levels of complexity incorporated into an FEA model have a significant impact on the result attained. The closer the modelled geometry reflects the actual test piece, the more accurate the results are likely to be. Simplified and de-featured models still serve a purpose as benchmark tests to form an approach to a more complex model. Mesh density has a significant effect on the ability if the numerical model to accurately detect changes in stress or deflection at specific points. A mapped mesh works best for hexahedral elements. Node numbers and computational running time have been shown to be reduced by reducing the density of the mesh around inconsequential areas while maintaining a high mesh density around stress raisers and other important areas. Result inconsistencies occur in areas where meshes do not transition smoothly between different volumes. Once o model is producing steady results, the mesh density can be reduced to check for model convergence. Stress raisers may cause artificial stress concentrations in models which do not incorporate damage conditions. These stress concentrations can be assumed to represent micro-cracks forming as yielding leads to failure. A more accurate representation of the average maximum stress is obtained by summing stress at many nodes across the surface of the model and calculating a mean. It is important to consider all possible ethical issues associated with an analysis involving medical devices. As these devices are intended for use or implant inside a human body, it is of very high Importance that they are both designed and researched in a humane and professional way, with all considerations for the pain and personal hardship of any patients involved in studying plate application.

Page 28

Experimental results will differ from finite element results if the yield criterion is not properly included. Micro-cracking at sites of stress raisers in real life scenarios will cause extra deformation at the site which serves to locally increase deflection, which has the by-product of decreasing the restoring force of the beam, causing a load/deflection graph to curve. In finite element modelling without yield criteria, this localised deformation is not considered, and the deflection continues to have a purely linear relationship with load.

9. References

[1] Cronier, P., Pietu, G., Dujardin, C., 2010, "The Concept of Locking Plates," Orthopaedics and traumatology: Surgery and Research, 96(4 SUPPL.). [2] Miller, D. L., and Goswami, T., 2007, "A Review of Locking Compression Plate Biomechanics and their Advantages as Internal Fixators in Fracture Healing," Clinical Biomechanics, 22(10) pp. 1049-1062. [3] Dee, R., Hurst, L. C., Gruber, M. A., 1997, "Principles of Orthopaedic Practice," McGraw-Hill, McGrawHill, New York(2nd ed) . [4] Egol, K., Kubiak EN, Fulkerson E, 2004, "Biomechanics of Locked Plates and Screws." - J Orthop Trauma Sep; 18(8): (0890-5339 (Print); 0890-5339 (Linking)) pp. 488-493. [5] Hasenboehler, E., Rikli, D., and Babst, R., 2007, "Locking Compression Plate with Minimally Invasive Plate Osteosynthesis in Diaphyseal and Distal Tibial Fracture: A Retrospective Study of 32 Patients," Injury, 38(3) pp. 365-370. [6] Baumgaertel, F., Buhl, M., and Rahn, B. A., 1998, "Fracture Healing in Biological Plate Osteosynthesis," Injury, 29(Supplement 3) pp. 3-6. [7] Esenkaya, I., Misirlioglu, M., Kelestemur, M. H., 2007, "Biomechanical Evaluation of Different Fixation Plates in Medial Opening Upper Tibial Osteotomy," The Knee, 14(1) pp. 46-50. [8] Szypryt, P., and Forward, D., 2009, "The use and Abuse of Locking Plates," Orthopaedics and Trauma, 23(4) pp. 281-290. [9] Wagner M, F. R., 2006, "AO manual of fracture management, internal xators, concept and cases using LCP and LISS." Anonymous Thieme, Stuttgart, New York. [10] Wood, D. J., 1993, "The Characterization of Particulate Implants,. Debris obtained from Failed Orthopaedic

[11] Arriaga, A., Lazkano, J. M., Pagaldai, R., 2007, "Finite-Element Analysis of Quasi-Static Characterisation Tests in Thermoplastic Materials: Experimental and Numerical Analysis Results Correlation with ANSYS," Polymer Testing, 26(3) pp. 284-305. [12] Mujika, F., 2007, "On the Effect of Shear and Local Deformation in Three-Point Bending Tests," Polymer Testing, 26(7) pp. 869-77.

Page 29

[13] Ferguson, S. J., Wyss, U. P., and Pichora, D. R., 1996, "Finite Element Stress Analysis of a Hybrid Fracture Fixation Plate," Medical Engineering & Physics, 18(3) pp. 241-50. [14] Eischen, J. W., 1991, "Matrix Analysis of Beams," NCSU, pp. 1-21.

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Appendix:

Figure - A Stress distribution at 1000N. Max local stress= 1.25GPa, indicating fracture at the centre of the figure.

Figure - A Stress distribution at 750N. Max local stress= 880MPa. Fracture would still occur in the red area.

Figure - A Stress distribution at 500N. Max local stress= 586MPa. At this point the yield has just been exceeded.

Figure - A Stress distribution at 250N. Max local stress= 300MPa. The beam remains elastic in this range.

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