A Finite Element and Experimental Investigation of The Femoral Component Mechanics in A Total Hip Arthroplasty - Cameron Gordon Bell - Thesis - 2005

A finite element and experimental
investigation of the femoral

component mechanics in a total hip
arthroplasty

Cameron Gordon Bell
Bachelor of Engineering (Mechanical) (Hons)
Queensland University of Technology, Australia

Submitted for the award of the degree of Doctor of Philosophy
2005

The Centre for Built Environment and Engineering Research,
School of Engineering Systems,
Queensland University of Technology.

A finite element and experimental investigation of the femoral component mechanics in a total hip arthroplasty

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Keywords
Total hip replacement, femoral component, biomechanics, finite element analysis


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Glossary
Anterior: Towards the front of the body or segment.

Aseptic loosening: Loosening without the presence of infection.

Cancellous bone: A type of bone that contains many pours, much like a sponge.

Cemented (stem): Refers to a stem that has been implanted with in intermediate
layer of PMMA between the stem and the bone.

Composite femur: See Sawbones femurs.

Cortex: the hardened outer layer of the cortical bone.

Cortical bone: The hard bone superficial to the cancellous bone on the surface of
long bones such as the femur.

Debonding: is defined as local loss of adhesion between two surfaces which were
initially bonded (in this case, the bone cement and the prosthesis) allowing local
relative shearing and separation between the surfaces.

Distal: Refers to regions away from the trunk.

Failure: is defined as the point where the level of loosening compromises the
functionality of the femoral component of the total hip arthroplasty.

Femoral constraint: A device designed specifically to constrain the femur in a
repeatable position for loading via a pneumatic load rig.


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Femoral Stem (or component): Unless otherwise specified this refers to the
femoral prosthesis of the total hip arthroplasty. In this case the femoral stem refers
specifically to the Exeter, number 1; 37.5mm offset, femoral stem (Howmedica,
NJ ).

In vitro: In an artificial environment, such as a laboratory, outside of the living
person or organism.

In vivo: Within a living person or organism.

Lateral: Refers to regions away from the centre of the body or segment.

Loosening: is defined as the process in which debonding progresses until a
physical gap exists at the cement-prosthesis interface, allowing overall relative
motion between the prosthesis and bone. The magnitude of the physical gap
increases as loosening proceeds.

Medial cortex: a region of the cortex that is immediately inferior to the lesser
trochanter along the medial aspect of the femur.

Medial: Refers to regions towards the centre of the body or segment.

Posterior: Towards the back of the body or segment.

Principal direction: Two mutually perpendicular directions that define the
direction in which the principal stresses act.

Principal strain: Principal strains are strains at an infinitesimal point that occur at
an orientation where there is no shear strain.


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Principal stress: Principal stresses are stresses at an infinitesimal point that occur
at an orientation where there is no shear stress.

Prosthesis: See Femoral stem.

Proximal: Refers to regions towards the trunk.

Reimplantation: The process of the removal and refitting of the same or identical
stem without the use of additional bone cement.

Rosette (Rectangular rosette): Refers to a series of three strain gauges that are
used to measure strain at a point on a surface in three directions. In this case
rectangular rosettes are used, where the angle between the gauges is 45 degrees.

Sawbones femurs: mechanically analogous femurs produced by Sawbones
Worldwide (Pacific Research Laboratories, Inc.).

Secure (fixed): A secure prosthesis is defined as one in which bone cement and
prosthesis are bonded together at the interface by mechanical or chemical means,
and no relative motion occurs. Fixed in terms of the finite element model refers to
the use of the *TIE definition at the stem-cement interface.

Specimen: within the context of the experimental process a specimen is a
Sawbones femur implanted with an Exeter femoral stem.

Stem: See Femoral stem.

Strain Gauge: A filament of fine wire cemented between two sheets of paper or
plastic that is used to measure the strain on the surface of a material.


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Torque rig: A device designed specifically to constrain the femur in a repeatable
position and apply a torque to the specimen via the tapered neck of the implant.

Uncemented (stem): Refers to a stem that has been implanted without in
intermediate layer of polymethyl methacrylate between the stem and the bone.

Valgus: A position of the implant that results in internal or medial rotation of the
leg.

Varus: A position of the implant that results in external or lateral rotation of the
leg.


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Abstract
Total hip arthroplasty (THA) is a successful surgical technique that can be used for
the effective treatment of fractured neck of femur, osteoarthritis, tumours,
avascular necrosis, failed internal fixation, developmental dysplasia and
rheumatoid arthritis. Revision surgery is necessary if loosening allows relative
motion between the femoral stem and femur, causing pain and mechanical
instability of the THA. The large number of revision operations undertaken each
year as a result of implant failure emphasises the need for better biomechanical
understanding of the femoral implant system. During 2001-02 in Australia 26,689
hip replacement operations were performed, with 3,710 of these being revision
operations. The Exeter stem is the most commonly used cemented stem for
primary and revision hip replacement in Australia. It is therefore very important to
understand the mechanics of this clinically successful implant. Few studies have
presented a through investigation into the mechanics of the Exeter stem from a
fundamental perspective.

To address these issues, mechanical and finite element (FE) methods were used to
conduct experiments and numerical investigations into the mechanics of the Exeter
stem. The femur geometry, for both the experimental and FE studies, was based
upon the Sawbones model 3303 medium left third generation femur. The stem
orientation for all specimens of the study was replicated from the orientation
achieved by the senior surgeon implanting into the Sawbones femur. Test rigs
were designed specifically to constrain the femur for the purposes of loading and
stability measurements.

The experimental investigation was used to investigate the torsional mechanical
stability of the stem and to monitor this stability following periods of cyclic
loading, using a resultant hip contact force, while monitoring the distal migration
of the stem. The experimental investigation was also able to provide data for the


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validation of the finite element model. The resultant hip contact force was
represented experimentally by a cyclic load of 1Hz applied to the head of the
implant. The specimen was tested for four days. The loading regime for the
initially implanted specimen involved the application of load for 6 hours a day,
allowing the specimen to relax under no load for 18 hours a day. The mechanical
stability of the initially implanted specimen was tested prior to the application of
the cyclic load and immediately after the loading periods, prior to relaxation.
Further tests were undertaken to assess the mechanical stability of the stem
following the removal and reimplantation of the same stem without the use of
additional bone cement (a procedure used surgically when only the acetabular
component requires replacement). The reimplanted specimens were tested for a
further two days following reimplantation. The six hours of loading for the
reimplanted specimen was achieved using three, two hour loading periods. The
stability of the reimplaned stem was assessed following each loading period.

Initial studies found that the material properties of the Sawbones femurs were
highly temperature dependent. If the temperature of the short glass fibre reinforced
(SGFR) epoxy used for the cortical bone analogue was increased from room
temperature to body temperature there was a reduction in the Youngs modulus of
up to 37 percent. This finding led to further investigation into the strain state of the
femur for varus and neutral stem orientations to reduce femur failure during cyclic
loading. The strains of the varus stem orientation were found to be higher than the
strains of the neutral stem. The experiments investigating the mechanical stability
under cyclic loading continued using the neutral stem orientation.

For the neutral stem orientation it was found that there was no perceivable variation
in the torsional stiffness of the initially implanted system during the cyclic loading
period even though distal migration was observed. Torsional stiffness was
observed to be compromised immediately after reimplantation. However, the
torsional stiffness of the reimplanted specimen was recovered within the first two
hour loading period. No perceivable variation in the torsional stiffness was


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observed between the initially implanted specimens and the reimplanted specimens
following the first two hours of loading.

The finite element model (FEM) found good agreement with the experimental
investigation in terms of measured strain at two of three rosette positions and
failure of the cortical bone. Trends for the stress-strain state of the stem showed
good agreement with the clinical findings of failure and wear of the stem. The
stress-strain state of the cement predicted the expected compressive and hoop
stresses once debonding of the stem-cement interface had progressed. Strain on the
surface of the femur was well predicted for pure torsional loading. The FEM has
provided a valuable tool for future investigation of the effect of factors such as
implant positioning on femoral component mechanics.

The experimental and finite element models developed within the scope of this
project have provided a powerful analysis tool for the investigation of the femoral
component mechanics in THA. Application of the model to clinically relevant
problems has given valuable insight into the mechanisms behind the success of this
particular implant type. Models such as this will provide information on implant
failure modes that will further lead to an increased implant life expectancy and a
reduction in the number of revision operations performed.


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Table of Contents
Keywords ...................................................................................................................................................iii
Glossary....................................................................................................................................................... v
Abstract...................................................................................................................................................... xi
Table of Contents ..................................................................................................................................... xv
Table of Figures...................................................................................................................................... xxv
Statement of Authorship...................................................................................................................... xxxv
Acknowledgments ..............................................................................................................................xxxvii
Nomenclature ...........................................................................................................................................xli
List of Abbreviations..............................................................................................................................xliii
CHAPTER 1 : INTRODUCTION........................................................................1
1.1 Research Aims and Objectives.................................................................................................... 5
CHAPTER 2 : LITERATURE REVIEW..............................................................7
2.1 Anatomical planes and references .............................................................................................. 7
2.2 Anatomy of the hip joint and lower extremity .......................................................................... 8
2.2.1 Bony structure...........................................................................................................................8
2.3 Structure and growth of long bones ......................................................................................... 13
2.4 Mechanical properties of bone.................................................................................................. 17
2.4.1 Cortical Bone..........................................................................................................................23
2.4.2 Cancellous Bone.....................................................................................................................24
2.5 Analogue Bone............................................................................................................................ 29
2.5.1 Use of Analogue femurs in orthopaedic research....................................................................38


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2.6 Failure mechanisms of the femoral stem................................................................................. 39
2.6.1 The Process of Loosening....................................................................................................... 40
2.6.2 Implant motion and wear particle formation.......................................................................... 41
2.6.3 Failure through Infection........................................................................................................ 42
2.6.4 Clinical diagnosis................................................................................................................... 42
2.7 Current concepts of component mechanics of the femoral stem........................................... 49
2.7.1 Stem-cement interface failure................................................................................................. 49
2.7.2 Cement-bone interface............................................................................................................ 51
2.7.3 Cement Creep......................................................................................................................... 51
2.7.4 Stress relaxation of the cement............................................................................................... 52
2.7.5 Dual Implications of Subsidence............................................................................................ 53
2.7.5.1 Taper-slip principle....................................................................................................... 54
2.7.6 Torsional Stability.................................................................................................................. 56
2.8 Exeter implant ........................................................................................................................... 58
2.9 Estimation of the in vivo hip contact force .............................................................................. 59
2.9.1.1 Analytical load determination....................................................................................... 59
2.9.1.2 Direct load measurement (telemetry)............................................................................ 62
2.9.2 Current in vitro loading techniques........................................................................................ 70
2.10 Relationship between stress-strain and bone remodelling..................................................... 72
2.10.1 Stress shielding.................................................................................................................. 74
2.10.2 Strain and the degradation and fatigue of cortical bone..................................................... 74
2.10.3 Clinical implications of bone remodelling following THA ............................................... 75
2.11 The use of FEM to study the femoral component of the total hip arthroplasty................... 76
2.11.1 Model Type........................................................................................................................ 77
2.11.2 Model Generation.............................................................................................................. 78
2.11.3 Material Properties............................................................................................................. 78
2.11.4 Interface modelling............................................................................................................ 80
2.12 Shortcomings of previous FE models....................................................................................... 80
2.13 Conclusions ................................................................................................................................ 82


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CHAPTER 3 : DESIGN OF THE APPARATUS AND PROTOCOLS
FOR THE EXPERIMENTAL INVESTIGATION OF THE IMPLANTED
EXETER STEM................................................................................................85
3.1 Introduction................................................................................................................................ 85
3.2 Experimental Aim and Hypothesis........................................................................................... 86
3.3 Experimental Objectives ........................................................................................................... 87
3.4 Experimental materials ............................................................................................................. 87
3.4.1 Mechanically analogous composite femur..............................................................................88
3.4.2 Stryker Exeter Stem................................................................................................................88
3.5 Design of femoral constraint ..................................................................................................... 88
3.5.1 Reproducibility of the clamping procedure.............................................................................91
3.6 Design of torsional loading rig.................................................................................................. 93
3.6.1 Rigid fixation of the Exeter stem and drilling technique.........................................................94
3.6.2 Exeter position within the Torque arm....................................................................................98
3.6.3 Repeatable implantation procedure.........................................................................................99
3.7 Femoral stem implantation..................................................................................................... 100
3.8 Femur instrumentation ........................................................................................................... 105
3.9 Relative displacement .............................................................................................................. 105
3.9.1 Calibration of the LVDTs.....................................................................................................107
3.10 Strain......................................................................................................................................... 109
3.10.1 Calibration of the strain gauges........................................................................................112
3.11 Specimen loading ..................................................................................................................... 113
3.11.1 Hip contact load...............................................................................................................113
3.11.2 Torsional load...................................................................................................................118
3.12 Data acquisition........................................................................................................................ 119
3.13 Equipment summary ............................................................................................................... 120
3.14 Finite element validation experimentation ............................................................................ 120


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3.14.1 Materials and methods..................................................................................................... 120
3.14.2 Data acquisition for finite element validation.................................................................. 122
3.14.3 Data analysis.................................................................................................................... 122
3.14.4 Results.............................................................................................................................. 123
3.15 Pilot study of the analogue femur/implant system using cyclic loading.............................. 126
3.15.1 Results.............................................................................................................................. 127
3.15.2 Conclusions...................................................................................................................... 128
CHAPTER 4 : THERMO-MECHANICAL INVESTIGATION OF THE
SHORT GLASS FIBRE REINFORCED EPOXY USED AS THE
CORTICAL BONE ANALOGUE IN SAWBONES FEMURS..........................131
4.1 Introduction............................................................................................................................. 131
4.2 Experimental Hypothesis........................................................................................................ 133
4.3 Materials and Methods ........................................................................................................... 133
4.3.1 Four point bending................................................................................................................ 135
4.3.2 Tensile test............................................................................................................................ 138
4.3.3 Fibre content......................................................................................................................... 139
4.4 Results ...................................................................................................................................... 141
4.4.1 Four point bending................................................................................................................ 141
4.4.2 Tensile testing....................................................................................................................... 143
4.4.3 Fibre content......................................................................................................................... 146
4.5 Discussion................................................................................................................................. 147
4.6 Conclusion................................................................................................................................ 148
CHAPTER 5 : STRAIN IN THE PROXIMAL FEMUR: THE EFFECT OF
STEM IMPLANTATION AND POSITION.......................................................151
5.1 Introduction............................................................................................................................. 151
5.2 Experimental Hypothesis........................................................................................................ 152
5.3 Materials and methods............................................................................................................ 153


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5.4 Results....................................................................................................................................... 156
5.4.1 Comparison of the femur strains under static load................................................................156
5.4.2 Macroscopic appearance of the implanted specimens after cyclical loading experiment.....160
5.5 Discussion ................................................................................................................................. 161
5.6 Conclusions............................................................................................................................... 163
CHAPTER 6 : EXPERIMENTAL TESTING OF THE ANALOGUE
FEMUR/IMPLANT SYSTEM...........................................................................165
6.1 Modified Experimental Protocol ............................................................................................ 165
6.2 Stem reimplantation ................................................................................................................ 166
6.3 Experiment using a neutral stem position ............................................................................. 167
6.3.1 Displacement of the specimen under a static load.................................................................168
6.3.2 Subsidence and stress relaxation...........................................................................................169
6.3.3 Distal migration of the head of the implant...........................................................................172
6.3.4 Torsional characteristics of the specimen.............................................................................174
6.3.5 Torsional Stiffness results.....................................................................................................180
6.3.6 Torsional Stiffness and relative motion.................................................................................185
6.3.7 Strain for initially implanted and revision reimplanted specimens under torsion.................186
6.4 Discussion ................................................................................................................................. 189
CHAPTER 7 : DEVELOPMENT OF THE FEM OF THE PROXIMAL
FEMUR WITH IMPLANTED EXETER STEM.................................................193
7.1 Introduction.............................................................................................................................. 193
7.2 CAD model generation ............................................................................................................ 195
7.3 Finite element pre-processor MSC.Patran
TM
........................................................................ 195
7.4 ABAQUS 6.3............................................................................................................................. 196
7.5 Description of the finite element method ............................................................................... 196
7.5.1 Basic finite element equations...............................................................................................197
7.5.2 Convergence..........................................................................................................................197


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7.6 CAD femur model ................................................................................................................... 199
7.7 Model of the Exeter femoral implant and centraliser .......................................................... 208
7.8 Position of the Exeter Stem within the Femur ...................................................................... 209
7.8.1 Relative coordinate system of the in vitro femur and prosthesis.......................................... 214
7.9 The cement mantle .................................................................................................................. 216
7.10 Assembly of the model components ....................................................................................... 217
7.11 Element Type........................................................................................................................... 218
7.12 Mesh Generation ..................................................................................................................... 220
7.12.1 Treatment of contact when meshing................................................................................ 221
7.13 Loads and boundary conditions ............................................................................................. 223
7.13.1 Surface based tie definition.............................................................................................. 223
7.13.2 *FRICTION..................................................................................................................... 225
7.14 Material Properties ................................................................................................................. 226
7.15 Validation................................................................................................................................. 227
7.15.1 Determination of the surface strain.................................................................................. 228
7.15.2 Validation Results............................................................................................................ 231
7.15.3 Three surface contact....................................................................................................... 241
7.15.4 Comparative strain analysis of the final model................................................................ 245
7.16 Model of the proximal femur with a reimplanted stem ....................................................... 248
7.17 Sensitivity analysis of the finite element model..................................................................... 249
7.17.1 Sensitivity results............................................................................................................. 250
7.17.2 Discussion on the sensitivity of the finite element model................................................ 252
7.18 FEM Discussion....................................................................................................................... 252
CHAPTER 8 : FINITE ELEMENT ANALYSIS OF THE PROXIMAL
FEMUR AND THE EXETER STEM................................................................257
8.1 Displacement of the system..................................................................................................... 258
8.1.1 Discussion of the displacement of the system...................................................................... 262


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8.2 Exeter stem............................................................................................................................... 265
8.2.1 Results...................................................................................................................................265
8.2.2 Discussion of the stress-strain state of the Exeter Stem........................................................269
8.3 PMMA bone cement ................................................................................................................ 269
8.3.1 Results...................................................................................................................................270
8.3.2 Discussion of the bone cement stress analysis......................................................................274
8.4 Stem-cement interface ............................................................................................................. 276
8.4.1 Comparison of the stem cement interface for the fixed and reimplanted models.................276
8.4.2 Discussion of the stem-cement interface...............................................................................279
8.5 Cancellous bone........................................................................................................................ 280
8.5.1 Results...................................................................................................................................280
8.5.2 Discussion of the cancellous bone stress analysis.................................................................282
8.6 FEM of the cortical bone......................................................................................................... 283
8.6.1 Results...................................................................................................................................284
8.6.2 Discussion of the stress analysis of the cortical bone............................................................290
8.7 Problem solving with the FEM............................................................................................... 293
8.7.1 Results...................................................................................................................................293
8.7.2 Discussion.............................................................................................................................295
8.8 Discussion of the comparison between the FEMs for the fixed and reimplanted stems .... 295
CHAPTER 9 : USE OF THE FEM TO INVESTIGATE TORSION OF THE
IMPLANTED FEMUR.....................................................................................299
9.1 Boundary conditions for the torsional model ........................................................................ 300
9.2 Comparison of the predicted strain to the experimentally measured strain ...................... 302
9.3 Discussion ................................................................................................................................. 305
CHAPTER 10 : DISCUSSION, RECOMMENDATIONS AND
CONCLUSIONS .............................................................................................307
10.1 Recommendations for future experimental work ................................................................. 310


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10.2 Recommendations for future FEM work.............................................................................. 311
10.3 Conclusions .............................................................................................................................. 312
References............................................................................................................................................... 315
APPENDIX A : PROTOCOL FOR THE SUBSIDENCE AND
ROTATIONAL STABILITY OF THE EXETER FEMORAL HIP
COMPONENT.................................................................................................329
A.1 Nomenclature........................................................................................................................... 329
A.2 Equipment................................................................................................................................ 329
A.3 Loading regimes ...................................................................................................................... 330
A.4 Materials .................................................................................................................................. 332
A.5 Destabilisation protocol .......................................................................................................... 332
A.6 Femoral instrumentation........................................................................................................ 333
A.7 Data acquisition channel allocation ....................................................................................... 334
A.8 Finite Element Validation....................................................................................................... 335
A.9 Torsional stability investigation............................................................................................. 335
APPENDIX B : ELEMENT VERIFICATION...................................................339
B.1 Element verification: Bending................................................................................................ 339
B.1.2 Results.................................................................................................................................. 340
B.1.3 Discussion and Conclusion.................................................................................................. 342
B.2 Element Verification: Contact............................................................................................... 342
B.3 Element Verification: Discussion .......................................................................................... 344


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Table of Figures
Figure 1-1. Flow diagram of the experimental and finite element process......................4
Figure 2-1. Planes of reference. .......................................................................................8
Figure 2-2. Male adult pelvis...........................................................................................9
Figure 2-3. Formation of the pelvic girdle showing the articulation of the hip joint.....10
Figure 2-4. Structure and muscle attachments of the femur. .........................................12
Figure 2-5. Femoral bone structure showing the cortical and cancellous bone
within the head and neck region of the femur. ........................................................13
Figure 2-6. Endochondral ossification of bone..............................................................14
Figure 2-7. Organisational structure of bone. .................................................................15
Figure 2-8. Principal stress trajectories in a cross section of the femur.........................17
Figure 2-9. Mechanical analogue models of viscoelasticity..........................................22
Figure 2-10. Loading curve for a viscoelastic material..................................................23
Figure 2-11. Compressive stress-strain response of the cellular cancellous bone
structure...................................................................................................................27
Figure 2-12. Axial loading with strain gauge position...................................................32
Figure 2-13. Four point bending test with extensor measurement shown. ....................34
Figure 2-14. Torsional loading in modified torsiometer................................................35
Figure 2-15. Medium left second-generation composite femur (3103).........................37
Figure 2-16. Medium left third-generation composite femur (3303).............................38
Figure 2-17. Radiograph showing loosening of the femoral component.......................43
Figure 2-18. Gruen Zones..............................................................................................44
Figure 2-19. Failure through pistoning. .........................................................................45
Figure 2-20. Failure through medial midstem pivot. .....................................................46
Figure 2-21. Failure through calcar pivot. .....................................................................47
Figure 2-22. Failure through cantilever fatigue. ............................................................48
Figure 2-23. Creep of a linear viscoelastic solid............................................................52
Figure 2-24. Stress Relaxation.......................................................................................52
Figure 2-25. The taper slip principal for a force closed system.....................................55


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Figure 2-26. Massive implant........................................................................................ 64
Figure 2-27. Co-ordinate system used by Bergmann et al. (2001) ............................... 67
Figure 2-28. Resultant hip joint force............................................................................ 69
Figure 2-29. Average moment data............................................................................... 69
Figure 2-30. Strain remodelling curve.......................................................................... 73
Figure 3-1. Flow diagram of the experimental and finite element process................... 86
Figure 3-2. Femoral constraint...................................................................................... 90
Figure 3-3. Measuring the error in the positioning of the Sawbones femur into the
femoral clamp......................................................................................................... 92
Figure 3-4. Torque rig with the femur removed to show the implant-torque arm
coupling................................................................................................................... 94
Figure 3-5. Machining and Drilling Clamp................................................................... 95
Figure 3-6. Positioning the Exeter stem for machining the taper in preparation for
rigid fixation and drilling........................................................................................ 96
Figure 3-7. Drilling dimensions for the Exeter stem relative to the machining and
drilling clamp.......................................................................................................... 97
Figure 3-8. Implant position within torque arm............................................................ 98
Figure 3-9. Positioning Block with implant................................................................ 100
Figure 3-10. Resection of the femoral head and neck................................................. 101
Figure 3-11. Preparation of the femur by the orthopaedic surgeon............................. 102
Figure 3-12. Depth position markers used to determine the correct depth of the
implant. ................................................................................................................. 103
Figure 3-13. Implantation of the Exeter stem into the Sawbones femur..................... 104
Figure 3-14. LVDT positioning system shown with the femur removed. .................. 106
Figure 3-15. LVDT measuring ensemble.................................................................... 107
Figure 3-16. Typical Voltage-Displacement relationship for LVDTs........................ 108
Figure 3-17. A. Rectangular rosette orientation and position. .................................... 109
Figure 3-18. Strain rosette positions on the proximal femur....................................... 111
Figure 3-19. Pneumatic loading rig.............................................................................. 114
Figure 3-20. Pneumatic diagram of the loading rig..................................................... 115
Figure 3-21. Experimental set up for calibration of the pneumatic actuator............... 116


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Figure 3-22. Force-Voltage relationship for the pneumatic actuator measured using
the pressure transducer. .........................................................................................117
Figure 3-23. Testing environment. Inlet and exhaust are highlighted. .......................118
Figure 3-24. Typical strain output for the Sawbones femur.........................................123
Figure 3-25. Typical strain analysis at the first rosette................................................124
Figure 3-26. Calculated Principal strains of the Sawbones femurs at rosette
position one............................................................................................................125
Figure 3-27. Failure of the femur under 24 hour cyclic loading at 650N....................128
Figure 4-1. Flow diagram of the experimental and finite element process..................132
Figure 4-2. Schematic diagram of the femur showing the two sections made to
obtain the specimens and the initial cuts made to form the test specimens using
anterior, posterior, medial and lateral quadrants. ..................................................134
Figure 4-3. Four point bending load diagram. .............................................................135
Figure 4-4. Tensile test specimen geometry. ...............................................................138
Figure 4-5. Tensile testing of the SGFR samples........................................................139
Figure 4-6. Stress-Strain relationship for the SGFR at room and body temperature...142
Figure 4-7. Stress-Strain response of the tensile specimens at the two temperatures..144
Figure 4-8. Microscopic images of the fracture surface of the tensile specimens
(40 magnification). ..............................................................................................144
Figure 5-2. Neutrally implanted Exeter stem shown with implant positioning
device.....................................................................................................................154
Figure 5-3. Radiographs showing the position of the implant in the coronal plane. ...155
Figure 5-4. Experimental strains at the first rosette position for the native femur
group and the neutral and varus stem positions....................................................157
Figure 5-5. Experimental strains at the second rosette position for the native femur
group and the neutral and varus stem positions....................................................158
Figure 5-6. Experimental strains at the third rosette position (medial calcar) for the
native femur group and the neutral and varus stem positions..............................160


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Figure 6-2. Block diagram of the experimental procedure showing the times
allocated to each period of loading and relaxation................................................ 168
Figure 6-3. Components of the specimen displacement.............................................. 169
Figure 6-4. Relative position of the implant, head of the implant, bearing plate and
actuator.................................................................................................................. 170
Figure 6-5. Displacement of the head of the implant immediately after the removal
of the load.............................................................................................................. 171
Figure 6-6. Distal migration of the head of the implant including the elastic and
viscoelastic components of displacement. ............................................................ 173
Figure 6-7. Distal migration of the stem over the 4 days of loading with the slip
component removed from the system. .................................................................. 173
Figure 6-8. Typical experimental result for a stable implant under torsion................ 175
Figure 6-9. Torque-rotation diagram without a specimen........................................... 176
Figure 6-10. Torque-rotation diagram showing the effect of the frictional torque. .... 177
Figure 6-11. Schematic of the torsional rig showing the problematic cap head
screw position. ...................................................................................................... 178
Figure 6-12. Torque-rotation diagram showing the effect of the tension in the base
plate screw............................................................................................................. 179
Figure 6-13. Torsional stiffness of the initially implanted stem as a function of the
number of applied loading cycles measured immediately after loading............... 182
Figure 6-14. Torsional stiffness of the stem as a function of the number of applied
loading cycles measured after relaxation.............................................................. 183
Figure 6-15. Torque rotation diagram of a specimen immediately following
reimplantation. ...................................................................................................... 184
Figure 6-16. Relative rotation of the implant relative to the femur............................. 186
Figure 6-17. Principal strain measured at all rosette locations for the first two
cycles of torsional loading. ................................................................................... 187
Figure 6-18. Strain-time plot showing the corresponding points in time on the
torque rotation diagram......................................................................................... 188
Figure 7-1. Flow diagram of the experimental and finite element process................. 194
Figure 7-2. Femur Geometry obtained from BEL....................................................... 199


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Figure 7-3. Polygon Mesh of the proximal CAD femur..............................................201
Figure 7-4. Overlapping patches of the femur before and after alignment..................202
Figure 7-5. Master and slave surface definitions for the trimming process.................203
Figure 7-6. Unified shell at the trim line......................................................................204
Figure 7-7. NURBS patches generated from the equivalenced surface polygon
mesh.......................................................................................................................204
Figure 7-8. Final femur showing a transparent cortical section and a solid
cancellous section..................................................................................................205
Figure 7-9. Resection of the CAD femur.....................................................................206
Figure 7-10. CAD model of the cancellous bone.........................................................207
Figure 7-11. Comparison between the original model of the Exeter stem and the
reconstruction. .......................................................................................................208
Figure 7-12. Centralisers..............................................................................................209
Figure 7-13. Relative position of the Exeter implant and the centraliser.....................210
Figure 7-14. Radiographs of the experimental system detailing the position of the
implant with respect to the bone............................................................................212
Figure 7-15. Angle of anteversion taken with respect to the posterior condylar axis..213
Figure 7-16. Measurement of the stem tip position. ....................................................214
Figure 7-17. Coordinate system of the left femur and implant....................................215
Figure 7-18. Cement mantle.........................................................................................216
Figure 7-19. Assembled model of the proximal femur and the cemented Exeter
37.5mm offset number 1 stem. ..............................................................................218
Figure 7-20. Solid elements used for stress/displacement analysis. (modified from
ABAQUS Standard Users Manual Section 14.1.4)..............................................219
Figure 7-21. Triangular and tetrahedral elements showing nodes (dots) and
integration points (crosses)....................................................................................221
Figure 7-22. Model meshed with 3, 2 and 1.5mm element lengths (not to scale).......222
Figure 7-23. Boundary conditions of the model. .........................................................224
Figure 7-24. Element based tied contact definition showing the effect of the adjust
parameter on the slave nodes.................................................................................225
Figure 7-25. Strain rosette locations relative to the NURBS surfaces of the femur....228


xxx
Figure 7-26. Node surface unit, with a central node and six surrounding nodes. ....... 229
Figure 7-27. Node Surface Units of the rosette node and the six surrounding nodes. 229
Figure 7-28. Strain results from the finite element model........................................... 230
Figure 7-29. Strain predictions for all models at the first rosette position.................. 233
Figure 7-30. Predicted strain vectors at the first rosette for the Lower-bound 2mm
element length model............................................................................................ 234
Figure 7-31. Strain predictions for all models at the second rosette position. ............ 236
Figure 7-32. Predicted strain vectors at the second rosette position for the Lower-
bound 2mm element length model........................................................................ 237
Figure 7-33. Strain predictions for all models at the third strain rosette..................... 239
Figure 7-34. Predicted strain vectors at the third strain rosette for the Lower-bound
2mm element length model................................................................................... 240
Figure 7-35. Von Mises stress of the cancellous bone................................................ 241
Figure 7-36. Strains from the lower bound Youngs modulus models at the first
rosette position...................................................................................................... 244
Figure 7-37. Strains from the lower bound Youngs modulus models at the second
rosette position...................................................................................................... 244
Figure 7-38. Strains from the lower bound Youngs modulus models at the third
rosette.................................................................................................................... 245
Figure 7-39. Linear regression of the strain without removing outliers...................... 246
Figure 7-40. Linear regression of the experimental and predicted strain.................... 247
Figure 7-41. A comparison of experimental and FEA strain values at the rosette
locations. ............................................................................................................... 248
Figure 8-1. Flow diagram of the experimental and finite element process................. 258
Figure 8-2. Displacement of the proximal femur under load...................................... 259
Figure 8-3. Displacement of the Exeter stem in the Y-direction................................. 261
Figure 8-4. Displacement of the cancellous bone under anatomical loading.............. 263
Figure 8-5. Von Mises stress of the Exeter stem......................................................... 266
Figure 8-6. Von Mises stresses for the medial and lateral edges along the length of
the stem for the fixed and reimplanted cases. ....................................................... 267


xxxi
Figure 8-7. Strain along the length of the Exeter stem for the fixed and reimplanted
stems. .....................................................................................................................268
Figure 8-8. Von Mises stress of the cement section.....................................................271
Figure 8-9. Von Mises stresses on the internal surface of the cement mantle.............272
Figure 8-10. Vector diagram of the principal stresses within a slice of the cement
mantle for the fixed model.....................................................................................273
Figure 8-11. Vector diagram of the principal stresses within a slice of the cement
mantle for the reimplanted model..........................................................................274
Figure 8-12. COPEN for the fixed and reimplanted stems..........................................277
Figure 8-13. COPEN of the stem cement interface for the reimplanted model...........278
Figure 8-14. Pressure at the interface for the fixed and reimplanted stem models......279
Figure 8-15. Von Mises stress of the cancellous bone under anatomical loading.......281
Figure 8-16. Cancellous-cortical interface of the cancellous bone for the fixed
model (A) and the reimplanted model (B). Contour legend in (Pa). ....................282
Figure 8-17. Von Mises stress of the cortical bone for the secure stem. .....................284
Figure 8-18. Typical failure of the SGFR epoxy of the Sawbones femurs after 24-
48 hours of loading with an Exeter stem implanted in a varus position................285
Figure 8-19. Cross sections of the cortical bone used to investigate the principal
stresses of the modelled cortical bone...................................................................286
Figure 8-20. Principal stresses of the distal cortical slice............................................287
Figure 8-21. Principal stresses of the mid-cortical slice..............................................288
Figure 8-22. Principal stresses of the proximal cortical slice. ......................................288
Figure 8-23. Strain of the fixed and reimplanted stem geometries measured along a
medial and lateral path...........................................................................................290
Figure 8-24. Von Mises stress for the secure and reimplanted stem geometries.........291
Figure 8-25. Body temperature results for four-point bending of the SGFR epoxy....292
Figure 8-26. Slice of the proximal section of the femur including the cement and
the cortical and cancellous bones...........................................................................294
Figure 9-2. Boundary conditions of the torsional model. ............................................301


xxxii
Figure 9-3. Principal strains of the torsional model compared to the normalised
experimental strains. ............................................................................................. 303
Figure 9-4. Principal angles of the torsional model compared to the experimental
principal angles. .................................................................................................... 303
Figure 9-5. Linear regression of the experimental and predicted strains for a
torsional load case................................................................................................. 305


xxxiii


xxxiv


xxxv
Statement of Authorship

The work contained in this thesis has not been previously submitted for a degree
or diploma at any other higher education institution. To the best of my knowledge
and belief, the thesis contains no material previously published or written by
another person except where due reference is made

Signed: ..
Cameron Gordon Bell

Date: ..


xxxvi


xxxvii
Acknowledgments
This is the section where the student generally says all nice things to the
supervisory team and they all walk away with warm fuzzy feelings in their
academically inclined persons. From my secondary school days the motto of in
balance we grow was calmly provided to my young and impressionable mind. I
would like to think that studying under the Super Professor that this motto and way
of life has been reinforced.

My thanks go to Mark Pearcy. Mark has been a constant source of calm
throughout the years that he has supervised me. It has been a very enjoyable time
working with you especially when we see eye to eye. Thank-you Mark for your
silent persistence and determination in trying to ensure that I found the ideas and
answers on my own, when you reminded me in no small way of Gandalf on the
bridge of Khazad Dum; you would not budge. To Ross, without whom I would
have been unable to undertaken this project. You had the knack of knowing the
opportune moment to place a well timed and appropriately aimed kick with the
pointy end of your polished RM Williams. For this, strangely enough, I am
appreciative. Thanks also to Clayton the master of FEA and the host of my other
supervisors for giving me your time throughout the years.

Computational and Data Visualisation resources and services used in this work
were provided by the HPC and Research Support Group, Queensland University of
Technology, Brisbane, Australia. That means a big thanks to Mark Barry, who has
always been patient with me, even when I cause the Super Computer to crash.

Thanks also go Stryker Howmedica for providing financial aid to obtain equipment
and consumables and to the Faculty of Built Environment and Engineering QUT
for giving me pocket money!


xxxviii
There was a ridiculous amount of manufacturing involved with this project and I
would like to thank Terry, Wayne and J ohono for all of their help, in both
manufacturing and sample preparation.

On a personal note I would like to thank the crazy people of the old CRSE and the
OBIEE. You formed the basis of all that was post graduate university. mr oCean
(the old CRSE representative), who has been a great friend for many years without
whom I would never have realised that madness can be voluntary and that its best
to go willingly rather than kicking and screaming. My room mate and fellow
conspirator, Lance. Youre a top bloke who, when you stop blowing things up, can
be very helpful with basically any engineering problem be it in the field of
tribology or medical engineering. Your help and patience with me over the years
has been nothing if not Herculean, thank-you. And to Patrick. You have given me
great insight into clinical orthopaedics; youre a top bloke (just like Boony) and a
great friend. Not only that but you have provided me with whats required when
dealing with all that is the rich tapestry of life.

And last but certainly not least my family. Mum, Dad and Kate have always been
there for me, whether its Mum and her cooking or Kate picking me up in The
Back of Bourke after getting two consecutive punctures while I was trying to ride
away from this thesis.

Most of all I would like to thank my Becca for being the love of my life and the
most beautiful lady in the entire world. You have provided me with all of the
encouragement that I needed to keep going. You have never doubted my ability to
finish this thesis even when I wanted to throw it out the window. There you are
darling, its in the book!


xxxix


xl


xli
Nomenclature
E =Youngs Modulus
f
=Coefficient of friction
=micro (10
-6
)
n
= Strain (the subscript indicates the component direction of the strain in
either the x, y or z directions)
n
= Shear strain (the subscript indicates the component direction of the shear
strain in either the x, y or z directions)
n
= Stress (the subscript indicates the component direction of the stress in
either the x, y or z directions)
n
= Shear stress (the subscript indicates the component direction of the shear
stress in either the x, y or z directions)
p
= Principal direction


xlii


xliii
List of Abbreviations
BW Body weight
FE Finite element
FEM Finite element model
kPa Kilopascal
LVDT(s) Linear variable differential transducer(s)
MPa Megapascal
PMMA Poly Methyl Methacrylate
THA Total hip arthroplasty
SGFR Short glass fibre reinforced
NURBS Non-Uniform Rational B-Spline
COPEN Distance between the slave node and the master surface within the
ABAQUS contact definition.
BEL Biomechanics European Laboratory


xliv


Chapter 1: Introduction
1
Total hip arthroplasty (THA) is a common surgical procedure for the treatment of
fractured neck of femur, osteoarthritis, tumours, avascular necrosis, failed internal
fixation, developmental dysplasia and rheumatoid arthritis (Australian Orthopaedic
Association 2003). During 2001-02 in Australia 26,689 hip replacement operations
were performed, with 3,710 of these being revision operations. Revision surgery is
necessary if loosening allows relative motion of the implant stem and femur,
causing pain and mechanical instability of the THA. The large number of revision
operations undertaken each year as a result of implant failure emphasises the need
for accurate diagnostic techniques to assess the condition of the prosthesis in vivo
and also the need for better biomechanical understanding of the femoral implant
system.

The existing, clinically successful Exeter stem was chosen for this work as a
functional polished double taper design. These stems are believed to be able to
stabilise via the self limiting mechanism of subsidence, effectively wedging the
stem within the cement mantle.

Subsidence is often used for clinically assessing the likelihood of femoral
component failure of the total hip arthroplasty. This research investigates the
supposition that subsidence should not be used as a failure criterion for all implant
geometries. Polished implants based on the taper slip principal such as the Exeter
implant are designed to subside in the belief that the implant will become more
stable with subsidence. An indicator of failure cannot be applied to all implant


2
types, as the geometry of the implant will determine if subsidence will in fact
detrimentally affect the stability of the implant. A review of literature covering the
fundamentals of the current concepts of femoral component mechanics, bony
anatomy of the hip, mechanical properties of bone and bone analogues, failure
mechanisms of the component, contact force definition and finite element models
(FEMs) in orthopaedics is presented in Chapter 2.

The aim of this research was to develop a FEM and experimental test protocol for a
cemented total hip replacement stem for the purpose of investigating the mechanics
of a polished double tapered stem design. An experimental protocol and testing
equipment were specifically designed to investigate the mechanics of the Exeter
stem. A description of the experimental equipment and protocol is given in
Chapter 3.

An initial pilot study was used to commission the equipment and protocol. During
this stage higher than expected strain was measured and repeated failure of the
femur specimens was observed. The results of the pilot study led to a study of the
mechanical properties of the short glass fibre reinforced (SGFR) epoxy used as the
cortical bone analogue in the Sawbones femurs, which is presented in Chapter 4.
The material properties of the SGFR epoxy used in the Sawbones femurs were
found to be highly dependent on temperature. The Youngs modulus of the SGFR
epoxy was found to decrease with a rise in temperature from room to body
temperature. This finding prompted further investigation to determine how femoral
failure of the specimens could be reduced or eliminated from the experimental
process.

To investigate the failiure of the specimens a study of strains in the proximal femur
for varying stem orientation was undertaken. An assessment of the stem
orientation found that the stem position of the failed specimens was slightly varus.
It was decided to examine the variation in strain between varus and neutral stem
orientations. Static resultant hip contact forces were used and the strain was


3
measured for the varus and neutral stem orientations. It was found that the strains
of the varus stem were higher than the strains of the neutral stem, and that this
increase in strain was the likely cause of the failure of the varus specimens.
Alteration of the stem orientation to the neutral position was found to reduce the
incidence of femoral failure. A full description of the investigation into the strain
of the proximal femur is presented in Chapter 5.

The information obtained from the studies carried out in Chapters 4 and 5 enabled
the experimental investigation to continue. A full description of the experimental
investigation is presented in Chapter 6.

The geometry of the finite element model was based upon the varus orientation of
the implant. The femur model obtained from the Biomechanics European
Laboratory (BEL) Repository (Papini 2003) was not able to be meshed and was
corrected to allow meshing by tetrahedral elements. The material properties for the
model were based on values obtained from current literature and manufacturer data.
The model was validated in terms of the mesh density and in variations in the
material properties of the SGFR epoxy based upon the results of the investigation
carried out in Chapter 4. A sensitivity analysis was then undertaken by varying the
material properties of the cancellous bone, bone cement and the stem-cement
interface coefficient of friction. A full description of the development and
validation of the FEM is provided in Chapter 7.

An analysis of the mechanics of the Exeter femoral component for the fixed and
reimplanted conditions is presented in Chapter 8, followed by further comparison
of experimental and predicted results for a torsional load case, presented in Chapter
9.

Finally, Chapter 10 summarises the findings of the research, presents the
conclusions and recommendations and discusses the possible directions of future
work.


4
A flow chart showing the structure of the research is presented in Figure 1-1
(Excluding the literature review Figure 1-1 is reproduced at the beginning of each
chapter highlighting the appropriate sections under consideration).
Experimental
finite element
validation
Experimental
finite element
validation
Finite element
model material
property definition
Implantation of the Exeter stem (Varus)
Validated finite
element model
Femur failure (3
Experiments)
Anatomical
loading protocol
Pilot study using
Anatomical
loading protocol
Finite element model
geometry
Neutral stem
position
Investigation using
the finite element
model
Anatomical
loading protocol
Destabilisation
protocol
Experimental
results for
torsional stability
and stem
migration
Material
properties
investigation
Redefine
anatomical
loading protocol

Figure 1-1. Flow diagram of the experimental and finite element process
The varus stem geometry was the initial geometry. The stem was 4.6 varus and believed to be
indicative of clinical practice. The geometry of the finite element model was based upon x-rays
of the 4.6 varus stem. Investigation into the material properties of the cortical bone material
occurred as a result of the consistent failure of the femurs. The neutral stem (0.30.1) was used
after consideration of the material properties and the loading protocol. Data were collected for
future work. A finite element model of the straight stem geometry was not produced.


5
1.1 Research Aims and Objectives
The aim of this research project was to investigate the mechanics of the cemented
Exeter stem under the conditions of initial primary implantation and after a process
of revision reimplantation. Revision reimplantation is a technique involving the
removal and subsequent replacement of the femoral stem in the existing cement
mantle to facilitate better access to the cup during acetabular revision.
The objectives of this research were to:
a. Design and develop a laboratory experiment to better understand the
femoral component mechanics of the Exeter total hip arthroplasty.
b. Use the experimental system to investigate how the stability of the system
changes during periods of loading following initial primary implantation
and revision reimplantation.
c. Generate a preliminary three-dimensional finite element model of the
proximal femur and the femoral component incorporating a high level of
geometric detail.
d. Develop a thorough understanding of the material properties of the
experimental system, for the purposes of validating the model.
e. Subsequently develop a fully validated finite element model of the proximal
femur and the femoral component.
f. Use the finite element model to simulate the secure and revision
reimplanted conditions of the femoral component and to observe the
variation in the mechanics between the two systems by investigating the
stresses and strains within the stem, cement and cancellous and cortical
bones.


6


Chapter 2: Literature Review
7
The bony structures of the hip are presented to give an overview of the geometry of
the system that is being investigated. The muscular anatomy is not presented
because although responsible for the generation of forces in the hip in vivo, they are
not a subject of this thesis. Current standard practices for investigation of the
femoral component mechanics are presented from the materials and methods of
experimentation to the current concepts in femoral component mechanics. The
materials of the system are presented in terms of both their mechanical and
mechanobiological properties. Finally, finite element modelling techniques are
described to present a starting point for the current body of work.

2.1 Anatomical planes and references
The three orthogonal planes of reference used to describe regions of interest in the
body are the; sagittal (mid-sagittal is the middle sagittal plane), coronal (or frontal)
and the transverse planes (Figure 2-1).
The relative positions of regions of the body are often given in terms of location with
respect to the trunk. Proximal and distal refer to regions of interest towards the trunk
and away from the trunk respectively. Medial and lateral refer to regions of interest
towards the centre of the body and away from the centre towards the periphery of the
body respectively. Anterior and posterior refer to regions towards the front of the
body and the back of the body respectively.


8
Figure 2-1. Planes of reference.
(Van De Graaff 1995)

2.2 Anatomy of the hip joint and lower extremity
The pelvic girdle and lower extremity provide stability for stance and bipedal
locomotion. The muscles and bones in this region are some of the most massive
structures in the body; for instance the femur is the longest bone in the body, and the
quadriceps muscles are some of the largest muscles in the body (Van De Graaff
1995).

2.2.1 Bony structure

The pelvic girdle or pelvis is a bony structure that is formed by two ossa coxae or hip
bones (Figure 2-2). The ossa coxae is a single bone formed by the fusion of three
smaller bones, the ilium, the ischium, and the pubis (Figure 2-2). The ilium (the
largest of the three bones), ischium and pubis will fuse, generally by adulthood,
though it is still common to refer to the ilium, ischium and pubis in adults.
This figure is not available online.
Please consult the hard copy thesis
available from the QUT library.


9
Figure 2-2. Male adult pelvis.
(Modified from Gray 1977)

The three bones of the pelvis meet at a concave structure where the head of the femur
articulates with the pelvis, called the acetabulum (Figure 2-2). The two ossa coxae
join to form the pelvis at the symphysis pubis, the sacrum and the vertebral column
(Figure 2-3). The structures of interest to this research are those involved with the
articulation of the femur and the acetabulum and also the structure of the iliac crest.



10

Figure 2-3. Formation of the pelvic girdle showing the articulation of the hip
joint.

The hip joint is a synovial ball and socket joint offering large rotations (Figure 2-3);
the ball of the joint is provided by the head of the femur and the socket of the joint is
provided by the acetabulum. The ligaments that support the joint are the anterior
iliofemoral, pubofemoral and ischiofemoral ligaments. These ligaments form the
capsular ligament of the hip joint, the nomenclature of the ligaments are related to
the origin and insertion of the ligament (for instance the ischiofemoral ligament
originates at the ischium and inserts at the femur).



11
The head of the femur is capped with articular cartilage where the femur interacts
with the acetabulum (Figure 2-4). The cartilage of the head of the femur possesses a
roughened indentation or depression for the ligamentum teres, which supports the
head of the femur against the acetabulum (Van De Graaff 1995). The neck of the
femur connects the head and the shaft. The angle of the neck varies with the age and
sex of a person, but for the most part possesses an angle with the shaft of
approximately 125 degrees. The neck of the femur is a common site for fractures in
the elderly. The trochanters (greater and lesser) provide sites for muscle attachment
providing the muscles with additional mechanical advantage. The greater trochanter
is situated at the junction of the neck and the shaft on the proximo-lateral side of the
femur. The lesser trochanter is found on the medial side of the femur, distal to the
greater trochanter. The intertrochanteric line, comprising of the anterior
intertrochanteric line (or spiral line) and the posterior intertrochanteric line, joins the
two trochanters. A ridge, called the intertrochanteric crest, is often present on the
posterior intertrochanteric line for the attachment of several muscles. The medial
and lateral condyles at the distal end of the femur allow articulation with the tibia to
form the knee joint. The medial and lateral epicondyles are bony protuberances that
form sites for tendon and ligament attachment.

The femur is typical of long bones in structure. The superficial bone of the femur is
cortical bone (compact bone), and the internal bone is known as cancellous bone
(spongy bone). Figure 2-5 shows the cancellous and cortical bone types at the head
of the femur. The structure of bone is considered in more detail in section 2.3:
Structure and growth of long bone.


12

Figure 2-4. Structure and muscle attachments of the femur.



13

Figure 2-5. Femoral bone structure showing the cortical and cancellous bone
within the head and neck region of the femur.
(Modified from Van De Graaff 1995)

2.3 Structure and growth of long bones
Long bones grow through a process of endochondral ossification (Figure 2-6). The
initial cartilage state of the long bone is gradually replaced as chondrocytes deposit
minerals within the cartilage matrix in a process known as calcification. The
periosteal bone collar is the first region of bone to form; this region expands to form
the primary ossification centre. Secondary ossification centres are then formed at the
proximal and distal epicondyles leaving a region of cartilage between the primary
and secondary ossification centres. The bone then gradually increases in length at
the epiphysial plates until the epiphysial plate itself ossifies. Ossification age of the
epiphysial plate varies but generally occurs between 18-20 years (Van De Graaff
1995).



14

Figure 2-6. Endochondral ossification of bone.
(Modified from Van De Graaff 1995)

This combination of the cortical and cancellous bone tissue allows the structure of
the long bone to possess a very good strength to weight ratio (Van De Graaff 1995).
Rho et al. (1998) have defined five levels of structure within the bone. The levels
proposed are: (1) macrostructure: cancellous and cortical bone; (2) microstructure
(from 10 to 500 m): Haversian systems, osteons, single trabeculae; (3) the sub-
microstructure (1-10 m): lamellae; (4) the nanostructure (from a few hundred
nanometres to 1 m): fibrillar collagen and embedded mineral; (5) the sub
nanostructure (below a few hundred nanometres): molecular structure of constituent
elements such as mineral, collagen, and non-collagenous organic proteins (Figure
2-7). The research presented within this thesis focuses on bone in the macrostructure
level in all instances, however bone mechanical properties are at times defined with
reference to their microstructure.



15
Figure 2-7. Organisational structure of bone.
(a) Cortical and cancellous bone; (b) osteons with Haversian systems; (c) lamellae; (d) collagen fibre
assemblies of collagen fibrils; (e) bone mineral crystals, collagen molecules, and non-collagenous
proteins.
(Rho et al. 1998).

Bone as a dynamic viscoelastic material
The structure of bone is not static. The current trend in bone modelling and
remodelling is that the bone responds to mechanical stimulus, the study of this field
has become known as mechanobiology. As stated in a recent paper presented by van
der Meulen and Huiskes (2002) mechanobiology is based upon the belief that
biological processes are regulated by the signals sent to cells as a result of
mechanical stimulus. This is of particular interest for understanding the response of
bone to interventions such as skeletal implants. The study of the theory of bone
adaptation to mechanical stimulus can be found in many papers over the last 20
years. The dynamic nature of the structure of bone and the current attempts to
understand the response of bone to external mechanical stimulus is described further
in section 2.10 Relationship between stress-strain and bone remodelling.



16
Intrinsic structure of the two bone types
The intrinsic composition of cortical and cancellous bones are almost the same, with
the organic matrix making up 35% of the wet bone, calcium compounds making up
about 45% and the water the remaining 20% (Carter and Spengler 1978). In a
review of the mechanical properties of bone, Rho et al. (1998) believe that the
variation in the properties of the bone types can be expressed in terms of the different
levels of metabolic activity of the bone. Cancellous bone is more active than cortical
bone and is therefore younger; the variation in material properties was attributed to
the age of the bone. The densities of cortical and cancellous bone are also very
similar at a fundamental level, with the density of cortical bone reported to be within
1800-2000 kg/m
3
(Carter and Hayes 1977) and the density of an individual trabecula
of cancellous bone averaging 1820 kg/m
3
(Galanteet al. 1970).

Cortical bone
The external cortical bone is a dense, hard bone that is formed by osteons. The
osteon is constructed of concentric rings or lamellae with a central canal containing
nutrient vessels and a nerve (Van De Graaff 1995). Osteocytes (bone forming cells)
are also found on the osteon within spaces called lacunae. Nutrients are able to
diffuse between the lacunae through canaliculi.

Cancellous bone
Cancellous bone (trabecular bone) is the bone type found in the internal region of the
femur. The cancellous bone is constructed of trabeculae, which form a lattice
structure of a density lower than the cortical bone. Cancellous bone is technically
defined as being any section of bone that has a relative density lower than 0.7
(Gibson and Ashby 1997). The architecture of cancellous bone is similar to
engineering cellular solids with the architecture varying with the anatomic location
(Keaveny and Hayes 1993). The structure of cancellous bone varies with density; at
low densities the structure is predominantly rod like, and as the density increases the
structure becomes more plate like (Gibson and Ashby 1997). The density of
cancellous bone is also highly correlated with the magnitude of the load that the bone
is subjected to.


17

The principal stresses are nearly equal in the femoral neck (Gibson and Ashby 1997).
Given that cancellous bone structurally adapts according to the stress state, the
structure and geometry of the cancellous bone in the region of the femoral neck
approaches a uniform structure. Figure 2-8 shows the principal stress trajectories
proposed by Thompson (1992). It should be noted that the pattern of the stress
trajectories shown here is similar to the structure of the cancellous bone (Gibson and
Ashby 1997).

Figure 2-8. Principal stress
trajectories in a cross section of
the femur.
(Thompson and Bonner 1992)

2.4 Mechanical properties of bone
As far as the author is aware there are no standardised tests for the determination of
the mechanical properties of bone. Reilly et al. (1974) attest that the experimentally



18
determined properties of bone tissue can be used to support or contradict various
hypotheses as a result of the absence of standardisation of experimental methods.
Common test types for determining the mechanical properties of bone include
mechanical (three point bending, buckling, tensile and compressive), ultrasound and
finite element analysis. The test type used will influence the value of the material
properties obtained. Variations in material properties can also occur within a specific
test type with the variations being regarded as a function of specimen origin (the
anatomical location from which the specimen was obtained), specimen structure,
specimen test geometry, specimen orientation, age of donor, degree of
mineralisation, test protocol, strain rate, specimen preparation (wet or dry), specimen
storage, storage temperature, physical characteristics (porosity, density and ash
content) and consideration of end effects (particularly for cancellous bone).

Important definitions
It is important to define the structural properties and the material properties of bone
as being distinctly different. The structural properties of the bone refer to the whole
bone properties, while the material properties refer to specific bone segments; in the
case of cortical bone, a machined section of the cortex; in the case of cancellous bone
isolated trabeculae. For cancellous bone the structural properties can be extended to
include the properties of a section of the bone including the trabeculae and pores.
Structural properties are important for global stress analysis, while material
properties are important for characterising various bone pathologies, microlevel
stress analyses and bone adaptation around implants (Rho et al. 1998). An
investigation into the likelihood of fracture of bones between old and young animals
is given by Currey (1970) to explain the hierarchical nature of the properties of bone.
Currey (1970) suggests that initially the whole bone could be used to ascertain that
the load required to cause fracture of the old bone is lower than the load for fracture
of the young bone. Even though the fracture load is now known the quality of the
bone specimens still remains unknown. The reasons for the variation in fracture load
need to be further investigated; this can initially be carried out by examining the
geometry of the specimens. Intuitively the geometry of the older bone may possess
thinner wall thickness in the cortical bone. If the reason for the variation in the test


19
pieces is still not determined then the testing of samples taken from each specimen
would need to be undertaken in an attempt to determine why there are differences in
the fracture load of the bone types at the fundamental level of the specimen material
properties. The level of bone properties used for any investigation is dependent on
the level of the problem being investigated. Relating this to the test methods outlined
earlier, investigations conducted mechanically will tend to present the structural
properties, while the investigations carried out using finite element analysis or
ultrasound will be more representative of the material properties.

The material properties of bone can be considered to be both anisotropic and
heterogeneous, however Ashman et al. (1984) observed that few studies have
investigated the degree of anisotropy of bone, nor have they attempted to determine
the elastic properties of the bone as a function of anatomical position. The reasons
suggested for this are that the traditional mechanical tests applied to engineering
materials are not directly applicable to bone. For instance, the dimensions of bone
are such that the specimen size of the bone must be small. The heterogeneity of the
bone requires that the specimen be small in order to obtain properties as close to
uniform (and as close to an engineering material) as possible. Ashman et al. (1984)
also mentions that at most four elastic coefficients can be extracted from a single
specimen of bone: the Youngs modulus and the two Poissons ratio can be obtained
from a tensile test, and if the cross section is circular then with the use of a torsion
test, the shear modulus can be determined, presumably for cortical bone specimens
only. Since there are 12 elastic coefficients for an orthotropic material three
specimens would need to be used to characterise the bone material. This raises the
issue that it is impossible to obtain three specimens of bone that contain the same
mechanical properties, on account of the fact that the three specimens cannot be
obtained from the same sample of bone. This makes it impossible to measure the
anisotropic material properties of bone at a point using traditional engineering testing
methods.


20
Two other methods are available that do not rely on mechanical testing that can be
used to determine the mechanical properties of bone; ultrasound and finite element
analysis.

Ultrasound
Ultrasound is a technique that uses the speed of a high frequency ultrasonic wave to
determine the Youngs Modulus of a material. Ultrasound does not have the
problems associated with mechanical testing and possesses the advantage that
smaller sample sizes with simple geometries are acceptable (Gibson and Ashby
1997). Limitations of this technique include the influence of the structural
properties on the material properties obtained and that the length that the wave
travels is not actually known.

Finite element analysis
When using finite element analysis a clear distinction can be made between the
apparent Youngs modulus and the effective tissue level modulus (Bayraktar et al.
2004). The apparent modulus is the modulus determined from the mechanical test;
the effective tissue level modulus is the modulus of the trabecular tissue itself, in this
case determined using iterative finite element techniques.

Relating the elastic constants to non-destructive test data
The use of non destructive testing to determine the material properties of bone (when
bone is considered to be a two phase porous material) was presented by Carter and
Hayes (1977) who developed what is now a well known equation for the
determination of the modulus and strength of bone as a function of the apparent
density given by Equations 2-1 and 2-2.

0.06
3
3,790 E
=
2-1

0.06
2
68 S
=
2-2


21
Where:
E =Compressive modulus (MPa)
S =Compressive strength (MPa)
=Strain rate (s
-1
)
=Apparent density (g/cm
3
)

These equations were based on the assumption that bone can be considered as a
composite structure consisting of a solid and fluid phase where the solid phase can be
considered to be a single material that can be defined in terms of density.

Interpretation of results using the various methods
The material properties determined using methods such as ultrasound and four point
bending are based upon different fundamental theories. For instance, ultrasound is
based upon wave speed theory within a medium; whereas four point bending is based
on classical stress analysis theory. The applicability of any materials testing theory
to bone should be considered in conjunction with the result. A comparison of
material properties using various testing methods can be undertaken so long as the
test method used is specified.

Viscous nature of bone
Bone is viscoelastic. This means that during a cycle of loading and unloading the
system of the bone being investigated will absorb energy (a non-conservative
system). Mechanical analogues for viscoelasticity include springs and dashpots to
represent the elastic (Figure 2-9 A) and viscoelastic (Figure 2-9 B) elements
respectively.


22

Figure 2-9. Mechanical analogue models of viscoelasticity.
A. Pure elastic; B. Pure viscous; C. Maxwell model; D. Kelvin-Voigt model.

If a spring-dashpot model is loaded cyclically energy will be absorbed between the
loading and unloading phase. The energy of the system is proportional to the area
under the load deflection curve, so; the energy absorbed between the loading and
unloading cycles is proportional to the area between the loading and unloading curve
of the stress strain curve (Figure 2-10).
At this point it is sufficient to note that the properties of bone are viscoelastic without
stating specific values for the material properties. The material properties of cortical
bone and cancellous bone are now considered separately.


23

Figure 2-10. Loading curve for a viscoelastic material.
Note that energy is absorbed between the loading and unloading phase.

2.4.1 Cortical Bone
The material properties of cortical bone are best described as being transversely
isotropic. Reilly and Burstein (1975) determined that the elastic modulus in the
longitudinal direction was larger than the elastic modulus in the transverse direction.
Relationships between the porosity and the elastic modulus of cortical bone have also
been investigated where it was found that the elastic modulus in the longitudinal
direction was significantly correlated with the porosity of the bone whereas the
elastic modulus in the transverse direction was not significantly correlated with the
porosity (Dong and Guo 2004).

The anisotropic ratio is a term that relates the elastic modulus in the longitudinal
direction with the elastic modulus in the transverse direction. The anisotropic ratios
of cortical bone are significantly negatively correlated with the porosity, indicating
that the bone becomes more isotropic as the porosity increases (Dong and Guo
2004).


24
Keller et al. (1990) determined the Youngs modulus, bending strength and the tissue
physical properties of cortical bone obtained from the shaft of the femur using a four
point bending test. Samples of approximately 30mm in length were taken from the
shaft with four samples (anterior, posterior, medial and lateral) taken from each
section. The samples were then formed into the final test specimen of a 3330mm
parallelepiped. Samples of an apparent density of over 0.5g/cm
3
were defined as
being cortical bone, the average apparent density of the samples included in the test
was given as 1.0g/cm
3
. Samples were frozen at -35C prior to testing. Ringers
lactate was used to hydrate the samples throughout the procedure. The equation used
to determine the Youngs modulus from the four point bending test assumes that the
Youngs modulus is the same in tension as it is in compression. This assumption
cannot be made for bone and as a result the authors have stated that the value
determined from the bending test is not a true material parameter. A compilation of
published values for the properties of the cortical bone are given in Table 2-1.

2.4.2 Cancellous Bone
The study of the structural and material properties of cancellous bone is of
considerable importance because of the possible relationship between the structural
quality of cancellous bone and the longevity of the orthopaedic implant and the
relationship between cancellous bone and osteoarthritis (Keaveny and Hayes 1993;
Gibson and Ashby 1997; Odgaard 1997).

A common interpretation of Wolffs law (Wolff 1986) is that the structure of the
cancellous bone will be dependent upon the stresses present at a particular region,
with the trabeculae aligning themselves with the principal stress trajectories. The
structure is also related to the density of the cancellous bone; for high density areas
the structure will consist of predominantly plate like structures forming a very close
packed geometry, while in the lower density regions the structure will consist of
predominantly rod like structures (Gibson and Ashby 1997).


25
Table 2-1. Youngs modulus of cortical bone
Source Site Testing method Value E (GPa)
Keller (1990) Femoral shaft 4-point bending
12.1

Sedlin and Hirsch
(1966)
Femur 3-point bending 10.4-19.3
Mather (1967b) Femur Cantilever bending 7.6-19.0
Mather (1967a) Tibia Cantilever bending 14.1
Mather (1967a) Humerus Cantilever bending 11.0
Mather (1968) Femur Cantilever bending 13.2
Currey and Butler
(1975)
Femur 3 point bending 13.4-16.2
Dempster and
Liddicoat (1952)
Dry rewetted
femur, tibia
and
humerous.
Tension, low strain rate 14.1
Kimura (1952) Femur
Compression, low
strain rate
10.4
Ko, (1953) Femur Tension, low strain rate 17.3
Sedlin, (1965) Femur
Bending, unknown
strain
15.8
Sedlin and Hirsch
(1966)
Femur, mid
portion. 3
point bending
Bending, no strain rate
given
6.0
Abendschein and
Hyatt (1970)
Femur and
tibia
Ultrasonic 24.5
Burstein and
associates (1972)
Femur
Tension, strain rate: 0.1
s
-1

14.1
Table adapted from (Reilly and Burstein 1974) and (Keller et al. 1990)

From a review carried out on current literature investigating the material properties
and characteristics of bone Rho et al. (1998) state that the variation in the material
properties of cancellous bone that results as a function of the structure and function
of the bone can vary by a factor of up to 2-5 from bone to bone. A list of
experimentally determined material properties of cancellous bone material is given in
Table 2-2.


26
Table 2-2. Estimations of the elastic modulus of cancellous bone material
Source Bone location Test method
Estimate of elastic
modulus (GPa)
Wolff (1892) Human Hypothesis 17-20 (assumption)
Runkle and Pugh
(1975)
Distal femur Buckling 8.69GPa
Townsend et al.
(1975)
Proximal tibia Inelastic buckling
11.38GPa (wet)
14.13GPa (dry)
Williams and
Lewis (1982)
Proximal
Tibia
Experimental with two-
dimensional finite
element method
1.30GPa
Ku et al. (1987)
Fresh frozen
human tibia
Three-point bending test 3.17GPa
Mente and Lewis
(1987)
Dried human
femur, fresh
human tibia
Cantilever bending with
finite element analysis
7.8GPa
J ensen et al.
(1990)
Human
vertebra (L3)
Structural analysis by
three-dimensional model
3.8GPa
Choi et al.
(1991)
Human tibia Four point bending 5.35 GPa
Rho et al. (1993) Human tibia
Tensile testing and
ultrasonic test
10.4GPa
14.8GPa

Odgaard (1997) observed that the mechanical properties of the cancellous bone
structure have never been definitively described and that the anisotropic nature has
lead to very few investigators attempting to fully describe cancellous bone.
In the case of a compression test, the properties that are determined will be
influenced by factors such as strain rate, specimen geometry, friction at endplates,
structural end phenomena, storage, continuum assumption, viscoelasticity and
temperature effects (Odgaard 1997). When considering these factors some authors
have estimated that the stiffness and strength of cancellous bone could be
underestimated by up to 20% (Odgaard and Linde 1991). Material properties of the
cellular cancellous bone structure are presented in Table 2-3.


27

Table 2-3. Elastic Modulus of the cellular cancellous bone structure
Strain Rate (s
-1
)
Elastic modulus (S.D) (GPa)
0.001 56.6 (9.7)
0.01 75.5 (11.8)
0.1 81.5 (8.0)
1 81.2 (17.1)
10

83.7 (13.8)
The apparent density of the specimens was adjusted to a mean value of 0.31g.cm
-3

The effect of bone marrow was considered to be important for this trial.
Data based on specimens without marrow.
(Carter and Hayes 1977)

The material properties of cancellous bone are similar to the properties of
engineering cellular solids. The compressive stress-strain relationship for the cellular
cancellous bone structure is shown in Figure 2-11 for increasing apparent density.
Figure 2-11. Compressive stress-strain response of the cellular cancellous bone
structure


28

The linear elastic region for stress oriented bone such as the cancellous bone found at
the head of the femur occurs as a result of compression or extension of the cell walls
and bending of the cell walls when a load is applied in line with the principal stress
and when a load is applied perpendicular to the direction of the principal stress
respectively (Gibson and Ashby 1997). The region of near constant stress for
increasing strain is as a result of plastic collapse of the cells (shown as the plastic
collapse region in Figure 2-11). The near-horizontal region of the stress-strain curve
continues until the cells collapse to a state where the opposing cell walls touch and
the stress increases significantly for a small increase in strain (shown as the
densification region in Figure 2-11).

The point at which the structure of the cancellous bone collapses is of particular
interest to determine the point at which failure will occur when modelling the bone.
The compressive strength of cancellous bone from the upper femoral region was
investigated by Martens et al. (1983), the results of which are presented in Table 2-4.

Table 2-4. Compressive strength of cancellous bone from the upper femoral
region
Mean Age Axis
Compressive Strength by region [MPa]
Mean (SD)
Head Neck Intertrochanteric
45 X 9.3(4.5) 6.6(6.3) 3.6(2.3)
60 Y 10.2(3.3) 2.8(3.3) 3.7(1.5)
67.5 Z 4.9(1.27) 0.965(0.332) 0.595(0.205)
(Martens et al. 1983)

Carter and Hayes (Carter and Hayes 1977) investigated the compressive properties of
human and bovine bone and found that in the presence of bone marrow, the Youngs
modulus was independent of the apparent density, which according to the authors
suggested that the viscous flow of the marrow was the dominant factor in the
mechanical behaviour of the specimen. The marrow was then removed and a clear
relationship between the Youngs modulus and the apparent density of the bone was
determined. The empirical equation given in Equation 2-3 states that the


29
compressive modulus of the bone specimen (E) was proportional to the cube of the
apparent density () and the strain rate (
) raised to the power of 0.06.

0.06
3
3790 E
=
2-3

The apparent density of the specimen was calculated by dividing the hydrated tissue
weight by bulk volume of the specimen as determined by micrometer measurements
prior to testing (Carter and Hayes 1977). Constant strain rate values of 0.001, 0.01,
0.1, 1.0 and 10.0 per second were used for the test protocol.

2.5 Analogue Bone
Cadaveric femurs have been used extensively for biomechanical investigations of hip
replacements and also applications such as intramedullary nails. The primary issue
with using cadaveric specimens in comparative biomechanical investigations is the
inter-specimen variability and the number of trials that are required in order to ensure
significance of results. According to Cristofolini (1996) the sample size for
cadaveric tests within the literature ranges from one to forty, and that the inter-
specimen strain variability can be larger than 100% of the mean stress. Therefore, in
order to obtain an acceptable confidence interval literally hundreds of femurs would
need to be tested (Cristofolini et al. 1996). Other distinct disadvantages of cadaveric
specimens include the lack of availability and the limitations imposed by the strict
protocols for handling and storing the specimens. These limitations have led
researchers to look for more reliable and accessible materials to use instead of
cadaveric specimens. One solution is to use mechanically analogous synthetic bones.
The benefits of a mechanically analogous femur for use as a substitute for cadaveric
femurs are clear: low inter-specimen variability, high availability, ease of storage,
handling and preparation. Pacific Research Laboratories (Vashton Island, WA)
produce a range of synthetic biomechanical test materials known as Sawbones that


30
are commercially available and that have been used and tested for biomechanical
applications in the past.

Mechanical validation of the second generation femurs (of the size described as
medium-left, model 3103) was carried out by Cristofolini et al. (1996). The 3103
femur is modelled on a medium male, the geometry of which was obtained from a
175cm Caucasian male weighing 83.9kg (Pacific Research Laboratories 2004a).
Heiner and Brown (2001) investigated the second and third generation femurs of a
size described as large-left, models 3106 and a femur using the composite and
structure of the third generation product in the same mould as the 3106 femur. The
3106 composite femur is modelled on a bone from a large male, 183 cm in height
and weighing 90.72 kg. The cortical bone analogue material used for the second
generation femur is described as a fibre fabric reinforced (FFR) composite. The
construction of these bones requires manual craftsmanship; the manufacturing
process is therefore not ideal, and the level of anatomical detail and inter-specimen
variability is also compromised as a result of this intervention. The third generation
femurs use a short-glass-fibre-reinforced (SGFR) epoxy for the cortical analogue
material. Heiner and Brown (2001) determined that the Youngs modulus for the
SGFR epoxy was 19 GPa using the American Society for Testing and Materials
(ASTM) standard D638-91, with a modified strain rate of 15.2cm/min. The SGFR
epoxy allows improved forming and therefore greater anatomical detail, including a
medullary cavity. The mechanical properties of the SGFR epoxy are also more
uniform and the fabrication of the bones is simplified (Heiner and Brown 2001). The
inclusion of the medullary cavity in the SGFR cortical analogue allows for improved
reaming for the implantation of the femoral component. Another geometric
improvement for the SGFR cortical analogue includes a more appropriately shaped
diaphysial cross-section (more oval shaped than the FFR composite analogue).

Cristofolini et al. (1996) undertook a comparative study of fresh frozen and dried-
rehydrated cadaveric specimens and the medium-left FFR composite femur. Heiner
and Brown (2001) investigated the variation in the FFR and SGFR composite femurs
and related the mechanical properties to previously published data on cadaveric


31
femurs for similar tests. Heiner and Brown (2001) tested the composite bones under
axial, bending and torsional loads using an MTS 858 Bionix materials testing
machine (MTS Systems Corp., Eden Prairie, MN).
Neither Cristofolini et al. (1996) or Heiner and Brown (2001) specified a temperature
at which the mechanical testing was carried out. It has been assumed that the tests
were carried out at room temperature, which according to ASTM D638-91 (used by
Heiner and Brown (2001) for the tensile material properties) should be 232C and
505% relative humidity.

Mechanical characterisation
A series of tests was carried out by Cristofolini et al. (1996) to mechanically
characterise the FFR composite analogue femur and compare the analogue femur to
the cadaveric specimens. These tests were carried out with the bone potted distally
in acrylic bone cement at 11 in adduction (Figure 2-12a). Twenty uniaxial strain
gauges were used to measure the strain at the surface of the FFR composite femurs.
Conditioning effects were investigated through the application of a cyclic load of
1.6kN for ten cycles. The second characterisation test was to perform a linearity test,
loading the femurs from zero to 1.6kN in 0.1kN increments. The third test was a
creep test, using a 1.6kN load applied with a 15 second ramp holding the load for 15
minutes. The load was removed using a further 15 second ramp. No conditioning
effect was observed and the mechanical response was found to be exceptionally
linear. Creep was observable at all strain gauges, but was of limited entity, and
decreased quickly after loading. The sum of the creep terms was found to always be
lower than 8 per cent of the elastic component.

Deflection under axial load and strain distribution
Deflection under axial load was assessed by Cristofolini et al. (1996) and Heiner and
Brown (2001). The femurs were potted distally for both investigations at an angle of
11 in adduction (Figure 2-12a). Loading at the proximal end was carried out using
an acrylic imprint of the head of the femur (Cristofolini et al. 1996; Heiner and
Brown 2001). The loading protocols, while similar, varied slightly between the two


32
groups. Cristofolini et al. (1996) used a loading protocol of zero to 800N at a
loading rate of 80 N/s, whereas Heiner and Brown (2001) applied a load from 60 to
600 N using a loading rate of 60 N/s. Heiner and Brown (2001) also included two
preconditioning loading cycles before the data collection cycle.
Cristofolini et al. (1996) noted that the deflection of the femur is dependent on the
boundary compliance of the femur and as a consequence the strain distribution of the
system should also be considered. Uniaxial strain gauges were used by both groups,
Cristofolini et al. used 20 gauges in positions shown in Figure 2-12a; Heiner and
Brown used 5 gauges along the proximo-medial diaphysis from the lesser trochanter
to the middle of the shaft (Figure 2-12b).

Figure 2-12. Axial loading with strain gauge position.
A. Strain gauge position for Cristofolini et al. (1996) ; B. Strain gauge position for Heiner and Brown
(2001).



33

Cristofolini et al. (1996) found that poor settling of the acrylic imprint at the head of
the femur caused considerable problems with reproducibility during loading.
Significant differences were observed between the fresh frozen, dried rehydrated
cadaveric and Sawbones specimens for the axial load test. Variance was defined in
terms of experimental and inter-specimen variability, and on the basis of this
differentiation, greater variability was observed for the cadaveric femurs than for the
composite femurs. No statistical difference was observed between the composite and
fresh frozen femur groups, while the dried-rehydrated group showed significant
differences between both of the other groups. The variance of the composite femurs
was determined to be 20 times lower than the variance of the two cadaveric groups.
No significant difference was determined between the strain distribution of the
composite femurs and the cadaveric femurs.

Heiner and Brown (2001) found no statistically significant difference in the femur
axial stiffness between specimens. For the FFR femurs the inter-specimen variability
for axial stiffness was determined to be 13.3% and for the SGFR femurs the inter-
specimen variability was 2.7%. The strain of the SGFR femur at the level of the
lesser trochanter was too high when compared to cadaveric specimens and the FFR
composite femur. Heiner and Brown (2001) state that at the time of publication
Pacific Research Laboratories (Vashton Island, WA) planned to increase the
thickness of the area to improve the stiffness. The strain of both the FFR and the
SGFR composite femurs at the level of the prosthesis stem tip was similar to
cadaveric specimens.

Bending stiffness
A four point bending test was used to assess the femur bending stiffness, with both
groups using equal spans of 62mm between points. Maximum loads of 550 N (34.1
Nm) (Cristofolini et al. 1996) and 500N (31 Nm) (Heiner and Brown 2001) were
used and the deflexion of the mid-diaphysis with respect to the two extreme rollers
was measured (Figure 2-13). The femurs were tested in the medial-lateral and
anterior-posterior planes.


34

Figure 2-13. Four point bending test with extensor measurement shown.
(Cristofolini et al. 1996)

Cristofolini et al. (1996) found that there were significant differences within the
femur groups in both planes. Overall variance was separated into experimental and
inter-specimen error, and the majority of the variance was attributed to the inter-
specimen variability. The authors suggest that this result is evidence enough to
indicate that the bending test may be a more capable test than the axial loading test
when investigating real inter-specimen differences. A comparison of the groups
showed no significant difference between femur groups. There was however
significant differences between the variances of the composite femurs and both of the
cadaveric femur groups. The variance of the composite femurs was 20 and 200 times
lower than the cadaveric femurs in the anterior-posterior and lateral-medial
directions respectively.

Heiner and Brown (2001) found that there was no statistically significant difference
between the FFR and SGFR composite bones for bending in the anterior direction
(anterior surface in tension), but the SGFR composite femur was significantly stiffer
than the FFR composite femur for bending in the lateral direction (lateral surface in



35
tension). The increase in stiffness in the lateral direction has been attributed to the
more realistic oval cross section of the SGFR composite femur.

Torsional stiffness
The torsional test was undertaken on the same specimens as the axial loading test. A
modified torsiometer was used to apply the load to the femur, the upper plate is
instrumented and the lower plate is free to move (Figure 2-14). Cristofolini et al.
(1996) applied rotation so that there was internal rotation of the head of the femur.
The composite femurs were tested up to 30 Nm without showing non-linear
behaviour, whereas the cadaveric femurs displayed non-linear behaviour for torque
values greater than 20 Nm. Heiner and Brown (2001) applied a torque from 0.5 to
15 Nm at 0.25/s, using one preconditioning torque cycle before the data acquisition
cycle.

Figure 2-14. Torsional loading in modified torsiometer.
(Cristofolini et al. 1996)



36
Cristofolini et al. (1996) found that the cadaveric femur group showed differences in
the stiffness (slope of the linear regression of the torque-angle measurement) of the
individual femurs, while no significant difference was detected in the stiffness of the
individual composite femurs. Inter-specimen variability was again shown to be very
low for the composite femurs when compared to the inter-specimen variability of the
cadaveric femurs. There was no significant difference between the femur groups,
showing little significant difference between the composite group and the cadaveric
group. The variance in the composite group was found to be approximately 200
times lower than the cadaveric groups.
Heiner and Brown (2001) found that there was less than a 10% difference between
the FFR and the SGFR composite bones, however the difference was found to be
statistically significant. The variance within the groups was found to be 3.2% and
5.2% for the FFR and the SGFR composite femurs respectively.

Cristofolini et al. (1996) noted that the diaphysial anterior-posterior bow of the
synthetic femur is smaller than that of some other femurs. However, the geometry of
the Sawbones femur has been modelled from a human subject, and as such geometric
variability should be expected. The viscoelastic effect observed indicated that a
settling time would be required so as to avoid the time dependent properties of the
bone associated with the viscoelastic effect observed. Four minutes was suggested as
a time to allow for the effects of the time dependent properties (Cristofolini et al.
1996).
Sawbones composite femurs present an extremely useful mechanical analogue
substitute for cadaveric bone that provides a standardised and highly repeatable test
model. The advantage of the SGFR composite femur is that it provides a model with
greater anatomic detail and superior uniformity of mechanical properties. The
variance of the SGFR composite femurs was found to be similar to the FFR
composite in bending and torsion, and lower than the FFR in axial loading.

Typical properties of the second and third generation femurs are given in Table 2-5
and Table 2-6.


37
Table 2-5. Published properties of the second-generation analogue femur
Tensile Flexural
Density
(g/cc)
Strength
(MPa)
Modulus
(MPa)
Strength
(MPa)
Modulus
(MPa)
Cortical 2.08 172 18,615 275 14,200
Cancellous 0.27 - - 4.8 104
(Pacific Research Laboratories 2005)

The second-generation femur geometry is shown in Figure 2-15.
Figure 2-15. Medium left second-generation composite femur (3103).
Dimensions: a=455mm b=43mm c=33mm d=135 e=28mm f=78mm.
(Pacific Research Laboratories 2004b)

Typical properties of third generation femurs are given in Table 2-6.

Table 2-6. Published properties of third-generation analogue femur
Tensile Compressive
Density
(g/cc)
Strength
(MPa)
Modulus
(MPa)
Strength
(MPa)
Modulus
(MPa)
Cortical 1.7 90 12,400 120 7,600
Cancellous 0.27 - - 4.8 104



38
The third-generation femur geometry is shown in Figure 2-16.

Figure 2-16. Medium left third-generation composite femur (3303).
Dimensions: a=455mm; b=45mm; c=31mm; d=135; e=27mm; f=74mm; g=13mm.
(Pacific Research Laboratories 2004b)

It should be noted that these analogue femurs offer an alternative to cadaveric bone
in terms of their mechanical characteristics, and are not representative of in vivo
bone.

2.5.1 Use of Analogue femurs in orthopaedic research
Analogue bone and subsidence
The composition of the cellular material representing cancellous bone of the
analogue femurs is very different from the composition of real cancellous bone.
Verdonschot et al. (2002) pointed out this discrepancy, indicating that the porosity of
the cellular material may affect cement penetration, in turn affecting the migration of
the stem. However, the subsidence of the stem within the analogue bone has been
shown by Maher and Prendergast (2002) to be comparable to the subsidence
expected with cadaveric bones. Maher and Prendergast (2000) investigated the
subsidence of two implants using a loading condition that included an encastre



39
boundary condition at approximately the midpoint of the shaft and the load was
applied to the head of the implant. This loading condition is intuitively very different
to the loading in vivo. So it is perhaps more accurate to state that when using
analogue bone in vitro with a modified loading regime, subsidence behaviour which
is comparable with cadaveric specimens can be expected.

2.6 Failure mechanisms of the femoral stem
Of the two component types available (cemented and cementless) the cemented
implant is by far the most prevalent. The National J oint Replacement Registry
(Australian Orthopaedic Association 2004) states that cemented implants make up
the top three implant types comprising 33.5% of the market (Table 2-7). Cemented
implants are therefore the focus of this investigation.

The two most predominant failure mechanisms of implants within Australia are
dislocation (30.9%) and loosening (29%) (Australian Orthopaedic Association 2004).
However, the Australian registry has only been acquiring data since 1999 indicating
that the data relating to the failure mechanisms will be offset towards short-term
failure mechanisms. The Swedish National Hip Arthroplasty Register is a report
based on data gathered since 1979, giving it a greater capacity to include long-term
failure mechanisms. According to the Swedish registry aseptic loosening is the
number one reason for revision accounting for 73.9% cases (Herberts et al. 2003).
For this reason it is important to understand the mechanism behind loosening.

Clinical failure of the femoral implant is evident when the interface between the bone
and the cement has deteriorated. It is important, therefore, to determine the cause of
the bone-cement interface failure and to assess whether it is possible to control the
process of loosening.


40
Table 2-7. Top ten femoral components used in primary total hip replacement
in Australia.
Femoral Component Type Number Percentage
Exeter Cemented 11268 21.8
BHR Cemented 3425 6.6
Spectron EF Cemented 2644 5.1
ABGII Cementless 2557 4.9
Synergy Cementless 2183 4.2
Elite Plus Cemented 2050 4.0
Secur-Fit Plus Cementless 1843 3.6
Alloclassic SL Cementless 1703 3.3
VerSys Cementless 1560 3.0
CPT Cemented 1455 2.8
Other (131) 21072 40.7
Total 51760 100.0
(Australian Orthopaedic Association 2004)

2.6.1 The Process of Loosening
J asty et al. (1991) found in a post-mortem examination of 16 implants that even with
no clinical radiographic or physical evidence of loosening some degree of debonding
at the cement stem interface existed. In all specimens, the bone cement interface was
found to be intact (J asty et al. 1991). The authors inferred from this finding that
failure of the femoral component initiated at the stem-cement interface. Scanning
electron microscopy has been used by Maloney et al. (1989) to investigate the stem-
cement interface of autopsy femurs, and it was found that the cement exhibited
fractures in various stages of development, originating primarily at the stem-cement
interface and also within the voids in both the cement and the cement-bone interface,
and propagating either radially or circumferentially.

The theory of femoral component failure through crack propagation was investigated
by McCormack and Prendergast (1996). The system was investigated using fracture
mechanics for a monotonic loading regime. In terms of the failure of the system a
crack that has a large angle of propagation will be directed towards the bulk of the
cement and will lead to failure in fewer cycles than a crack that has a small


41
propagation angle. It was found that the angle of the fracture is related to the ratio of
the normal and shear stresses at the stem-cement interface and that as the ratio
increases the angle of crack propagation decreases.

This finding has important ramifications when considering the properties of the stem-
cement interface. If the femoral component possesses a rough surface finish the
tendency for crack generation will be towards the generation of a large angle of crack
propagation. For a smooth femoral component the ratio of the normal and shear
stress will tend to generate cracks that will be contained along the interface rather
than propagating into the cement mantle (McCormack and Prendergast 1996).

Therefore, while clinical failure of the femoral component is governed by the
condition of the cement-bone interface, this failure is preceded by crack propagation
in the cement mantle that is initiated at the cement-stem interface. Prevention of
crack initiation at the stem-cement interface would therefore be a step towards
prolonging the time to failure of the system.

2.6.2 Implant motion and wear particle formation
As indicated in section 2.6.1 the process of loosening has been shown to begin at the
stem-cement interface and propagate through the cement leading to clinical failure.
Cement fracture can lead to the generation of a fibrous membrane that develops in
response to the presence of debris generated by the mechanical failure mechanisms.

Motion of the implant either initiates other failure mechanisms or is in itself a
function of other failure mechanisms. Implants that have been incorrectly implanted,
and consequently do not possess a functional bond between the bone or cement, will
generally experience some form of micromotion (Bauer and Schils 1999). The
motion of the implant leads to a discontinuity between the prosthesis and the bone or
cement and may lead to the formation of wear particles. The surface that is not
bonded will tend to become covered with some form of fluid (blood) or soft tissue.


42
When exposed to normal anatomical loads the debonded surface may allow larger
displacements, which will increase the level of debonding and correspondingly
increase the failure rate of the system (Viceconti et al. 2001b). Implant motion,
without the presence of other mechanisms, is believed to have some effect on bone
resorption. The success of the implant therefore relies on a good functional bond
between the implant and the bone or cement. In order to achieve a functional bond
the uncemented implant generally possesses a textured surface produced by coatings
such as hydroxyapatite (Simmons et al. 2001).

2.6.3 Failure through Infection
Bauer (1999) stated that, at the time of publication, infection was responsible for
between 1-5% of total joint arthroplasty failures. It was also indicated that the
proportion of hip arthroplasties that fail through infection would be lower than that of
the total knee replacement. The risk of infection is influenced most directly by the
complexity of the operation. Therefore, a patient undergoing a revision operation, or
a patient requiring a bone graft would be under greater risk of infection than a patient
undergoing an initial and uncomplicated replacement (Bauer and Schils 1999).

2.6.4 Clinical diagnosis
Currently the only certain method of determining failure, after utilising existing
diagnostic techniques, is through invasive surgical assessment (Rosenstein et al.
1989; Schmalzried and Callaghan 1999). The most widely used and accepted
diagnostic tool currently being used to determine prosthetic failure is the radiograph
(Brand et al. 1986). Radiographs show the shadow graph of the implant, with
particular focus given to the representation of the interface between the implant and
cement or the cement and the bone (Figure 2-17). The appearance of a radiolucent
line between either of the interfaces of the implant is believed to represent
mechanical failure at that interface.


43

Figure 2-17. Radiograph showing loosening of the femoral component.
The radiograph on the left shows the cemented femoral component of a 56 year old man immediately
after surgery. The radiograph on the right shows the same man 7 years post surgery. The radiograph
on the right shows an osteolytic region which could be consistent with proximal stress shielding and
also a linear radiolucent line extending beyond the distal half of the prosthesis consistent with
loosening.
(Harkess 1999)

The clinical definition of failure is based upon the physical condition of the patient,
whether or not the patient is experiencing pain, and the appearance of the prosthesis
on the radiograph, which then has to be verified through surgical procedure (Brand et
al. 1986; Lieberman et al. 1993; Weber et al. 1996; Donnelly et al. 1997; Kobayashi
et al. 1997a; Kobayashi et al. 1997b; Berry et al. 1998; Burt et al. 1998; Howieet al.
1998). It is therefore important to note that while clinical failure may include
mechanical failure of the interfaces, the presence of mechanical failure will not
necessarily result in clinical failure.
What has become perhaps the most influential work on diagnosing prosthetic
loosening using radiographic techniques is that undertaken by Gruen, McMeice and
Armstatutz (Gruen et al. 1979). This group utilizing earlier work from McNeice and



44
Gruen, used seven delineated sections around the prosthesis in order to define failure
by grouping the failed regions into a particular region or zone, which further allows
for the monitoring of progressive failure. The Gruen zones are shown in Figure
2-18.

Gruen et al. (Gruen et al. 1979) categorised the modes of failure according to the
zone at which the failure occurred. The frequency and zone position of failure was
determined for three general conditions of failure; fractured acrylic, radiolucency at
the stem-cement interface and radiolucency at the bone-cement interface. The zones
defined by Gruen are useful when considering a planar radiograph, representing a
cross section of the implant. However, their use when considering a three-
dimensional system undergoing debonding is limited and eventually a more accurate
representation of the system will be required. While the metallurgy, geometry,
cement composition and implantation techniques of the prosthesis have changed
considerably since this work was published, the basic nomenclature and system of
classifying failure proposed by Gruen is still used today.

Figure 2-18. Gruen Zones


45
To determine clinical failure four modes of failure were introduced; pistoning (stem
within cement or stem within bone), medial mid-stem pivot, calcar pivot and bending
or cantilever motion (which is a function of fatigue).

Pistoning (compound subsidence of the cement and prosthesis) (Figure 2-19) occurs
when the relative motion of the prosthesis with respect to the cement and bone is
similar to that of a piston. The effect of this motion is the appearance of a
radiolucent line around the entire implant.

(A)

(B) (C)
Figure 2-19. Failure through pistoning.
A. shows a schematic of pistoning (Gruen failure mode 1b); B. Shows a radiograph of the implant
initially after surgery (Harkess 1999); C. Shows the implant nine years after surgery (Modified from
Harkess 1999). Note that subsidence of both the implant and the cement has occurred. There is a
bony pedestal formation at the distal tip and a linear radiolucent line consistent with cement-bone
interface failure.

Medial midstem pivot (Figure 2-20) is essentially the motion that the prosthesis
would experience if it were fixed by a pin joint midway along the stem and a couple



46
is applied to the stem such that the proximal end migrates medially and the distal end
migrates distally.

(A)

(B)
Figure 2-20. Failure through medial midstem pivot.
A. shows a schematic of Gruen failure mode 2 medial mid stem pivot; B. shows an implant showing
characteristics of medial midstem pivot (Modified from Harkess 1999). The medial section of the stem
has migrated medially and the distal tip has migrated laterally.

Calcar Pivot (Figure 2-21) is the medial-lateral motion of the distal tip of the stem
with the proximal end fixed.



47

(A)
(B) (C)
Figure 2-21. Failure through calcar pivot.
A. Shows a schematic of Gruen failure mode 3 calcar pivot; B. Shows a radiograph of an implant
shortly after surgery (Harkess 1999); C. Shows the implant five years after surgery (Modified from
Harkess 1999). Varus migration is produced by lateral migration of the distal stem.

Cantilever fatigue (Figure 2-22) occurs when the proximal support is lost.
Anatomical loading of the stem at the proximal end, while the distal end is fixed,
produces a system similar to that of a cantilever beam.



48

(A)

(B) (C) (D)
Figure 2-22. Failure through cantilever fatigue.
A. Shows a schematic of Gruen failure mode 4 cantilever failure; B. Shows a radiograph of a Charnley
implant with a varus alignment of the stem (Harkess 1999); C. Shows the stem one year later (Modified
from Harkess 1999). Figure (D) shows the fractured stem four years after surgery (Modified from
Harkess 1999). The distal end of the implant remains well fixed.



49
2.7 Current concepts of component mechanics of the
femoral stem
The method of fixation of the cemented femoral stem is a topic of contention. The
two proposed mechanisms of fixation are absolute bonding at the stem cement
interface and subsidence within the cement mantle to produce bonding forces. These
two mechanisms of fixation can be related to the engineering structures of a
composite beam (shape closed system) and a loaded Morse taper (force closed
system) respectively (Huiskes et al. 1998).
In the case of the shape closed system the load applied is carried by the stiffest
member, which indicates that the load applied to the head of the implant is carried by
the implant and transferred through the implants tip to the cement and surrounding
bone (Shen 1998). This method of loading suggests that the load bypasses the
proximal femur, which could lead to calcar resorption and loss of proximal bone.
The strain will be equal in the cement and the stem at the interface of the cement and
the stem in a plane parallel to the interface for the shape closed system.
For the force closed system (smooth collarless implant with a double taper) the fit of
the implant is maintained by the subsidence of the implant within the cement mantle
(taper-slip principle). Load applied to the implant will improve the fit of the
implant in the cement. When slip occurs radial compressive forces are generated in
the cement mantle, which are transferred to the bone as hoop stresses.

2.7.1 Stem-cement interface failure
An investigation into the failure process and probability of the femoral component
using a CT scan finite element model was presented by Verdonschot and Huiskes
(1997a; 1997b). The investigation into the interface was prompted by the work
carried out by J asty et al. (1991), which indicated that cement-stem debonding
preceded implant failure. The failure criteria used for this model was presented by
Hoffman (1967). The original fracture condition proposed by Hoffman is:


50
1 ) ( ) ( ) (
2
9
2
8
2
7 6 5 4
2
3
2
2
2
1
= + + + + + + + +
xy zx yz z y x y x x z z y
C C C C C C C C C
2-4
Where:
, , , , ,
x y z xy yz zx
are the six unique stress components of the stress tensor for a
three-dimensional stress state.

These constants are given by:
( ) ( ) ( )
( ) ( )
( )
1
1 1
1
2 3
1 1
4
5 6
2
7
8 9
1
2
and by permutation of x,y,z
ty cy tz cz tz cz
tx cx
syz
C F F F F F F
C C
C F F
C C
C F
C C

= +

=
=

2-5

Where,
F
tx
, F
ty
, F
tz
are the three uniaxial tensile strengths,
F
cx
, F
cy
, F
cz
are the three uniaxial compressive strengths,
F
sxy
, F
szx
, F
sxy
are the three pure shearing strengths.

However, if only the normal stress and the surface shear stress of the interface are of
interest the above equations reduce to a simplified form using a failure index (FI)
shown in Equation 2-6.
2 2
1 1 1 1

s c t c t
S S S S S
FI +
+ =

For the bonded case, and

2-6
FI =0 For the debonded case
Where for the cement stem interface:
S
t
=8MPa and is the tensile strength of the interface.
S
c
=70MPa and is the compressive strength of the interface.
S
s
=6MPa and is the shear strength of the interface.
=Normal stress at the interface (MPa).
=Shear stress at the interface (MPa).


51
Equation 2-6 can be implemented into a finite element model and iterated to
calculate predicted failure of the stem cement interface. Knowledge of the stem-
cement interface is important when considering the load transfer mechanism acting at
the interface.

2.7.2 Cement-bone interface
The cement bone interface has for the most part been ignored from a modelling
perspective. The most likely scenario is that the cement-bone interface is assumed to
be fixed. This is not often the case clinically, however the Exeter stem is unique in
that the distal migration of the stem is achieved entirely at the stem-cement interface
(Alfaro-Adrian et al. 1999). This clinical finding validates the choice of fixing the
cement-bone interface for the Exeter stem, whereas a fixed cement-bone interface
will not be valid for most other stem geometries.

2.7.3 Cement Creep
Cement creep is defined as the change in strain with time in a sample held at
constant stress
In terms of metallurgy, creep is the time dependent, permanent deformation of a
material when it is subjected to a constant load or stress (Callister 1994). When
applied to polymers at low strains (1%) creep is recoverable after unloading without
annealing at an elevated temperature (Ward 1971).


52

Figure 2-23. Creep of a linear viscoelastic solid.
The total strain of the system is a combination of instantaneous elastic strain (e1), time dependent
creep strain e2 and the Newtonian flow of the viscous material (e3).

Figure 2-23 shows the viscoelastic response of a polymer when a step load is applied
and then removed.

2.7.4 Stress relaxation of the cement
Stress relaxation is defined as the change in stress with time in a sample held at
constant strain. Stress relaxation (for a linear viscoelastic solid) is defined as the
reduction in stress while the strain in the body is held constant over time (Figure
2-24).

Figure 2-24. Stress Relaxation.
When a strain is applied to a viscoelastic material the resultant stress will decrease with time.


53

When considering the mechanical behaviour of the cement over time stress
relaxation, defined as the steady relaxation of the stress in the system over time while
the strain is held constant, is a very important parameter (Hughes et al. 1997). The
shape closed system of the implant requires perfect bonding at the stem-cement
interface, and that the cement provides good support to the structure. Stress
relaxation of the cement is therefore not possible unless there is failure at the stem-
cement interface (Shen 1998). Shen (1998) hypothesised that during periods of no
applied load the stem of a force closed system does not move with respect to the
cement, indicating that the strain of the system is constant during this time. It can
therefore be assumed that stress relaxation of the cement occurs during periods of
rest (Hughes et al. 1997).

2.7.5 Dual Implications of Subsidence
Subsidence is often used as an indicator when clinically assessing the likelihood of
failure. Maher and Prendergast (Maher et al. 2000) used subsidence (defined as
distal migration) of the stem as the primary indicator of failure of the femoral
component in their investigation. The use of subsidence as an indicator of failure
cannot be applied to all implant types, as the geometry of the implant will determine
if subsidence will in fact detrimentally affect the stability of the implant. Relating
subsidence back to the engineering models of the composite beam and the taper slip
mechanism introduced in section 2.7, subsidence as a mechanism of failure should be
considered only when investigating implants based upon the composite beam theory.

Composite beam
For systems that are governed by the composite beam theory, subsidence of the stem
would indicate that there has been failure at the cement-stem interface. Subsidence
of such a stem would therefore be a clear indicator that the likelihood of failure has
increased (J asty et al. 1991). Maher and Prendergast (2002) investigated the
subsidence of two collared stems mechanically analogous to the composite beam
(Mller Curved Prosthesis (J RI Ltd., UK) and the Lubinus SPII prosthesis (W. Link,


54
Germany)). The investigators concluded that it was possible to distinguish between
the migration of the two implants, and from the migration determine which implant
was most likely to loosen more rapidly.

Taper-slip system
Shen (1998) points out that, in the case of the Exeter stem, the system may be on the
verge of failure if assessed with the standards of the composite beam theory,
however through the subsidence the stem will theoretically reach a stable position.
A clear distinction between the two models therefore must be made when discussing
subsidence as an indicator of failure or as a possible stabilisation mechanism.
The contribution and importance of stress relaxation of the cement was investigated
by Verdonschot et al. (2002). The subsidence of the Exeter stem was compared for
the loading cases of continuous loading and loading including a relaxation period. It
was found that the overall subsidence of the continuously loaded specimens was
higher than the subsidence of the specimens with relaxation periods. However, the
specimens that included the relaxation period subsided on average four times more
per loading cycle than the continuously loaded specimens.
Hughes et al. (1997) point out that investigations into the subsidence of the stem, and
in particular stems that are collarless and double tapered, must include periods of rest
to allow for stress relaxation. The equilibrium of the system, presumably
equilibrium of the stress-strain state, has been proposed as the governing criteria for
the subsidence of the stem of the force closed system (Hughes et al. 1997).
Therefore, after periods of rest, when the cement has been able to relax, the
subsidence of the stem will continue until equilibrium of the stress-strain state has
been reached.

2.7.5.1 Taper-slip principle
Taper-slip occurs when a moderate axial load (F) is applied to a system such that the
stresses (radial and hoop) generated by the contact between the stem and the cement
generate a firm bond. Generally a stem with a low coefficient of friction is
required, which would decrease the shear stress of the cement prosthesis interface


55
while correspondingly increasing the hoop and radial stresses (Norman et al. 2001).
The taper-slip principal therefore allows the prosthesis to debond with the cement
but still maintain a functional bond between the prosthesis and the cement-femur
system. A figure showing the stresses and geometry of a system in taper lock is
shown in Figure 2-25.

Figure 2-25. The taper slip principal for a force closed system

It has been noted that when the friction at the interface is increased the radial and
hoop stresses decrease and the taper lock mechanism becomes less effective. Thus
for the taper-slip principal to be efficient the friction at the surface must be reduced
to allow for an increase the radial and hoop stresses (Norman et al. 1996). This
increase in radial and hoop stress may be detrimental to the integrity of the interface,
and subsequently the implant, if at any stage during gait cycle or general motion
these stresses exceed the yield stress or cyclic limit of the surrounding bone and
cement. This infers that while taper-slip maintains a firm bond within the cement


56
mantle, the stresses generated by the taper-slip mechanism itself may work to the
detriment of the overall integrity of the hip arthroplasty.

2.7.6 Torsional Stability
A total hip replacement (THR) stem undergoes torsional as well as axial loading
forces in vivo (Kotzar et al. 1991; Bergmann et al. 2001). This occurs particularly
during activities of daily living that entail standing on the flexed hip, such as rising
from a chair and stair climbing. Under those circumstances, a posteriorly directed
force is applied on the prosthetic head, thus generating an internal rotation moment
about the long axis of the stem. In a telemetrised in vivo experiment, Kotzar et al.
(1991) calculated that peak torque during stair climbing reached 20Nm in the early
postoperative period. They also acknowledged that torsional forces might well
become higher at a later date, when the patient has fully rehabilitated from the
operation.
Immediate torsional stability of a THR stem has been found to be due to several
factors, including use of cement (Burke et al. 1991). Prosthesis geometry is also
relevant, with flatter and curved shapes being more stable than cylindrical and
straight ones (Callaghan et al. 1992; Berzins et al. 1993; Mohler et al. 1995; Chang
et al. 1998). Harrington et al. (2002) also demonstrated the relative importance of the
patients body weight as opposed to the prosthesis neck length. In that same study, it
was also shown that the presence of a prosthesis collar in good contact with the
femoral calcar could reduce the torsional strains by a factor of 1.5.
The micromotion at the cement-stem interface has potential important implications
for the generation of wear particles and the long-term life of the implant (Mohler et
al. 1995; Howell et al. 2004). In a study of 172 retrieved cemented femoral stems of
a variety of surface finishing and designs, Howell et al. (2004) found polishing and
pitting wear on the surface of 94% of the implants. This and other studies found the
wear to be more pronounced on the lateral part of the anterior surface and the medial
part of the posterior surface of the stems; this pattern of polishing is in keeping with


57
repeated torsional micro-movement in internal rotation (Dobbs and Robertson 1983;
Anthony et al. 1990; Howell et al. 2004).

A number of studies have focused on determining the torsional stability of collared
cemented and cementless implants (Phillips et al. 1991; Callaghan et al. 1992;
Berzins et al. 1993; Harman et al. 1995; Chang et al. 1998; Harrington et al. 2002;
Cristofolini et al. 2003). Table 2-8 summarises the use of torsional stability within
current literature.

Table 2-8. Torsional stability
Author Implantation type Test variable
Schneider et al. (1989) Cementless Initial stem stability
Nunn et al. (1989) Cemented Stability with neck retention
Phillips et al. (1991) Cementless
Failure analysis

Berzins et al. (1993) Cementless Initial stability
Harman et al. (1995) Cementless Stem implantation variables
Harrington et al. (2002) Cemented
Multi-variable analysis

Baleani et al. (2000) Hybrid

Initial stability
Stability of the implant was assessed in terms of deflection under a predominantly torsional applied
load.
Hybrid stem is both cementless and cemented.
Variables of stem neck length, body weight,

stem size and calcar-collar contact.

To the best of the authors knowledge, the torsional stability of a polished double
tapered cemented stem have not been investigated. This type of stem is known to
subside by a few millimetres within the cement mantle in vivo, due to creep of the
acrylic cement (Fowler et al. 1988; Timperley et al. 1993; Alfaro-Adrian et al. 2001;
Williams et al. 2002). This subsidence could contribute to the torsional stability of
the system by engaging the tapered stem into a tighter interlock within the cement
mantle. We therefore designed our study to further investigate torsional stability after
debonding and controlled loosening followed by axial loading with subsidence of the
stem.


58
2.8 Exeter implant
The Exeter femoral stem was designed in 1969 by Prof. Robin Ling and Dr. Clive
Lee in conjunction with the Department of Engineering Sciences of the University of
Exeter (Fowler et al. 1988). The Exeter stem was initially implanted in 1970 and has
since become one of the largest selling implants in the world (Australian Orthopaedic
Association 2004; The Norwegian Arthroplasty Register 2005). The uniqueness of
the first generation Exeter stem was the distinct lack of the collar and the polished
surface of the stem. Clinical observations were made on existing designs of the
period indicated that contact between the calcar and the collar was lost by the time of
revision (Fowler et al. 1988). The collarless geometry of the original Exeter stem, in
combination with the double taper was intended to act as an extruder of the cement
into the endosteal bone surface of the femur (Fowler et al. 1988). Clinical follow up
of 17 years indicates that the Exeter stem moves distally within the cement mantle,
without disruption of the cement-bone interface (Fowler et al. 1988; Alfaro-Adrian et
al. 1999).
The original 1970 geometry of the implant was relatively slim in the anterior-
posterior section, narrow and standard sizes were available. In 1976 in order to
accommodate heavier patients the anterior-posterior section was increased, and two
neck offsets of 40-mm and 37.5-mm were introduced with five and four sizes
respectively. The head diameter for all implants was set at 30-mm, an additional
three sizes were made with a head size of 22-mm for congenital dislocation of the
hip. The surface finish of the implant was also modified in 1976 from a polished
surface finish to a matt surface finish. The alteration of the surface finish was found
to be detrimental to the longevity of the implant and the alteration was reversed in
1986. In 1986 the metal of the implant was changed from 316L stainless steel to
Orthonox alloy allowing the stem to be highly polished and has similar properties to
forged high strength Vitallium. In 1988 a mark 2 range of implants were introduced
that used a taper fixation between the head and the neck. The fundamental geometry
of the implant throughout all modifications since the original design in 1970 has
remained the same (Fowler et al. 1988). The surface finish of the current Exeter
implant has a published surface roughness (Ra) of 0.01 to 0.03m, measured using a


59
Surtronic 4 Taylsurf (Rank Taylor Hobson, UK) (Williams et al. 2002)
1
. Timperley
et al. (1993) state that the surface finish and geometry of the Exeter stem has been
shown in laboratory studies to fulfil the criteria of a taper.

Table 2-9. Changes in design of the Exeter stem.
Year Generation Surface Name Feature
1970 First Polished Original Double taper
1976 Second Matt Matt Slight AP increase
1986 Third Polished Monoblock Hollow centraliser
1988 Fourth Polished Universal Modular/full taper
Modified from Table I. (Shen 1998, p755)

In terms of the function of the implant the polished surface appears to be
advantageous in that the wear particle generation, common in matte surface stems, is
greatly reduced with the debris appearing to be retained on the surface of the stem
without significant damage to the cement mantle (Howell et al. 2004). Another
advantage of the Exeter stem is that the stem subsides within the cement mantle
without damaging the cement-bone interface (Alfaro-Adrian et al. 1999).

2.9 Estimation of the in vivo hip contact force
A complex system of forces act at the hip joint, generated by the muscles and the
inertial forces of the human body acting through the mechanical interfaces of the
femur and the pelvis. There are two methods of determining the resultant load at the
head of the implant; analytical determination and direct measurement of the loads
using telemetric devices within the implant.

2.9.1.1 Analytical load determination
Analytical determination of the resultant load at the hip joint has been used by
investigators in the past when direct measurement was not possible. It has also been

1
Measurements taken during the course of this research support this result.


60
proposed that analytical determination may be a more appropriate method of
determining the resultant loads in a healthy hip joint than telemetry because
instrumented implants are not an accurate representation of healthy joints
(Crowninshield et al. 1978). There are two commonly used analytical methods; the
reduction method and the optimisation method (Crowninshield et al. 1978). The
reduction method solves the indeterminate system by reducing it such that the system
becomes determinant. The optimisation method introduces an objective function,
optimised through its minimisation or maximisation, which in the case of gait could
be considered as being kinetic in nature (Crowninshield et al. 1978).
In the analytical method, the limbs of the body are considered to be rigid links and
articulate with frictionless pin joints. In order to obtain data on the position of the
subject during the test, clearly visible markers (reflective or light emitting) are
positioned at the hip, knee and ankle joints. The external forces acting on the foot
can be considered in terms of three forces and three moments; the external forces are
measured using a force plate. Muscle influence obtained using EMG data is
collected simultaneously as the subject is walking. The velocity and acceleration of
the limb segments are obtained by numerically differentiating the measured
displacement values. Values of the centre of mass and the mass moment of inertia
can then be calculated for the segments (Paul 1964). Muscle activation data may
then be incorporated into the analysis, depending on the solution methodology being
used.

The muscles included in the analysis vary from group to group. The model presented
by Paul (1964) identified 22 muscles acting at the hip joint, grouped according to
function. The groups of muscles considered were the muscles believed to produce
significant pressures at the hip joint and included groups producing flexion,
extension, abduction and adduction. Hip rotators were excluded as it was believed
that the component of force generated between the femur and the acetabulum by the
rotators was not significant. Crowninshield et al. (1978) identified 27
musculotendinous structures that could generate force.


61
Reduction method
The reduction method was used by Paul (1964). Using the 6 muscle groups and the
rigid links of the lower limb a system of equations was generated. The number of
variables was reduced by using EMG data, assuming that if there is no signal then
the muscle is not producing force. For synergistic actions the moments were
determined as if only one of the two simultaneously acting muscles was acting at that
time. This method generated a value for the force that was the upper limit for the
muscle force for that instant. For antagonistic actions the lower limit of the muscle
force is obtained by assuming that only two muscles act and that the moments
generated by those muscles must balance the applied moments.
The following assumptions were made: (1) Un-energised muscle requires no force to
stretch; (2) friction between the acetabulum and the femur can be neglected; (3) the
hip system will not rotate to a point that the ligaments will carry a load; (4) the
direction of the muscle force is in a straight line from the origin to the insertion. The
hip load from the investigation undertaken by Paul (1964) was not, as previously
mentioned, explicit. The magnitude of the load bound by the limits calculated by the
reduction method for gait was found to be 580 per cent body weight.

Optimisation method
The optimisation method was used by Crowninshield (1978). A total of 27 muscle
groups acting at the hip joint were included in this study. Ligaments were again
ignored on the assumption that the limit of motion would not be reached. The force
and moment equations at the hip, containing 30 unknown scalar variables, were then
generated. Two joint muscles that cross both the hip and the knee were assumed to
act in flexion or extension of the knee, their function at the hip was ignored. Flexion
extension moment equations were then generated at the hip and the knee. These
equations were used with the previously defined force and moment equations to
define the mechanical system. The optimisation criteria used was a linear objective
function J(t) for the minimisation of muscle stress (Equation 2-7).


62
30
1
( )
( )
j
j
j
f t
J t
A
=

=

2-7
Where A
j
is the physiological cross sectional area of the j-th muscle and f
j
is the force
of that muscle.
The stress was calculated with respect to the physiological cross sectional area of the
muscle. The constraints placed upon the muscle forces were that the muscle must be
in tension and that the maximum stress in the muscle must not exceed the maximum
allowable value corresponding to the physiological cross sectional area. EMG data
were not used directly during the optimisation process, but was used to validate the
results. The value of the resultant load determined by the optimisation technique for
gait ranged from 330 to 500 per cent body weight.

2.9.1.2 Direct load measurement (telemetry)
Instrumented implants have the advantage of being able to directly measure the
resultant load at the hip joint, eliminating the assumptions introduced when using
analytical methods. There are two varieties of instrumented implants that warrant
discussion. The first, and most relevant to this work, is the instrumented proximal
implant. The telemetered proximal femoral implant allows the investigator to
measure the reaction forces at the head of the implant, where the implant articulates
with the acetabular cup. The second instrumented implant is dubbed the massive
implant, replacing the entire proximal section of the femur and measures the reaction
forces along the long axis of the femur. A brief explanation of studies involving
various types of instrumented implants is given here.

To the authors knowledge the earliest attempts to measure the hip reaction force
using instrumented implants was undertaken by Rydell (1966) who developed a
measuring prosthesis using strain gauges in the neck of the implant. Rydell (1966)
determined peak loads of 1.59 and 1.76 times body weight for a subject with a
weight of 735N and peak loads of 2.95 and 3.27 times body weight for a subject of
441N for level walking at speeds of 0.9 and 1.3m/s. The direction of the contact


63
force was defined in terms of and , which were in turn defined by the following
relationships:
tan =
y
x
F
F

and
tan =
z
y
F
F

Where:
F
x
, F
y
and F
z
are the orthogonal components of the hip reaction force;
and are the angles made by the force components F
x
and F
y
when projected to the
frontal and sagittal planes respectively and;
BW is the body weight of the subject.

The table below is a summary of the peak loads and directions determined by Rydell
(1966).
Table 2-10. Summary of reaction loads measured by Rydell et al.
Subject Subject
weight
Walking
speed
y
F
BW

z
F
BW

x
F
BW

1 735N 0.9m/s 1.060.09 0.260.09 1.150.11 433 133
1 735N 1.3m/s 1.20.15 0.340.06 1.240.13 446 163
2 441N 1.1m/s 1.520.08 0.500.04 2.490.15 311 181
2 441N 1.4m/s 1.710.17 0.520.09 2.740.28 321 173

English and Kilvington (1979) used an instrumented femoral implant with strain
gauges positioned in the neck to measure dynamic hip loads in vivo. For the one
subject examined in the study a peak load of 2.56 times body weight was recorded
when the subject was walking at 0.44m/s, 12 days post surgery.

Forces transmitted through the long axis of the femur have been measured using a
massive implant. The proximal end of the femur is removed to allow for the implant.
The proximal main shaft of the massive implant is approximately 215mm in length


64
with a secondary shaft running down the medullary cavity of the distal end of the
femur almost to the epicondyles. The bone is resected to allow for the proximal shaft
of the implant to rest on the cortical bone. The implant (Figure 2-26) consists of the
head and neck, a shaft cavity with strain gauges, a shoulder allowing the implant to
rest on the distal femur, a stem hole, a stem tip cavity with strain gauges, and an
implant coil (Bassey et al. 1997; Lu et al. 1997).

Figure 2-26. Massive implant.
(Modified from Bassey et al. 1997, Page 214)

Two subjects were involved in the study. One subject was involved in the initial
study (Bassey et al. 1997), with a further subject included in the second study (Lu et
al. 1997). The first subject was a 47 year old, weighing 73.6kg and the second
subject was a 48 year old, weighing 86.5kg.
The use of the massive implant by Bassey (Bassey et al. 1997) was to relate the
ground reaction force of the patient to the measured force within the implant and the
activity of particular muscle groups. The magnitudes of the forces transmitted
through the bone are similar to those determined by other investigators.



65
One example of a telemetric proximal implant has been presented by a group from
the Orthopaedic Engineering Laboratory, Case Western Reserve University Clevland
U.S.A (Davy et al. 1988; Kotzar et al. 1991; Kotzar et al. 1995). Davy, Kotzar and
co-workers have used an implant based on the geometry of the DF80 Zimmer
implant. The neck of the implant has been modified to include an electronic cavity, a
battery, board clip, oscillator board, transmitter board, hip cap, and the prosthesis
ball.
Data gathered by this implant were gathered using a 3 axis load cell and were
organised in terms of resultant load, polar angle and cone angle. The polar angle and
cone angle define the position of the resultant hip contact force on the ball of the
prosthesis. A polar angle of zero would define the resultant hip contact force acting
in the plane of the prosthesis on its superior aspect. A cone angle of zero would
define the resultant hip contact force as being located at the apex of the ball and
acting directly down the neck. The implant used an internal battery for a power
source.
Two patients were involved in the study, a 67 year old woman 56.7kg in mass and a
72 year old man approximately 1.7m tall and 62.6kg in mass.

Initial results indicated that the magnitudes of the resultant hip contact force were
approximately 0.86BW for double limbed stance, 2.1BW for single limbed stance
and 2.64BW for walking (with walking aids). It was noted that as the time from the
operation increased the vigour with which the patient moved increased and there was
a corresponding increase in the resultant hip contact force observed (Davy et al.
1988).
Kotzar and co-workers (Kotzar et al. 1991; Kotzar et al. 1995) addressed the issue of
torques and moments produced during various activities. It was found that the
maximum torque during gait was 35Nm (at a velocity of 1.7m/s), maximum torque
during stair ascent was 23Nm, and the maximum torque when rising from a seated
position was 15Nm (Kotzar et al. 1995). The internal battery powering the implant
failed in both patients, after 31 days for the first patient and after 58 days for the
second patient.


66
An exceptionally detailed investigation into the hip contact force in vivo that
included two subjects was undertaken by Bergmann et al. (1993). An inductively
powered telemetric femoral stem was developed, allowing real time measurement of
three-dimensional loading. The implant was modified from a cemented titanium
implant, type Uni-Hip (Mecron). Three semiconductor strain gauges were placed
inside the implant along with the telemetry devices and the antenna was placed in the
ceramic head. The force was calculated by transforming the strain measurements
made at the implant neck.

Of the two subjects, one was healthy and active with bi-lateral implants, the other
patient was suffering from a neurologic disorder. The authors believed that the data
from the first subject would be representative of healthy patients, and the data from
the second subject would be characteristic of the loading patterns of patients with
abnormal gait (abnormal gait was thought to increase the hip contact load). A
comprehensive coordinate system was defined, and eventually built upon during later
investigations carried out by the group. Figure 2-27 shows the coordinate system as
described by Bergmann et al. (2001). Fx, Fy and Fz are the resultant hip contact
forces in the x, y and z directions respectively. The angles Ax, Ay and Az are the
angles of inclination of the resultant hip contact force. Mx, My and Mz are the
moments about the axes. The angle made between the axis of the femur and the axis
of the implant is denoted S. The moment M acting on the implant generated by the
resultant load has components Mx, My and Mz. The anteversion angle of the
implant is denoted Av. The coordinate system is set up such that the forces Fx, Fy
and Fz are almost always negative in value. The values of S and Av were measured
from x-rays and values of 8 and 13.5 were determined.
The patients were filmed using two video cameras while the telemetric data were
being simultaneously recorded.
Two important points were observed that deserve mention:
1. Stresses in the implant are not only influenced by the hip reaction force but
also by the moments that the reaction force generates.


67
Leading to the statement that:
2. The ability of an implant to resist moments in the frontal and transverse
planes is a sound indicator of the implants ability to function under in vivo
conditions (Bergmann et al. 1993, p65).

Figure 2-27. Co-ordinate system used by Bergmann et al. (2001)

The results presented here are for the healthy patient unless otherwise specified. The
largest force obtained while the patient was fast walking/jogging, 584% BW at a
speed of 7km/h, 12 months postoperatively. A force of 720% BW was recorded
when the subject stumbled. It was found that the forces increased with an increase in
walking speed and that the direction of the resultant hip contact force in the frontal
plane was nearly independent of walking and jogging speed and a near linear
relationship existed for the direction of the resultant in the transverse plane
(Bergmann et al. 1993). The maximum moment measured in the frontal plane while
walking or jogging was 10% BW (Nm) at 7km/h 17 months postoperatively. The



68
largest stumbling moment produced was 14.8% BW (Nm). The maximum moment
measured in the transverse plane (torsion) was 6.2% BW (Nm) at 7km/h 17 months
postoperatively, and when stumbling the torsional moment was 5.4% BW (Nm).

The authors state that as the patient regains normal activity levels after the operation,
the loads experienced at the hip joint will return to values indicative of a healthy joint
before implantation. However the authors noted that the gait patterns of patients
after surgery may never return to normal and therefore state that the results presented
can be generalized and applied to normal people only with caution.

Results for additional patients are presented in the more recent paper from the same
group (Bergmann et al. 2001). One of the useful additions of the recent paper is that
is also includes a CD containing the results (Bergmann 2001). The importance of the
torsional moment in the transverse plane is again emphasised, with the author also
stating that the other two components of the total moment are specific to the
definition of the centre of rotation and are also of little significance.

The average peak magnitude of the resultant hip contact force was approximately
238% BW for walking at a speed of 4km/h. The F
y
component, which causes much
of the implant torque is larger when going upstairs than for level walking. The F
y

component was found to be higher when going downstairs than for going upstairs;
and was found to be very small when sitting down. The peak forces measured when
standing on one leg were similar to the forces produced when walking.

To confirm the finding in the earlier study (Bergmann et al. 1993), the direction of
the force in the frontal plane was found to have low variation during all activities
(Bergmann 2001). The angle of the resultant in the transverse plane was found to
vary more than the angle in the frontal plane. The relationship between the
transverse angle and the magnitude of the resultant was not specified, however the
transverse angle was said to increase with the magnitude of the resultant hip contact
force. Results from the CD HIP98 are shown in Figure 2-28 and Figure 2-29,
giving results for the force and moment data respectively.


69

-50
0
50
100
150
200
250
0 0.2 0.4 0.6 0.8 1 1.2
Time (sec)
F
o
r
c
e

[
%
B
W
]
Fx[%BW] Fy[%BW] Fz[%BW] F[%BW]

Figure 2-28. Resultant hip joint force.
Shown for the average of four participants.
-2
-1
0
1
2
3
4
5
0 0.2 0.4 0.6 0.8 1 1.2
Time (sec)
M
o
m
e
n
t

[
%
B
w
.
m
]
Mx[%BW*m] My[%BW*m] Mz[%BW*m] M[%BW*m]

Figure 2-29. Average moment data.
Shown for the average of four participants.


70
2.9.2 Current in vitro loading techniques
As far as the author is aware, there are no standardised loading criteria for anatomical
loading of the femoral component in vitro. The loading vectors and boundary
constraints used to represent anatomical loading in vitro vary over the studies
included in this review with papers extending from 1990 to 2003. An important
paper on the standardisation of pre-clinical anatomical loading was presented by
Heller et al. (2005). This paper post-dates the anatomical loading study presented
within this thesis and the load profile developed by Heller et al. (2005) has not been
incorporated into this work. However, any further pre-clinical testing would benefit
from the inclusion of the load profile developed by Heller et al. (2005).

The loads that have been considered are the loads of the proximal femur. There are
many muscles acting at the head of the femur, however unless a specific
investigation into the contribution of muscles is being performed, it is common
practice to reduce these muscles into a single abducting force acting at the greater
trochanter. The boundary constraints applied to the femur are of great significance.
The manner in which the femur is constrained will impact on the stress and strain of
the system. The focus of this review is on the loads and boundary constraints applied
to the femur during in vitro studies that were used to validate finite element models.

Of the 33 papers reviewed 14 of these (many by common authors) used the two
forces of the abducting force acting at the greater trochanter and the resultant load
acting at the head of the femur. Table 2-11 shows a typical loading vector used when
two reaction forces are considered.

Table 2-11. Maximum Contact Force For Normal Walking
Force (N) x y Z
hip contact -451.4 -274.2 -1916.1
abductor 484.9 35.9 723.1
(Bergmann 2001)


71
An incorporation of muscle forces will be necessary if the analysis considers the
stresses generated within the femur. If the analysis considers the subsidence and
motion of the prosthesis within the femur then the boundary conditions of the system
are simplified to only account for the joint reaction force (Schneider et al. 1989;
Claes et al. 2000; Maher and Prendergast 2002). Even when some of the muscles are
incorporated into the analysis, a full stress analysis of the femur and surrounding
system will be very difficult as data pertaining to the forces produced by all of the
muscles acting on the femur at any point in time is not available, making validation
of such a model virtually impossible. An attempt was made by Duda et al. (1998) to
characterise the influence of muscle forces on femoral strain distribution using finite
element modelling. The authors acknowledge that the forces used were a rough
approximation of the in vivo situation. However, they observed that the muscles of
the thigh had a large influence on the strain distribution (largely used as the bases of
bone remodelling) of the femur.

The manner in which the femur itself has been treated during in vitro
experimentation varies considerably from author to author. The majority of authors
have used a truncated femur retaining the proximal end (Schneider et al. 1989;
Buhler et al. 1997; Claes et al. 2000; Speirs et al. 2000; Gotzeet al. 2002; Maher and
Prendergast 2002). Proximal lengths of 18cm (Schneider et al. 1989) to 37cm (Claes
et al. 2000) have been used. Other groups have used the entire femur and cast the
epicondyles usually in PMMA (Cristofolini et al. 1996; Viceconti et al. 2001a). The
loading condition used by the groups retaining the epicondyles is often such that no
anterior-posterior force is introduced, thus reducing the bending moments within the
bone and subsequently reducing the stress and the risk of failure. A loading regime
including anterior-posterior forces has not been seen in the literature when the entire
length of the femur is retained.

The loading regime suggested for this investigation is novel in that it retains the
entire femur and uses a resultant loading vector that includes forces producing both
compressive bending and torsional loads.


72
2.10 Relationship between stress-strain and bone
remodelling
When considering finite element modelling of bony structures the relationship
between stress-strain and bone remodelling is an extremely important one. Bone
adaptation as a result of mechanical stimuli was first described by Wolff (Wolff
1986) in the law of bone remodelling. In more recent years the law of bone
remodelling has been developed in terms of a mathematical theory of adaptive
plasticity (Cowin and Hegedus 1976). An applied load will generate a strain field
within the bone, and the bone structure will adapt in shape and density such that for a
typical load the strain field produced will be a reference strain (Huiskes and Hollister
1993).

Strain adaptive remodelling theory is often used to predict the bone response to a
strain stimulus that is different from the homeostatic conditions (reference strain).
Such changes in the bone strain would be observed following a hip arthroplasty. The
theory is based on the assumption that the strain at a point of the bone prior to the
implantation of the arthroplasty is at a reference strain S
ref
and that deviations from
this reference strain will cause the bone to remodel. The strain of the bone with the
implant inserted is measured in terms of an equivalent strain tensor S (where
S= ( )
ij ij
). The type and rate of the bone adaptation is determined by the
difference between the reference strain and the equivalent strain. The magnitude and
direction of the deviation from the reference strain will influence the rate of the
remodelling as shown in Figure 2-30.


73
Figure 2-30. Strain remodelling curve
(Turner et al. 2005)

The rate of the change in apparent density loss and gain
d
dt

is modelled using
Equations 2-8 (Turner et al. 2005).
( ) ( (1 ) ) (1 )
0 (1 ) (1 )
( ) ( (1 ) ) (1 )
inc ref ref
ref ref
dec ref ref
a C S s S where S s S
d
where s S S s S
dt
a C S s S where S s S
+ > +
= +
>

2-8

Where a() is the surface area density, C
inc
and C
dec
are the density increase and
decrease rates and s is a parameter that defines the width of the dead zone.

This theory states that if the applied load changes, then there will be deviation in the
strain field and the change in the strain field becomes the driving factor in bone
remodelling. Remodelling can include changes in bone density and internal and
external shape changes.



74
2.10.1 Stress shielding
The theory of adaptive bone remodelling has been applied to the femoral component
with the belief that the maintenance of bone is related to the stress and strain
properties of the bone-cement and cement-stem interfaces. It has been proposed that
the differences in osseointegration can be explained by local tissue strains and that
the rate of tissue formation is dependent on the strain invariants (Simmons et al.
2001). Furthermore, the highest level of bone remodelling is said to occur at the
points of highest equivalent stress (Barbier et al. 1998) (where the equivalent stress
would be proportional to the equivalent strain defined in Section 2.10). The
reduction of mechanical stress acting on bone surrounding an implant is often
referred to as stress shielding (Sumner et al. 1998). Stress shielding is therefore
believed to have a negative effect on the overall long-term stability of the hip
arthroplasty. Mechanically the stress-strain patterns surrounding the implant are
dictated by the geometry, material properties and external loading conditions of the
system. Therefore by examining the geometry and material properties of the implant
the stress-strain conditions, and subsequently the presence of stress shielding, can be
determined (Verdonschot and Huiskes 1997a; Sumner et al. 1998; Simmons et al.
2001). The minimisation of mechanisms such as stress shielding will decrease the
disruption to the mechanical lock and subsequently increase the longevity of the
implant.

2.10.2 Strain and the degradation and fatigue of cortical bone
A study conducted by Pattin et al. (1996) examined the changes in the secant
modulus and cyclic energy dissipation behaviour during axial load controlled fatigue
loading of cortical bone. The investigation found that cortical bone behaves as a
linear viscoelastic material at strain levels below 1500 even if the bone has
experienced fatigue damage accumulation that can occur at strain ranges between
1500-3500. The bone undergoes a change from linear viscoelastic behaviour at a
range of 1500-2500, during which the bone increases in cyclic energy dissipation
and decreases in the modulus as a result of damage accumulation. A single value of


75
strain for which the transition between linear viscoelastic behaviour and damage
accumulation is not given as the point at which damage accumulation occurs will be
dependent on the loading history of the specimen and the level of previous damage
accumulation.

2.10.3 Clinical implications of bone remodelling following THA
Strains in the proximal native femur in vitro, when loaded anatomically with a single
hip contact resultant force directed inferio-laterally 15 degrees in the coronal plane,
are characterized by a pattern of compressive strains on the medial cortices, tensile
strains on the lateral cortices and proportionally smaller transverse strains that are
compressive laterally and tensile medially (Oh and Harris 1978; Otani et al. 1993).
The insertion of a collared cemented or cementless total hip replacement (THR) stem
considerably reduces the compressive strains at the medial calcar (Oh and Harris
1978; McBeath et al. 1980) and produces a small increase in tensile circumferential
strains at this level (McBeath et al. 1980). This reduction in longitudinal strain and
potentially also equivalent strain may result in stress shielding which could further be
linked to the reduction in bone mineral density at the femoral calcar (Bocco et al.
1977; Blacker and Charnley 1978; Engh et al. 1993; Cohen and Rushton 1995;
Pritchett 1995; Kroger et al. 1998; Venesmaa et al. 2003). Bocco et al. (1977)
investigated bone response to implant position and found that there was a lower
incidence of bone resorption in a valgus group than in a control group that included
neutral, varus and valgus specimens. Mc Beath et al. (1980) investigated the strain
patterns of native and implanted femurs using Charnley and Charnley-Muller
implants in neutral, varus and valgus positions. For a load applied at an angle of 9
degrees to the axis of the femoral shaft (in the coronal plane) the longitudinal
compressive strains along the medial cortex decreased for both the Charnley and
Charnley-Muller implants when implanted in a varus position from approximately
900 to below 200. The tensile circumferential strain at the medial calcar
possessed a native bone strain of 140. When the stems were implanted in a varus
position the strain increased to 250 for the Charnley implant but decreased to 80
for the Charnley-Muller implant. Previous research has found that varus positioning


76
of collared cemented stems may be a predisposing factor for early loosening
(Sutherland et al. 1982; Callaghan et al. 1985; Kristiansen and J ensen 1985;
Munuera and Garcia-Cimbrelo 1992; Kobayashi et al. 1994). In contrast the
survivorship of the Exeter (Stryker Corporation) stem, featuring a polished collarless
double taper design, has not been shown to be adversely affected by varus
positioning (Williams et al. 2002). To the best of the authors knowledge, there is no
biomechanical study in the literature concerning the position dependent strain on the
proximal femur around a polished collarless double tapered cemented stem.

2.11 The use of FEM to study the femoral component of
the total hip arthroplasty
The prevalence and accessibility of computers has ensured that numerical methods in
combination with computer aided design (CAD) are being widely used in many
engineering disciplines, including biomedical engineering. Of the numerical
methods currently available the most common and useful in engineering terms are
arguably the finite element method and the boundary element method. For the
purposes of this study the finite element method has been selected, as the condition
of the entire body, including the interfaces is required. The finite element method
by general definition includes a numerical description of the geometry, boundary
conditions, loading state and material properties of the system under investigation.
The finite element method discretizes the body under investigation into a finite
number of elements. The response of the system is then obtained by applying an
interpolation function to each individual element. The numerical solution will, in
theory, approach the exact solution to the model as the number of elements
approaches infinity. The exact solution to the model is determined by the
assumptions made regarding the model type, the material properties, loads and
boundary conditions used to generate the model.


77
Finite element models have been used in a variety of ways to investigate the femoral
arthroplasty including investigations into the load transfer at the interfaces (stem-
cement and bone-cement) of the system, sensitivity analyses of component geometry,
component stiffness, bone quality and failure analysis. J oshi et al. (2000) proposed
that the limits of the finite element method in describing the biological system of the
femoral component include the inability to model the nonhomogenous anisotropic
nature of bone, an inability to fully define the contribution of the muscles and the
effect that they have on the femur stresses and the inability to system interfaces in an
accurate manner. It could be said that these are not limits of the finite element
method per se; rather they are practical limitations of the method when determining
and validating complex models that include anisotropic materials and complex
loading regimes.

2.11.1 Model Type
It is common to consider only the proximal region of the femur, including the
femoral stem and surrounding cement mantle when considering a cemented femoral
component. There are several model types available; these include axisymmetric,
two-dimensional and three-dimensional models. The model type selected imposes
limits on both the input to the model (geometry, loads and boundary conditions) and
the data obtained from the model (displacement, stress, strain). The geometry of the
femur and the femoral stem is complex and for this reason the femoral component
cannot be modelled in detail using two-dimensional (i.e. plane stress) or
axisymmetric models. However, many two-dimensional and axisymmetric models
exist in the literature generally as tools for the purpose of initial investigation.
Axisymmetric models have been used successfully to determine the effect of creep of
the bone cement and debonding of the stem-cement interface (Norman et al. 1996;
Verdonschot and Huiskes 1996b). Two-dimensional models are still used for
computationally expensive problems such as non-linear interface analysis and shape
optimisation (J oshi et al. 2000).


78
2.11.2 Model Generation
When modelling the femoral component three-dimensionally it has become common
to use Computed Tomography (CT) scans to generate the geometry and the finite
element mesh of the femur. A model generated using CT scan data can not only
capture the complex geometry of the femur but it can also be used to approximate the
material properties of the bone, for example using the empirical equation developed
by Carter and Hayes (1977) (Equation 2-3, Page 29).
CAD models of various structures of the body are currently available and their use is
encouraged by some member of the research community to provide uniformity in
model geometry. When such models are used a pre-processor is used to mesh the
existing model geometry.

2.11.3 Material Properties
Bone and bone analogues
The material properties for both cancellous and cortical bone are anisotropic and
non-homogeneous, but behave approximately in a linear-isotropic manner by
approximation (Huiskes and Chao 1983). The properties of cadaveric bone are often
simplified and estimated using the empirical Equation 2-3 (Page 29) developed by
Cater and Hayes (1977). This method is generally used when the modeller has
developed the geometry using CT scans.

When modelling the second generation Sawbones femur Stolk et al. (2002) assumed
that the material properties of the cortical bone analogue were elastic and
transversely isotropic with the following values:

E
x
,E
y
=7.0GPa; E
z
=11.5GPa; G
xy
=2.6GPa; G
yz
,G
zx
=3.5GPa; v
xy
,v
zy
,v
zx
=0.4.

This was a suitable decision as the glass fibres of the second-generation Sawbones
femurs were aligned. The third-generation Sawbones femurs are short glass fibre
composites and the assumption that the material behaves as a linear isotropic


79
material is sound. The manufacturer details of the material properties of the bone
were given in Table 2-6 (Page 37).

Cement
The method of modelling cement depends greatly upon the specific purpose of the
model. Time dependent models (i.e. cyclic or long term subsidence models) often
define cement as a viscoelastic solid. The general form:

1.55 0.1
45997
cr
t
=
2-9

Where
cr
is the time dependent creep strain, is the equivalent uniaxial stress (MPa)
t is the loading time (seconds) and
1
45997
is a dimensionless constant (McKellop et
al. 1988).

For short term loading models that are not time dependent modelling the creep
behaviour of cement can add unnecessary computational expense to the calculation.
In these cases the cement is modelled as a linear elastic and isotropic material with
Youngs modulus values in the range of 2.1 to 2.3GPa with a Poissons ratio of
approximately 0.3 (Verdonschot and Huiskes 1997a; Verdonschot and Huiskes
1997b; Norman et al. 2001; Stolk et al. 2002).

Implant
The Exeter implant is made using Orthinoxultra high strength stainless steel alloy.
When modelling the Exeter implant Verdonschot and Huiskes (1996a) assumed that
Orthinoxbehaved in much the same manner as a stainless steel prosthetic material.
Assuming that the prosthesis possesses similar material properties to stainless steel
the Youngs modulus is typically of the range 200 to 210GPa with a Poissons ratio
of 0.28 to 0.3 (Verdonschot and Huiskes 1997a; Barker et al. 2000; Stolk et al.
2002).


80
2.11.4 Interface modelling
An investigation into the failure process and probability of failure of the femoral
component using a CT scan finite element model was presented by Verdonschot and
Huiskes (1997a; 1997b). The investigation into the interface was prompted by the
work carried out by J asty et al. (1991), which indicated that cement-stem debonding
preceded implant failure. Material properties were again obtained using Equation
2-3. The failure criteria used for this model was presented by Hoffman (1967)
presented in Section 2.7.1 (Page 49).

2.12 Shortcomings of previous FE models
Axisymmetric models
An example of an axisymmetric model was used by Huiskes et al. (1989) to
investigate the optimisation of the geometry of a simplified model of intramedullary
fixation. An optimisation criteria was applied to the longitudinal profile of the stem
in an attempt to optimise the longitudinal profile of the stem. The objective function
of the optimisation process was to minimise cement-bone interface stress
concentrations. Current literature highlights the importance of torsional loads and
out of plane forces when considering the component mechanics of the femoral
component (Bergmann et al. 2001). The process used for this study was clearly not
capable of determining the ideal geometric characteristics of the implant, as the
femoral component is never cylindrical, so the stress produced from bending and
torsional loads would not be representative of the actual femoral stem. The authors
attempted to address this problem by including a two-dimensional plane stress
model. The element thickness was selected to produce suitable stiffness values and
side plate spanning elements were used to maintain the three-dimensional nature
of the system. The plane stress model was used to investigate the profiles
determined from the axisymmetric model for this more realistic configuration.
Despite the simplified models being used the authors believed that the method was
acceptable for providing a meaningful basis to the design process. Axisymmetric


81
models are not able to model a stem of irregular cross-section exposed to out of plane
loads, which is necessary when modelling the femoral component.

Plane Stress
A two-dimensional plane stress model was presented by Weinans et al. (1990) to
investigate the mechanical implications of a fibrous membrane around the femoral
component. The structure of the model was almost identical to that of the Huiskes
(1989) model, with the exception of the femoral stem which possessed a collar. Side
plate elements were again used to maintain the three dimensional nature of the
geometry. The authors clearly state that the nature of the model presented is such
that the results obtained can be used only as an indication of how the debonding
process behaves. One significant conclusion of this work is that the interface
condition considerably affects the stresses in the system.

Three-dimensional CT
Three-dimensional models of the proximal femur have been prepared and discussed
in several papers by Keyak and co-workers (Keyak et al. 1990; Keyak and Skinner
1992; Keyak et al. 1993; Keyak et al. 1997; Keyak and Rossi 2000; Keyak 2001;
Keyak et al. 2001a; Keyak et al. 2001b). These models were created using CT scan
data and were meshed automatically for the purposes of rapidly generating patient
specific models. The material properties of the models were obtained from Equation
2-3. Initially the model results were compared to previously published stress values
from models presented by various authors (Keyak et al. 1990), or by using one of
three models as a control model (Keyak and Skinner 1992). This method does not
provide true validation of the models hence results from them must be considered
with care in evaluating clinical relevance.

Using the Hoffman failure criteria, Verdonschot and Huiskes (1997a) used a model
developed previously by the same authors (Verdonschot and Huiskes 1996a) to
investigate the theory that failure of the cement-stem interface is a fatigue process
and is not immediate. They also theorised that while the debonding process


82
progresses the maximum stresses of the interface do not increase, indicating that a
partially loose implant is no less safe than a fully bonded one. This result is not in
the least surprising, as the paper investigates a collarless stem said to represent the
Exeter implant. The Exeter implant is a force closed design, and any investigation
into the effects of cement-stem debonding should be based on a shape closed
implant. The Exeter stem has been shown to possess excellent clinical follow up
results. An analysis of fatigue failure of the stem-cement interface of a cemented
Exeter stem may therefore have no clinical relevance as according to Howell et al.
(2004) the issue with wear particle formation and migration is of limited effect for
the highly polished double tapered design of the Exeter stem.

If a FEM is developed it should be undertaken with due care to ensure that the
generation of the model includes not only experimental validation but clinical
significance. Models generated without adequate reference to the clinical aspects of
femoral component function are at risk of producing poor data and irrelevant
conclusions.

2.13 Conclusions
From the review of literature it was concluded that a full numerical and experimental
investigation into the torsional stability of a cemented polished tapered femoral stem
for conditions of fixed and revision reimplanted states would provide valuable
information. The information obtained from this investigation would improve the
current level of understanding of femoral component mechanics, in particular the
mechanisms by which polished tapered stems maintain their stability.

An experimental and finite element modelling approach is proposed to assess the
torsional stability and component mechanics of the Exeter stem. This combined
approach provided a unique opportunity to study the femoral component and how it
interacts with the surrounding cement and bone. A validated finite element model of
the proximal femur and the femoral component will allow an in depth analysis of the
external surface strain of the femur and an internal analysis of the state of stress at


83
points within the cortical bone, cancellous bone, cement and the cement-stem
interface. This information will be valuable in determining the fundamental
mechanisms behind the success of the Exeter stem and enable clinical questions to be
answered.


84


Chapter 3: Design of the apparatus and protocols for the experimental
investigation of the implanted Exeter stem
85
Chapter 3: Design of the apparatus and
protocols for the experimental
investigation of the implanted Exeter
stem

3.1 Introduction
This chapter describes the apparatus and protocol design for two complementary
experimental procedures that were used to validate a finite element model and to
investigate the torsional stability of the Exeter femoral stem when subjected to
various levels of loading. The chapter begins by specifying the experimental
hypothesis and aims. A description of the experimental materials is then followed by
an outline of the design of the femoral constraint and the torsional loading rig.
Consideration is given to the repeatable implantation of the stem within the femur
and an explanation of the implantation technique. The specimen instrumentation is
described for the strain and relative displacement measures and the testing
environment is then given before the experimental protocol is outlined.
A pilot study using the equipment and the experimental protocol was then
undertaken to commission the experimental system. A flow chart of the
experimental and finite element process for the research is shown in Figure 3-1 with
the work covered in this chapter highlighted.


86

Topics shown in grey are not covered within this chapter.

3.2 Experimental Aim and Hypothesis
The Exeter stem subsides by approximately 1mm in the first year of implantation
(Alfaro-Adrian et al. 2001). The longevity of the Exeter stem does not appear to be
impaired as a result of this subsidence as is evident by the excellent survivorship
record (The Norwegian Arthroplasty Register 2003). This study investigated the
mechanics of the femoral component of the Exeter total hip arthroplasty focusing on
the torsional stability of the stem after periods of loading, to assess the changes in
torsional stability (if any) with increased stem migration.


87
The experimental hypotheses investigated during this study were:
1. An Exeter stem will experience stem migration during the early loading
period (load cycles 86,400) and will remain torsionally stable during this
time;
2. If presented in an unstable state with the implant removed and replaced
without new cement being used (as occurs during an acetabular cup revision
if the stem is removed to enhance the exposure) the Exeter stem will become
increasingly torsionally stable under the application of simulated
physiological compressive cyclic loading.

3.3 Experimental Objectives
To investigate the hypotheses the following objectives were proposed:
1. To develop a representative experimental model of the proximal
femur/implant system using synthetic (Sawbones) femurs;
2. To develop a test jig to measure the torsional stability of the femoral stem;
3. To measure forces, relative displacements and strains at three locations under
compressive loads for the purpose of validating the finite element model;
4. To monitor the stability of the femoral stem after periods of cyclic loading
where the head of the implant is loaded using a hip contact force that is
representative of the loading force observed during walking;
5. To assess the change in stability of the implant from an unstable
(reimplanted) state when loaded cyclically for a 6 hour period followed by
relaxation for an 18 hour period.

3.4 Experimental materials
Synthetic Sawbones femurs (Pacific Research Laboratories) were used in the
experimental program to produce a femur/implant system with realistic and
reproducible geometry and material properties.


88

3.4.1 Mechanically analogous composite femur
The Sawbones third generation medium analogue femur (#3303) was selected as the
analogue femur type. This selection was made on the grounds that in addition to an
improved analogue cortical material the #3303 femur possesses geometry closer to
that of cadaveric specimens than previous generation Sawbones with the inclusion of
a medullary cavity and greater anatomic detail (Pacific Research Laboratories 2005).
When approached regarding the geometric variation of the Sawbones femurs Pacific
Research Laboratories did not have quantitative data, but were of the opinion that the
geometry of the femurs would be consistent (J ames 2004).

3.4.2 Stryker Exeter Stem
According to the Australian Orthopaedic Association National J oint Replacement
Registry (2003) a cemented stem is used in 83.2% of cases with the Exeter stem
being used in 43.4% of primary total hip replacements for cemented fixation (both
femoral and acetabular components were cemented) and 44.1% of cases for hybrid
fixation (femoral component is cemented and the acetabular component is
cementless). This makes the Exeter stem the most commonly used cemented stem in
Australia (Australian Orthopaedic Association 2004).

3.5 Design of femoral constraint
It is important to draw attention to the fact that the loading configuration (resultant
loading vector and boundary conditions of the femur) was not intended to reproduce
all of the hip contact forces experienced by the in vivo femoral component. The aim
was to develop a loading regime that was in keeping with the anatomical system and
that would promote subsidence throughout the loading cycle.
It has been shown by Stolk et al. (Stolk et al. 2001) that the inclusion of muscle
forces reduces the cement mantle stresses within the cement mantle by less than


89
11%. Pancanti et al. (2003) presented results indicating that the effect on relative
micro-motions between the implant and the bone for a cementless implant will be
negligible with the inclusion of muscle loads. A single force representing the
resultant hip contact load was used for this investigation, allowing a simplification of
the loading protocol without adversely affecting the results.

Design considerations
The direction of the resultant hip contact load used for this investigation was based
on the data of Bergmann et al. (2001). The hip contact force of four subjects was
measured using telemetrised implants while the subject walked at a normal speed.
The results from each subject were recorded and expressed in terms of a force per
unit weight. The average unit vector for the resultant hip contact load was found to
be -0.037, -0.965, -0.223 in the x, y and z-directions respectively.
This load vector was achieved by designing a constraint that positioned the femur at
an angle of 10 in the frontal plane and 11 in the sagittal plane. A vertical cyclic
load (1Hz) was then applied to the head of the implant using a materials testing
machine.

Other design criteria for the femoral constraint were as follows:
1. The bone was to be whole while constrained and;
2. The bone could be constrained repeatedly in the same position irrespective of
the number of times that the femur is removed and replaced.

Material selection, machining and manufacturing considerations
In order to expedite the manufacturing process and to reduce cost, marine grade
aluminium was used. The aluminium combined ease of manufacturability with the
strength and stiffness required for such a test.


90

Figure 3-2. Femoral constraint

Design solution
The final design of the femoral clamp is shown in Figure 3-2. Since the variation in
the geometry of the Sawbones femurs is minimal, the epicondyles were used as a
reference for the angular rotation and position of the femur. The epicondylar
constraint was bolted to an inclined plane, to set the rotation and position of the
femur. The angle of the femur was constrained in this position by the femoral mid-
shaft support. To accommodate the irregular geometry of the femur poly-methyl
methacrylate was used to fill the mid-shaft support to provide the maximum contact
area between the support and the femur. The most proximal point of contact between


91
the PMMA of the mid-shaft support and the femur was four diameters of the implant
distal tip from the most lateral point of the implant.

Clamping protocol
When clamping a femur the epicondyles were positioned in the following manner:
1) Tighten the medial-lateral clamp plate until there is contact between the
lateral epicondyle and the epicondylar constraint;
2) Tighten the anterio-posterior clamp plate until there is contact between the
anterior condyles and the epicondylar constraint and the posterior condyles
and the clamp plate;
3) Ensure that there are 6 points of contact at the condyles;
4) Lock the plates into position by tightening the middle screw finger tight and
nipping the 4 remaining screws a quarter of a turn;
5) Ensure that there are 6 points of contact at the condyles.

The femoral mid-shaft support was then positioned and the four screws were
tightened to 0.4-Nm, and were tightened carefully to ensure an even and repeatable
clamping force.

3.5.1 Reproducibility of the clamping procedure
The reproducibility of the clamping procedure was tested using a #3303 Sawbones
femur. An analogue femur was clamped into the femoral constraint. A line was
drawn on the mid-shaft support perpendicular to the point of the femur closest to the
angled plate of the mid-shaft support. A patch of graph paper was fixed onto the
femur with tape so that the centre of the grid paper was aligned with the line drawn
of the mid-shaft support. The relative Y-axis of the grid paper was oriented so that it
was parallel with the top surface of the mid-shaft support. The position of the grid
paper was then checked using a ruler aligned with the line drawn on the mid-shaft
support and held flat against the top surface of the mid-shaft support.


92

Figure 3-3. Measuring the error in the positioning of the Sawbones femur into
the femoral clamp

An independent researcher who had never seen the femoral clamp and the designer
of the clamp each carried out five trials, consisting of the removal and clamping of
the femur. The independent researcher was instructed in the clamping protocol prior
to the repeatability test being carried out. The position of the femur was marked with
a pen using the ruler for alignment. The error in the position could then be measured
with a digital vernier calliper in both the X and Y-directions.

Results
Both researchers found that there was no measurable error in the position of the
femur in the relative Y-axis. The error in the Y-axis position was not significant
given the thickness of the line forming the X-axis and the thickness of the pen used
to mark the graph paper. Slight error was found in the X-axis. However, the error
was very hard to measure given the equipment available and for the reasons
mentioned above. The error in the X-axis was estimated to be between 0-0.5mm
over the 10 trials.

Discussion
The magnitude of the error in the repositioning of the unloaded femur was very small
given the magnitude of the loads being applied during the experiment and the


93
reproducibility of the manufacturing of the femurs. The femur is positioned on the
basis of the epicondylar geometry and as such any permanent deformation of the
epicondyles would generate error in the positioning. However, the magnitude of the
error produced by deformed epicondyles would be minimised by the mid-shaft
constraint.

3.6 Design of torsional loading rig
Design considerations
A pure torsional load is defined in the context of the Exeter femoral component as a
moment about the long axis of the implant. The torsional load will therefore produce
pure rotation of the distal tip of the implant without translation.

Design solution
The torsional loading rig consists of the following components (Figure 3-4):
1. Base plate
2. Bearing
3. Torque arm
4. Epicondylar constraints
A loading arm of 0.1m couples the torsional loading rig to the Hounsfield Materials
Testing Machine (Hounsfield Test Equipment Ltd., Salford, England).

The Hounsfield Materials Testing Machine is an S-series H25K-S Universal Testing
Machine. The machine used for this experiment uses a 25kN load cell of Z-beam
construction (suitable for tension and compression) with test speeds from 0.001 to
1000mm per minute for loads of 10kN and to 500mm per minute for 25kN.
The linear motion of the Hounsfield was converted into a torsional load using a shaft
within a bearing housing. The bearing shaft is then attached to the torque arm, which
transmits the torsional load to the head of the implant. The bearing is mounted onto
a base plate which attaches to the Hounsfield.


94

Figure 3-4. Torque rig with the femur removed to show the implant-torque arm
coupling

The coupling between the implant and the torque arm needed to be firmly attached to
eliminate any movement and the position of the implant within the torque arm must
be repeatable.

3.6.1 Rigid fixation of the Exeter stem and drilling technique
To achieve secure fixation of the Exeter stem within the torque arm a flat edge was
machined on the superior aspect of the taper. Drilling holes into the lateral edge of
the stem for the insertion of the pins for attachment of linear variable differential
transformers (LVDTs) was also required (see section 3.9 Relative displacement).
The modification clamp was built to hold the implant in a repeatable manner in order
to undertake these modifications (Figure 3-5). This device would also be used to
drill holes through the femur into the Exeter stem for the LVDT pins.


95
The modification clamp consisted of:
A datum base, from which all measurements were made;
A head, to accommodate the taper of the implant;
A collar, to secure the head into position in the line of the axis of the taper;
A femur/implant support, to support the femur and the implant during
drilling;
Support arms, to give adjustability in all directions to the femur/implant
support; and
A locking block, to be used once the flat was machined onto the taper to
secure the implant.

Figure 3-5. Machining and Drilling Clamp

In order to machine the flat onto the taper the following protocol was used:

1. Remove top block from the machining and drilling clamp,
2. Assemble prosthesis within the top block. Assemble retaining collar and
fasten lightly (Figure 3-6),
3. Fit block in mill device,
4. Align the long axis of the prosthesis with the horizontal.


96
A.

B.

C.

Figure 3-6. Positioning the Exeter stem for machining the taper in preparation
for rigid fixation and drilling.
A. Machining and drilling clamp shown with datum base and top block disassembled; B. Clamping
procedure for the milling of the taper. Region (1) highlights a block used to align the long axis of the
prosthesis to the horizon. Region (2) highlights the top block; C. Centralising the distal tip of the
implant prior to modification

5. Rotate prosthesis so that the long axis of the implant or centre line is parallel
to the clamping blocks (Figure 3-6 C).
6. Lock the collar tight and remove from vice
7. Clamp prosthesis into padded aluminium vice block (face rest on jaw top
surface).


97
8. Mill superior aspect of the taper so that the machined flat is flush with the
neck
9. Remove block
10. Reattach the top block to the datum base
11. Find the centre line of the prosthesis head (X and Y)
12. Drill and ream 2 holes n2.0 4 (Figure 3-7).

Figure 3-7. Drilling dimensions for the Exeter stem relative to the machining
and drilling clamp

Fixation of the stem into the torque arm was carried out using the following protocol:
1. Insert the head of implant into the taper of the torque arm.
2. Fix the collar to the torque arm and tighten leaving some play in the screws.
3. Tighten the screws of the torque arm to bring the locking block into position
ensuring that the locking block is flush with the machined flat on the head of
the implant.


98
4. Tighten the screws of the collar until firm.
5. Adjust the distal epicondylar clamps using only the blocks associated with the
posterior condyles and the medial condyle so that the blocks are just in
contact and are applying minimal pre-load.
6. Tighten the grub screws of the clamping blocks associated with the anterior
and lateral condyles until the system is firmly in place.

3.6.2 Exeter position within the Torque arm
The position of the Exeter stem was investigated for each of the four stems to
determine if any significant variations exist in the geometry of the implants. An
arbitrary datum in the X and Z directions was defined and maintained for all implants
(Figure 3-8).

Figure 3-8. Implant position within torque arm

The results of the implant position test are given in Table 3-1.


99

Table 3-1. Implant position within Torque arm
Implant X-POSITION
(mm)
Z-POSITION
(mm)
1 40.10 84.31
2 40.05 84.72
3 40.25 84.68
4 39.95 84.72
Mean 40.09 84.61
Variance 0.015 0.04
Range 0.30 0.41

The reproducibility of the position of the implant within the torque arm was also
tested. Figure 3-8 shows the dimensions and Table 3-2 gives the results.

Table 3-2. Stem position repeatability in torque arm.
Test 1
Stem Trial X (mm) Z (mm)
1 A 71.79 33.55
B 71.81 33.73
2 A 71.79 32.98
B 71.84 32.85
C 71.81 32.9
D 71.80 32.94
3 A 72.04 33.03
4 A 71.74 33.27
B 71.74 33.28
Maximum Variation (%) 0.42% 2.61%

3.6.3 Repeatable implantation procedure
The position of the Exeter stem within the femur was controlled with the use of a
positioning device. The device was designed to attach to the force support of the
femoral constraint. The positioning device was designed to control the position of


100
the implant in all degrees of freedom relative to the femur, and considered only the
final position of the implant of interest (i.e. the insertion path was not controlled).

Figure 3-9. Positioning Block with implant

The positioning device was designed to enable reproducible implantation of the stem
identical to an optimal implantation performed by the senior surgeon. A block was
fixed onto the head of the implant, using the machined flat edge to position the block
(Figure 3-9). Three mutually perpendicular planes were milled on the block to mate
with a three-plane surface supported by a column and bolted to the force support of
the femoral constraint. The device therefore controlled both the rotation and the
translation of the implant.

3.7 Femoral stem implantation
The Exeter stems were implanted using the femur clamp and the implant positioning
device. Variation in the internal geometry of the femurs gives rise to the possibility
of a thin cement mantle being produced between the stem and the cortex. If it
appeared that the cement mantle in this region would be unacceptably thin (i.e.
thinner than 2mm) the internal surface of the cortex was broached until clearance for
a satisfactory mantle was produced.


101
Careful attention was paid to the implantation process to ensure that the procedure
followed in the laboratory was as close as possible to the clinical procedure. All
implantations were carried out by the same orthopaedic surgeon.

A.

B.
Figure 3-10. Resection of the femoral head and neck.
A. Marking the cut with the protractor head; B. Femur showing resected neck.

A casting of the trochanters was made to control the resection of the head and neck
(Figure 3-10). The casting was milled to provide a reference plane for angular
measurements to be made. A Mitutoyo protractor head at an angle of 59 to the
machined face was used to produce the line of the resection. A femur with a resected
neck is shown in Figure 3-10.


102

The composite femur was then fixed into the femoral constraint rig and entry into the
femoral canal was obtained using a large T-handle reamer (Figure 3-11).

A.

B.
Figure 3-11. Preparation of the femur by the orthopaedic surgeon.
A. Reaming of the Sawbones femur; B. Broaching the Sawbones femur.

A Lexcell double action bone nibbling rongeur was used to remove the posterior-
lateral cortex from the piriformis fossa to enable an appropriate entry point for the
prosthesis. The femurs were then prepared using an Exeter 37.5mm offset number
zero broach (Figure 3-11). Prior to implantation the stem was examined for
scratches and defects. Once the condition of the implant was deemed to be
satisfactory the implant was wiped free of surface debris with the use of acetone.
Implantation was undertaken no earlier than 5 minutes after the application of
acetone, at which time the surface was dry and clean of debris.


103
Howmedica Surgical Simplex
P Polymethylmethacrylate (PMMA) cement was

used in conjunction with a winged centraliser and a Bucks cement restrictor. The
PMMA was mixed in proportions according to the manufacturers recommendations.

Mixing and cement implantation technique
The cement was mixed by hand without the use of vacuum apparatus at the rate of
one cycle per second for 60 seconds at room temperature 22C. The cement was
then poured into the cavity of the femur. Cement pressurisation with the use of a
cement gun and proximal restrictor was not conducted however, during prosthesis
insertion the Howmedica horse collar was used to aid the extrusion of cement into
the femur. The depth of the implant was set according to the geometry of the system
and ideally should be at the level of the second marker (Figure 3-12) on the posterior
side (Crawford 2004).

Figure 3-12. Depth position markers used to determine the correct depth of the
implant.
The correct depth of the implant was defined using the second marker.

The following points were considered when deciding on the cementing and
implantation technique. Cement pressurisation is undertaken surgically to account
for back bleeding pressure. This was not a concern when cementing Sawbones


104
femurs. The cement was inserted early (while in a liquid state) and it was assumed
that this process would achieve adequate interdigitation. The structure of the
cancellous bone analogue of the Sawbones femurs is a closed cell foam and
interdigitation of the cement and the foam would not be improved with
pressurisation.

The stem was then inserted using the positioning device (Figure 3-13) and
Howmedica proximal horse collar restrictor. The positioning device was clamped to
the support column for 15 minutes while the cement cured.

Figure 3-13. Implantation of the Exeter stem into the Sawbones femur

The environment of the test was considered in terms of the physical and material
properties of the Sawbones and the PMMA. When considering the Sawbones it is
known that the foam used as a cancellous bone analogue begins to degrade when in a


105
moist environment (J ames 2004). When considering the creep properties of the bone
cement it is desirable to test the cement at body temperature 37C. The experiments
were therefore undertaken at 37C (2C). This temperature was maintained
throughout all phases of the experimentation to provide uniform conditions which
potentially influence the material properties of the specimens.

Once the stem had been implanted the specimen was kept at the testing temperature
of 37C (2C) for 24 hours during which time the femur was instrumented.

3.8 Femur instrumentation
The femurs were instrumented using two types of measuring devices, linear variable
differential transformers (LVDTs) and 45 350 strain rosettes. The LVDTs were
used to measure the relative displacement of the Exeter stem and the femur. Strain
rosettes were used to measure the surface strain of the fibre reinforced epoxy
(cortical analogue).

3.9 Relative displacement
Two Solartron DC spring return displacement transducers with a calibrated range of
5mm measured the relative displacement of the implant with respect to the femur.
A measurement technique similar to that presented by Maloney et al. (1989) was
used. This involved mounting an LVDT on the surface of the femur, fixing a pin to
the implant and measuring the displacement of the pin with the LVDT. The
displacement of the implant was determined by scaling the displacement measured
by the LVDT relative to the length of the pin. Oversized holes were drilled through
the analogue femur using the machining and drilling clamp at the same location as
the existing stem holes.


106
Casting the LVDT brackets
The LVDT brackets were positioned using the torsional loading rig as a reference. If
the face of the torque arm was horizontal then the coronal plane of the stem was also
horizontal, this position is the neutral position of the torsional loading rig. This
allowed the casting brackets to be positioned perpendicular to the coronal plane of
the implant. A schematic showing the system for positioning the LVDTs is shown in
Figure 3-14.

Figure 3-14. LVDT positioning system shown with the femur removed.

Two right angle L-shaped brackets were fixed to the base of the torque rig. Prior to
casting the LVDT bracket onto the femur the slide plate was positioned (without the
LVDT bracket in place) so that both edges were in full contact with the L-shaped
bracket. This step was introduced to ensure that the final position of the LVDT
bracket was controlled and the distance between the LVDT and the prosthesis would
remain constant for all tests.


107
The LVDT bracket was then placed onto the casting support and was locked into
place with a dowel pin and fastened into position with a screw. The LVDT bracket
was then fixed onto the femur using PalaPress
PMMA.
The brackets were left for 15 minutes to ensure that the PalaPress
had cured and

that no motion of the brackets with respect to the femur could occur. The LVDT
pins were then secured to the implant using a two part epoxy adhesive. A complete
bracket (on the left) showing the LVDT and the LVDT pin is shown alongside a
bracket prior to casting in Figure 3-15.

Figure 3-15. LVDT measuring ensemble

3.9.1 Calibration of the LVDTs
The LVDTs were calibrated using an LVDT calibration device (Sylvac D 50 P). A
calibrated precision micrometer was used to displace the LVDT and the voltage


108
obtained from the data acquisition system was correlated with the displacement of
the precision micrometer. Figure 3-16 shows the relationship between the calibrated
displacement and the measured LVDT voltage.

Figure 3-16. Typical Voltage-Displacement relationship for LVDTs

Each LVDT was labelled and calibrated using a corresponding channel allocation.
The channel allocation for the LVDTs remained constant for the calibration stage
and throughout the experimental stage. Each LVDT possessed a slightly different
calibration curve. These differences were accounted for during the analysis of the
data.
The energising voltage of the LVDT is 10V DC. The specified sensitivity of the
LVDT is 540mV/mm. Theoretically the LVDT has an infinite resolution. In reality
this resolution is limited by the data acquisition equipment and noise. The data
acquisition board used for this research contained a 16 bit A/D converter. Given the
sensitivity and the energising voltage of the LVDT the minimum measurable
displacement (ignoring noise) is 0.2m.


109
3.10 Strain
Three rectangular strain rosettes (TSM model #2/350/PC11/TRI/A1m8 with an
active gauge length of 3mm and a total rosette size of 5 by 5mm) were used on the
proximal femur to measure the strain in the analogue cortical bone. The positions of
the rosettes on the bone were chosen to allow repeatability of positioning and also to
maximise the useful strain information collected for the finite element validation.
The rosettes were oriented such that one of the gauges (designated gauge a) was
parallel with the long axis of the femur. The orientation and numbering system
adopted for the rosettes is shown in Figure 3-17A.
A B
Figure 3-17. A. Rectangular rosette orientation and position.
The Z-axis is parallel with the long axis of the femur. The X-axis is the relative axis of the rosette that
is perpendicular to the long axis of the femur. The gauges on the rosette were numbered 1 for the Z-
axis, 2 for the gauge at 45 to the Z-axis and 3 for the gauge in the X-axis; B. The proximal femur
showing the positions of rosettes one, two and three.

A decision was made to position the first rosette in line with and directly between the
two LVDTs along the lateral edge of the femur. The state of stress at this point was
thought to be in tension with the predominant loading condition being bending. The
second rosette was positioned in line with the first rosette in the transverse plane with


110
gauge a parallel to the long axis of the femur. The third rosette was positioned on
the calcar and transversely aligned with the lesser trochanter. The rosette positions
are shown in Figure 3-17B.

A single femur was selected to be the template femur for the position of the
rosettes. The rosettes were carefully positioned using the long axis of the femur as a
reference. The femoral mid-shaft support was used as a reference for the long axis of
the femur. The top surface of the mid-shaft support is, by property of the geometry
of the system, perpendicular to the long axis of the femur. Using this relationship the
rosettes were positioned with gauge 1 parallel with the long axis of the femur (Figure
3-18).
Once the positions of the rosettes were defined the centre positions of the rosettes
were measured and reproducibly marked with a compass. A series of indentations
were then made on the mid-shaft support to enable the repeatable positioning of the
compass. To minimise error in the construction of the rosette positioning
indentations were made on the base plate of the femoral constraint marking the
length of the compass.


111

A

B

C

D
Figure 3-18. Strain rosette positions on the proximal femur.
A. shows the position of the first rosette; B. shows the creation of the line transverse to the long axis
of the femur for the position of gauge two; C. shows the final mark up for the second rosette; D.
shows the mark up of the second and third rosettes.


112
Temperature compensation of the strain gauges was achieved using a second femur
without an Exeter stem implantation. The compensating femur was instrumented
with rosettes in identical positions to the sample. To reduce any temperature
differential between the specimen and the compensating femur the compensating
femur was mounted onto the femoral clamp as close as possible to the specimen.

3.10.1 Calibration of the strain gauges
The strain gauge circuit was designed to measure a maximum strain of 2000. The
strain gauges were calibrated by measuring the change in gauge output voltage for a
change in equivalent strain produced by a strain gauge calibrator. The strain gauge
calibrator was used over a range of 100 to 2000. Data were recorded using the
DAQview software over a 10 second period and the mean value of the voltage was
calculated. Table 3-3 shows the mean voltage measured for a given applied
equivalent strain.
Table 3-3. Strain Gauge Calibration
Equivalent Strain Mean Voltage Produced (V)
0 -0.06859
100 1.1916
200 2.4687
500 6.3214
1000 12.7246
2000 25.5470

A linear regression was applied to the data using equivalent strain as the ordinate
axis and the regression Equation 3-1 relating strain to measured voltage (V
m
) was
determined.

0.0128 0.0848
m
V Strain =
3-1

The gradient of the regression equation was then used to convert the voltage obtained
from the data acquisition system into strain.


113

3.11 Specimen loading
The methods and processes behind the application of the resultant hip contact load
and the pure torsional load for the torsional stiffness measurement are now described.

3.11.1 Hip contact load
It has been shown by Stolk et al. (2001) that the inclusion of muscle forces reduces
the cement mantle stresses by less than 11%. Pancanti et al. (2003) presented results
indicating that the effect on relative micro-motions between the implant and the bone
for a cementless implant will be negligible with the inclusion of muscle loads. A
single force representing the resultant hip contact load was therefore used for this
investigation, allowing a simplification of the loading protocol without adversely
affecting the results.
The direction of the resultant hip contact load used for this investigation was based
on the data of Bergmann et al. (2001). The hip contact force of four subjects was
measured using telemetrised implants. The results from each subject were recorded
and expressed in terms of a force per unit weight. The average unit vector for the
resultant hip contact load was found to be -0.037, -0.965, -0.223 in the x, y and z-
directions respectively.

The magnitude of the resultant hip contact load was chosen using the following
criteria:
a. The load magnitude will be sufficient to obtain strain and displacement data
from the specimen;
b. Cyclic loading of the specimen using the resultant load will not cause failure
of any component of the specimen (implant, cement or Sawbones femur)
during the first four days of loading;
The magnitude of the resultant hip contact load determined by Bergmann et al.
(2001) using the average of the four participants during normal walking was found to


114
be approximately 1950N. A conservative loading regime using a load of 650N
2
was
used in the present study to ensure that the fatigue limit of the material was not
exceeded. This load was selected to reduce the likelihood of premature femur failure
while maintaining a relevant and achievable load regime.
The test machine used was required to produce a cyclic load at 1Hz for various
periods of time depending upon the test being undertaken. The loading machine was
able to produce the required cyclic loading pattern and was also able to accommodate
a system for warming the test specimen and the temperature compensated strain
gauge femur during the loading period.
A pneumatic loading rig was selected to apply the resultant load to the head of the
implant (Figure 3-19). The rig was designed and built within the School of
Mechanical, Manufacturing and Medical Engineering.

Figure 3-19. Pneumatic loading rig

The air source for the pneumatic loading machine was a local outlet within the
laboratory suppled by a compressor that serviced the entire building. The supply
pressure varied throughout the day as a result of the loads applied by other users

2
1/3 of the in vivo load measured by Bergmann et al. (2001)


115
within the building. This presented a problem as the pressure supplied to the actuator
needed to be constant over the duration of the test.
Two pressure regulator valves were used to maintain a constant pressure. One
regulator valve was positioned at the local outlet while the second was positioned
before an accumulator. The valve at the local outlet was set to a pressure below the
minimum pressure supplied by the compressor while the valve before the
accumulator was set to control the pressure to the actuator (Figure 3-20).

Source
Accumulator
Pressure Regulator
Valve 1
Pressure Regulator
Valve 2
Actuator
Exhaust 2 position valve

Figure 3-20. Pneumatic diagram of the loading rig.
Pressure regulator valve 1 was set to 510kPa (a pressure less than the minimum fluctuation pressure of
the source). Pressure regulator valve 2 was set to 240kPa to produce the force applied to the specimen
via the actuator.

Calibration of the pneumatic actuator
The pneumatic actuator was calibrated in terms of the output force generated for a
given applied pressure. The applied pressure was measured by a pressure transducer
and was recorded through the DAQview software as volts. The force produced by
the actuator was measured using the Hounsfield load cell and the force values were
recorded from the Hounsfield display (Figure 3-21).


116

Figure 3-21. Experimental set up for calibration of the pneumatic actuator

One loading cycle for a calibration trial involved increasing the pressure from zero to
a maximum pressure to achieve a range of force of approximately 2500N and
returning to a pressure of zero. The pressure and the corresponding force produced
were recorded at discrete points through the loading cycle. No distinction could be
seen between the positive and return stages of the cycle. The calibration curve for
the pneumatic actuator is given in Figure 3-22.


117
Figure 3-22. Force-Voltage relationship for the pneumatic actuator measured
using the pressure transducer.

It was found that the force applied by the actuator was related to the pressure
transducer voltage according to Equation 3-2.

Force =604.V+32.15
3-2

Where force is measured in Newtons and the voltage (V) is the measured voltage of
the pressure transducer. Once calibrated this relationship was used to determine the
force applied to the specimen by the pneumatic actuator.

Testing Environment
The experiment was run at body temperature 37C (2C). To elevate the specimen
to 37C (2C) from ambient temperature the entire pneumatic load rig was placed in
a translucent bag and warm air from a patient warmer (WarmTouch patient warming
system, Mallinckrodt Medical) was fed into the bag (Figure 3-23). A translucent bag
was used so that the state of the specimen could be assessed without removal of the


118
bag and subsequently, without altering the specimen temperature. An exhaust line
was required to remove hot air so that the patient warmer did not overheat.

Figure 3-23. Testing environment. Inlet and exhaust are highlighted.

The specimen was kept dry so that the material properties of the synthetic bone
(formed from glass fibre epoxy resin and cellular foam) did not degrade.

3.11.2 Torsional load
In order to carry out the torsion test the specimen was removed from the warm
environment and was tested in the laboratory. The temperature of the room at this
point was approximately 30C.


119
The torsional load was applied as a diagnostic test to experimentally assess the
stability of the system. It was therefore desirable to apply a load that adequately
assessed the stability and stiffness of the system without causing irrecoverable
deformations to the femur and implant system.
The magnitude of the torsional load was determined using an implanted femur. The
femur was coupled to the torque rig and a torsional load was applied. The load was
steadily increased until audible cracking could be heard. This cracking was assumed
to be either failure of the analogue femur itself or failure of one of the interfaces of
the specimen. A load of 40N produced by the Hounsfield (4Nm moment) was
determined as a safe load at which failure of the specimen was unlikely to occur.

As previously described, the torsional loading rig was a specially designed rig for the
application of the torsional load about the long axis of the Exeter stem. A load was
applied to the specimen via the Hounsfield. The torque rig was bolted to a stainless
steel base plate (25600400mm) using four 10mm screws. The stainless steel base
plate was then fixed to the Hounsfield base with a single bolt.

A specimen preload was avoided by using the following protocol when clamping the
specimen into the torque rig:
1. The torque arm was moved into the neutral position and the Hounsfield was
zeroed in displacement and force;
2. The specimen was clamped into the torque rig using the fixation protocol;
3. If any preload existed in the system the cross head was moved at 5mm/min
until the force reading was again zero.

3.12 Data acquisition
Data were acquired using a DaqBoard/2000 PCI-bus acquisition board (Iotech, Inc.)
in conjunction with a DBK207/CJ C (cold junction compensated) 5B compatible
signal conditioning board. 5B modules were used for the strain and temperature
channels. DaqView software was used to operate the DaqBoard/2000 acquisition


120
board. Data were gathered over 15 channels measuring nine strain channels, four
LVDT (displacement) channels and two temperature channels.

3.13 Equipment summary
Equipment was designed for the purpose of constraining a medium left model 3303
Sawbones femur in a repeatable manner. A cyclic load of 650N applied at 1Hz was
applied to the specimen via a pneumatic loading rig, constructed and calibrated for
that purpose. The specimen was tested in a dry environment where the temperature
was elevated to body temperature. The stability and stiffness of the specimen was
assessed using a torque rig designed to apply a 4Nm torque about the long axis of the
Exeter stem. Data were acquired over 15 channels measuring strain, displacement
and temperature.

3.14 Finite element validation experimentation
This section is concerned with the determination of surface strains at three points on
the Sawbones femur specimens for validation of a finite element model of the
implanted femur. Strains were measured and the principal strains and their directions
were calculated. These strains were then directly compared to the strains obtained
from the finite element model.

3.14.1 Materials and methods
Cristofolini et al. (1996) investigated the time dependency of strain measured on
Sawbones femurs when mechanically characterising the composite bone materials. It
was found that the measured strain was predominantly instantaneous and that the
creep velocity decreased with time, with 65% of the creep strain obtained within the
first 3 minutes. After 10 minutes of loading the authors believed that any additional
creep strain would be indistinguishable from noise. From this information it is


121
believed that a loading period of 7 minutes will be sufficient to obtain a quasi-
steady state response in the measured strain.

A study was carried out in Chapter 5 that was used to comparatively assess the
measured strain data obtained from a single specimen loaded multiple times against
strain data obtained from multiple specimens. The study found that there was no
statistically significant difference between the strain data obtained from multiple
samples and the strain data obtained from a single specimen loaded multiple times.
However, there was a significant difference between the standard deviations of the
data sets, with the standard deviation of the single specimen data significantly lower
than the standard deviation of the multiple specimen data (P=0.03). Therefore, by
using a single specimen the variation of the data will be reduced and the mean of the
strain data will not be adversely affected.

A single Sawbones femur was prepared and instrumented in accordance with the
protocol described in Sections 3.7 and 3.8. The specimen was then fastened into the
femoral constraint and loaded using the pneumatic loading machine with a static load
of 650N. The load was maintained for 7 minutes before being removed and the
specimen was able to recover for a further 7 minutes. Strain data were recorded
for the full 15 minutes. The rosettes were always orientated according to the diagram
of Figure 3-17 A (Page 109). The principal strains (
1
and
2
) were calculated using
Equation 3-3, relating the rectangular rosette gauge strains to the principal strains.

( ) ( )
2 2
1,2
1
2
2
a c a c b a c

= + +

3-3
Where
a
,
b
and
c
are the measured strains at gauges a, b and c respectively.
The angle of the principal strains (
p
) with respect to the axis made by gauge a was
calculated using Equation 3-4.
2
tan2
b a c
p
a c

3-4


122

The maximum shear strain (
max
) was then calculated from Equation 3-5.
( )
max 1 2
=
3-5

3.14.2 Data acquisition for finite element validation
The finite element validation process was undertaken on the specimens prior to the
torsional loading protocol. Data were acquired when the femur was subjected to a
static anatomical load. Of particular interest during the validation process were the
strain and deflection data.
The static anatomical load was in effect a square wave with a period of 900 seconds
(15 minutes). The load was therefore held for 450 seconds and removed for 450
seconds. Data were acquired for the whole 900 seconds.

Sample preparation and size
Strain analysis for the finite element validation was undertaken on a single sample
prepared and instrumented using the procedures outlined in Sections 3.7 to 3.10. A
single sample was used so that direct measurements could be made of the sample to
compare to the model geometry and to reduce any inter-specimen variability that
may result from geometric variability of either the physical 3303 femur or the
relative position of the implant with respect to the bone. The single specimen was
tested seven times. After each static loading regime of 15 minutes all loads were
removed from the specimen and it was left to recover for two hours.

3.14.3 Data analysis
The data acquired through the DAQ system was analysed using two programs
written using MatLab (7.0 R14, The MathWorks. inc). The programs were written
with GUI interfaces for direct analysis of the loading data of the finite element
validation investigation.


123
3.14.4 Results
Typical strain gauge results from the static loading are presented in Figure 3-24.
A.
B.

C.

Figure 3-24. Typical strain output for the Sawbones femur.
A. Shows the strain at rosette position one; B. Shows the strain at rosette position two; C. Shows the
strain at rosette position three.

The principal strains were then calculated for each rosette using the strains obtained
from the rosette gauges a, b and c. A typical strain analysis plot generated from the
raw data showing the calculated principal strains, the principal directions and the
maximum shear strain is given in Figure 3-25.


124
A.

B.

C.

Figure 3-25. Typical strain analysis at the first rosette.
A. Shows the principal strain; B. Shows the principal angle; C. Shows the maximum shear strain.

The maximum principal strain values, their directions and the maximum shear strain
were graphed. The mean and standard deviations were calculated. Graphs of the
calculated strains are presented in Figure 3-26.


125

Figure 3-26. Calculated Principal strains of the Sawbones femurs at rosette
position one.

The descriptive statistics for all three rosettes are given in Table 3-4.

Table 3-4. Mean values of the surface strain
Rosette 1 Rosette 2 Rosette 3
Maximum principal strain () 1309.9 (123.7) 320.9 (56.1) 193.9 (45.8)
Minium principal strain () -549.7 (54.4) -423.9 (48.9) -516.3 (28.9)
Maximum shear strain () 1858.9 (85.7) 744.3 (36.2) 706.0 (39.8)
Principal angle (
p
) -1.2 (0.7) -42.1 (1.7) 16.5 (1.4)
Values in parenthesis are one standard deviation


126
A comparison of these finite element validation strains with the predicted model
strains is given in Section 7.15.

3.15 Pilot study of the analogue femur/implant system
using cyclic loading
The pilot study was used to commission the experimental protocol and in particular,
assess the loading regime given the environmental factors and boundary conditions
placed upon the femur/implant system. Previous investigations using Sawbones did
not specify the temperature at which the investigation took place. This being the
case it was assumed that if a temperature was not specified the experiment was
undertaken at room temperature. This investigation was undertaken at body
temperature (372C). The commissioning was based on the failure criteria of the
femur/implant system. Failure of the femur was defined as:
a. Any visible region on the surface of the femur resulting from contact between
the femur and the femoral constraint;
b. Any visible region within the epoxy indicating mechanical failure of the
fibre/matrix composite.

Loading regime
For the purpose of the pilot study the specimen was clamped within the femoral
constraint and a cyclic load of 650N at 1Hz was applied to the head of the implant
for 24 hours a day (being removed only for torsional testing) until failure was
observed. The specimen was loaded for six hours before being assessed for torsional
stability. The specimen was then replaced in the pneumatic machine and loaded for a
further 18 hours. The experimental protocol is given in Appendix A. A loading
regime that did not allow the specimen to relax was used in order to provide a worst
case scenario to determine the rigor of the protocol and to determine if the materials
and specimen geometry was sufficient.


127

Data acquisition
During periods of cyclic loading data were acquired every 10 minutes (at 10-Hz for 4
second bursts). This method of data acquisition was used so that the short time
events (such as the applied load function) could be monitored, while obtaining
information over the duration of the test to measure the long time events (such as
subsidence) by sampling every 10 minutes. Transient events were not considered
here as it was unlikely that the occurrence of these events would correspond with the
acquisition period.
During the torsional stability testing data were acquired at a rate of 2Hz for the
duration of the 15 cycles. This sampling frequency was assumed to be adequate to
observe any transient events generated by the applied torque without over sampling.

3.15.1 Results
Three femurs with stable Exeter stems were used in the 24 hour loading regime.
During these tests very large and unexpected deformations of the Sawbones femurs
occurred producing very large strain values. All three of the pilot femurs in fact
showed signs of failure. A failed femur specimen from the test protocol is shown in
Figure 3-27.


128

A.

B.
Figure 3-27. Failure of the femur under 24 hour cyclic loading at 650N.
A. Failure of the SGFR epoxy of the posterior-medial surface showing regions of contact and
fibre/matrix failure; B. Failure of the SGFR epoxy of the anterior-lateral surface showing a region of
fibre/matrix failure.

The contact regions on the posterior-medial surfaces of the femur resulted from
larger than expected deflections of the femur under the cyclic load. The test
specimen was retired once failure was observed and the results of that test were not
used in the final study.

3.15.2 Conclusions
It was found that using the Sawbones femurs with the Exeter stem implanted in a
varus orientation using a 650N cyclic load applied for a 24 hour period produced
consistent failure of the femur at the posterior-medial and anterior-lateral regions.
This indicated that there was a possible problem with the Sawbones material.
Although the Sawbones are advertised as an analogue representative of a real
(cadaveric) femur no mention is made of the temperature dependence of the


129
Sawbones. It is known that bone cement (PMMA) is temperature dependent and
hence it is necessary to test at body temperature. These tests indicated that the
material properties of the Sawbones femurs are sensitive to temperature and the
following chapter presents the investigation into this.


130


Chapter 4: Thermo-mechanical investigation of the short glass fibre reinforced
epoxy used as the cortical bone analogue in Sawbones femurs
131
Chapter 4: Thermo-mechanical
investigation of the short glass fibre
reinforced epoxy used as the cortical bone
analogue in Sawbones femurs
4.1 Introduction
Biomechanical test materials are commonly used in preliminary orthopaedic research
to eliminate ethical, financial and accessibility issues that can accompany cadaveric
studies and to improve repeatability. Sawbones (Pacific Research Laboratories Inc.,
Vashon, WA) biomechanical test materials are a popular choice for the replacement
of cadaveric specimens. To the authors knowledge there are currently two papers
that assess the mechanical properties of Sawbones composite replicate femurs and
tibias (Cristofolini et al. 1996; Heiner and Brown 2001). These papers concentrate
on the structural properties of the composite bone, not the material properties per se.
The studies have focused on characteristics of the whole analogue bone such as
deflection under axial load, strain distribution under axial load, bending stiffness and
torsional stiffness. However, the paper by Heiner and Brown (2001) also included
ASTM D638-91 testing to determine the Youngs modulus of the cortical material of
the third generation femur (19GPa). The temperature at which these investigations
were undertaken was not specified and it has been assumed that previous mechanical
testing has been undertaken at room temperature. In orthopaedic research it is
desirable that the test materials are elevated from room temperature to body


132
temperature to ensure that the bone cement possesses the viscoelastic response (creep
and stress relaxation) that is expected in vivo.

In this study, tensile and four point bending tests were used to assess the material
properties of the short glass fibre reinforced (SGFR) epoxy resin that is used as the
cortical analogue in the medium left (#3303) Sawbones femurs at both room and
body temperatures (37C). The glass fibre content was then investigated to ascertain
the theoretical properties of the system for a predefined fibre efficiency ratio. A flow
chart of the experimental and finite element process for this research is shown in
Figure 4-1 with the work covered in this chapter highlighted.

Experimental
finite element
validation
Experimental
finite element
validation
Finite element
model material
property definition
Implantation of the Exeter stem (Varus)
Validated finite
element model
Femur failure (3
Experiments)
Anatomical
loading protocol
Pilot study using
Anatomical
loading protocol
Finite element model
geometry
Neutral stem
position
Investigation using
the finite element
model
Anatomical
loading protocol
Destabilisation
protocol
Experimental
results for
torsional stability
and stem
migration
Material
properties
investigation
Redefine
anatomical
loading protocol



133
4.2 Experimental Hypothesis
This study investigates the material properties of the SGFR epoxy resin used as the
cortical bone analogue in the Sawbones 3303 femurs.

The experimental hypothesis investigated during this study is:
The stiffness of the Sawbones femurs is lower at 37C (body temperature) than at
room temperature. The lower stiffness is a result of a reduction in the Youngs
modulus of the SGFR epoxy when at elevated temperature.

So the null hypothesis is:
Ho: The Youngs modulus of the SGFR epoxy resin does not change between room
temperature and 37C.

H
1
: The Youngs modulus of the SGFR epoxy resin reduces with an elevation in
temperature to 37C.

The manufacturers value for the Youngs modulus of the SGFR epoxy is given in
Table 4-1.
Table 4-1. Properties of third-generation analogue femur
Tensile Compressive
Density
(g/cc)
Strength
(MPa)
Modulus
(MPa)
Strength
(MPa)
Modulus
(MPa)
Cortical 1.7 90 12,400 120 7,600

4.3 Materials and Methods
The tests were performed at room temperature (222C) and at body temperature
(372C). Conditioning of the body temperature specimens was achieved using a
Thermoline -50C to 250C chamber. All specimens were held at the test


134
temperature for at least 48 hours prior to testing. Specimens were machined from
the shaft of the femur obtaining four sections from the anterior, posterior, lateral and
medial quadrants, with the long axis of each specimen correlating with the long axis
of the femur (Figure 4-2).

Figure 4-2. Schematic diagram of the femur showing the two sections made to
obtain the specimens and the initial cuts made to form the test specimens using
anterior, posterior, medial and lateral quadrants.

A total of 8 specimens were taken from each femur. The geometry of the specimens,
and in particular the height and the width of the specimen, was constrained by the
geometry of the femur itself. The final dimensions of the specimens were decided
upon by considering the maximum possible repeatable geometry achievable when
using the #3303 femurs, and through consideration of the relevant standards.
Specimens were finished using a milling machine to final dimensions of
3.3960mm and were measured to the final tolerances using a digital vernier
calliper. The procedures used for the bending and tensile tests followed ASTM


135
standards. Both the ISO and the Australian Standards were consulted; however the
ASTM standard was used on account of the variability that it allowed for in the
geometry of the specimen. The glass fibre content of the composite was determined
using ASTM D2584-02: Standard test method for ignition loss of cured reinforced
resins.

4.3.1 Four point bending
The four point bending test is used to determine the flexural properties of the
specimens giving information on the flexural modulus (tangent modulus of
elasticity), flexural strength, and maximum fibre stress and strain. The maximum
axial fibre stress is constant between the two central supports for a four point
bending test, as compared to the maximum fibre stress occurring directly under the
loading nose in a three point bending test. This is a clear advantage of the four point
bending test. The flexural properties of the specimens were determined using ASTM
standard D 6272-02. The free body diagram of the system is shown in Figure 4-3.

Figure 4-3. Four point bending load diagram.
Where P is the applied load and L is the length of the support span.


136
The support span and the load span used for this test were 38.4mm and 19.1mm
respectively. A pre-existing four point bend loading apparatus (with the radius of the
loading noses and supports of approximately 2mm) was used to carry out the tests.
It was assumed throughout that the compliance of the specimen was considerably
lower than the compliance of the testing apparatus and the materials testing machine.
This being the case, the displacement of the materials testing machine could then be
assumed to be the displacement of the supports. Measurements of the specimen
cross section were obtained using a digital vernier calliper to within 0.005mm. The
specimen was then placed in a central position on the supports to ensure an overhang
of at least 10% of the support span. The cross head motion of 0.75mm/min used for
the test was obtained from Equation 4-1 in accordance with ASTM D 6272-02.

2
0.167
ZL
R
d
=
Where;
R=Rate of Crosshead motion (mm/min),
L=support span (mm),
d=depth of beam (mm),
Z=Rate of straining of the outer fibres (mm/mm.min),
in this case Z=0.01.
4-1

In accordance with the ASTM standards all four point bending tests continued until
fracture or until the maximum strain in the outer fibres reached the prescribed value
of 0.05 (mm/mm). The displacement of the cross head correlating to the maximum
strain of the outer fibres was calculated using Equation 4-2.

lim 2
0.23 =
MAX
L
D
d
Where;
D=mid-span deflection,
lim
MAX
=prescribed strain limit at the external
fibres of the specimen (0.05).
4-2


137

The stress-strain relationship was calculated directly from the load-displacement data
using Equations 4-3 and 4-4.
2
4.36
MAX
Dd
L
=
4-3

2
3
4
PL
S
bd
=
Where;
S=stress in the outer fibre throughout the load span (MPa)
MAX
=maximum strain in the outer fibres
P=Load at a given point on the load deflection curve (N)
b=width of beam (mm)
4-4

The tangent modulus of elasticity was then calculated using Equation 4-5.
3
3
0.17
B
L m
E
bd
=
Where:
E
B
=Modulus of elasticity in bending [MPa],
m =Slope of tangent to the initial straight line.
4-5

The standard deviation of the data was obtained using Equation 4-6.
( )
( )
2 2
1
X nX
s
n
Where:
s =estimated standard deviation
X =single value estimation
n =number of observations
X =Arithmetic mean of the set of observations.

4-6


138
4.3.2 Tensile test
The tensile properties of the SGFR samples were obtained using ASTM D638-02.
The samples were machined into dumbbell-shaped specimens as shown in Figure
4-4. The test was used for the determination of the tensile Youngs modulus. The
sample size prevented the use of an extensometer to measure the strain in the
transverse direction; the Poissons ratio was therefore not determined.

Figure 4-4. Tensile test specimen geometry.

A Hounsfield H25K-S UTM was used to apply the load to the specimens. Grips with
a serrated pattern were used to hold the specimens and prevent slippage. A
Hounsfield PS 25/100 extensometer set to the full gauge length of the specimen was
used to measure deformation.
To limit the effect of inter femur variability the number of test specimens was limited
to eight specimens (four specimens at each temperature), which is the maximum
number of specimens obtainable from each femur. The testing speed was set at
10mm/min for all tests. Specimens were measured prior to testing to within 0.01mm.
Specimens at body temperature were measured without taking them out of the
chamber, to maintain the specimen temperature. A heat gun was used to maintain
the temperature of the specimen at body temperature (Figure 4-5) and an infrared
thermometer (Digitech QM 7222) was used to measure the temperature of the
specimen at regular intervals to ensure that the temperature was maintained at
372C.


139

Figure 4-5. Tensile testing of the SGFR samples

4.3.3 Fibre content
The glass fibre content was determined by measuring the ignition loss of the samples
subsequent to mechanical testing. This test has been used to determine the fibre
content based on the assumption that the short glass fibre is the only reinforcement of
the organic resin, and that any small amount of residue is ignored. The result
therefore is that the ignition loss is assumed to be the resin content of the sample.
An electric furnace was used at a test temperature of 565C. A porcelain crucible
was used to contain the specimen during testing.


140
The following procedure was carried out to determine the ignition loss of the
specimens:
1. The crucible was heated to, and maintained at, the test temperature for 30
minutes. The crucible was then removed and placed immediately into a
desiccator. Once cooled the crucible was weighed.
2. The specimen was placed into the crucible and the combined crucible and
specimen was weighed.
3. The crucible containing the specimen was then placed in the furnace for one
hour. After an hour the crucible and specimen were removed and placed in a
desiccator. Once cooled the crucible and specimen were weighed.
4. The crucible and specimen were then replaced into the furnace for a further
half an hour, before being cooled in the desiccator and weighed for a second
time.
5. The process of replacing the crucible and specimen into the furnace continued
until the mass of the crucible and specimen was within 1.0 mg of the previous
result.

The ignition loss can then be used to calculate the volume fraction of the composite
constituents. Once the volume fraction of the composite is known it is possible to
estimate the elastic modulus using the following equation:

c f f m m
E =KE V +E V
4-7

Where E
c
is the elastic modulus for the composite, E
f
and V
f
are the elastic modulus
and volumetric fraction of the fibre respectively, E
m
and V
m
are the elastic modulus
and volumetric fraction of the matrix respectively and K is a fibre efficiency
parameter (dependent on V
f
and the E
f
/E
m
ratio). For a truly unidirectional composite
the reinforcement efficiency can be approximated as 3/8 (Callister 1994). The
material properties of the constituents of the composite are given in Table 4-2.


141
Table 4-2. Material properties of the composite constituents
Material Density (kg/m
3
) Youngs Modulus (GPa)
E-Glass fibre 2500

72

Epoxy 1400
*
2.41
*
(Gibson 1994);
*
(Callister 1994).

4.4 Results
4.4.1 Four point bending
Figure 4-6 shows the load-displacement relationship for the room temperature and
body temperature specimens. At no point was significant indentation of the sample
(resulting from the loading noses and the supports) observed. It was noted that the
specimens tested at room temperature exhibited brittle fracture at a point between the
central supports (in the presence of the maximum bending moment); whereas the
specimens tested at body temperature deformed to the point of maximum surface
strain (the external fibres reached a strain of the value defined by Equation 4-2 and
did not fracture.

The mean values of the Youngs modulus (with the standard deviation in
parenthesis) for the room temperature and body temperature tests are 10.74(0.88)GPa
and 3.98(0.9)GPa respectively. This is a variation in Youngs modulus of
approximately 2.7 times. The descriptive statistics for the four point bending test are
presented in Table 4-3.


142

Figure 4-6. Stress-Strain relationship for the SGFR at room and body
temperature.
The insert shows the condition of the specimens at the end of the tests.

Table 4-3. Bending Youngs Modulus (MPa)
Variable Mean StDev CoefVar Minimum Maximum Range
Room
Temperature
10747 881 8.20 9717 11649 1931
Body Temperature 3983 901 22.63 2303 4779 2477

The mean presented in Table 4-3 is the arithmetic mean, the standard deviation is
defined by equation 4-6 and the coefficient of variation is the standard deviation of
the data expressed as a percentage of the mean.


143
The mean values of the yield strength at a strain offset of 0.002 were found to differ
by a factor of 5.86. The mean and standard deviation of the yield strength was found
to be 118.54(7.92)MPa and 20.00(2.98)MPa for the room temperature and the body
temperature specimens respectively. The descriptive statistics for the yield strength
are presented in Table 4-4.

Table 4-4. Yield Strength (MPa) (strain offset of 0.002)
Room
Temperature
118.54 7.92 6.68 108.43 126.94 18.51
Body Temperature 20.00 2.98 14.90 14.93 22.72 7.78

Statistical significance
A two-sample t-test was carried out on the data to determine if there were significant
differences between the room temperature and body temperature results. The
bending Youngs modulus and the offset yield strength were both found to be
significantly lower at body temperature than at room temperature with test statistics
of P<0.001 and P=0.023 respectively.

4.4.2 Tensile testing
Figure 4-7 shows the tensile stress-strain relationship for the room temperature and
body temperature specimens.

The surface geometry and surrounding geometry of the specimens at the point of
specimen fracture were geometrically different between the test groups. Figure 4-8
shows microscopic images of the fracture surfaces for room and body temperature
specimens. The fracture surfaces of the room temperature specimens were
characteristic of a brittle fracture whereas the fracture surfaces of the body
temperature specimens were characteristic of a moderately ductile fracture.


144

Figure 4-7. Stress-Strain response of the tensile specimens at the two
temperatures

A.

B.
Figure 4-8. Microscopic images of the fracture surface of the tensile specimens
(40 magnification).
A. Smooth surface of the room temperature specimen; B. Rough irregular surface of the body
temperature specimen.


145
The tangent Youngs modulus values and statistics for the two temperature sets is
presented in Table 4-5. The mean value for the tensile Youngs modulus for the
room temperature specimens is 1.75 times higher than that of the body temperature
specimens.

Table 4-5. Tensile Youngs Modulus (MPa)
Room
Temperature
9443 781 8.27 8667 10229 1562
Body
Temperature
5385 1332 24.74 4120 6775 2655

The offset yield strength of the composite was assessed using a two percent offset is
shown in Table 4-6. The mean value for the room temperature specimens was found
to be 1.48 times the value of the body temperature specimens.

Table 4-6. Offset Yield Strength (MPa) (0.2% offset)
Room
Temperature
61.77 5.18 8.38 57.61 67.57 9.96
Body
Temperature
41.50 6.26 15.09 34.54 46.68 12.14

Statistical significance
A two-sample t-test was carried out on the data to determine if there were significant
differences between the room temperature and body temperature results. A p-value
of 0.02 was determined indicating that the difference in tensile Youngs modulus
between room temperature and body temperature is statistically significant.
A p-value of 0.023 was determined for the offset yield strength values, indicating
that the offset yield strength of the room and body temperature specimens is
significantly different.


146
4.4.3 Fibre content
The results for the determination of fibre content in the composite specimens are

Table 4-7. Ignition loss of composite
Test
Weight
of
crucible
Combined
weight of
crucible
and
specimen
1
st

weighing
2
nd

weighing
3
rd

weighing
Weight
of
specimen
Weight
of
residue
Ignition
loss
(%)
1 17.029 23.3016 20.6449 20.6440 20.644 6.2726 3.615 42.368
2 17.0308 23.3199 20.6900 20.6900 * 6.2891 3.6592 41.817
3 17.0296 23.3312 20.7279 20.7279 * 6.3016 3.6983 41.312
All weight measured in grams.
*Note that for test two and three the third weighing was not necessary.

The average ignition loss of the specimens was 41.8 (0.5) percent. Using values for
material properties presented in Table 4-2 and assuming 100g of the composite
material the mass of the glass fibre and the epoxy will be 58.2g and 41.8g
respectively. Using these mass fractions and the density values from the material
properties table (Table 4-2) the volumetric fractions become:
V
f
=0.438
V
m
=0.562
Using these volumetric fractions and the Youngs modulus values from the material
properties table (Table 4-2) Equation 4-7 becomes

9 9
3
72(10 ) (0.438) 2.41(10 ) (0.562)
8
c
E = +
13.18 =
c
E GPa
4-8

Determination of the fibre efficiency parameter
If the Youngs modulus values determined from the bending and tensile tests are
used to determine the fibre efficiency parameter by rearranging Equation 4-7 the


147
values are 0.13 and 0.11 for bending and tension respectively. These fibre efficiency
parameters can be compared to the theoretical parameter of 3/8 used in Equation 4-8.

4.5 Discussion
The properties of bone cement vary with temperature with the cement acting in a
brittle manner at low temperatures (0C) and leathery at high temperatures (95C).
Lee et al. (2002) showed that the strain rate of bone cement at 37C was significantly
higher than at room temperature concluding that bone cement under load will
experience a range of creep strains depending upon the temperature and
environment. For this reason the consideration of temperature and environment is
imperative when designing orthopaedic laboratory tests.

The primary finding from this investigation was that there is a significant difference
in the room temperature and body temperature Youngs moduli of the SGFR epoxy.
The Youngs modulus in bending is 2.7 times greater at room temperature than it is
at body temperature and the tensile Youngs modulus is 1.7 times greater at room
temperature than it is at body temperature. The experimentally determined Youngs
modulus (13.18GPa) at room temperature compares well to the published Youngs
modulus of 12.4GPa. This result shows that any investigation using Sawbones
femurs for orthopaedic investigation must specify the temperature at which the
investigation is undertaken.

By definition, a composite material is comprised of two or more materials that are
physically delimited from each other (Iglesias et al. 2002). In terms of the SGFR
epoxy cortical bone analogue the epoxy is the matrix and the glass fibres are the
reinforcement. The properties of a composite are determined not only by the matrix
and the reinforcement but also by the adhesion between them. The interface can be
affected by environmental factors such as temperature, moisture and the state of
stress. A process known as sizing of the glass fibres has been shown to increase
the interface adhesion and durability between the matrix and the reinforcement


148
(Iglesias et al. 2002). However, Pegoretti et al. (1998) found that as temperature
increased there was a significant reduction in the interfacial toughness of both sized
and unsized composites. Another factor to consider is the fact that glass fibres are
particularly hygroscopic, and over time there can be a build up of water at the
interface resulting in a loss of adhesion and a reduction in the fibre strength
(DiBenedetto 2001). Neither of the two principal components of the composite
undergoes a phase change within the temperature range investigated here. A phase
transition test carried out on the epoxy showed no indication that the material
underwent any phase transition between room and body temperature. The glass
fibres were not tested, however it is known that there is no variation in the material
properties of glass within the temperature range investigated here.
The most likely reason for the variation in the material properties of the SGFR epoxy
is the effect of temperature on the interface between the epoxy and the glass fibres,
rather than the effect of temperature on the epoxy and glass components themselves.

4.6 Conclusion
There is a significant change in the material properties of the SGFR epoxy used as
the analogue for cortical bone in the Sawbones femurs between room and body
temperature. It is a fundamental requirement of experimental orthopaedic research
that the temperature of the test is increased to (372C) in order to ensure that the
material properties of the PMMA bone cement more closely represent the material
properties of bone cement in vivo. This research has shown that if the temperature of
the experiment is increased from room temperature to body temperature there will be
a reduction in the Youngs modulus of the SGFR epoxy of up to 37 percent. Hence,
this material, that is promoted as the analogue to use for mechanical studies of joint
replacement, is not an appropriate model for testing the mechanics of implants that
use bone cement.
Furthermore, if third generation Sawbones femurs are used as mechanical analogues
within orthopaedic research the temperature and environment at which the
experiment is undertaken must be defined if the material properties of the Sawbones


149
are to be known. The overall outcome of this investigation is that care must be taken
in the experimental design if Sawbones are considered for use within orthopaedic
research.


150


Chapter 5: Strain in the proximal femur: The effect of stem implantation and
position
151
Chapter 5: Strain in the proximal femur:
The effect of stem implantation and
position
5.1 Introduction
This investigation has been designed to determine the strain patterns in the proximal
femur for an intact non-implanted femur (native femur) and to compare this to the
strain of the proximal implanted femur for both the neutral and varus stem
geometries. It was desirable to determine the strain of the proximal femur for the
varus stem after observing failure following cyclic loading (Section 3.15 Pilot study
of the analogue femur/implant system using cyclic loading). The data from the
neutral stem was used as a reference for this implant type as the neutral position is
the ideal position for the Exeter stem. The information obtained by comparing the
strains of the native proximal femur to the strains of the implanted femurs will not
only aid in understanding the failure observed in the varus stem specimens (Section
3.15) but also help to identify possible variations in the in vivo bone response to the
implant for the two positions. A flow chart of the experimental and finite element
process for this research is shown in Figure 5-1 with the work covered in this chapter
highlighted.


position
152

Figure 5-1. Flow diagram of the experimental and finite element process.

5.2 Experimental Hypothesis
This study investigated the variation in the measured surface strain of the Sawbones
analogue femurs for specimens with neutral and varus stem position and compares
them to the strain of a native (non-implanted) femur.

The two experimental hypotheses investigated during this study are:

1. The measured strains along the surface of the femur will vary once implanted
with an Exeter stem.


position
153
H
0
: The strain of the proximal femur will remain unaltered from the native
state when implanted with an Exeter stem.
With an alternative hypothesis:
H
1
: The strain of the proximal femur will either increase or decrease from the
native state when implanted with an Exeter stem depending upon the position
of the measured strain.

2. The measured strains along the surface of the femur with the varus stem position
specimens are higher than the strains of the neutral stem position specimens.
H
0
: The strain of the varus stem position specimens will be identical to the
strain of the neutral stem position specimens.
With an alternative hypothesis:
H
1
: The strain of the varus stem position specimens will be greater than the
strain of the neutral stem position specimens.

5.3 Materials and methods
Three native femurs were instrumented with strain rosettes in accordance with the
procedure outlined in Section 3.10. Nine medium left (model 3303) Sawbones
(Pacific Laboratory, Vashton Island WA) were prepared by an orthopaedic surgeon
to accept an Exeter stem (number 1, 37.5 mm offset). The cement used was one mix
of non-antibiotic Simplex (Stryker Corporation, Rutherford, NJ , USA) in all cases.
Five of the femora received an Exeter stem positioned in neutral with reference to the
coronal plane. Four of the femora received an Exeter stem in which it was aimed to
achieve a varus position of approximately 5. The neutral or varus implantation, as
well as flexion, anteversion and depth of insertion were standardized by using the
femoral constraint and the positioning device (Sections 3.5 and 3.6.3). The
positioning device was modified to produce the neutral stem position. An implanted
femur with a neutrally positioned Exeter stem was clamped into the femoral


position
154
constraint with the implant positioning device attached. The positioning block was
then attached to the head of the implant and the change in the implant position
between the varus and neutral positions could be visualised (Figure 5-2 A and B).

A

B

C
Figure 5-2. Neutrally implanted Exeter stem shown with implant positioning
device.
A & B. shows the variation in the head of the implant between the varus and neutral stem positions; C.
Shows the mould made to reproduce the position of the head of the implant using the existing
positioning device.

The relative position of the block and the arm of the positioning device was fixed by
moulding the gap between them with PalaPress(Figure 5-2 C). The position of
the implant was then fixed in rotation and translation with minimal modification to


position
155
the existing equipment, while maintaining the same level of repeatability as existed
with the positioning of the varus stem.

The femora were instrumented in accordance with the procedures outlined in
Sections 3.8, 3.9 and 3.10. The temperature of the system was maintained constant
in a dry environment at 37 (2C) at all times during the preparation and testing.
The position of the stem relative to the femur was verified at the completion of the
experiment by radiograph. Four neutral and four varus implanted specimens were X-
rayed and the alignment checked using PACS CD-viewer software (Agfa-Gevaert).
The angle between the long axis of the femur and the stem was measured three times
for each specimen and averaged by two independent observers and found to be
0.30.1 for the neutral specimens and 4.60.35 for the varus specimens (Figure
5-3).

A.

B.
Figure 5-3. Radiographs showing the position of the implant in the coronal
plane.
A. Shows the neutral position of (0.30.1); B. Shows the varus position of (4.60.35).


position
156
Loading regimes
Two loading cases were carried out during this study. The first was a static loading
case used within the finite element validation experimentation (Section 3.14). The
implanted and native femurs were loaded using the static loading case. The second
load case involved the application of a cyclic anatomical load as used within the pilot
study (Section 3.15). Only the implanted femurs were loaded using the cyclic
anatomical loading case.

Loading groups
Three loading groups were used, the native femur group (three specimens), the
neutral group (five specimens) and the varus group (four specimens).

Statistical analysis
As the strain data were not normally distributed the difference in strain between the
varus and neutral groups was analysed using the Mann-Whitney U test.

5.4 Results
5.4.1 Comparison of the femur strains under static load
Rosette 1 (Lateral femur rosette-Gruen zone 1)
The strain results of the native femur, neutral and varus groups under a static load at
the first rosette position are presented in Figure 5-4. Data are arranged in terms of
strain measured by the longitudinal, circumferential and 45 degree gauges. Overall,
greater strains were observed in the longitudinal direction for all groups followed by
the circumferential direction, with the least strain observed in the 45 degree gauge.
The intact native femur responded differently than the implanted femurs with the
neutral and varus stem positions. The longitudinal strain decreased relative to the
native femurs for the neutral stem position but increased for the varus stem position.
There was a statistically significant difference in the strain between the native femur


position
157
and the neutral stem position (P<0.05) and between the native femur and the varus
stem position (P<0.05). The variation in strain between the neutral and varus groups
in the longitudinal direction was statistically significant (P<0.005) with the strain for
the varus group almost twice that of the neutral group.

-1500
-1000
-500
0
500
1000
1500
2000
Longitudinal circumferential 45 degrees
M
e
a
s
u
r
e
d

S
t
r
a
i
n

(
m
i
c
r
o

s
t
r
a
i
n
)
Native Neutral Varus

Figure 5-4. Experimental strains at the first rosette position for the native
femur group and the neutral and varus stem positions

The circumferential strain increased relative to the native femurs for both implant
geometries. The variation in the measured circumferential strain between the native
femurs and the neutral stem position was not statistically significant. However the
variation in the measured circumferential strain between the native and varus stem
position was statistically significant (P=0.012). The variation in the measured
compressive strain in the circumferential direction between the neutral and varus
stem positions was statistically significant (P<0.005) with greater strain measured for
the varus stems than for the neutral stems.


position
158
A slight decrease in the strain at the 45 degree gauge for the neutral stem position
relative to the native femurs was not statistically significant. However the increase
in strain for the varus stem position relative to the native femurs and the neutral stem
position was statistically significant in both cases (P<0.012).

Rosette 2 (Anterior femur rosette):
-500
-400
-300
-200
-100
0
100
200
300
400
500
600
M
e
a
s
u
r
e
d

S
t
r
a
i
n

(
m
i
c
r
o

s
t
r
a
i
n
)

Figure 5-5. Experimental strains at the second rosette position for the native
femur group and the neutral and varus stem positions

the second rosette position are presented in Figure 5-5. Considerable variation was
observed at this rosette position at all rosette gauges between the native femurs and
the neutral and varus stem positions. The variation in the compressive longitudinal
strains for the native and neutral stem positions was not statistically significant. The
variation between the varus stem position and both the native femurs and the neutral
stem position was statistically significant in both cases (P<0.018). The mean of the


position
159
varus strain in the longitudinal direction was tensile compared to the compressive
strain observed in the native femur and the neutral stem position groups.
The circumferential strains in the native femur and the neutral stem position groups
were tensile with larger strains observed in the native femur than in the neutral stem
position group, this difference was statistically significant (P=0.038). The
circumferential strain of the varus group was observed to be in compression when
compared to the tensile strains observed in the native femur and neutral stem position
groups.
Tensile strains were measured for all groups at the 45 degree gauge. The reduction
in strain within the neutral stem position when compared to the native femur group
was not strongly statistically significant (P=0.07). Whereas the increase in strain in
the varus group when compared to the native femur group was statistically
significant (P=0.012). The relatively large tensile strain measured in the varus stem
position group in the 45 degree gauge (and the small strains measured at the
longitudinal and circumferential gauges) indicates that the state of strain at the point
of rosette position two was predominantly in torsion for this stem position.

Rosette 3 (Medial femur rosette)
the third rosette position (medial calcar) are presented in Figure 5-6.

There is an overall reduction in the strain at the third rosette (medial calcar) when the
femur is implanted with either a neutral or varus implant. The longitudinal strains
for all groups are in compression at the third rosette position. There is a statistically
significant reduction in the strain for both the neutral (P=0.04) and varus (P=0.02)
stem position groups when compared to the native femur group. There was no
significant difference between the neutral and varus stem position longitudinal
strains at the third rosette. The magnitude of the circumferential strains reduce for
both the neutral and varus stem positions when compared to the tensile native femur
strain, with the neutral strain changing sign and becoming compressive.


position
160
-2500
-2000
-1500
-1000
-500
0
500
1000
M
e
a
s
u
r
e
d

S
t
r
a
i
n

(
m
i
c
r
o

s
t
r
a
i
n
)

Figure 5-6. Experimental strains at the third rosette position (medial calcar) for
the native femur group and the neutral and varus stem positions

Strain measured at the 45 degree gauge is significantly reduced from the compressive
strain of the native femur when implanted with a neutral stem (P=0.036) and almost
zero strain measured at the gauge for a varus stem (P=0.018).

5.4.2 Macroscopic appearance of the implanted specimens after
cyclical loading experiment
All of the varus implanted bone specimens failed catastrophically after 24-36 hours
of cyclical loading. No failure was observed in the femurs with neutrally aligned
stems. Femur failure for the varus specimens occurred in the form of antero-lateral
bowing of the composite Sawbones material. There was obvious discoloration due to
delamination on the antero-lateral surface of the femur at the level of the prosthesis


position
161
tip. A radiograph of the failed specimens confirmed the above findings. There was
no evidence of prosthesis or cement failure.

5.5 Discussion
This study has shown that relative to the native femur the strain in the proximal
femur was altered when implanted with an Exeter stem. This confirmed the first
experimental alternative hypothesis. It was also shown that the stem position caused
changes to the strain in the proximal femur, which confirmed the second
experimental alternative hypothesis.

Variation of strain following implantation
Strain of the lateral aspect of the femur, measured by the first rosette, showed that the
strain patterns of the implanted femurs remained in the same direction and a similar
magnitude for both stem orientations. The varus stem group produced larger strain
magnitudes than the native femurs at all gauges.
Strain along the anterior aspect of the femur, measured by the second rosette, showed
considerable variation in the measured strain between the native femurs and the
implanted femurs. The most prominent variation was observed in the longitudinal
direction with the measured strain dropping from 438 to 38 for the neutral stem
specimens and changing sign to -105 for the varus specimens. The most
significant strain for the varus specimens was measured in the 45 degree gauge
whereas in the longitudinal direction the strain decreased to almost zero. The native
femur specimens possessed large compressive strains in the longitudinal direction at
the medial calcar. These strains decreased for both implanted cases. The magnitude
of the strains decreased for the other gauges of the medial calcar (circumferential and
45 degree directions) with a change in sign accompanying the decrease in strain for
the neutral specimens in the circumferential direction.


position
162
Variation in strain between the neutral and varus stem orientations
In a study of bone adaptive response to stem orientation it has been observed that
valgus stems exhibited a lower incidence of bone resorption than the control group
(Bocco et al. 1977). It has also been shown that the longitudinal compressive strains
along the medial cortex of the native femur decrease when the femurs are implanted
with collared stems (McBeath et al. 1980). Such findings have led many authors to
investigate the predisposing factors of early loosening and it has been proposed that
varus positioning may be a predisposing factor for early loosening (Sutherland et al.
1982; Callaghan et al. 1985; Kristiansen and J ensen 1985; Munuera and Garcia-
Cimbrelo 1992; Kobayashi et al. 1994).

This investigation found that the strain at all the strain rosettes varied from the native
femur strain when a stem was introduced. The clinical survivorship of the Exeter
stem is excellent. However, this analysis was necessary to understand the
experimental failure of the Sawbones femurs observed in the pilot study (Section
3.15) and to determine whether experimentation using Sawbones femurs could
continue by varying the stem orientation. The first and second rosettes were most
proximal to the failure region of the Sawbones femurs. A comparison of the strain
observed for the neutral and varus groups gave the best indication of the components
of the measured strain that may be contributing to failure. The largest variation
between the neutral and varus groups occurred in the 45 degree axis with the varus
stem geometry producing strain values 5.4 and 20.3 times greater than the neutral
stem geometry at the first and second rosette positions respectively. The
quantification of surface strain between the two stem orientations showed that the
strain of the varus stem orientation was almost always greater in magnitude than the
strain of the neutral stem orientation. This gave significant weight to the
consideration of the argument of why the Sawbones implanted with the varus stem
orientation failed and the neutrally implanted stem specimens did not. The increase
in strain for the varus stems may have been enough to raise the stresses in the femur
above the cyclic fatigue limit of the material.


position
163

5.6 Conclusions
This investigation has shown that the introduction and orientation of the Exeter stem
into the proximal femur markedly alters the strains measured on the surface of the
cortical bone at the rosette positions. Failure of the femurs was eliminated by
altering the stem orientation from varus to neutral. This finding allowed the
experimental research to continue using the neutral stem orientation.


position
164


Chapter 6: Experimental testing of the analogue femur/implant system
165
Chapter 6: Experimental testing of the
analogue femur/implant system
The final anatomical loading protocol was developed using the equipment and
protocol presented in Chapter 3 in conjunction with the material properties
investigation presented in Chapter 4 and by altering the stem orientation as presented
in Chapter 5. A flow chart of the experimental and finite element process for this
research is shown in Figure 6-1 with the work covered in this chapter highlighted.

6.1 Modified Experimental Protocol
The results from Chapter 3, Chapter 4 and Chapter 5 indicated that alterations needed
to be made to the experimental protocol to account for a lower than expected
Youngs modulus of the SGFR epoxy at body temperature and the elevated strains of
the varus orientation of the initial femurs. The boundary conditions, material
properties and the magnitude of the applied load were already determined and were
not altered.


166


6.2 Stem reimplantation
It is common in clinical practice when revising the acetabular cup, to remove the
femoral stem to gain better access to the cup. If the cement mantle of the femoral
stem is undamaged and believed to be of high integrity the stem can be replaced
without re-cementing. This process of stem reimplantation has been used to produce
a loose stem experimentally. Stem reimplantation was carried out on the specimens
after four days of the loading protocol.


167
Experimental reimplantation protocol
Reimplantation was carried out by removing the stem from the cement mantle and
then replacing the stem within the mantle in its original position, to the second
marker (Figure 3-12). Removal of the stem was undertaken while the specimen was
at 37C. Acetone was used to clean the stem of any residue that may have remained
on the surface. The femur was placed in the femoral constraint and secured. The
stem was then replaced into the femur (using the existing cement mantle). Every
attempt was made to position the stem in the original position by using the second
marker on the implant to determine the position in the Z-axis and the drilled holes to
ensure that rotation was correct. The shape of the cement mantle made it quite easy
to accurately reposition the stem.

Loading after reimplantation
The torsional stiffness of the stem was assessed after the reimplantation protocol and
then monitored after periods of loading. The specimen was loaded after
reimplantation for three two hour periods followed by 18 hours of recovery for two
days. The torsional stiffness of the system was monitored after each loading period.

6.3 Experiment using a neutral stem position
The experimental loading protocol used for the neutral stem involved the application
of a cyclic (1Hz) 650N load for 6 hours followed by 18 hours of relaxation. The
stable stem (prior to removal and reimplantation process) was loaded and monitored
for four days before the reimplantation process was undertaken. The stability of the
specimen prior to the reimplantation process was monitored at the end of every six
hour loading period. The reimplanted specimen was then loaded for a further two
days. The stability of the reimplanted stem was monitored after every two hours of
the six hour loading cycle. The stability was monitored more frequently after
reimplantation in case there was a rapid increase in the torsional stiffness over a
relatively short period of time. A block diagram showing the activities of the
experimental procedure is given in Figure 6-2.


168

Figure 6-2. Block diagram of the experimental procedure showing the times
allocated to each period of loading and relaxation

6.3.1 Displacement of the specimen under a static load
The static loading protocol defined in Section 3.14 was used to obtain the
displacement data. The experimentally measured axial displacement of the head of
the implant was considered in terms of elastic and viscoelastic components. The
elastic component is the displacement observed immediately after application of the
load. The viscoelastic component is the sum of the elastic displacement and the
displacement that is observed to vary with time under a constant load. Figure 6-3
shows the displacement of the head of the implant measured in the direction of the
applied load when the load is applied statically.


169

Figure 6-3. Components of the specimen displacement.
Where
E
is the elastic displacement and
V
is the viscous displacement. The magnitude of the
viscoelastic displacement was defined as
E
+
V
. Sampling frequency was 2Hz.

Over five experimental trials the mean(SD) elastic displacement was determined to
be 0.27(0.04)mm and the viscoelastic component was determined to be
0.36(0.04)mm.

6.3.2 Subsidence and stress relaxation
Displacement of the head of the implant was measured from a point on the actuator
using an LVDT that was rigidly mounted to the pneumatic loading machine during
the loading cycle. The vertical height of the specimen (and the head of the implant)
was affected by the position of the specimen within the femoral clamp, the geometry
and position of the head of the implant fitted to the taper of the neck of the implant
and the geometry and position of the bearing plate between the head of the implant
and the actuator.


170

Figure 6-4. Relative position of the implant, head of the implant, bearing plate
and actuator.

The configuration of head of the implant, the bearing plate and the actuator is shown
in Figure 6-4. The head of the implant engages the Morse taper of the neck, the
relative position of the head with respect to the implant can therefore vary between
tests if the head does not seat in an identical manner to the previous test. The
interface between the bearing plate and the head of the implant was not designed or
manufactured to be a precision interface and the relative position of the bearing plate
and the head of the implant could also vary with repositioning of the femur. The
combined effect of these factors means that the displacement measurements made by
the LVDT would not be continuous after repositioning the specimen within the
femoral clamp.

Continuous displacement
The displacement of the head of the implant needs to be considered in terms of the
elastic and viscoelastic deformations and both of these components were measured
using this experimental protocol. The process of removing the specimen from the
loading rig and replacing it after torsional stability testing introduced considerable
complexity into the determination of total displacement. The specimen was removed
from the loading rig for approximately 10 minutes for the torsional stiffness


171
experiment. During this time it was assumed that the relative position of the implant
with respect to the cement and the femur did not change, and that if a reference
displacement was recorded prior to the removal of the specimen then this reference
displacement could be used to define the initial displacement or distal migration of
the stem within the femur when the specimen was replaced and loading was
resumed.

The reference displacement was measured immediately after the last applied cyclic
load was removed from the system. A 10 second period was measured to include the
last loading cycle and 7-8 seconds of no load (Figure 6-5).

Figure 6-5. Displacement of the head of the implant immediately after the
removal of the load.
The recovery during the load reduction period is almost instantaneous. Minimal recovery is observed
during the early stage of the no load phase.

The change in the displacement between the applied load and no load regions was
the elastic deformation of the specimen. The elastic displacement was recorded. The
reference displacement is taken as the maximum displacement within the 10 second
period. Any further displacement of the stem within the system will be viscoelastic
and it is assumed that no significant viscoelastic displacement of the stem occurs
during the torsion test.


172
Treatment of the slip between bearing plate and the head and neck of the implant
The slip of the specimen was determined by comparing the initial elastic
displacement of the system to the final elastic displacement of the system. In the
case of the displacement immediately after the application of the load the
instantaneous change in displacement is a function of the elastic deformation and the
slip displacement; whereas the displacement as load is removed from the system is
assumed to be a function only of the elastic deformation. The difference between
these two measures therefore gives the slip of the system, where the magnitude of the
slip is a result of the seating of the head to the neck of the implant and the settling of
the bearing plate. Data is presented before and after the slip displacement has been
removed.

6.3.3 Distal migration of the head of the implant
The distal migration of the head of the implant is presented in Figure 6-6 prior to the
removal of the slip displacement. The displacement includes elastic and viscoelastic
components. The displacements of four specimens are shown over the four days of
loading. The loading and relaxation periods are given in Figure 6-6.

The slip displacement was then removed from the data to give the estimated distal
migration of the head of the implant. Removal of the slip displacement reduces the
cumulative displacement of the head of the implant Figure 6-7.


173
-0.9
-0.8
-0.7
-0.6
-0.5
-0.4
-0.3
-0.2
-0.1
0
0 1000 2000 3000 4000 5000 6000
Time (Mins)
D
i
s
p
l
a
c
e
m
e
n
t

(
m
m
)
S31694 S31763 S31791 S31733
Load 1
Relax 1
Load 2
Relax 2
Load 3
Relax 3
Load 4
Relax 4

Figure 6-6. Distal migration of the head of the implant including the elastic and
viscoelastic components of displacement.
The slip component of displacement has not been removed from this data. Data are shown for four
specimens with labels S31694, S31763, S31791 and S31733.
-0.8
-0.7
-0.6
-0.5
-0.4
-0.3
-0.2
-0.1
0
0 1000 2000 3000 4000 5000 6000
Time (mins)
D
i
s
p
l
a
c
e
m
e
n
t

(
m
m
)
S31694 S31763 S31791 S31733

Figure 6-7. Distal migration of the stem over the 4 days of loading with the slip
component removed from the system.
Data are shown for four specimens with labels S31694, S31763, S31791 and S31733.


174
6.3.4 Torsional characteristics of the specimen
When considering a circular bar under a pure torsional load T the total angle of twist
can be determined using Equation 6-1.
=
p
TL
GI
6-1

Using SI units the torque T applied to the system is measured in Newton metres
(Nm), the length L in metres (m), the shear modulus in Pascals (Pa) and the polar
moment of inertia I
p
in metres to the fourth power (m
4
). The product GI
p
is known as
the torsional rigidity of the shaft (Equation 6-2), and the ratio of GI
p
/L is known as
the torsional stiffness (Equation 6-3).

= =
p
TL
Torsional Rigidity GI
6-2
= =
p
GI
T
Torsional Stiffness
L
6-3

Thus, if the applied torque is plotted verses the rotation of the head of the implant
then the torsional stiffness over a range of rotation can be calculated as the gradient
of the curve over that range of rotation.

Properties of the torsional device
The torque-rotation diagram in Figure 6-8 possesses two distinct components, a
linear section and a non-linear section. The linear section of this diagram was
believed to represent the torsional stiffness of the system in accordance with
Equation 6-3, where the torsional stiffness of the system can be considered as the
torque required to produce a unit angle of rotation. However, the non-linear section
was not expected and was investigated to determine the cause and whether it affected
the measurement of torsional stiffness.


175
Figure 6-8. Typical experimental result for a stable implant under torsion.
The loop begins at the marked start point and travels in the directions of the arrows following
ABCD. Upper stiffness and lower stiffness correspond to the torsional stiffness values
calculated from the slope at regions A and C respectively.

The non-linear section of the graph was found to be caused by the torque required to
overcome friction within the bearing resulting from a change in direction with each
torque cycle. The non-linear frictional torque is best shown with a torque-rotation
diagram with no specimen attached (Figure 6-9). Figure 6-9 shows that after the
initial non-linear friction torque the friction required to continue to produce rotation
of the torque arm becomes constant. Figure 6-9 also shows that the gradient of the
linear portion is zero since there is no specimen stiffness.


176

Figure 6-9. Torque-rotation diagram without a specimen

A load cell (Precision Transducers Ltd. Model LPX 5000) was used to investigate if
the magnitude of the friction torque was a function of the applied torque (generated
by the Hounsfield). The load cell (used to obtain values of measured torque) was
placed underneath the torque arm below the position of the head of the implant. A
range of torques were applied to the load cell from a zero load position and it was
found that the magnitude of the non-linear friction torque did not change with an
increase in the magnitude of the applied torque. The load measured at the load cell
was observed to be equal to the total magnitude of the torque applied by the
Hounsfield minus the magnitude of the non-linear friction torque (Equation 6-4).

- = MT AT FT
6-4

Where MT is the measured torque, AT is the applied torque and FT is the non-linear
friction torque.

Variation in the non-linear friction force
The non-linear friction torque was found to vary between trials to such an extent that
at times the data obtained did not show a linear torsional stiffness region. Figure
6-10 shows the possible variation in the magnitude of the non-linear friction torque


177
for the same specimen. The typical response with linear and non-linear components
is shown as curve A and an entirely non-linear response is shown as curve B.

Figure 6-10. Torque-rotation diagram showing the effect of the frictional
torque.
A. Shows a torque rotation diagram with a frictional torque of approximately 4Nm; B. Shows a
torque rotation diagram where the non-linear bearing alignment frictional torque eclipses the torsional
stiffness data (no linear region). Torsional stiffness data is not available from the torque rotation
diagram B.

Variation in the friction force
The variation in the non-linear friction torque shown in Figure 6-10 was found to be
generated from the tension in a single screw that was positioned adjacent to the
bearing (Figure 6-11). Varying the tightening torque in the screw introduced a
misalignment to the torsion rig bearing which in turn varied the undesired frictional
torque.


178

Figure 6-11. Schematic of the torsional rig showing the problematic cap head
screw position.

The issue of the tension of the screw was investigated retrospectively to the results
being obtained. It was necessary to ascertain whether the tension in the screw
influenced the measured torsional stiffness (linear region of the curve). An
experiment to determine the effect of the screw tension was undertaken. The
torsional stiffness of a specimen was tested while increasing the tension of the screw
throughout the 15 test cycles. A torque-rotation diagram showing the effect of
increasing tension in the screw is given in Figure 6-12.

It can be observed from Figure 6-12 that while increasing the screw tension changes
the frictional torque in the system, the measured torsional stiffness of the system as
measured by the linear slope of the graph does not change with increasing tension of
the screw.


179
Figure 6-12. Torque-rotation diagram showing the effect of the tension in the
base plate screw

In Figure 6-12, the tension was increased from zero to a maximum value in three
arbitrary increments. The magnitude of the non-linear friction torque is clearly seen
to increase as the tension in the screw is increased. As the tension is increased
towards a maximum value it can be seen that the size of the linear section of the
diagram (with slope equal to the torsional stiffness of the system) is reduced. A
point is reached at which the linear region is obscured by the non-linear friction
torque and torsional stiffness data is no longer available. Equation 6-4 then
becomes:


180
6-5
If AT>FT
MT=AT-FT
Else,
If ATFT then,
MT=0

Or
If AT>FT
MT=AT-FT
else
MT=0

Equation 6-5 states that if the friction force exceeds the applied torque then the
measured torque becomes zero. The measured torque can therefore be considered as
the torque that is applied to the head of the implant and that if the measured torque
becomes zero the rotation of the head of the implant will be a result of the non-linear
friction torque only. Therefore, the results obtained from the torsional investigation
can be used to assess the torsional stiffness of the system if the non-linear friction
force does not exceed the applied load. In other words, if the torque-rotation
diagram showed a definite linear portion (from the measured torque) then the
gradient of this portion could be used to define the torsional stiffness of the
specimen.

6.3.5 Torsional Stiffness results
The torsional stiffness of the specimen was calculated as the gradient of the linear
region of the torque-rotation diagram. The linear regions corresponding to regions A
and C (Figure 6-10) were used to calculate the torsional stiffness. Upper stiffness
and lower stiffness correspond to the torsional stiffness values calculated from the
slope at regions A and C respectively (Figure 6-10). Two of the five specimens
tested using the neutral stem position protocol yielded acceptable torsional stiffness


181
results (i.e. the applied load was larger than the non-linear friction load). The
torsional stiffness for each acceptable sample was plotted according to the previous
loading condition of the specimen. The trial number, previous loading condition and
corresponding loading cycles are given in Table 6-1.

Table 6-1. Trial number, state of the specimen and the number of loading cycles
Trial Previous loading condition Loading Cycles
1 Rest 0
2 6 hours of Loading 21600
6 After Relaxation 86400
R1 Reimplantation 86400
R2 2 hours of loading 93600
R5 relaxation 108000
Trials with the prefix (R) are trials undertaken after the reimplantation process.

Torsional stiffness values for the initially implanted stem are presented for the two
acceptable specimens (S31763 and S31694) in Figure 6-13. The error bars show
standard deviation in the torsional stiffness values calculated for each of the 15
cycles.


182
A.
0
1
2
3
4
5
6
7
8
0 (Trial 1) 21600
(Trial 2)
43200
(Trial 3)
64800
(Trial 4)
86400
(Trial 5)
86400
(Trial 6)
Number of Loading Cycles
T
o
r
s
i
o
n
a
l

S
t
i
f
f
n
e
s
s

[
N
m
/
d
e
g
r
e
e
]

Upper Stiffness Lower Stiffness

B.
0
1
2
3
4
5
6
7
8
0 (Trial 1) 21600
(Trial 2)
43200
(Trial 3)
64800
(Trial 4)
86400
(Trial 5)
86400
(Trial 6)
T
o
r
s
i
o
n
a
l

S
t
i
f
f
n
e
s
s

[
N
m
/
d
e
g
r
e
e
]

Figure 6-13. Torsional stiffness of the initially implanted stem as a function of
the number of applied loading cycles measured immediately after loading.
A. Shows the torsional stiffness of specimen S31763; B. Shows the torsional stiffness of specimen
S31694.


183
A.
0
1
2
3
4
5
6
7
8
86400
(Trial R1)
93600
(Trial R2)
100800
(Trial R3)
100800
(Trial R4)
108000
(Trial R5)
115200
(Trial R6)
122400
(Trial R7)
129600
(Trial R8)
T
o
r
s
i
o
n
a
l

S
t
i
f
f
n
e
s
s

[
N
m
/
d
e
g
r
e
e
]

B.
0
1
2
3
4
5
6
7
8
86400
(Trial R1)
93600
(Trial R2)
100800
(Trial R3)
100800
(Trial R4)
108000
(Trial R5)
115200
(Trial R6)
122400
(Trial R7)
129600
(Trial R8)
T
o
r
s
i
o
n
a
l

S
t
i
f
f
n
e
s
s

[
N
m
/
d
e
g
r
e
e
]

Figure 6-14. Torsional stiffness of the stem as a function of the number of
applied loading cycles measured after relaxation.
A. Shows the torsional stiffness of specimen S31763; B. Shows the torsional stiffness of specimen
S31694.


184

The torsional stiffness values of the specimens measured after a period of rest are
presented in Figure 6-14. The torque-rotation diagram of the reimplanted specimen
immediately following reimplantation (Test R1) is presented in Figure 6-15.

Figure 6-15. Torque rotation diagram of a specimen immediately following
reimplantation.
The regions A and C are no longer linear, indicating that there is a change in stiffness of the system
with relative rotation of the head of the implant.

The variation in the stiffness vales presented for the upper and lower stiffness for
Trial R1 (Figure 6-14) is a result of the two stiffness values apparent at paths A and
C (marked in red on Figure 6-15). Where possible the maximum and minimum
torsional stiffness values were reported for the Trial R1 specimens.


185
The descriptive statistics for the torsional stability investigation for both of the
specimens are presented in Table 6-2.

Table 6-2. Mean values of the torsional stiffness for the upper and lower
stiffness values for both specimens
Specimen Calculated from Loaded Stiffness
[Nm/degree]
Mean(SD)
Relaxed specimens
[Nm/degree]
Mean(SD)
S31763 Upper linear region 6.2(0.2) 6.5(0.1)
Lower linear region 6.3(0.2) 6.3(0.3)
S31694 Upper linear region 6.4(0.7) 6.6(0.2)
Lower linear region 6.2(0.6) 6.3(0.2)

An analysis was undertaken to determine if there was any statistically significant
difference between the measured torsional stiffness before and after the
reimplantation procedure. A paired t-test found no statistically significant difference
between the values of the torsional stiffness measured before and after the
reimplantation process.

A paired t-test was then used to determine if a statistically significant difference
existed between the values of the upper and lower stiffness values. A paired t-test
found no statistical significance to indicate that there was any difference between the
upper and lower stiffness values calculated from the two samples.

6.3.6 Torsional Stiffness and relative motion
The recovery of the torsional stiffness of the specimen following two hours of
loading after the revision reimplantation process can be described in terms of the
relative motion of the implant and bone. There was no quantifiable relative rotation
of the implant relative to the bone measured by the LVDTs for the trials 1 to 6. The
reduced torsional stiffness of the reimplanted specimen correlated to observable
relative rotation at both LVTD positions (Figure 6-16). The torsional stiffness of
the specimen was regained after two hours of cyclic anatomical loading (Figure


186
6-14) at which point the relative rotation of the implant and the femur returns to zero
(Figure 6-16).

Figure 6-16. Relative rotation of the implant relative to the femur.
Note that the rotation measured after two hours of loading is negligibly small in comparison to the
rotation measured immediately after the revision reimplantation process.

6.3.7 Strain for initially implanted and revision reimplanted
specimens under torsion

The variation of strain generated by the torsional moment with respect to time for the
fixed implant is almost entirely linear as shown in Figure 6-17A. The magnitude of
the strain increases from zero with an increase in rotation and reaches a peak strain
before rotating in the opposite direction and reducing the magnitude of the strain.
The strain relationship for the loose (reimplanted) implant follows a similar trend to
the fixed implant, however the strain is no longer linear with respect to rotation and
time as shown in Figure 6-17B.


187
A.
B.

Figure 6-17. Principal strain measured at all rosette locations for the first two
cycles of torsional loading.
A. Shows that the strain relationship with respect to rotation and time is predominantly linear; B.
Strain is no longer linear with respect to rotation and time for the reimplanted stem.

Relationship between strain and the rotation of the specimen
An understanding of the relationship between rotation, strain and time is necessary
when interpreting the strain results obtained from the rotation rig. Strain of the
femur is a result of the rotation of the system. It can be seen that the system is
rotating during the period of bearing alignment (frictional torque) from previously
presented torque rotation diagrams. It should therefore be noted that the strain of the
femur will vary during the bearing alignment phase of the rotation. Figure 6-18
shows the relationship between strain, rotation and time.


188
A.

B.

Figure 6-18. Strain-time plot showing the corresponding points in time on the
torque rotation diagram
Points A, B, C and D represent the first cycle of the torque-rotation experimentation. Point A
represents the start point of the second cycle. Note that the torque-rotation data between points D and
A will describe the second alignment phase of the first cycle.

Point A on Figure 6-18A and B represents time zero and point B represents the peak
rotation corresponding to the peak strain (Figure 6-18B). The region between points
B and C has been previously been defined as the alignment phase, corresponding to
the friction torque. From Figure 6-18B it can be observed that the system is rotating
during the alignment phase even though no force is being transferred to the specimen
itself (Section 6.3.4). Figure 6-18A shows the change in strain with respect to time
during the alignment phase. When the strain produced from torsion is used in further
studies (Section 9.2) only the strain produced by the measured torque is used, the
strain of the alignment phase is ignored.


189

6.4 Discussion
An experimental protocol has successfully been developed that enables axial
subsidence and torsional stiffness data to be gathered in order to assess the stability
of the femoral component of the total hip arthroplasty. The experimental program of
this research project investigated the stability of the Exeter stem immediately after
implantation and at periods of relaxation during the cyclic loading regime. The stem
was then reimplanted and retested. It was found that although the torsional stability
of the stem was compromised immediately after reimplantation, the stability returned
with minimal loading (2 hours). The stem was monitored in terms of distal migration
in the direction of the applied load. It was found that the stem did in fact subside
within the cement and femur system. It was also found that there was no perceivable
variation in the torsional stiffness of the system during the loading period.
Subsequently, the conclusion was reached that the highly polished double taper
design of the Exeter allowed the stem to subside within the mantle while maintaining
the initial stability of the stem. This stability was fully recovered after a short
duration of loading following the reimplantation process.

Some issues became apparent with the equipment and the capacity of the test to
produce accurate and repeatable data. For instance, this protocol was developed for
the measurement of both the distal migration of the stem and the torsional stiffness of
the specimen. A multi-axial materials testing machine was not available so the two
tests needed to be undertaken in two different machines, or at least within two
different constraints (i.e. femoral constraint and the torsional loading device). Two
major problems arise as a result of the relocation of the specimen from one constraint
to the other. The first is that this process takes time. The materials involved in this
analysis are by definition viscoelastic and by definition the distal migration
measurements are intended to measure the viscoelastic displacement of the system.
The exponential nature of the viscoelastic response results in the largest recoverable
displacements occurring immediately after the removal of the load. This means that


190
valuable distal migration data may be lost during the period of time in which the
torsional stability is being measured.
The second major problem is that in removing the specimen from the anatomical
loading rig the measurements of displacement are no longer continuous. Great care
has been taken in ensuring that the position of the femur is repeatable within the
femoral constraint. Considering that the total magnitude of the distal migration of
the head of the implant was less than 1mm it would be necessary to replace the
specimen to within fractions of a millimetre. This is not possible given the irregular
non-linear geometry of the femur.

Another issue arose as a result of the bearing and torque arm used to couple the
bearing shaft to the Hounsfield. An undesired non-linear frictional torque that varied
with the tension in a single cap head screw was noted. This friction force (and
certainly the variation in the friction force) was unexpected for the following reasons.
The bearing was mounted onto a base of aluminium that was machined flat at the
region of the bearing attachment. The base of aluminium was machined flat on both
the top and bottom surfaces of the plate and was securely mounted with four cap
head screws to a 25mm thick stainless steel plate. At the time of design, it was
believed that these base plates would provide an alignment of the bearing which was
constant with respect to the Hounsfield.
In order to account for what appears to be a misalignment with the axis of rotation of
the bearing shaft (i.e. the axis of the bearing shaft is not perpendicular to the motion
of the Hounsfield load cell) a modified torque arm to couple the bearing shaft to the
Hounsfield must be used. The modified coupling arm would need to allow for an
additional rotational degree of freedom by replacing the pin joint at the elbow of the
coupling arm. This modification is required prior to any further testing using the
torsional loading rig.


191


192


Chapter 7: Development of the FEM of the proximal femur with implanted Exeter
stem
193
Chapter 7: Development of the FEM of the
proximal femur with implanted Exeter
stem
7.1 Introduction
Definition of finite element models requires numerical description of the geometry,
boundary conditions, loading state and material properties of the system under
investigation. The finite element method discretizes the body under investigation
into a finite number of elements. The response of the system is then obtained by
applying an interpolation function to each individual element. The numerical
solution will, in theory, approach the exact solution to the model as the number of
elements approaches infinity. The exact solution to the model is determined by the
assumptions made regarding the model type, the material properties, loads and
boundary conditions used to generate the model.

This chapter describes the generation of a finite element model of the proximal femur
and the cemented Exeter femoral component. The generation of the geometry of the
components is discussed prior to the final assembly of the model. The element type
and a description of the meshing techniques are then presented followed by a
description of the material properties and boundary conditions applied to the model.
The model is then validated using the results presented in Chapter 3 for the varus


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stem position. A flow chart of the experimental and finite element process for this
research is shown in Figure 7-1 with the work covered in this chapter highlighted.


The Exeter stems were originally implanted by hand by the senior orthopaedic
surgeon. The mean(SD) position of these stems was found upon inspection to be
approximately 4.6(0.35) varus orientation (Section 5.3). The FEM was developed
using this stem orientation. It became clear from mechanical testing undertaken on
the Sawbones (Chapter 4) and an investigation carried out on the influence of stem
position on the strain patterns of the proximal femur (Chapter 5) that the position of
4.6 varus had a major effect on the survivorship of the femora. The investigation
into the varus stem position is valuable, as it is the position obtained by the senior


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surgeon by hand without technical aid for the geometry of the model 3303 Sawbones
femur. The varus stem orientation should therefore be considered as a very real
clinically possible stem orientation for a similarly sized femur. Future work will
investigate the mechanics of the neutral stem position, with a significant body of data
already available from the research conducted in Chapter 6. The effect of stem
position will be carried out in future FE studies.

7.2 CAD model generation
SolidWorks Education Edition (SolidWorks Corporation, Massachusetts) mechanical
design software has been used as the principal software to assemble the base CAD
model. SolidWorks was used to generate the CAD models of the cement mantle,
Exeter stem and to modify the geometry of the femur. Modifications of the femur
model were undertaken using MAYA 5.0.1 (Alias Systems Corporation) and
RapidForm2001 (Inus Technologies).

7.3 Finite element pre-processor MSC.Patran
TM

MSC.Patran
TM
(MSC.Software Corporation, Santa Ana) was used exclusively as the
finite element analysis pre-processor. MSC.Patran
TM
is a general purpose computer
aided engineering software that supports three-dimensional modelling.
MSC.Patran
TM
was used to import the CAD model from the solid modelling package
(SolidWorks) after the model was assembled and positioned. Boolean operations
were then performed on the solids to generate the final geometry. During pre-
processing of the model the ABAQUS analysis preference was used to generate the
solver input file for direct use within ABAQUS.


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7.4 ABAQUS 6.3
ABAQUS/Standard 6.3 produced by ABAQUS, Inc (formerly Hibbitt, Karlsson &
Sorensen, Inc) is a commercially available finite element solver that is well suited to
the study of the femoral component of the total hip arthroplasty. ABAQUS/Standard
supports both linear and non-linear analysis types and is supported as a solver within
the ABAQUS/CAE modelling environment. ABAQUS/CAE was used for
visualisation and post-processing of the model after submission of the input file
generated by MSC.Patran
TM
to ABAQUS/Standard for solving.

7.5 Description of the finite element method
The finite element method involves the discretization of a body in one, two or three
dimensional space into discrete sections known as elements. The elements are
interconnected at a finite number of points known as nodes (Zienkiewicz 1971). The
discretized body is then said to be represented by a finite element mesh. The method
was initially introduced in the form we know now in the 1950s and has been
dominant in its development and use throughout many engineering disciplines
including biomedical engineering (Fagan 1992). Once the body has been meshed
loads and boundary conditions are applied.
The solver code used for this investigation was ABAQUS. The finite element
method will therefore be explained using ABAQUS as an example of the direct
application of finite element theory. ABAQUS considers linear and non-linear
analyses using two distinct solution methods. Linear problems are solved using
linear perturbation analysis, which considers the base state of the model as the initial
condition and solves for the step. Non-linear problems are solved using Newtons
method and are considered in terms of a sequence of increments, where an increment
is a subdivision of the step, that are solved such that the initial conditions for the n
th

increment are given by the solution of the (n-1)
th
increment.


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7.5.1 Basic finite element equations
The equations governing the meshed body are determined by assembly of the
individual element equations that are, in the case of a linear mechanical system,
defined in terms of force, displacement and the stiffness of the system (Equation
7-1).

[ ]{ } { } k U F =
7-1

Where [k] is the stiffness matrix, { } U is a vector of unknown displacements and { } F
is the vector of nodal forces.

In order to determine an exact solution of Equation 6-1 both the forces and moments
must be in equilibrium at all times over any region of the body. The displacement
finite element method replaces the exact solution with a weak requirement that
equilibrium must be maintained in an average sense over a finite number of divisions
of the volume body (ABAQUS Theory Manual (2002b), Section 1.5.1). ABAQUS
uses the principal of virtual work as the weak statement.

7.5.2 Convergence
ABAQUS divides the problem into steps, containing the definitions of the model
geometry, loads and boundary conditions. If multiple steps are being used the loads
and boundary conditions applied to the model geometry can vary between steps with
the history of the previous step included in the new step. Each step is considered in
terms of time, with the default step time equal to one second. Two forms of control
are available for the solution of non-linear problems, direct user control where the
user defines the increment, and automatic control where the user defines the step,
tolerance or error parameters and ABAQUS automatically selects the increment


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based on the response of the step. Automatic incrimination was used for non-linear
problem solution.

ABAQUS checks the convergence of the solution for each iteration. For mechanical
stress analysis, ABAQUS defines displacement as a field () and force as the
conjugate flux (q
). The measures used to test for convergence of the field equation

are:
max
r =the largest residual in the balance equation for field ;
q
~
=An overall time averaged value of the typical flux or field so far
during this step including the current increment;
n
R =a tolerance that is defined by default as 0.005;
max
u
=Largest change in the nodal variable of type ;

max
c
=The largest correction to any nodal variable of type .

The residuals are used to test for convergence using the following criteria:

q R r
n
~
max

7-2

Convergence is accepted if the inequality given in Equation 7-2 is satisfied and the
largest correction to the solution (
max
c
) is small in comparison to the incremental

change in the solution variable (

max
u ).

max max

n
c C u

7-3

Where
n
C is a tolerance with a default value of 10
-2
.
Convergence is also deemed likely if the estimated correction (
est
c
) is substituted
into the inequality of Equation 7-3 where the estimated correction is given as:


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max
max 1 2
max max
( )
min(( ) ,( ) )

=
i
est i i
r
c c
r r

7-4

Where Equation 7-3 becomes:
max est n
c C u

7-5

ABAQUS requires that every step of the calculation adheres to these criteria for
convergence to occur.

7.6 CAD femur model
The initial structure used for the geometry of the 3
rd
generation femur (analogue
femur) was obtained in the form of an IGES file from the Biomechanics European
Laboratory (BEL) Repository (Figure 7-2). This 3
rd
generation femur model has
been created by Marcello Papini (2003) and is available on the Internet through the
BEL Repository managed by the Istituti Ortopedici Rizzoli, Bologna, Italy (Papini
2003).

Figure 7-2. Femur Geometry obtained from BEL.
Papini (2003)


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An investigation into the model geometry found that the CAD model was larger than
the Sawbones model 3303 femur. Further investigation found that there were
multiple and dissimilar Non-Uniform Rational B-Spline (NURBS) surfaces at the
proximal end of the femur intersecting and overlapping between the head of the
femur and the shaft of the femur. The non-congruent NURBS surfaces would cause
errors in the meshing process and needed to be corrected. The following process was
carried out to modify the femur to ensure that the model was the correct scale and
could be meshed for finite element analysis.

Femur scaling
The scale of the CAD femur was corrected by measuring the tip-to-tip length of the
bone for both the CAD femur and a model 3303 Sawbones femur. The ratio of the
lengths was calculated and the size of the CAD femur was altered in order to correct
the length ratio to unity. The length of the model 3303 femur was measured and
found to be 455mm, which was confirmed from the manufacturing data (Pacific
Research Laboratories 2005). The length of the CAD femur (from the original IGES
model obtained from the BEL Repository) was found to be 487mm. The CAD femur
was therefore approximately 7% larger than the model 3303 femur.

NURBS surface correction
The proximal region of the CAD femur including the greater and lesser trochanters,
and the neck of the femur contained multiple and overlapping NURBS surfaces that
required correction before meshing could be undertaken. MAYA 5.0.1 (Alias
Systems Corporation) was used to improve the correlation of the NURBS patches in
the proximal region. MAYA was used to modify the existing NURBS surfaces by
converting them into a polygon mesh. The polygon mesh showed the region of
overlap from the initial NURBS surfaces (Figure 7-3).


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Figure 7-3. Polygon Mesh of the proximal CAD femur.
The region of overlap from the original NURBS surfaces is visible as a region from the neck of the
femur immediately distal to the head of the femur (point A) to the proximo-medial shaft below the
lesser trochanter (point B) to the most lateral aspect of the greater trochanter (point C).

The boundary of the polygon mesh between points A and B (Figure 7-3) was found
to be non-congruent, indicating that the topography of the overlapping patches was
not identical.

RapidForm2001 (Inus Technologies) was used to correct the variation of the
topology of the polygon mesh representing the original NURBS surfaces. The file
was exported from MAYA as indexed face sets (VRML polygon) into
RapidForm2001.

In order to generate a single consistent surface from the two misaligned surfaces a
trim line (the line used to cut and remove the redundant surface) needed to be
defined. The trim line for the polygon mesh was chosen to be the circumferential
line from point B to point C (Figure 7-3). Prior to trimming and equivalencing the
meshes the variation and misalignment between the two meshes needed to be


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minimised. Figure 7-4 shows the deviation of the overlapping polygon meshes as a
contour map before and after alignment has taken place.

A B
Figure 7-4. Overlapping patches of the femur before and after alignment.
A. Shows the variation between the two surfaces prior to alignment; B. shows the variation between the
surfaces after alignment.

The process of aligning the meshes reduced the maximum variation by a factor of
approximately 1.6. Master and slave surfaces were defined as being the retained
surface mesh and removed surface mesh respectively. The greater trochanter, neck
and calcar surface mesh was selected to be the master surface (Figure 7-5 A). The
slave surface comprised the meshes that created the surface from the neck of the
femur to the lateral point of the greater trochanter extending down the shaft of the
femur (Figure 7-5 B).


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203

A B
Figure 7-5. Master and slave surface definitions for the trimming process.
The master surface has been coloured maroon and the slave surface has been coloured green. A.
Shows the master surface highlighted (in green mesh); B. Shows the medial aspect of the slave
surface highlighted.

With the slave surface trimmed the remaining mesh surfaces were interpolated to
form a single uniform shell. Figure 7-6 shows the unified shell along the trim line
after the two surface meshes had been equivalenced. The region of the trim line can
be seen where the two uniform surface meshes of the head of the femur and the shaft
of the femur meet.

The surface of the femur was now defined by a single surface mesh. The CAD
model of the femur needed to be manipulated and positioned within SolidWorks to
create the geometry of the finite element model. The surface mesh was converted
into a new set of NURBS surfaces prior to importing the model into SolidWorks
(Figure 7-7).


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Figure 7-6. Unified shell at the trim line.
The position of the trim line is visible as the region where the two uniform surface meshes meet.

Figure 7-7. NURBS patches generated from the equivalenced surface polygon
mesh.
These patches were created prior to importation into SolidWorks and defined the final surface
geometry of the femur that was used within the finite element model.


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The final geometry of the femur defined by the NURBS patches is shown in Figure
7-8 with the cortical bone transparent to show the position of the cancellous bone.

Figure 7-8. Final femur showing a transparent cortical section and a solid
cancellous section.

Sectioning the femur
The CAD model of the femur was sectioned in an identical manner to the physical
3303 Sawbones femur. The angle of the neck resection of a femur prepared using the
protocol defined in section 3.7 was measured to be 45 using a goniometer. The
point of neck resection (defined by the measurements taken in section 7.8) was used
to position the resection plane.

The anterior-posterior and medial-lateral views of the final resection of the CAD
femur are shown in Figure 7-9.


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A B
Figure 7-9. Resection of the CAD femur.
The cortical bone is shown as a translucent material to show the geometry of the cancellous bone. A.
Shows the AP view of the section of the femur; B. Shows the medial-lateral view of the section of the
femur.

The CAD model of the cortical bone was still a solid volume at this point (i.e. the
volume of the cancellous bone had not been removed). The volume of the cancellous
bone was removed within MSC.Patran
TM
using a Boolean operation to subtract the
cancellous bone geometry from the cortical bone geometry. The femur was
sectioned to remove the distal shaft and epicondyles. Prior to removing the distal
end, the femur was oriented so that the Z-axis of the femur was aligned with the Y-
axis within SolidWorks. The section point was defined as the point where the mid-
shaft support clamped the femur (four implant distal tip diameters from the distal tip
of the implant).


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Cancellous bone
The geometry of the cancellous bone model was based on the geometry of the
retained cancellous bone of the Sawbones femurs prepared using the protocol from
Section 3.7 (Figure 7-10).

A B
Figure 7-10. CAD model of the cancellous bone.
A. The original geometry of the cancellous bone before removing the reamed and broached regions;
B. The cancellous bone after removing the reamed and broached regions. Note the lack of bone in
the proximo-medial region and the small amount of bone retained in the proximo-lateral region.

Figure 7-10 shows that the retained cancellous bone was predominantly in the
proximal region with the majority of the distal bone removed. A small amount of
cancellous bone was retained at the proximo-medial region with most of the retained
bone in at the greater and lesser trochanters and the proximal lateral edge.


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7.7 Model of the Exeter femoral implant and centraliser
A CAD model of the Exeter number 1, 37.5mm offset V40 femoral stem was
obtained from Stryker as an IGES file (Figure 7-11 A). The model as presented was
unable to be meshed using MSC.Patran
TM
so a replica of the original model using a
slightly simplified geometry to allow meshing was constructed (Figure 7-11 B).

A B
Figure 7-11. Comparison between the original model of the Exeter stem and the
reconstruction.
A. The original Exeter geometry supplied by Stryker; B. The rebuilt Exeter geometry.

Although the model was simplified, care was taken to maintain all critical
dimensions of the stem including the taper angle and the implant cross section.
Simplifications were made to the geometry of the head and proximal neck of the
implant as they were not in contact with the cement or bone at any time and were
thought to be of importance in their load carrying capacity only.


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The centraliser was constructed to provide an air gap at the distal tip of the Exeter
implant. The geometry of the centraliser was based upon the three winged centraliser
used in the experimental protocol (Figure 7-12). It was assumed that the most
important aspect of the centraliser (given that the position of the implant and
subsequently the centraliser is defined by the x-rays of the system) was that an air
gap was included at the distal tip of the implant. The wings of the centraliser were
therefore not included in the model.

A B
Figure 7-12. Centralisers.
A. The three-winged centraliser used when implanting the Exeter femoral component; B. The CAD
model of the centraliser that does not include the wings.

The relative position of the centraliser to the implant is shown in Figure 7-13. The
centraliser is transparent to show the position of the distal tip of the Exeter implant.

7.8 Position of the Exeter Stem within the Femur
Knowledge of the femoral component geometry was required to ensure that the
component was positioned in a manner that would be described as clinically
acceptable and to gather positional data for the generation of a finite element model.
The following process was used to define the component position.


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Figure 7-13. Relative position of the Exeter implant and the centraliser.
Note that the centraliser is transparent so that the distal tip of the Exeter is visible.

Four analogue femurs were implanted with an Exeter femoral stem by the senior
orthopaedic surgeon. Each stem was identified by numbers one to four. These
femurs were then x-rayed and the results were obtained in electronic format as a CD
viewer for a Picture Archiving and Communications System (PACS) (Agfa-Gevaert
2001). The CD viewer allowed measurements of distances and angles to be made
from the x-ray image. A ruler was placed beside the femurs in all x-rays to verify
any measurements made using the CD viewer. The four implanted femurs were then
assessed by the senior surgeon to determine which system could be considered as
having a position that would be defined as being themost clinically acceptable.


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The following criteria were used to define the position of the implant with respect to
the femur:
1. Position and angle of neck resection and entry point of the stem relative to the
proximal femur;
2. Depth of implant referenced from the greater to the top of the shoulder of the
implant;
3. Angle of the implant relative to the long axis of the femur in the sagittal
plane;
4. Angle of the implant relative to the long axis of the femur in the coronal
plane;
5. Axial anteversion of the stem neck relative to the posterior condylar axis; and
6. Stem distal tip relative to the outer cortices in lateral and AP radiographs.

The first stage of the implantation process is the neck resection. The neck resection
of the femurs was undertaken with a single cut as described in section 3.7. The point
of neck resection was chosen as an arbitrary geometric location from which to
measure the angle of the resection from the radiograph. Figure 7-14 (A) shows the
point of neck resection using the AP radiograph.

The angle of the neck resection was measured from the point of neck resection. The
angle of neck resection was found to be 45 degrees to the long axis of the femur
(Figure 7-14 B).


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Figure 7-14. Radiographs of the experimental system detailing the position of
the implant with respect to the bone.
A. The point of the neck resection is found relative to the greater trochanter; B. AP radiograph of the
angle of the neck resection relative to the long axis of the femur; C. Depth of implant relative to the
greater trochanter; D. lateral radiograph showing the angle of stem relative to the long axis of the
femur.

Depth of implant
The depth of the Exeter implant in a surgical situation is measured using markers on
the side of the implant (Figure 3-12). The depth position markers were not visible on
the x-ray, so the depth of the implant was ascertained from measurements taken from


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the greater trochanter to the proximal flat of the implant shoulder in the sagittal plane
relative to the long axis of the femur Figure 7-14 (C).

Angle of the implant relative to the long axis of the femur from the lateral radiograph
A lateral radiograph in Figure 7-14 (D) shows that the long axis of the Exeter stem
makes an angle of 2 with the long axis of the femur.

Angle of the implant relative to the frontal plane (angle of anteversion).
The angle of axial plane anteversion was measured to be 13 relative to the posterior
condylar axis from a photograph (Figure 7-15).

Figure 7-15. Angle of anteversion taken with respect to the posterior condylar
axis.

Distal tip position
The following measurements were made to ascertain the position of the distal tip of
the implant relative to the cortices of the femoral shaft:
1. Medial edge cortical diameter: measured from the medial to the lateral cortex
using the AP radiograph.
2. Posterior edge cortical diameter: measured from the posterior to the anterior
cortex using the lateral radiograph.


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From the lateral radiograph (Figure 7-16 (A)) the ratio value of 0.45 was obtained,
and from the AP radiograph (Figure 7-16 (B)) a ratio of 0.60 was obtained. It should
be noted at this point that according to the senior orthopaedic surgeon, the distal tip
of the implant should be in the centre of the medullary canal. The variation is being
accepted in this case as the orthopaedic surgeon advised that a variation of this
magnitude would be considered normal in a surgical environment.

Figure 7-16. Measurement of the stem tip position.
A. Stem tip position in the coronal plane (anterior-posterior x-ray) markers (a) and (b) show the
medial and lateral cortex respectively. Marker (c) shows the stem tip; B. Stem tip position in the
sagittal plane (lateral x-ray). Markers (d) and (e) show the posterior and anterior cortex respectively.
Marker (c) shows the stem tip.

7.8.1 Relative coordinate system of the in vitro femur and prosthesis
The relative coordinate system used within this investigation is based on the
coordinate system generated by Bergmann et al. (2001) and is shown in Figure 7-17.
The long axis of the femur passes through the mid point of the most proximal edge of
the greater trochanter and through a point parallel to the medial edge of the lateral
epicondyle. The z-axis is parallel to the long axis of the femur. The x-axis is parallel


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to a line drawn through the two epicondyles, and the y-axis is perpendicular to both
the x and y-axes. Axes have also been defined relative to the prosthesis. The z-axis
is formed by the long axis of the prosthesis, such that the z-axis and the z-axis will
be parallel when the prosthesis is implanted in a neutral position.
The resultant hip contact force is shown on the diagram and can be broken down into
three components in the x, y and z directions.

Figure 7-17. Coordinate system of the left femur and implant
Where: Fx, Fy and Fz are the loads applied in the x, y and z directions respectively; Mx, My and Mz
are the moments in the x y and z directions respectively; S is the angle made between the long axis of
the femur and the long axis of the implant; Av is the angle of anteversion of the implant; Ax is the
angle that the resultant force makes in the Z-Y plane; Ay is the angle that the resultant force makes in
the Z-X plane


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7.9 The cement mantle
The geometry of the cement mantle was modelled on the observed geometry of the
mantle produced using the implantation protocol (Section 3.7). The cement mantle
was constructed using the assumption that the mantle is at no point thinner than 2mm
and accommodated both the Exeter stem and the centraliser. The cement mantle
geometry (Figure 7-18) was generated by using a subtraction Boolean operation
within MSC.Patran
TM
on the solids of the cancellous bone prior to reaming and
broaching (Figure 7-10 A) and the reamed cancellous bone (Figure 7-10 B).

A B
Figure 7-18. Cement mantle.
Note the additional mantle created by removing the medial cortex using the Exeter 37.5mm offset
number zero broach geometry. A. Shows the final CAD model of the cement mantle; B. shows a line
drawing of the cement mantle clearly showing the broached section.


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The CAD model of the femur possessed an internal cortical geometry such that the
stem (modelled on the varus geometry) would intersect cortical bone at the medial
cortex. If such an eventuality had occurred within the experimental protocol the
cortex would have been broached with an Exeter 37.5mm offset number zero broach.
This process was modelled by removing the medial cortex using a similar geometry
to the broach (Figure 7-18 B). The cement mantle also included the region of the
cortical bone that was removed by the broaching and reaming process. This was
achieved in the CAD model by adding the cortical volume that is removed during the
preparation of the femur to the volume of the cement mantle with the Boolean add
operation. After the model had been assembled and positioned the volumes of the
Exeter stem and centraliser were removed from the cement mantle volume using the
Boolean subtract operation.

7.10 Assembly of the model components
The components were positioned within SolidWorks prior to any Boolean operations
taking place within MSC.Patran
TM
. This was to minimise any tolerance errors that
may have been generated when transferring files multiple times between SolidWorks
and MSC.Patran
TM
. All of the assembled components of the finite element model
after the Boolean operations had been performed are shown in Figure 7-19.


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Figure 7-19. Assembled model of the proximal femur and the cemented Exeter
37.5mm offset number 1 stem.

7.11 Element Type
ABAQUS possesses a large element library from which to choose the element type.
The type of problem investigated (stress-strain, thermal etc) will limit the number of
elements available and simplify the selection process. The model of the femoral
component presented here is a three-dimensional stress-strain problem, which
narrows the selection of elements considerably. The stress-displacement elements
within ABAQUS possess active degrees of freedom in the x, y and z directions (i.e.
the degrees of freedom for rotation are not active). Tetrahedral, triangular prism
(wedge) and hexahedron elements (Figure 7-20) are the solid elements available for a
three-dimensional stress-displacement analysis.


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4-node tetrahedral element
(first order)

10-node tetrahedral element
(second order)

6-node wedge element
(first order)

15-node wedge element
(second order)

8-node brick element
(first order)

20-node brick element
(second order)
Figure 7-20. Solid elements used for stress/displacement analysis. (modified
from ABAQUS Standard Users Manual Section 14.1.4)

Gaussian quadrature is used to numerically integrate the elements to determine the
displacements (field). In the case of a first order tetrahedral element the stiffness
calculation is made using one integration point. For a second order tetrahedral
element the stiffness calculation is made using 4 integration points. ABAQUS uses
full integration to define the behaviour of triangular and tetrahedral elements,
reduced integration can be used for quadrilateral and hexahedral elements.

The first order tetrahedral element is a constant stress element that should not be
used in stress analyses unless a fine mesh density is used or if the stress gradient is
high. Second order tetrahedral elements give accurate results in stress problems
without contact. Second order elements are more accurate than the first order



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220
elements in stress problems that do not involve contact. Regular second order
tetrahedral elements will experience convergence problems generated by
significantly different contact forces at the corner and mid-side nodes when used in
contact problems. Modified second order elements have been developed to
overcome the issues effecting second order elements in contact analysis. The
modified elements produce contact forces that are consistent with the direction of the
contact.

Considering that the model of the femoral component involves the use of automatic
meshing algorithms, high stress gradients are possible, and that there are multiple
contacting bodies, the element selected was the modified second order tetrahedral
element. The capacity of the modified second order tetrahedral element to produce
valid results was tested for bending and contact conditions the results of which are
supplied in Appendix B.

7.12 Mesh Generation
An automatic meshing algorithm was used to mesh the model using a constant mesh
density over the entire model. All of the model solids were uniformly seeded.
Surface meshing was used to control the solid mesh. Prior to meshing with solid
elements the model surfaces were meshed using six-node triangular elements
(CPE6). The modified 10-node tetrahedral elements (C3D10M) were then used to
mesh the solid volumes. The elements used for this model are shown in Figure 7-21.
Using the data from the element validation study the model was meshed using
element sizes of 3, 2 and 1.5mm edge length. These meshes were used later to
validate the model. All of the meshes used to validate the model are given in Figure
7-22.


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221

CPE6
(six-node quadratic plane strain triangle)

C3D10 and C3D10M
(ten-node quadratic tetrahedron)
Figure 7-21. Triangular and tetrahedral elements showing nodes (dots) and
integration points (crosses).

7.12.1 Treatment of contact when meshing
The four interfaces in the model were the stem-cement, cement-cancellous, cement-
cortical and the cancellous-cortical. The cement-cancellous, cement-cortical and the
cancellous-cortical interfaces were assumed to be fixed so that no relative motion
would occur at the interface. There are two principal methods of constraint available
within the MSC.Patran
TM
pre-processor, they are the *TIE function (see section
7.13.1), which numerically ties two surfaces together, and equivalent meshing.
Equivalent meshing is a time consuming process where the surfaces are meshed such
that the nodes of one surface coexist with the nodes of the other surface. The
coexisting nodes are then reduced to a single node using the process of
equivalencing. After the equivalencing process the node that remains retains the
lowest identification number of the two original nodes and belongs to both surfaces.
All of the contact surfaces of the initial models presented for the validation were
treated with the numeric tie function. Node equivalencing was used once the
validation had been undertaken and the mesh density had been determined.



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A

B

C

D

E

F

G

H

I

J

K

L
Figure 7-22. Model meshed with 3, 2 and 1.5mm element lengths (not to scale).
A-D. Components meshed with a 3mm element length; E-H. Components meshed with a 2mm
element length; I-L. Components meshed with a 1.5mm element length.


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7.13 Loads and boundary conditions
The loads and boundary conditions applied to the experimental specimen of the
Sawbones implant specimen are replicated within the model. The accuracy of the
boundary conditions and applied load used within the model was high as the position
of the femur and the manner in which the femur was constrained were known
relative to the applied load.

Boundary conditions
The experimental femoral constraint was simulated by constraining all of the nodes
associated with the resected face in all active degrees of freedom (the rotational
degrees of freedom are not active in the tetrahedral element). This was the only
numerical constraint applied to the model and was representative of the experimental
femoral constraint (Figure 7-23).

Applied load
The experimental resultant load of 650N was represented in the model with a
concentrated load acting through the central node on the surface of the head of the
implant (Figure 7-23).

7.13.1 Surface based tie definition
All of the fixed interfaces within the model that were too geometrically complicated
to mesh equivalently were treated with a surface based tied contact formulation. A
surface pair is defined in terms of a master and a slave surface where the master
surface tends to be the stiffer body when using the *TIE definition within ABAQUS.
The surface definitions for this model of the three remaining tied surfaces are given
in Table 7-1.


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Figure 7-23. Boundary conditions of the model.
The distal end is constrained in all directions (rotational degrees of freedom are not active in the
tetrahedral elements). The components of the concentrated load representing the hip contact force are
shown acting at the head of the implant.


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Table 7-1. Master-Slave definitions
Contact pair Master Slave
Stem-Cement Stem Cement
Cement-Cortical Cortical Cement
Cement-Cancellous Cement Cancellous
Cancellous-Cortical Cortical Cancellous
The master-slave definition for the stem-cement interface is consistent for both the tied contact
formulation and for the relative tangential contact friction (coulomb friction model). This definition
was for the preliminary validation models only; surface definitions were not required when node
equivalencing was used.

The ABAQUS adjust parameter was used to move all of the slave nodes not
initially in contact with the master surface into contact without producing any strain.
Figure 7-24 shows a master surface and a slave surface, and a position tolerance set
by the adjust parameter to account for variation in the position of the slave nodes.
The adjust parameter was set to 1mm for all surfaces and models.

Figure 7-24. Element based tied contact definition showing the effect of the
adjust parameter on the slave nodes
(Hibbit et al. 2002a)

7.13.2 *FRICTION
The second model presented is a model of the Exeter stem within the analogue femur
with a fully debonded stem. This condition will model the system of the



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226
experimental specimen immediately after the reimplantation protocol had been
undertaken. The Coulomb friction model allows two contacting surfaces to transmit
a shear stress across the interface until a critical shear stress (
crit
) is reached. The
critical shear stress is calculated as a fraction of the contact pressure P (Eq. 7-1).

crit f
P =

Eq. 7-1

The fraction relating the contact pressure to the critical shear stress is known as the
coefficient of friction. By default the Coulomb friction model uses an isotropic
coefficient of friction. A coefficient of friction (
f
) of 0.22 was used to model the
interface between the stem and cement after the specimen had undergone the
reimplantation protocol (Hampton 1981).

7.14 Material Properties
The material properties given in Table 7-2 were used to define the finite element
model. Isotropic linear elastic material properties were assumed for all materials.
Table 7-2. Material properties for the Sawbones femur/implant system
Part Material Elastic Modulus Poissons ratio
Cortical Bone SGFR epoxy 2.3 to 11.6GPa 0.3
Cancellous Bone Closed cell foam 104MPa 0.3
Cement PMMA 2.4GPa 0.3
Exeter Stem Stainless Steel 200GPa 0.3

A lower and upper bound (being the absolute minimum and absolute maximum
values obtained from the thermo-mechanical testing) was used for the material
properties of the SGFR epoxy.


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7.15 Validation
The validation of the FEM involved the comparison of the results produced by the
three mesh densities using three Youngs modulus values calculated for the SGFR
epoxy from Chapter 4 with experimental data (Section 4.4). Three models were used
so that the convergence of the model with respect to mesh density could be observed.
The upper and lower bounds of the Youngs modulus determined in Chapter 4 were
used as the first two points. The third Youngs modulus value the best guess
Youngs modulus was chosen as being the material property that was believed to be
the most likely experimental value of the Youngs modulus of the SGFR epoxy
during the testing. Given the properties of the SGFR epoxy determined from
Chapter 4 an estimated value of 4GPa was used as the best guess for the Youngs
modulus of the material when elevated to 37C. The values of the material properties
used to model the SGFR epoxy are given in Table 7-3.

Table 7-3. Material properties for the SGFR Epoxy used in the model
validation
Part Model name Elastic Modulus Poissons ratio
Cortical Bone Lower-bound 2.3GPa 0.3
Cortical Bone Best guess 4GPa 0.3
Cortical Bone Upper-bound 11.6GPa 0.3

ABAQUS does not provide surface strains of the external elements, so a program
was written that used the geometry of the region to convert the global strains into
surface strains. The position of the strain rosettes on the analogue Sawbones femur
were then measured and replicated on the geometry of the model. The gauge
positions were defined in terms of the relative position from easily measurable points
using the geometry of the NURBS patches. The nodes associated with the position
of the strain gauges are denoted as rosette nodes. The positions of the rosette nodes


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are given in Figure 7-25. A description pertaining to the position of the rosettes is
given in section 3.10.

Rosette 1

Rosette 2

Rosette 3
Figure 7-25. Strain rosette locations relative to the NURBS surfaces of the
femur

7.15.1 Determination of the surface strain
The surface strains at the rosette nodes were determined by calculating the normal
vector to the surface of the femur at the point of the rosette node and transforming
the three-dimensional strain at the rosette node into two-dimensional strain of the
surface perpendicular to the normal vector. The position of the rosette nodes and the
nodes surrounding the rosette node were obtained. Tetrahedral elements possess
geometry that generally forms a group of surface nodes with a central node and six
surrounding nodes (Figure 7-26), which for this discussion shall be called a node
surface unit.


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Figure 7-26. Node surface unit, with a central node and six surrounding nodes.

Element faces and nodes were labelled A-F and a-g respectively for every node
surface unit (Figure 7-26), where node a was always the central node and the label
order increases in the clockwise direction. The six nodes surrounding the rosette
node were used to generate their own node surface units such that normal vectors
were calculated for the rosette node and all surrounding nodes. The geometry of the
surface surrounding the rosette node representing rosette 1 from the experimental
system is shown in Figure 7-27 where the rosette node is defined as node a.
Figure 7-27. Node Surface Units of the rosette node and the six surrounding
nodes.
The normal vectors are shown in red. The blue axis is parallel with the global X-Y plane.


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230

The normal vectors are shown in red with the arrows pointing from the inside to the
outside of the femur volume. The relative x-axes (shown in Figure 7-27 as the blue
axes) is parallel with the global X-Y plane, which was parallel with the x-axis made
by gauge a.

Figure 7-28. Strain results from the finite element model.
The node indices along the x-axes correlate with the node surface unit definition given in Figure 7-27.
Node index (a) correlates with the rosette nodenodes b-g are the nodes adjacent to the rosette node.

A series of strain values corresponding to the node locations of the node surface unit
were calculated for the rosette region (Figure 7-28) and the mean of these values
were used to represent the modelled strain of the rosette.


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7.15.2 Validation Results
The results from the finite element model were compared to the results obtained from
the static load test carried out on the 5 varus stem. Three mesh densities were used
for the validation process. The magnitudes of the elements used were chosen to
show how the convergence of the model was affected by the mesh density. The
largest element selected of 3mm (providing the lowest mesh density) was chosen to
provide an accurate solution based on the bending theory by ensuring that there were
at least three elements through the cortical bone at regions of high bending stress.
The smallest element selected of 1.5mm (providing the highest mesh density) was
chosen based on the computational solution time of the model. The time taken to
solve the 1.5mm element model was 17 times greater than the 3mm element model
with a total solution time of 16975 seconds. This section of work shows that the
mesh density provided by the 1.5mm elements would give a solution close enough to
the exact solution while not being overly computationally expensive.

Rosette one
The modelled strain results for the first strain rosette were in good agreement with
the experimental results (Table 7-4 and Figure 7-29) for the lower bound case.
Table 7-4. Strain results for the first rosette
Model
Max Principal
()

Mean (SD)
Min
Principal
()

Mean (SD)
Max Shear
()
Mean (SD)
p
(Degrees)
Mean
(SD)
Experimental 1309.9(123.8) -549.7(54.4) 1858.9(85.7) -1.2(0.7)
Mesh 3mm Lower-bound 1270 (135) -385(42) 1656(175) 3(1)
Mesh 2mm Lower-bound 1391(107) -418(34) 1809(139) 2(1)
Mesh 1.5mm Lower-bound 1423(74) -434(25) 1856(99) 2(0.4)
Mesh 3mm Best guess 904(95) -273(32) 1177(126) 3(1)
Mesh 2mm Best guess 987(71) -297(24) 1284(94) 2(1)
Mesh 1.5mm Best guess 1004(50) -307(17) 1311(66) 2(0.4)
Mesh 3mm Upper-bound 401(38) -122(13) 523(50) 2(2)
Mesh 2mm Upper-bound 436(29) -133(10) 570(39) 1(1)
Mesh 1.5mm Upper-bound 442(20) -137(7) 579(27) 1(0.5)


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The best estimate for
1
was made by the 3mm lower-bound model, producing an
error of only 40. The 1.5mm lower-bound model produced the best estimate for
2

and
max
with predicted strains of -434(25) and 1856(99) respectively. All of
the models produced good results for
p
. The best prediction of
p
was made by the
2mm and 3mm upper-bound models. Strain at the first rosette was best modelled
using the lower-bound Youngs modulus.

The plot of strain values has been ordered in such a way as to group the three
Youngs modulus models. This shows the variation in the model output as a function
of the material properties of the SGFR epoxy while still showing the convergence of
the models as the mesh density is increased.

Figure 7-29 shows that of all the models the lower-bound Youngs modulus models
produced the best estimates of the measured strain (the lower-bound Youngs
modulus models are grouped to the left of the graph). Mesh refinement of all models
showed good convergence with little change in predicted strain between the 2mm
and 1.5mm element lengths.


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-200
0
200
400
600
800
1000
1200
1400
1600
Experimental 3mm mesh 2mmmesh 1.5mm mesh 3mm mesh 2mmmesh 1.5mm mesh 3mm mesh 2mm mesh 1.5mm mesh
S
t
r
a
i
n

(
M
i
c
r
o

s
t
r
a
i
n
)
Lower-bound Young's modulus 'Best Guess' Young's modulus Upper-bound Young's modul us

Figure 7-29. Strain predictions for all models at the first rosette position.
The results are grouped in terms of their material properties.

A vector diagram was then used to visualise the modelled strain at the rosette
positions. Vector diagrams show the calculated strain at the integration point of the
element as an arrow, where the magnitude of the arrow shows the relative magnitude
of the strain at that point. The direction of the arrow indicates compressive strain if
the arrow heads are pointing towards the arrow shaft or tensile strain if the arrows are
pointing away from the arrow shaft.
The modelled state of strain at the point of the first rosette is shown in Figure 7-30.


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234
A.

B.

Figure 7-30. Predicted strain vectors at the first rosette for the Lower-bound
2mm element length model.
A. Shows the state of strain from the lateral aspect of the femur looking perpendicular to the surface
of the rosette; B. Shows the state of strain from a transverse cut and looking down the edge of the
external surface of the bone.


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As expected from the results in Table 7-4 the axes of the principal strains are
virtually in line with the Z-axis of the femur and the X-Y plane. Figure 7-30A shows
the maximum principal strain as a tensile strain in line with the Z-axis. The
relatively large magnitude of the arrow indicates that the maximum principal strain is
the dominant strain in the system. The minimum principal strain is parallel with the
surface (at right angles with the maximum strain) and is in a state of compressive
strain (as indicated by the arrows pointing towards the shaft). The magnitude of the
minimum principal strain is small compared to the maximum principal strain. The
intermediate principal strain acts in compression perpendicular to the surface.

Rosette Two
Of all three rosette positions, the second rosette showed the largest discrepancy
between the experimental and numerical results. The tabulated strain results for the
second strain rosette are given in Table 7-5.
Table 7-5. Strain results for the second rosette
Model
Max
Principal
()

Mean (SD)
Min
Principal
()

Mean (SD)
Max Shear
()
Mean (SD)
p
(Degrees)
Mean
(SD)
Experimental 320.9(56.1) -423.9(48.9) 744.3(36.2) -42.1(1.7)
Mesh 3mm Lower-bound 945(142) -172(168) 1116(74) -10(3)
Mesh 2mm lower 1234(97) -109(52) 1342(51) -8(1)
Mesh 1.5mm lower 1263(72) -99(44) 1362(36) -9(0.5)
Mesh 3mm Best guess 656(111) -97(78) 753(98) -7(4)
Mesh 1.5mm Best guess 854(51) -86(31) 940(26) -8(1)
Mesh 3mm Upper-bound 258(50) -53(38) 311(33) -10(3)
Mesh 1.5mm Upper-bound 338(24) -40(8) 378(18) -8(1)

The 2mm and 1.5mm upper-bound models produced strains of 340 and 338
respectively, a good prediction of the experimental maximum principal strain of
321. No numerical model produced an accurate representation of
2
. However the
best prediction of
2
was produced by the 3mm lower-bound model, however even


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this model presented an error of 246%. The strain of
max
was predicted well by the
3mm best guess model. The principal angle values were consistent between all of
the meshes and all of the Youngs modulus values. However, the experimentally
determined value of
p
of 42.1 compared poorly to the modelled
p
of 8 (average
across all models). No single value for the Youngs modulus predicted superior
values for strain at the second rosette position.

The graphical representation of the strain given in Figure 7-31 shows clearly that
there is no one material property value that can generate accurate strain predictions at
this point (rosette 2). All models underestimate the magnitude of the second
principal strain. The models that predict a value of
2
close to the measured strain
overestimate
1
, therefore overestimating
max
.
-600
-400
-200
0
200
400
600
800
1000
1200
1400
1600
Experimental 3mm mesh 2mmmesh 1.5mm mesh 3mm mesh 2mmmesh 1.5mm mesh 3mm mesh 2mm mesh 1.5mm mesh
S
t
r
a
i
n

(
M
i
c
r
o

s
t
r
a
i
n
)
Lower-bound Young's modulus 'Best Guess' Young's modulus Upper-bound Young's modul us

Figure 7-31. Strain predictions for all models at the second rosette position.


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A.

B.

C.
Figure 7-32. Predicted strain vectors at the second rosette position for the
Lower-bound 2mm element length model.
A. Shows the external surface of the femur, perpendicular to the surface; B. Shows the top view of
the cortical section (the surface on the right is the external surface); C. Shows a section of all of the
model components at the level of the rosette to highlight the source of the large strains shown on
figure B.


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The maximum principal strain is tensile and parallel with the surface of the femur at
an angle of approximately 10 degrees to the Z-axis (Figure 7-32A). The minimum
principal strain is compressive and also parallel with the surface of the femur with a
slightly smaller magnitude than the maximum principal strain. The intermediate
principal strain is perpendicular to the femur surface. The increase in strain at the
internal surface of the cortical bone occurs at the junction point for a three-surface
contact condition between the cortical, cancellous and cement surfaces. The steps
taken to remove this effect are described further in section 7.15.3.

Rosette Three
The results from the finite element models are presented for the third strain rosette in
Table 7-6 and graphically in Figure 7-33.
Table 7-6. Strain results for the third rosette
Model
Max
Principal
()

Mean (SD)
Min
Principal
()

Mean (SD)
Max
Shear ()
Mean
(SD)
p
(Degrees)
Mean
(SD)
Experimental 193.9(45.8) -516.3(28.9) 706.0(39.8) 16.5(1.4)
Mesh 3mm Lower-bound 333(103) -462(128) 795(231) -23(5)
Mesh 2mm lower 333(50) -488(53) 821(101) -25(4)
Mesh 1.5mm lower 390(29) -571(29) 961(55) -25(3)
Mesh 1.5mm Best guess 316(22) -473(21) 789(40) -26(3)
Mesh 1.5mm Upper-bound 180(13) -282(10) 462(21) -28(3)

The upper-bound Youngs modulus models produced a good estimate of the
experimental
1
, with the best prediction produced by the 1.5mm mesh with a strain
value of 180 compared to an experimental value of 194. The lower-bound
models all produced good approximations to the experimentally measured
2
strain
with the best estimate produced by the 2mm mesh producing a strain of -488
compared to the measured strain of -516. The model using the best guess


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Youngs modulus presented the best strain results for
max
with a value of 712
from the 2mm mesh.

The graphical representation of the strain at the third rosette (Figure 7-33) shows that
all models predicted the strain well at this point. The models do not appear to have
reached the asymptote of their convergence between the 2mm and 1.5mm models, as
has been the case for the other two rosette positions. Therefore there is still some
mesh dependence in the FEM results at this location.
-800
-600
-400
-200
0
200
400
600
800
1000
1200
Experimental 3mmmesh 2mmmesh 1.5mmmesh 3mmmesh 2mmmesh 1.5mmmesh 3mmmesh 2mmmesh 1.5mmmesh
S
t
r
a
i
n

(
M
i
c
r
o

s
t
r
a
i
n
)
Lower-bound Young's modulus 'Best Guess' Young's modulus Upper-bound Young's modulus

Figure 7-33. Strain predictions for all models at the third strain rosette.

The vector plot of the strain at the third rosette (Figure 7-34A) shows that the cortical
bone is in a state of compression with the minimum principal strain acting at an angle
of approximately 25 degrees from the Z-axis where the strain vectors are parallel
with the outer surface. The maximum principal strain is parallel with the outer
surface of the bone and is of a smaller magnitude to the minimum principal strain.


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A.

B.
Figure 7-34. Predicted strain vectors at the third strain rosette for the Lower-
bound 2mm element length model.
A. Shows the strain for elements surrounding the third rosette, perpendicular to the surface of the bone
(medial to lateral); B. Shows the state of strain using a transverse cut of the cortical bone the enlarged
section is showing the strain vectors at the point of the third rosette. Note that different colours have
been used to represent the principal strain vectors in this figure in an attempt to improve the clarity of
the vectors.


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Figure 7-34B shows a transverse section of the cortical bone at the third rosette
position and shows that the maximum and minimum strains become parallel towards
the outer surface of the femur.

7.15.3 Three surface contact
The initial models used the tied surface contact definition for the stem-cement,
cement-cancellous and cement-cortical interfaces. This produced a stress raiser at
the point (or in this case the line) at which all of these surfaces intersect. The stress
raiser affects the cortical, cancellous and cement stresses but it is most easily visible
when viewing the cancellous bone (Figure 7-35).
A.

B.

Figure 7-35. Von Mises stress of the cancellous bone.
A. Showing the stress raiser generated by the contact of the stem-cement, cement-cancellous and
cement-cortical interfaces. The stress raiser is along the distal edge of the cancellous bone and
includes only the elements that are in contact with all three contact pairs; B. The equivalenced model
showing the reduction in stress along the distal edge of the cancellous bone.


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The stress raiser is seen to affect only the elements that are juxtaposed along the line
where all three contact pair definitions meet. In order to remove this stress raiser the
cancellous-cement interface was meshed equivalently and the nodes equivalenced so
that the tie definition between this interface was not necessary.
The cancellous-cement interface was selected for equivalent meshing as a result of
the existing similarity between the two contacting surfaces of the volumes. Any
variation between the geometric entities of the surfaces was accounted for by
associating the entities to the opposite surface so that the mesh of the surfaces would
become equivalent. The result was that the stress raiser was removed and the stress
gradients of the components were no longer dominated by the line of elements at the
intersection of the three contact definitions.

Model selection
A single model was selected for equivalencing as a result of the inherent complexity
of the process. The model selected for equivalencing was the model that showed the
best convergence from the material property group that provided the most accurate
strain data. The lower bound Youngs modulus group showed the best correlation to
the experimental strain data. The models displayed mesh independence for the first
and second strain rosette despite the variation in the predicted strain at the second
rosette. The strain values at the third rosette did not display mesh independence.
While investigating mesh size effects with tetrahedral elements three modified
tetrahedral elements through the thickness were shown to be sufficient to accurately
predict bending stress in a cantilever beam (Appendix B).

The thinnest section of the meshed cortical bone at the level of the third strain rosette
using a 2mm element length contains at least three elements. This would indicate
that either the mode of stress at this point is not bending or that the model geometry
at this point varies from the experimental femur specimens.


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The model meshed with an element length of 2mm was selected for the
equivalencing process considering the computational expense of the models and the
convergence of the strain at the first and second rosettes.

Comparison of the equivalently meshed model with the existing lower bound
Youngs modulus models and the experimentally measured strain was then
undertaken. Figure 7-36 shows the strain at the first rosette position. The maximum
and minimum principal strains of the equivalenced model are larger in magnitude
than the corresponding 2mm element length model. The maximum principal strain
predicted by the equivalenced model is the largest of the predicted maximum
principal strains and possesses the greatest variation between the predicted and
experimental strains with a variation from the experimental strain of 24 percent.

Figure 7-37 shows the predicted strains for the second rosette position. The
equivalenced model produces the worst estimate of strain at this position with a
variation of 380 percent from the experimentally determined strain. The source of
error for the variation between the measured and predicted strain is discussed in
section 7.18.
Variation in the predicted strain at the third rosette position between the existing
models and the equivalenced model shown in Figure 7-38 was similar to the trend at
the first rosette position. The strain values of the equivalenced model were greater
than those predicted by the models using the *TIE definition at the cement-bone
interface. The strain predicted at the third rosette is an acceptable approximation to
the experimentally measured strain.


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0
500
1000
1500
2000
2500
Experimental 3mm mesh 2mm mesh 2mm Equivalent
Mesh
1.5mm mesh
S
t
r
a
i
n

(
m
i
c
r
o

s
t
r
a
i
n
)
Principal 1 Principal 2 Max Shear

Figure 7-36. Strains from the lower bound Youngs modulus models at the first
rosette position.
A comparison of the strain at the first rosette shows that the equivalently meshed model produces
acceptable strain results when compared to the other lower bound Youngs modulus models.
-1000
-500
0
500
1000
1500
2000
Mesh
1.5mm mesh
S
t
r
a
i
n

(
m
i
c
r
o

s
t
r
a
i
n
)

Figure 7-37. Strains from the lower bound Youngs modulus models at the
second rosette position.
A comparison of the strain at the second rosette shows that the equivalently meshed model produces
strain results with the greatest deviation from the experimental values.


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-800
-600
-400
-200
0
200
400
600
800
1000
1200
Mesh
1.5mm mesh
S
t
r
a
i
n

(
m
i
c
r
o

s
t
r
a
i
n
)
Figure 7-38. Strains from the lower bound Youngs modulus models at the
third rosette.
A comparison of the strain at the third rosette shows that the equivalently meshed model produces
strain results with the greatest deviation from the experimental values.

7.15.4 Comparative strain analysis of the final model
A linear regression analysis was undertaken to determine the overall correspondence
between the experimental and predicted strains. Such an analysis has been used in
similar finite element studies of the femoral component (Stolk et al. 2002) and is
believed to be relevant for this application. The linear regression is undertaken by
treating the experimental strain as the independent variable and predicted strain as
the dependent variable. Perfect correlation between the experimental and predicted
strains will be evident by a unit slope a zero y-intercept and a unit R
2
. The goodness
of fit is therefore defined by the relative proximity of the abovementioned variables
to their perfect fit value. Stolk et al. (2002) defined an acceptable fit if the y-
intercept was small and the regression value for the slope of the line was between 0.9
and 1.1.


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Results
Figure 7-39 shows the regression analysis for all of the strain values, including the
strains at the second rosette. The slope of the regression line fitted to all of the data
is 1.12 which is larger than the 10% error specified by Stolk et al. (Stolk et al. 2002).
The Y-intercept has a value of 345 which is approximately 18% of the mean value
of the maximum measured strain.
FEA Strain =1.1247(Exp. Strain) +345.62
R
2
=0.8498
-1000
-500
0
500
1000
1500
2000
2500
3000
-1000 -500 0 500 1000 1500 2000 2500
Experimental Strain (Micro strain)
F
E
M

S
t
r
a
i
n

(
M
i
c
r
o

s
t
r
a
i
n
)

Figure 7-39. Linear regression of the strain without removing outliers.
Error bars are shown for the standard deviation of the experimentally measured strain.

Based on the reasons already discussed in Section 7.15, the poorly predicted values
of strain from the second rosette were removed from the analysis and the fit of the
data was again undertaken using linear regression. The slope of the linear regression
is 1.13 for the first and third rosette data. The Y-intercept of the regression is 121,
which equates to approximately 7% of the largest experimentally measured strain.
While the variation in the slope is larger than 10% it is believed that the results of
this regression analysis show that the predicted strain data from the equivalenced
model are in good agreement with the experimental data.


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FEA Strain =1.1339(Exp. Strain) +121.4
R
2
=0.9914
-1000
-500
0
500
1000
1500
2000
2500
-1000 -500 0 500 1000 1500 2000 2500
Experimental Strain (micro strain)
F
E
A

s
t
r
a
i
n

(
m
i
c
r
o

s
t
r
a
i
n
)
FEA Linear (FEA)
Figure 7-40. Linear regression of the experimental and predicted strain.
A linear regression is used to determine the correlation between the experimental and FEA strains.
The strains of the second rosette were considered to be outliers and were removed from the regression
calculation.

Strain predictions for the equivalenced model are provided in Figure 7-41. At the
first rosette position the model predicted the experimental strains for the maximum
principal, minimum principal and maximum shear to within 24, 11 and 14%
respectively. The model predicted the principal angle to within 0.8 of the
experimental value at the first rosette. At the second rosette position the model
predicted the experimental strains for the maximum principal, minimum principal
and maximum shear to within 379, 71 and 122% respectively. The principal angle
varied by approximately 32 between the modelled and experimental values at the
second rosette position. At the third rosette position the model predicted the
experimental strains for the maximum principal, minimum principal and maximum
shear to within 122, 17 and 46% respectively. The principal angle varied by


stem
248
approximately 40 between the modelled and experimental values at the third rosette
position.

Unless otherwise specified from this point forward the term finite element model will
refer to the equivalenced 2mm element length, lower bound Youngs modulus
model.

-1000
-500
0
500
1000
1500
2000
2500
R1
Principal 1
R1
Principal 2
R1 Max
Shear
R2
Principal 1
R2
Principal 2
R2 Max
Shear
R3
Principal 1
R3
Principal 2
R3 Max
Shear
S
t
r
a
i
n

(
m
i
c
r
o

s
t
r
a
i
n
)
Experimental FEA

Figure 7-41. A comparison of experimental and FEA strain values at the rosette
locations.
The values shown are the first and second principal strains and the maximum shear strain.

7.16 Model of the proximal femur with a reimplanted
stem
The national joint replacement registry for the Australian orthopaedic association
presents data indicating that the most common component used in major revision hip
replacement is the acetabular component. Hip revision replacement surgery where


stem
249
only the acetabular component is replaced is the most common surgery accounting
for 41.6% of cases. This infers that the acetabular cup will need to be replaced while
the femoral component is essentially well fixed. The femoral component often
hinders the surgery and acetabular revision is facilitated by femoral component
removal. For a taper slip system such as the Exeter it is possible to remove the
implant and if the cement mantle is judged to be of acceptable integrity the stem can
be replaced without re-cementing. The clear advantages of this are that there will be
reduced blood loss, decreased risk of femoral perforation, the cement-bone interface
remains intact and the time of surgery is reduced.

It is possible in clinical practice when revising the acetabular cup, to remove an
Exeter femoral stem to gain better access to the cup. If the cement mantle of the
femoral stem is undamaged and believed to be of high integrity the stem can be
replaced without re-cementing. This process of stem reimplantation has been used to
produce a loose stem experimentally. Stem reimplantation was simulated in the
finite element model by describing the stem-cement interface using a friction
coefficient (
f
) of 0.22 (Hampton 1981). The results of this analysis are presented in
Chapter 7.

7.17 Sensitivity analysis of the finite element model
Section 7.15 has investigated the sensitivity of the model to mesh density and
cortical bone material properties. Further sensitivity analysis of the model was
undertaken to determine if the model was sensitive to variations in the following
parameters:
1. Youngs modulus of the cancellous bone for the initially implanted model;
2. Youngs modulus of the bone cement for the initially implanted model;
3. Coefficient of friction at the stem-cement interface for the reimplanted model.
Three variation models were generated. In each variation model one parameter was
varied by 10%. The original and variation parameters for the three models are


stem
250

Table 7-7. Parameters for the original and variation models.
Parameter Base value Varied value
E (Cancellous bone) 104MPa 114.4MPa
E (Bone cement) 2.4GPa 2.64GPa
f
(stem cement interface) 0.22 0.2
For instance the cancellous bone Youngs modulus in model V1 is increased from 104 to 114.4MPa.

The base value from Table 7-7 refers to the value of the parameter used within the
validated finite element model (referred to as the benchmark model) and the varied
value refers to the value of the parameter within the variation model.

The sensitivity of each variation model was assessed using two criteria. The first
assessment criterion was based on the percentage variation in the Von Mises stress
measured in the component that was most sensitive to the variation in the parameter.
The second assessment criterion was based on the percentage variation in the surface
strains at the rosette positions.

7.17.1 Sensitivity results
Table 7-8 shows the results of the sensitivity analysis for the first criterion (varying
the three parameters defined within Table 7-7).

In all models the stress contours were indistinguishable with only a slight variation
occurring between the magnitudes of the stresses.

Table 7-9 shows the results of the sensitivity analysis for the first criterion (varying
the three parameters defined within Table 7-7).


stem
251
Table 7-8. Model sensitivity analysis results First Criterion
Parameter altered Assessment criteria Change in stress between
models (%)
E (Cancellous bone) Von Mises stress in the
cancellous bone
2.3
E (Bone cement) Von Mises stress in the
cement
3
(stem cement interface) Von Mises stress in the
cement
4.2
Note that the percentage change in stress for all three variational models was larger than the stress
within the benchmark model.

Table 7-9. Model Sensitivity Second Criterion
Parameter altered
Strain
position Principal 1 Principal 2 Max Shear
E (Cancellous bone) Rosette 1 0.07% 0.15% 0.09%
Rosette 2 0.07% 2.45% 0.24%
Rosette 3 -0.16% -0.23% -0.20%
E (Bone cement) Rosette 1 -0.39% -0.35% -0.38%
Rosette 2 -0.66% -2.14% -0.77%
Rosette 3 0.48% 0.16% 0.11%
(stem cement interface) Rosette 1 0.28% 0.19% 0.26%
Rosette 2 0.60% -5.07% 1.27%
Rosette 3 -1.09% -0.90% -0.98%
Note that negative values indicate that the variation model value was smaller in magnitude
than the value obtained from the benchmark model.

The results of the sensitivity analysis using the second criterion show that the model
is relatively insensitive to changes in these parameters at the strain rosette positions.
The largest variation in the strains modelled at the rosette positions was 5.07% in the
minimum principal strain at the second rosette.


stem
252
7.17.2 Discussion on the sensitivity of the finite element model
The criteria used to assess the sensitivity of the model not only assessed the change
in stresses within the components of the model but it also assessed the variation in
the strain measured at the rosette positions, used for the validation of the model. The
sensitivity analysis found that the model was relatively insensitive with respect to
both stress and strain for variations (of 10%) in the model parameters when one
parameter is varied at any one time.

7.18 FEM Discussion
The lower-bound Youngs modulus models were more effective at predicting strain
at the first and third rosette positions than were the best guess and upper-bound
Youngs modulus models. Based on these two rosette positions the material property
value that best estimates the SGFR epoxy of the Sawbones is given by the lower-
bound Youngs modulus of 2.3GPa.

Strain at the second rosette was not predicted well by any of the material properties.
The lower-bound Youngs modulus models (that predicted strain very well for
rosette positions one and three) overestimated the maximum principal strain by a
minimum of 624 for the 3mm element length model where the magnitude of the
experimental strain was measured at 320. Conversely the minimum principal
strain was underestimated by the lower-bound Youngs modulus models. The
maximum shear strain for all lower-bound models was overestimated, the minimum
overestimation being produced by the 3mm element length model with a strain of
1116 compared to 744 from the experimental model.

The modelled strain at the second rosette position is not an accurate representation of
the experimental strain at the same position. The variation in the differences in the
strain at this point must, by definition of the finite element model, be explained in


stem
253
terms of the model geometry, applied loads, boundary conditions, material properties
and mesh density.
The geometry of the model is based on the model available from the BEL repository
developed by Papini (2003) and the basic geometry (i.e. the cortical bone thickness)
was not modified in any way. A model 3303 Sawbones femur was cut at the point of
the second rosette, the cortical bone was measured and found to be 5mm. This
thickness was compared to the measured thickness of 4mm of the cortical bone at the
same position on the CAD model developed by Papini (2003). This would indicate
that given identical material properties between the FE model and the experimental
model the experimental model will present itself as the stiffer of the two. Referring
to the lower-bound Youngs modulus models, this explains the overestimation of the
magnitude of the first principal strain; however it does not explain the
underestimation of the magnitude of the second principal strain. It is known that the
geometry of the femur obtained from the BEL differs from the physical model 3303
Sawbones femur in terms of the length by 7% and the cortical thickness by 20% at
the second rosette position. Given the highly nonlinear geometry of the femur and
the existing and known variations between the CAD and physical models it is
conceivable that other unknown variations will exist between the two models. The
variation in the geometry at the second rosette location has the potential to change
the second moment of area of the cross section by a factor of two and may therefore
be responsible for the difficulties in validation at this rosette position. However, the
BEL CAD model is the most up to date model for finite element mesh generation.

The material properties have been assumed to be isotropic. This is a result of the
geometry of the femur and the fact that material samples were only obtainable in the
long axis of the femur. Because of this the Youngs modulus of the cortical bone
was defined as isotropic and any possible anisotropy of the material that may exist if
there is alignment of the reinforcing fibres was ignored. The load applied to the head
of the implant has been carefully defined experimentally with the femoral clamp to
simulate the loading vector determined by Bergmann et al. (2001). The mesh at the


stem
254
second rosette is three elements thick, which would indicate that the bending stresses
will be represented accurately.

A finite element model of a cemented Exeter component within the proximal femur
has been developed. The strength and limitations of the model have been outlined
and the analysis of the model is presented in Chapter 8.


stem
255


stem
256


Chapter 8: Finite element analysis of the proximal femur and the Exeter stem
257
Chapter 8: Finite element analysis of the
proximal femur and the Exeter stem
This chapter presents further investigation and analysis of the FEM generated in
Chapter 7. An analysis is presented for the system when a secure fixed stem is
modelled and when a reimplanted stem is modelled. Reimplantation was modelled
using Coulomb friction (
f
=0.22) between the stem and the cement. The results are
compared to clinical results of the Exeter stem and also to relevant models presented
in current literature. The ability of the FEM to assist in providing improved
understanding of the mechanics of the THA is discussed. A flow chart of the
experimental and finite element process for this research is shown in Figure 8-1 with
the work covered in this chapter highlighted.


258


8.1 Displacement of the system
The displacement of the system is presented in Figure 8-2 to show the un-deformed
and deformed shape of the model when loaded using the anatomical loading vector
as defined in Section 7.13.


259

C.
B.

A.
Figure 8-2. Displacement of the proximal femur under load.
The deformed femur is shown in green with a deformation scale factor of 20. The undeformed shape
shown in black. A. Front view; B. Left view; C. Top view.

The displacement of the system is shown with a deformation scale factor of 20 and
shows that the displacement of the head of the implant is predominantly in the
posterior-medial direction. The experimentally determined displacements can be
compared to the displacement of the FEM by considering the component of the


260
measured displacement in the direction of the applied load. The displacement of the
implant obtained from the FEM for the fixed stem (measured at the node at which the
hip contact load was applied) was found to be -0.00257, -0.0007 and 0.00153 (m) in
the X, Y and Z-directions respectively. The displacement of the implant obtained
from the FEM for the reimplanted stem was found to be slightly larger than the
displacement of the fixed stem with displacements of -0.0027, -0.0008 and 0.0016
(m) in the X, Y and Z-directions respectively. The differences in the displacements
of the two models are 172, 69 and 68m in the X, Y and Z-directions respectively.
The percentage difference in displacement between the two models in the X, Y and
Z-directions respectively are 6.7, 9.9 and 4.5 percent respectively. The component of
this displacement in the direction of the applied load was predicted to be
approximately 0.8mm for both the fixed and reimplanted stems. The modelled
displacement was not sensitive to variations in the material properties of the cement
and cancellous bone or the friction coefficient at the stem cement interface (models
developed in Section 7.17) with variations in displacement for the three models of
0.7%, 0.03% and 0.06% respectively.

No time dependent material properties were used in the FEM so the modelled
displacement was compared to the experimentally determined elastic displacement
(mean(standard deviation)) of 0.27(0.04) mm. The FEM overestimated the
displacement of the head of the implant by 0.53mm or 66%. Figure 8-3 shows the
displacement of the Exeter stem in the Y-direction (with a deformation scaling factor
of 20 to accentuate the displacement) for both the fixed and reimplanted stems (note
that the directions x, y and z correlate to the directions 1, 2 and 3). The displacement
in the Y-direction is used as the displacement of the specimen in this direction is
similar in magnitude to the displacement in the direction of the applied load.


261

A.

B.
Figure 8-3. Displacement of the Exeter stem in the Y-direction.
A. Displacement of the fixed system; B. Displacement of the reimplanted system. Contour legend in
(m).

The displacement of the distal end of the stem for the fixed stem is 5.07m, whereas
the displacement of the distal end of the reimplanted stem is 43.5m. The difference
in these values is 38.41m and can be considered to be the slip component of the
total displacement of the reimplanted stem. The difference between the maximum
displacements of the two models at the neck of the implant is 73.3m. The variation
in the displacement between the head of the implant and the distal tip is a result of
the displacement that occurs as a result of the bending of the femur and implant at
the distal tip of the implant.

The primary component of the displacement of the cancellous bone is translation in
the Y-Z plane and rotation about the Z-axis. There is no visible deformation
resulting from bending moments, as the majority of the deformation of the system


262
resulting from the bending moments occurs below the level of the most distal region
of the cancellous bone. The contour bands for the X-direction and Z-direction show
that the displacement increases from the distal to the proximal regions (Figure 8-4).
The contour plots of the displacement show that in the X-direction (Figure 8-4A) the
proximal section of the cancellous bone is displaced by the greatest magnitude of
approximately 2mm, while the minimum displacement occurs at the distal end with a
value of 0.2mm. The contour band plot in the Y-direction shows that the
displacement in the Y-direction (Figure 8-4B) ranges from a positive value of 0.3mm
to a negative value of -0.6mm.

8.1.1 Discussion of the displacement of the system
The contour bands for cancellous bone displacement in the X-direction and Z-
direction show that the displacement increases from the distal to the proximal regions
indicating that the displacement is generated through translation and rotation of the
femur in a posterior-medial direction. The contour plot in the Y-direction indicates
that the rotation or translation of the system occurs primarily in the Y-Z plane.
The discrepancy between the displacements of the FEM and the experimental system
is a matter of some concern. All of the material properties used within the FEM were
isotropic linear elastic, so the displacements of the FEM (for the fully bonded
initially implanted model) were fully recoverable, whereas some of the experimental
displacement was attributable to the viscous properties of the materials and was
therefore not fully recoverable.

The displacement of the distal end of the implant is minimal compared to the
displacement of the head and neck of the implant. The exaggerated scale factor
shows that the major contributor to the displacement of the system in the direction of
the applied load is not direct displacement in the direction of the applied load; rather
it is a result of the bending of the system. The FEM displacement showed that the
distal region of the stem in the reimplanted model possessed greater displacement in
the Y-direction than the stem of the fixed model. This was to be expected, as by


263
definition the stem cement interface of the fixed model does not allow relative
motion, whereas the stem-cement interface of the reimplanted model does allow
relative motion.

A.
B.

C.
Figure 8-4. Displacement of the cancellous bone under anatomical loading.
A. Shows the displacement in the X-direction; B. Shows the displacement in the Y-direction; B.
Shows the displacement in the Z-direction. Contour legends in (m).


264
The variation in the FEM and experimental displacement may therefore simply be a
result of larger bending displacements of the FEM. The reason for the larger bending
displacement could be a result of variations in the material properties of the system
(particularly the material properties of the cortical bone), the applied loads and the
boundary conditions or it could be a result of the geometry of the system. The
material properties of the cortical bone analogue have been carefully considered,
both experimentally and during the FEM definition during the validation process.
The hip contact load is experimentally applied to the head of the implant through the
bearing plate, within the FEM the load is applied to the tapered neck of the implant.
The variation in the effective point of application of the load is hard to quantify, as it
was not possible to measure the exact location of the tapered neck of the implant
when it was fitted to the head or the contact point of the head of the implant with the
bearing plate. The distal section of the cortical bone of the FEM was constrained at
the same level as the experimentally constrained femur. It is believed that all
possible steps were taken in order to ensure that the loads and boundary conditions
applied to the femur within the FEM matched those of the experimental system.

The geometry of the bone was obtained directly from Papini (Papini 2003) and while
the original CAD model was edited to correct the NURBS patches, the basic
geometry of the femur was left in the original form. Variations between the
Sawbones model 3303 femurs and the CAD model were noted and it is possible that
they have contributed to the increased bending displacement observed in the FEM.

The variation in the measured and FEM displacement is curious in that the measured
strains are in good agreement with the FEM strain both in magnitude and in direction
for gauges one and three. If the loads and boundary conditions were not correct then
the measured strains would not be in such good agreement. The variation of the
experimental and FEM displacement results is most likely to occur as a result of a
reduced stiffness of the distal region of the proximal femur. This reduction in
stiffness could occur as a result of the variation in the cross sectional area of the
distal end of the proximal femur or in the material properties of the SGFR epoxy.


265

8.2 Exeter stem
The stated advantage of the Exeter stem is that it subsides within the cement mantle
without damaging the cement-bone interface (Alfaro-Adrian et al. 1999) thus
producing a relative increase in the compressive forces and a reduction in the shear
forces both within the cement and at the stem-cement interface (Timperley et al.
1993).

8.2.1 Results
The peak stresses of the stem obtained from the two models are almost identical in
magnitude. The stress contour lines are also very similar in both models, with only
slight variations between the two (Figure 8-5). A node path was generated along the
medial and lateral edges of the stem to allow a direct comparison of stress and strain
between the two models. Figure 8-6 shows the Von Mises stress for the fixed and
reimplanted models. The trend of the variation in the stress along the length of the
stem is almost identical for the two models. The peak stresses occur at the same
point along the length of the stem with the larger stresses along the medial and lateral
edges occurring in the fixed and reimplanted models respectively. The stress reaches
a peak value in the distal third of the implant (4cm and 4.5cm on the medial and
lateral edges respectively) before reducing in magnitude towards the proximal
section. The medial and lateral stresses increase to produce a secondary peak at
approximately 11cm from the distal tip.


266

A.

B.
Figure 8-5. Von Mises stress of the Exeter stem.
A. Shows the Von Mises stress for the fixed stem; B. Shows the Von Mises stress for the reimplanted
stem. The grey area on the neck of the stem is the point of application of the hip contact load. The
stresses immediately surrounding the point of application are of no interest to the analysis and the
limits of the stress have been modified to remove this stress raiser from the diagram. Contour legend
in (Pa).

The peak stress for the fixed stem along the medial edge was 99.6MPa and occurred
4cm from the distal tip of the implant. The peak stress for the fixed stem along the
lateral edge was 73.6MPa and occurred at a distance of 4.5cm from the distal tip of
the implant. The peak stress for the reimplanted stem along the medial edge was
92MPa and occurs at a distance of 4cm from the distal tip. The peak stress for the
reimplanted stem along the lateral edge was 81MPa and occurred at a distance of
4.5cm from the distal tip.


267
Medial edge
(m)
0
0.02
0.04
0.06
0.08
0.1
0.12
0.14
0 2
0
0
0
0
0
0
0
4
0
0
0
0
0
0
0
6
0
0
0
0
0
0
0
8
0
0
0
0
0
0
0
1
0
0
0
0
0
0
0
0
1
2
0
0
0
0
0
0
0

Stress (Pa)

Lateral edge
(m)
0
0.02
0.04
0.06
0.08
0.1
0.12
0.14
01
0
0
0
0
0
0
0
2
0
0
0
0
0
0
0
3
0
0
0
0
0
0
0
4
0
0
0
0
0
0
0
5
0
0
0
0
0
0
0
6
0
0
0
0
0
0
0
7
0
0
0
0
0
0
0
8
0
0
0
0
0
0
0
9
0
0
0
0
0
0
0

Stress (Pa)
Figure 8-6. Von Mises stresses for the medial and lateral edges along the length
of the stem for the fixed and reimplanted cases.

The strains of the fixed and reimplanted models using the same node path as for the
stress analysis are presented in Figure 8-7.


268
Medial edge
(m)
0
0.02
0.04
0.06
0.08
0.1
0.12
0.14
-
6
0
0
-
5
0
0
-
4
0
0
-
3
0
0
-
2
0
0
-
1
0
0
01
0
0
2
0
0

Strain ()

Lateral edge
(m)
0
0.02
0.04
0.06
0.08
0.1
0.12
0.14
-
2
0
0
-
1
0
0
01
0
0
2
0
0
3
0
0
4
0
0
5
0
0

Strain ()
Figure 8-7. Strain along the length of the Exeter stem for the fixed and
reimplanted stems.

The trend of the strain follows that of the stress. The peak strains are observed in the
distal section of the implant at 4 and 4.5cm from the distal tip for the medial and
lateral edges respectively. The strain of the medial edge is predominantly
compressive whereas the strain along the lateral edge is predominantly tensile. The
strain of the reimplanted stem is greater than the fixed stem strain on the lateral edge,
while the fixed strain is greater than the reimplanted strain along the medial edge.
The reimplanted strain is greater than the fixed strain at the point of the secondary
peak on the medial edge.


269
8.2.2 Discussion of the stress-strain state of the Exeter Stem
The variety of femoral stems currently on the market and subsequently, under
academic scrutiny makes it difficult to obtain data from which to directly compare
results on the stress state of the implant. Mann et al. (1995) investigated a range of
stems and found similar trends to those presented here for values of maximum
principal stress.
The increased stress in the posterior-medial and anterior-lateral regions of the
implant for the reimplanted model indicates that these regions are likely to
experience some form of localised failure or wear under cyclic loading. This finding
is in agreement with the clinical findings of wear marks on the stems that are
predominantly found on the anterior-medial and posterior-lateral surfaces (Howell et
al. 2004).
While the stress and strain of fixed and reimplanted stems appear almost identical
there should conceivably be a slight shift in the stress-strain contours in the direction
of the elastic slip of the stem in the reimplanted case. The predicted slip component
of the reimplanted stem was 38.41m, which in terms of the path used to measure the
stress-strain contours, is too small to measure.

8.3 PMMA bone cement
Mechanical interaction of the femoral stem with the bone cement will often lead to
the generation of wear particles. It has been shown that motion of the stem-cement
interface will occur (Alfaro-Adrian et al. 1999). Considering this it is also feasible to
assume that wear will begin to occur between these two dissimilar materials with this
mechanical interaction. The consequences of wear at this interface will be two fold,
the first is that wear particles (of metal and PMMA) will be produced and the second
is that damage of the cement mantle, with the possible distortion of the internal
dimensions of the mantle, may occur (Howell et al. 2004). It has been found during
a study of implants retrieved after implantation that the cement mantle of a polished
stem such as the Exeter will remain relatively undisturbed. This indicated that wear


270
particles formed by the interaction between the stem and cement were not released
into the interfaces and bearing surfaces of the prosthesis (Howell et al. 2004).
The difference between the fixed and reimplanted cement mantles is caused by the
variation in the contact definition of the stem-cement interface. The cement is
investigated in terms of the Von Mises stresses at the cement bone interface and the
cement-stem interface. A slice of the cement is then used to show the direction of
the principal stresses using a stress vector diagram.

8.3.1 Results
The reimplanted cement mantle has peak stresses twice that of the fixed cement
mantle. The reimplanted mantle shows increased stress at the proximo-medial region
(Figure 8-8). The stresses in the region of contact between the cement mantle and
the cortical bone are also elevated for the reimplanted model with the majority of the
contact area elevated from approximately 1MPa in the fixed model to 2MPa in the
reimplanted model. The cement stress of the contact surface between the stem and
cement is given in Figure 8-9. The peak stresses for the fixed model occur towards
the distal tip of the implant. Slightly elevated stresses (below 2MPa) are also
apparent along the anterior-lateral and posterior-medial edges and also along the
proximo-medial edge.


271

A.

B.
Figure 8-8. Von Mises stress of the cement section.
A. Shows the stress for the fixed stem; B. Shows the stress for the reimplanted stem. The maximum
stress generated in the cement mantle is in the region of contact between the cement and the cortical
bone. The contour plots of the fixed and reimplanted cement mantles have been given similar contour
bands to allow for direct comparison. Contour legend in (Pa).

The stresses for the internal surface of the reimplanted cement mantle are elevated
compared to the fixed model. The peak stresses occur at the proximal region in the
anterior and posterior aspects of the contact region. The stresses in the proximal
anterior-medial region exceed the 10MPa contour limit of this diagram. Stresses are
elevated along the posterior-lateral and anterior-medial edges. Stresses are also
elevated in the medial aspect of the distal region. A banded stress is visible along
the anterior-lateral edge indicating a stress of approximately 1 to 2MPa.


272
A.

B.

Figure 8-9. Von Mises stresses on the internal surface of the cement mantle.
A. Shows the Von Mises stress for the fixed stem; B. Shows the Von Mises stress for the reimplanted
stem. The contour plots of the fixed and reimplanted cement mantles have been given identical
contour bands to allow for direct comparison. Contour legend in (Pa).


273
The change in the stress between the fixed and reimplanted cement mantles can be
seen using vector diagrams of the principal stresses. From the slice of the cement
mantle shown in Figure 8-10 it can be seen that there are no stresses normal to the
surface for the fixed model (Figure 8-10) along the lateral and posterior edges.
Tensile and compressive stresses (predominantly perpendicular to the interface)
dominate the anterior and medial regions of the mantle. Tensile stresses are evident
in the posterior-medial and anterior-lateral regions of the interface.

Compressive normal stresses (shown in blue in Figure 8-11) appear in the
reimplanted model in the anterior-lateral, posterior-lateral, posterior-medial and
anterior-medial regions. The tensile stresses for the reimplanted model are
perpendicular to the surface of the interface between the regions of the compressive
normal stress. Circumferentially aligned tensile stresses (hoop stresses) are evident
along the posterior, medial and anterior regions.

Figure 8-10. Vector diagram of the principal stresses within a slice of the
cement mantle for the fixed model.


274

Figure 8-11. Vector diagram of the principal stresses within a slice of the
cement mantle for the reimplanted model.

8.3.2 Discussion of the bone cement stress analysis
The question of cement failure is of significant clinical importance. Cement-stem
debonding was addressed in a paper by Verdonschot and Huiskies (1997b) using a
polished implant with a distal centraliser, that while not specifically defined by the
authors could be assumed to be an Exeter stem. The authors simulated damage
accumulation within the cement for bonded and unbonded stems over 1, 10 and 25
million loading cycles. The authors theorised that the cement would fail for the
bonded and unbonded models at regions of both the stem-cement and cement-bone
interfaces. However, in a long term follow up study of the Exeter stem Fowler et al.
(1988) found that even with the distal migration of the Exeter stem no disruption to
the cement-bone interface was observed. No cracking or splitting of the cement
mantle was observed by Fowler et al. (1988), contradicting the finite element study
carried out by Verdonschot and Huiskies (1997b). Further evidence that the cement


275
mantle of the Exeter stem does not fail catastrophically is presented by Alfaro-
Adrian et al. (1999) who found that the Exeter stem migrates distally by 1mm in the
first year at the cement-stem interface. The authors stated that motion at the cement-
stem interface is not indicative of failure for this implant and that the motion at the
stem-cement interface may be of overall benefit to the stability by expanding the
cement mantle and improving the bone cement interface. The hoop stresses observed
within the cement mantle of the reimplanted model lend support this theory. The
minimum principal stresses acting normal to the stem-cement interface for the
reimplanted model are consistent with the 1.2 retroversion observed clinically
within the first 2 years of implant use (Stefansdottir et al. 2004). It is possible that
the cement at these points does not fail; rather the cement deforms via viscoelastic or
plastic mechanisms over time allowing the retroversion of the implant to occur
without failure of the stem-cement interface and subsequently maintaining the
integrity of the cement-bone interface.
If Von Mises stress is to be used as a failure criterion (Harrigan et al. 1992), then this
model shows that the regions of initial cement failure will occur at the distal tip of
the implant for the fixed model and for the reimplanted model the additional sites of
the proximal anterior-medial and posterior-medial regions. The high stress predicted
at the distal section is in good agreement with clinical failure of the cement assessed
using radiography, which indicates that the distal third of the cement mantle has the
highest incidence of failure in both 5-10 and 10-16 year follow up (Fowler et al.
1988). Fractures in the upper third of the cement were less likely than in any other
region bringing into question the increased stresses observed in the proximal
anterior-medial and posterior-medial regions of the reimplanted model. The two
dominant stresses acting at the proximal anterior-medial and posterior-medial regions
are compressive stresses acting perpendicular to the stem-cement interface and
tensile hoop stresses. It is possible that these stresses in combination with the
geometry of the region do not provide the necessary conditions to initiate cement
failure. Another possibility is that the material at the localised regions of high stress
undergoes crazing and that the applied load is not sufficient to continue the fracture
process through to the generation of a crack. Crazing generally occur at highly
stressed regions, they can be associated with scratches, and will tend to propagate


276
perpendicular to the tensile stress axis (Callister 1994). While there is sufficient
evidence based on the FEM that increased regions of stress exist at these points, there
is no clinical evidence of which the author is aware to either support or deny the
existence of failure.

8.4 Stem-cement interface
The difference between the fixed and reimplanted models is the definition of the
stem-cement interface. Variations between the two models will originate as a result
of this interface definition. The interface is investigated in terms of the overclosure
and separation, the pressure and the stresses of the stem and cement interface.

8.4.1 Comparison of the stem cement interface for the fixed and
reimplanted models
The displacement of the stem for the two models varies as a result of the relative
motion of the stem with respect to the cement in the reimplanted model. The
clearances and contacting regions of the interface can be displayed in ABAQUS
using the COPEN contour plot. The COPEN contour plots of the fixed and
reimplanted stems are given in Figure 8-12. The clearance between the stem and the
cement for the fixed stem is small with a maximum value of overclosure and opening
of 2.110
-17
m and 2.210
-17
m respectively. This suggests that the overclosure and
separation of the fixed model is effectively zero and that no motion is evident. The
clearance between the reimplanted stem and the cement ranges from a maximum of
36m of separation to a minimum of 5.710
-14
m overclosure. The contour plot of
the reimplanted model shows separation in the proximal region on the lateral and
anterior sections of the interface. The largest separation occurs in the lateral section
with a magnitude of 36m. Separation continues along the anterior-medial edge of
the stem to the distal tip.


277

A.

B.
Figure 8-12. COPEN for the fixed and reimplanted stems.
A. Shows the separation and overclosure of the fixed model; B. Shows the separation and
overclosure of the reimplanted model. The contact definition of the reimplanted model allows
separation whereas the contact definition of the fixed model does not allow separation to occur.
Positive values indicate clearances and negative values indicate overclosure, where overclosure can be
considered as contact. Contour legend in (m).

The separation of the reimplanted model is shown further in Figure 8-13. Separation
of a magnitude of approximately 9m is visible along the posterior-lateral (Figure
8-13A) and the anterior-medial edges (Figure 8-13C) of the interface. The majority
of the separation occurs in the proximal region of the interface.


278

A.

B.

C.
Figure 8-13. COPEN of the stem cement interface for the reimplanted model.
A. Shows the posterior face of the interface; B. Shows the medial and lateral edges with the largest
opening on the lateral edge of the interface; C. Shows the anterior edge of the interface. The contour
limits for this plot are identical to the contour limits of the plot presented in Figure 8-12B. Contour
legend in (m).

Contour plots of the pressure of the interface are given in Figure 8-14. The pressure
of the fixed model ranges from negative (tensile) values to positive (compressive)
values. The negative values for the fixed model appear in regions that would tend to
separate if the interface was not adhesively bonded. The pressures at the interface of
the reimplanted model are either zero (indicating that separation has occurred) or
positive indicating compressive forces between the stem and cement. The majority
of the interface for the reimplanted stem is below 1MPa with only small regions of
higher pressure in the proximo-medial region and along the posterior-medial and
anterior-lateral edges.


279

A.
B.
Figure 8-14. Pressure at the interface for the fixed and reimplanted stem
models.
A. Shows the fixed stem; B. Shows the reimplanted stem. Contour legend in (Pa).

8.4.2 Discussion of the stem-cement interface
By definition the interface of the fixed model is not able to separate. The model
shows that this is indeed the case with overclosure and separation of a very small
magnitude presented in the contour plot of the interface. The reimplanted model
allowed separation to occur, which was shown in the contour plot presented in Figure
8-12 and Figure 8-13. An analysis of the interface of the reimplanted model showed
that the model was in good agreement with the clinical findings of wear marks along


280
the posterior-medial and anterior-lateral edges of the implant. The increased
pressure measured along the posterior-medial and anterior-lateral edges and the
separation along the posterior-lateral and the anterior-medial edges predicted that
relative motion will occur at this region of the interface when the system is placed
under dynamic loading. Of interest was the fact that the pressure contour plot tended
to indicate that the contact between the stem and cement of the reimplanted stem was
predominantly line contact and therefore contact occurred over a relatively small
area. This is in contrast to the pressure contour for the fixed model for which the
contact pressure occurred over a much larger area resulting in lower peak pressure
values.

8.5 Cancellous bone
The transfer of load between the cement mantle and the cancellous bone is an
important factor to consider clinically. If the cement-cancellous bone interface is
exposed to high stresses then potential for failure of the interface will increase.
Alternatively low stresses could indicate stress shielding by the implant with
potential for bone resorption.

8.5.1 Results
The cancellous bone stresses change markedly between the fixed and reimplanted
models. The variation in the cancellous bone between the two models is most
evident at the cement-cancellous interface and the area immediately surrounding the
interface (Figure 8-15). The peak stress in the reimplanted cancellous bone is 1.4
times greater than the peak stress in the fixed cancellous bone. The contour of the
stress at the cement-cancellous interface for the fixed model shows stresses of 0.3-
0.4MPa in the proximo-lateral trochanteric region. These stresses are not evident in
the reimplanted model. Greater stresses were observed at the proximal posterior-
medial region.


281

A.

B.
Figure 8-15. Von Mises stress of the cancellous bone under anatomical loading.
A. shows the cancellous bone stresses for the fixed implant; B. shows the cancellous bone stresses for
the reimplanted stem. The contour plots of the fixed and reimplanted cement mantles have been given
identical contour bands to allow for direct comparison. Contour legend in (Pa).

Of further interest is the state of stress at the interface between the cancellous and
cortical bone. The contour plot of the cancellous-cortical bone interface (Figure
8-16) shows that the state of stress at the interface for the fixed and reimplanted
models is similar in both magnitude and distribution. Both models show an increase
in stress of approximately 2-4MPa at the distal anterior-lateral region. The majority
of the remaining surface of the cancellous bone at this interface in both models is at a
stress value of less than 70kPa.


282

A. B.
Figure 8-16. Cancellous-cortical interface of the cancellous bone for the fixed
model (A) and the reimplanted model (B). Contour legend in (Pa).

8.5.2 Discussion of the cancellous bone stress analysis
The cement bone interface was fixed using the *TIE function within ABAQUS when
generating this model. This assumption was based upon the observation made by
Alfaro-Adrian et al. (Alfaro-Adrian et al. 1999) that migration does not occur at the
cement-bone interface for the Exeter stem. It is believed that this boundary condition
is acceptable on account of the clinical evidence to support the integrity of the
cement-bone interface. The *TIE boundary condition was also applied to the
cancellous-cortical interface over which the stress contours were very similar for
both models.

The maximum calculated stress of 0.7MPa and 1.1MPa for the fixed and reimplanted
models for the current load condition are well below the compressive stresses of


283
cancellous bone determined by Martens et al. (1983) who found that the smallest
compressive strength for cancellous bone was 2.8MPa in the neck of the femur.
Given that the fixed model is linear the maximum stress of the cancellous bone when
loaded using the full hip contact load of 1950N as determined by Bergmann et al.
(2001) can be approximated by increasing the maximum modelled stress by a factor
of three. This produces a stress of 2.1MPa which is still below the compressive
stress calculated by Martens et al. (1983).
If the non-linear reimplanted model was loaded with the full hip reaction force then it
is conceivable that the compressive strength of the bone would be exceeded and that
crushing would follow. However, the region of high stress is in a posterior region
where the thickness of the bone is smaller than 1mm. This geometry was possible
using the Sawbones on account of the solid rigid polyurethane foam used to simulate
the cancellous bone. Anatomically the cancellous bone will not be as dense as the
foam of the Sawbones and it is possible that the region of high stress within the
model will be filled with bone cement. If this region of high stress was filled with
cement then the difference in the peak stresses would not be as pronounced.

8.6 FEM of the cortical bone
The cortical bone is often used as the point of measurement for in vitro and
subsequent FEM investigations into the mechanics of the femoral component. When
considering the femoral implant it is therefore desirable to know the state of stress
within the cortical bone immediately after implantation (fixed) and once debonding
has initiated and progressed (reimplanted). The cortical bone is first analysed in
terms of the Von Mises stress. The predicted FEM Von Mises stresses were found to
correlate with the regions of failure observed during the experimental study of the
varus stem specimens (Chapter 3 and Chapter 4). Sections of cortical bone are then
taken and are analysed in terms of the principal stress vectors to show not only the
relative magnitudes of the stresses but also their directions. The stress and strain
along the length of the cortical bone for the two models is then compared.


284
8.6.1 Results
Contour plots of the Von Mises stress of the cortical bone are given in Figure 8-17A
and Figure 8-17B for the fixed and reimplanted models respectively.

A.

B.
Figure 8-17. Von Mises stress of the cortical bone for the secure stem.
A. Cortical stress for the fixed stem; B. Cortical stress for the reimplanted stem. Contour legend in
(Pa).

The stress contours in the distal region of the bone are similar for both load cases
with a region of stress of approximately 2MPa extending further towards the
proximal region for the reimplanted model. The predicted peak stress was only 0.2%
higher for the reimplanted model than for the fixed model. The principal stresses
have been plotted in vector form to further understand the state of stress within the
cortical.

SGFR epoxy failure
The geometry of the FEM is based upon the 5 varus stem geometry, of which there
were many failures during the experimental program. A comparison of the cortical
bone analogue and the FEM cortical bone shows that the region of failure for
experiments with the fixed varus stem is well predicted in the FEM (Figure 8-18) in


285
both anterior and posterior failure regions. The peak Von Mises stress predicted by
the model is 20MPa. The region of failure appears to correlate with a level of stress
between 8 and 9MPa (orange and red contours in Figure 8-18 A2 and Figure 8-18
B2).

A1 A2 B1 B2
Figure 8-18. Typical failure of the SGFR epoxy of the Sawbones femurs after
24-48 hours of loading with an Exeter stem implanted in a varus position.
A1 and A2 show the posterior aspect of the femur for the experimental and FEM respectively; B1 and
B2 show the anterior aspect of the femur for the experimental and FEM respectively. Contour in (Pa).

Vector analysis of the stress through the cortical sections
The cortical bone is sectioned in proximal, mid and distal cuts to ascertain the state
of stress at the given level of the bone. The sections used are shown in Figure 8-19.


286

Figure 8-19. Cross sections of the
cortical bone used to investigate the
principal stresses of the modelled
cortical bone

The principal stresses at the distal section show that at this point the bone is in a state
of bending (Figure 8-20). The principal tensile and compressive stresses are in line
with the long axis of the femur, indicating that the dominant moment is acting in a
plane that is perpendicular to the long axis. Hoop stresses are not dominant within
this section. The top view of the section (Figure 8-20A) shows the maximum
principal (red) and minimum principal stresses (blue) as dots, indicating that they are
acting perpendicular to the page. The front view of the section (Figure 8-20B)
confirms that the maximum and minimum stresses are acting in line with the long
axis of the femur. An approximate bending axis (neutral axis) has been drawn into
the top view (Figure 8-20A) to show the tensile and compressive sides of the bone.
The anterior-lateral section is predominantly tensile and the posterior-medial is
predominantly compressive.


287

A.

B.

Figure 8-20. Principal stresses of the distal cortical slice.
A. Shows the top view of the distal slice with the tensile and compressive sections marked; B. Shows
the front view of the distal slice.

The principal stresses for the middle cortical slice are shown in Figure 8-21. The
stresses of the mid-cortical slice also indicate a state of bending. The tensile and
compressive regions of the cross-section are shown on the top view of the section
(Figure 8-21A). The anterior-lateral section is predominantly tensile and the
posterior-medial is predominantly compressive. The angle of the neutral axis is
similar in both the distal and mid-cortical slices.

The principal stresses of the proximal cortical slice are presented in Figure 8-22. The
views that are used to show the stresses are a view of the slice perpendicular to the
plane of the cut, and an off axis view of the slice using the plane of the cut. The
stress state through this slice is predominantly compressive with tensile stresses
observable in the anterior-lateral and posterior-medial regions.


288

A.

B.

Figure 8-21. Principal stresses of the mid-cortical slice.
A. Shows the top view with the tensile and compressive regions marked; B. Shows the front view of
the section.

A.

B.
Figure 8-22. Principal stresses of the proximal cortical slice.
A. Shows the view of the slice perpendicular to the plane of the cut; B. Shows an off axis side view to
show the variation between the stresses on the anterior and posterior sides.


289

Analysis of stress and strain along the length of the cortical bone
The maximum and minimum principal strains are plotted in Figure 8-23 for paths
generated along the medial and lateral sides of the bone. The path has been defined
using the distal section as zero and increases in true distance from the distal section
in the Y-direction. Overall there is good agreement between the predicted strains for
the fixed model and the reimplanted model. The maximum variation occurs in the
minimum principal strain with a variation of 40% occurring on the medial path at a
distance of 9cm from the distal section. The average percentage difference for the
minimum principal strain between the two cases along the medial path was
approximately 16%. Ignoring the end effects generated by the encastre boundary
condition, the maximum tensile and compressive strains for the medial path occur in
the fixed model and are 1029 and -2963 respectively. Both of these strains
occur a distance of 1.5cm from the distal section. The maximum tensile and
compressive strains in the lateral path occur in the fixed model and are 2021 and
656 occurring at distances of 5.6 and 3.6cm from the distal section respectively.

The medial and lateral cortical bone paths are also used to plot the Von Mises stress
between the fixed and reimplanted models (Figure 8-24). The trends of the stress are
similar between the two models. The magnitude of the stress decreases moving up
the shaft away from the distal section towards the trochanters. The largest
discrepancy for the Von Mises stress between the two models occurs along the
medial path with a variation of 41% occurring at a distance of 9.3cm from the distal
section.


290
Medial

(m)
0
0.02
0.04
0.06
0.08
0.1
0.12
0.14
-
4
0
0
0
-
3
5
0
0
-
3
0
0
0
-
2
5
0
0
-
2
0
0
0
-
1
5
0
0
-
1
0
0
0
-
5
0
0
05
0
0
1
0
0
0
1
5
0
0

Strain ()

Lateral

(m)
0
0.02
0.04
0.06
0.08
0.1
0.12
0.14
-
2
5
0
0
-
2
0
0
0
-
1
5
0
0
-
1
0
0
0
-
5
0
0
05
0
0
1
0
0
0
1
5
0
0
2
0
0
0
2
5
0
0

Strain ()
Figure 8-23. Strain of the fixed and reimplanted stem geometries measured
along a medial and lateral path.

8.6.2 Discussion of the stress analysis of the cortical bone
The strain contours predicted by the fixed and reimplanted models are similar in both
magnitude and in the strain distribution. Mann et al. (1995) also found that the
maximum principal strains in the bone were almost identical for bonded and
Coulomb friction models. This is an important finding in that a clear understanding
of the condition of the stem-cement interface is not achievable by measuring strain
on the surface of the cortical bone. According to these results the externally
measurable strain of the cortical bone is not sensitive to variations in the condition of
the stem-cement interface. The solution to this problem would involve the direct


291
measurement of the conditions at the cement-stem interface for fixed and
reimplanted conditions. The measurement of the condition of the stem-cement
interface has been investigated using strain gauges (Cristofolini and Viceconti 2000;
Stolk et al. 2002) and pressure transducers (Cristofolini et al. 2000). To the best of
the authors knowledge this work has generally measured the condition of the stem-
cement interface when the interface is assumed to be fully bonded (fixed). The
extension of this idea to measurement of the interface for a debonded (reimplanted)
stem would allow better understanding of the condition of the stem-cement interface.

Medial
(m)
0
0.02
0.04
0.06
0.08
0.1
0.12
0.14
0 1
0
0
0
0
0
0
2
0
0
0
0
0
0
3
0
0
0
0
0
0
4
0
0
0
0
0
0
5
0
0
0
0
0
0
6
0
0
0
0
0
0
7
0
0
0
0
0
0
8
0
0
0
0
0
0

Stress (Pa)

Lateral
(m)
0
0.02
0.04
0.06
0.08
0.1
0.12
0.14
01
0
0
0
0
0
0
2
0
0
0
0
0
0
3
0
0
0
0
0
0
4
0
0
0
0
0
0
5
0
0
0
0
0
0
6
0
0
0
0
0
0
7
0
0
0
0
0
0

Stress (Pa)
Figure 8-24. Von Mises stress for the secure and reimplanted stem geometries


292
The state of stress in the distal and medial sections of the cortical bone as defined
using Figure 8-19 is predominantly due to bending of the femur shaft. Compressive
and tensile stresses are also prevalent in the proximal region, however a state of pure
bending is not apparent in this region.
Knowledge of the state of stress at the distal region of the cortical bone can be used
to predict the failure of the SGFR epoxy given the previous analysis of the material
response to bending as presented in Chapter 4 (the stress-strain diagram for four-
point bending from Chapter 4 is repeated in Figure 8-25). The failure region is
approximately 9MPa, which has been drawn as a red line on Figure 8-25. For static
loading, this level of stress is well within the linear region of the material
properties. However, the experimentally observed failure occurred under cyclic
loads, where the predominant mode of loading is bending. The simplest explanation
for the failure at these points is fatigue damage accumulation. The cyclic fatigue
limit of a material can be considerably lower than the yield point for the same
material under a static load (Callister 1994).

Figure 8-25. Body temperature results for four-point bending of the SGFR
epoxy.


293
The failure regions of the cortical bone predicted using the model were in good
agreement with the failure regions found experimentally.

8.7 Problem solving with the FEM
It has been stated clinically that the proximal cut neck surface of the femur is well
preserved and that the Exeter implant has a lower incidence of reported
radiolucencies at in the upper third of the femur (Gruen zones 1 and 7) than for other
implant designs (Fowler et al. 1988). To investigate this statement a slice of cortical,
cancellous bone and bone cement has been taken at the most proximal region of the
femur (Figure 8-26 A) and the stress vectors plotted (Figure 8-26 B).

8.7.1 Results
The stress vectors for all of the sections (cement, cortical and cancellous bone) are
substantially different in both magnitude and direction for the fixed and reimplanted
models. The posterior-medial region of the section for the fixed model is
predominantly in compression with a small zone of tensile stress in the posterior-
medial region. The anterior-lateral region is predominantly in tension, with regions
of compression evident at the interfaces or along the external cortical bone.

For the reimplanted model the stresses with in the cement mantle are larger in
magnitude than the stresses observed within the bone. Compressive stresses of
relatively large magnitude act perpendicular to the interface along the medial stem-
cement interface. Compressive stresses of smaller magnitude extend along the
lateral surface of the stem-cement interface. A pattern of tensile hoop stress is
generated within the medial cement mantle and extends through to the cancellous
bone to a depth shown as the hoop stress depth (Figure 8-26 B). The generation of
the hoop stresses in this region are a result not only of the taper of the stem but also
of the curved region of the medial edge leading up to the tapered neck. As the stem
subsides the curvature of the implant will tend to increase the relative magnitude of
the hoop stresses in the medial region.


294
A.

B.

C.

Figure 8-26. Slice of the proximal section of the femur including the cement and
the cortical and cancellous bones.
The stem has been removed for clarity of the stress vectors. A. Shows the cross section used to
produce the vector plot; B. Shows the vector plot of the fixed model; C. Shows the vector plot of the
reimplanted model.


295
8.7.2 Discussion
Shen (1998) speculated in a recent paper comparing the two methods of implant
fixation (taper-slip and composite beam theory) that the successful retention of bone
observable for implants using the taper-slip system may be as a result of the hoop
stresses generated in the bone as a result of the compressive stress from the stem-
cement interface. This model clearly supports this speculation on two counts. The
first is that taper slip must occur for the hoop stresses to become dominant. The
second is that the medial region of the cement and bone possesses hoop stresses
generated by the compressive stresses and that these hoop stresses extend well into
the retained cancellous bone of the proximal region. This model therefore suggests
that taper-slip is required to maintain hoop stresses throughout the cement and the
surrounding bone, thus avoiding bone loss due to implant stress shielding.

8.8 Discussion of the comparison between the FEMs for
the fixed and reimplanted stems
It is important when discussing the results of the finite element model to keep in
mind the clinical success of the implant. The following pertinent points of interest
relating to the behaviour of the implant have been observed through clinical
experience with the Exeter stem:
1. The lower incidence of radiolucent lines for Gruen zones 1 and 7 at the
cement-bone interface than for other stem geometries;
2. Few hips require revision as a result of aseptic loosening;
3. The implant subsides within the mantle without damaging the cement;
(Fowler et al. 1988; Timperley et al. 1993)

The FEM found good agreement with the experimental investigation in terms of
measured strain and location of failure regions. Trends for the stress-strain state of
the stem showed good correlation with the clinical findings of failure and wear of the
stem. The stress-strain state of the cement was well predicted with the introduction


296
of compressive and hoop stresses once debonding of the stem-cement interface had
progressed.

The utility of a model such as this for providing valuable information pertinent to
clinical questions has been demonstrated. The success of the implant retaining the
structural integrity of the system components and interfaces was shown to be a result
of the taper-slip mechanism of the proximal stem. The model was able to show that
retention of bone may be a result of the compressive and hoop stresses generated at
the stem-cement interface. The model also showed that the dominant compressive
and hoop stresses were not evident for the fixed model, indicating that taper-slip is
required for optimum bone maintenance and retention.


297


298


Chapter 9: Use of the FEM to Investigate Torsion of the Implanted Femur
299
Chapter 9: Use of the FEM to Investigate
Torsion of the Implanted Femur
The model has previously been validated using compressive anatomical loading.
The model can now be used to investigate other load cases and situations to further
understand the mechanics of the femoral component. This section presents an
analysis of the FEM using torsion. Torsion has been shown to be a predominant
loading condition during activities such as standing from a seated position and stair
climbing. During these activities a posteriorly directed force is applied to the head of
the prosthesis generating in internal rotation about the long axis of the implant.
Section 2.7.6 describes the clinical importance of torsional stability in more detail.
By choosing pure torsion as a load case not only can the system response to the
torsional load be observed but a comparison between the modelled response and the
experimental response can be made through the data already gathered during the
pilot study (Section 3.15). A flow chart of the experimental and finite element
process for this research is shown in Figure 9-1 with the work covered in this chapter
highlighted.


300


9.1 Boundary conditions for the torsional model
The loads and boundary conditions applied to the experimental specimen of the
Sawbones implant specimen for the torsional loading regime are replicated within the
model. As with the anatomical loading model the experimental femoral constraint
was simulated within the torsional model by constraining all of the nodes associated
with the resected face in all active degrees of freedom (the rotational degrees of
freedom are not active in the tetrahedral element). This was the only numerical
constraint applied to the model that was representative of the experimental femoral
constraint (Figure 9-2).


301

A torque of 4Nm was applied to the Exeter stem about the long axis of the femur by
applying a couple to the implant at two nodes equally spaced from the long axis. The
couple consisted of two parallel forces acting in opposing directions with a
magnitude of 328N (Figure 9-2B). The initial direction of the measured torque
during the experimental bench-top tests was in the anterior direction (an anteriorly
directed moment can be defined as a moment that causes displacement at the head of
the implant in the anterior direction). An anteriorly directed moment was therefore
applied to the stem for the purposes of comparison.

A.

B.
Figure 9-2. Boundary conditions of the torsional model.
A. Side view of the model showing the distal encastre boundary condition and the moment about the
long axis of the implant; B. Top view of the isolated Exeter showing an anteriorly directed couple
used to generate the moment about the long axis for the validation procedure.


302
9.2 Comparison of the predicted strain to the
experimentally measured strain
The predicted strains from the FEM were converted from three-dimensional strain to
surface strain using the procedure outlined in Section 7.15.1. The strains generated
by the initial anteriorly applied moment were used to compare to the predicted
strains. The experimental strains were considered in terms of the measured torque
(Equation 6-5). The measured strain was considered to be the change in strain of
the specimen for the given measured torque. The measured strain was normalised so
that the measured torque was equal to 4Nm for each case. This was achieved by
equating the ratio of the measured torque and the applied torque to the ratio of the
measured strain and the normalised experimental strain (Equation 9-1).

Applied torque
Normalised strain =Measured strain
Measured torque
9-1

The normalised strain measurements were then compared to the modelled strain
values when an anteriorly directed moment was applied to the implant. The principal
strains and the principal angles for the anteriorly applied torsional load are presented
in Figure 9-3 and Figure 9-4 respectively.

At the first rosette position the model predicted the experimental strains for the
maximum principal, minimum principal and maximum shear to within 17, 13 and
15% respectively. At the first rosette the model predicted the principal angle to
within 1.53% (0.6) of the experimental value.


303
-1000
-500
0
500
1000
1500
R
1

P
r
i
n
c
i
p
a
l

1
R
1

P
r
i
n
c
i
p
a
l

2
R
1

M
a
x

S
h
e
a
r
R
2

P
r
i
n
c
i
p
a
l

1
R
2

P
r
i
n
c
i
p
a
l

2
R
2

M
a
x

S
h
e
a
r
R
3

P
r
i
n
c
i
p
a
l

1
R
3

P
r
i
n
c
i
p
a
l

2
R
3

M
a
x

S
h
e
a
r
S
t
r
a
i
n

(
m
i
c
r
o

s
t
r
a
i
n
)
FE Exp Mean
Figure 9-3. Principal strains of the torsional model compared to the normalised
experimental strains.

0
10
20
30
40
50
60
70
A
n
g
l
e

(
D
e
g
r
e
e
s
)
FE Exp Mean

Figure 9-4. Principal angles of the torsional model compared to the
experimental principal angles.


304
At the second rosette position the model predicted the experimental strains for the
maximum principal, minimum principal and maximum shear to within 53, 82 and
67% respectively. The principal angle varied by approximately 61% (25) between
the modelled and experimental values at the second rosette position. At the third
rosette position the model predicted the experimental strains for the maximum
principal, minimum principal and maximum shear to within 61, 56 and 19%
respectively. In absolute terms the variation in the measured and predicted strains at
the third rosette is 112, 58 and 54 for maximum principal, minimum principal and
maximum shear strains respectively. The principal angle varied by approximately
19% (11) between the predicted and experimental values at the third rosette
position.

A linear regression was undertaken on the strain values of the first and third rosettes
to determine the correspondence of the experimental and predicted strains (Figure 9-
4). A discussion of the variation between the measured and predicted strains at the
second rosette (carried out in Section 7.18) indicated that the most likely cause of the
strain discrepancy this point is the variation in the geometry of the physical and CAD
models. The strains at the second rosette were therefore removed from the linear
regression analysis.

The slope of the linear regression is 0.87 with a Y-intercept of 38, which equates
to 3.2% of the largest experimentally measured strain. While the variation of the
slope of the regression is larger than 10% (of the perfect regression of 1) it is
believed that the results of this regression analysis show that the predicted strain data
for the torsional loading condition is in good agreement with the experimentally
measured strain at the first and third rosette positions. The variations in the strains at
the second rosette were expected (Section 7.18) and were found to be lower than the
variations observed for the anatomical loading case.


305
Predicted strain =0.8675(EXP strain) - 37.9
R
2
=0.9955
-800
-600
-400
-200
0
200
400
600
800
1000
1200
-1000 -500 0 500 1000 1500
Experimental Strain (Micro strain)
F
E
M

S
t
r
a
i
n

(
M
i
c
r
o

s
t
r
a
i
n
)

Figure 9-5. Linear regression of the experimental and predicted strains for a
torsional load case.
Linear regression of the experimental and predicted strains at the first and third rosettes. The strains at
the second rosette are shown circled on the graph are not included in the regression. The equation of
the predicted strain as a function of experimental strain is shown with units in .

9.3 Discussion
It is important, when considering models of this type, to be confident of the models
ability to predict the behaviour of the system when exposed to conditions that are not
reproducible in a purely experimental (in vitro) situation. This investigation was
used to show that the model can be used to predict the response of the proximal
femur under various loading conditions. It has been shown within this chapter that
the model (with the exception of the variation in strain as a result of the suspected
variation in the geometry between the experimental and modelled femora, at the
second rosette) can predict the response of the system for both anatomical (walking)
and pure torsional load types. Therefore, validation of the model using torsion gives
confidence when applying more complicated load types that would be expected in
vivo such as the inclusion of muscle forces.


306


Chapter 10: Discussion, Recommendations and Conclusions
307
Chapter 10: Discussion, Recommendations
and Conclusions
The goal of this research was to develop a finite element and experimental test
protocol for a cemented total hip replacement stem for the purpose of investigating
the femoral component mechanics of a polished double tapered stem design. The
existing, clinically successful Exeter stem was chosen for this work as a functional
polished double taper design. A fortunate consequence of the original design of the
Exeter stem allows them to stabilise via the self limiting mechanism of subsidence
within the cement mantle. The research goal was achieved through the completion
of the experimental design and the validation of a finite element model.

An experimental program was developed using equipment designed within the
course of this research project. The experimental model was prepared for two
purposes, an initial study into the mechanical integrity of the stem (using torsion as a
mechanical indicator of integrity) and the generation of strain and displacement data
for the validation of a finite element model. In order to simplify the mechanical
system and to obtain a fundamental understanding of the component mechanics the
experimental protocol utilised a loading regime that relied on a single hip contact
force applied to the head of the implant.

A preliminary experimental protocol was developed, based upon current literature,
pertaining to topics ranging from the in vivo loading of the femoral component to the
mechanical properties of the analogue materials of the Sawbones femurs. The
preliminary protocol was implemented during a pilot study as part of the equipment


308
commissioning stage. The experiments were undertaken in a dry environment at
body temperature during this study. The reason for this is twofold. The first relates
to the temperature as it is recognised that PMMA bone cement possesses different
properties at room temperature than at body temperature. The second is that the
SGFR epoxy and the solid rigid polyurethane foam used as the mechanical analogues
for the cortical and cancellous bones will degenerate in moist environments. Failure
of the femurs occurred regularly during the pilot study for the loads and boundary
conditions used. This prompted a study of the mechanical properties of the cortical
bone analogue, a short glass fibre reinforced epoxy resin, used within the third
generation Sawbones.

The mechanical properties testing aimed to provide an understanding of the thermo-
mechanical properties of the material and to subsequently provide material property
data for the finite element model. To eliminate any variability that may be evident in
the manufacturing of the SGFR epoxy, the specimens were obtained from sections of
the third generation model 3303 femurs. It was found that the Youngs modulus of
the SGFR epoxy varied by a factor of almost three between the experiments
undertaken at room temperature and body temperature. The mode of failure of the
specimens at the two temperatures also varied, with brittle failure dominant at room
temperature and ductile failure at body temperature.

A preliminary FEM was developed in parallel with the experimental program. The
geometry of the implanted stem and femur from the pilot study was used to develop
the FEM using X-rays of pre-loaded specimens. Prior to meshing the model it was
found that the initial geometry of the femur (freely available from the internet
through the BEL Repository managed by the Istituti Ortopedici Rizzoli, Bologna,
Italy (Papini 2003)) possessed multiple and dissimilar Non-Uniform Rational B-
Spline (NURBS) surfaces at the proximal end of the femur intersecting and
overlapping between the head of the femur and the shaft of the femur. The CAD
model was corrected and the FEM geometry generated on the basis of the
experimental X-rays. The FEM geometry was meshed using three levels of mesh


309
density. These models were used to validate the model against the experimental data
obtained from the initial anatomical loading protocol.

The implications of the lower than expected Youngs modulus of the SGFR epoxy at
body temperature were twofold. Whether the varus geometry of the stem within the
femur was creating high stresses that were reducing the time to failure of the femur
under cyclic loading, or that the applied load simulating the hip reaction force was
too great. The effect of stem position and orientation on the strains developed in the
proximal femur under static loading was investigated. It was found that the failure of
the femur was a result of the relatively high strains developed in the varus specimens.
By altering the stem orientation to a neutral position the strains were lowered and
femur failure was avoided.

The experimental program investigated the torsional stability of the Exeter stem
immediately after implantation and at intermittent periods during the cyclic loading
regime. After initial testing the implant was removed, reimplanted and then tested
again. The stem was monitored in terms of distal migration in the direction of the
applied load. It was found that the stem did in fact subside within the cement and
femur system by a small amount. It was also found that there was no perceivable
variation in the torsional stiffness of the system during the loading period for the
initial implant. Subsequently, the conclusion was reached that the highly polished
double taper design of the Exeter allowed the stem to subside within the mantle
while maintaining the initial stability of the stem. It was found that although the
stability of the stem was compromised immediately after reimplantation, the stability
returned with minimal loading (2 hours).

The experimental data were compared with the three meshed FEMs used in
conjunction with the SGFR material properties data to validate the appropriate
model. The selected FEM was then equivalently meshed to remove numerical stress
risers generated by the confluence of three contact surface definitions.


310
The FEM found good agreement with the experimental investigation in terms of
measured strain (at the first and third rosettes) and failure of the cortical bone. Strain
at the second rosette was not predicted well, most likely a result of variations in the
geometry of the femur between the physical and modelled femur geometry. Trends
for the stress-strain state of the stem showed good correlation with the clinical
findings of failure and wear of the stem. The stress-strain state of the cement was
well predicted with the appearance of compressive and hoop stresses once debonding
of the stem-cement interface was introduced through revision reimplantation.

The FEM also demonstrated the applicability and usefulness of numerical
approaches in addressing pertinent clinical questions. It has been shown that the
success of the implant in Gruen zones 1 and 7 is a result of the taper lock mechanism
of the proximal stem. The model was able to show that the retention of bone
achieved by the Exeter stem may be a result of the compressive and hoop stresses
generated at the stem-cement interface.

The experimental and finite element models developed during this research have
provided valuable insight into the component mechanics of a highly polished double
tapered stem. The experimental model showed that the torsional stiffness of the stem
remains stable even after reimplantation. The finite element model has, in the
limited scope of this research, provided valuable answers and insight to existing
clinical questions.

10.1 Recommendations for future experimental work
The continuation of the experimental study can progress in two ways. The first is
with the continued use of the Sawbones femurs. The advantage of Sawbones usage is
that highly repeatable results between specimens can be achieved as was shown in
this study. However, there are issues with the temperature dependent material
properties of the Sawbones femurs which have been highlighted in Chapter 4. The
temperature dependence of the Sawbones analogues poses a serious issue for the use


311
of these analogues for studies in orthopaedic research that involve PMMA. The
progression of the experimental protocol would therefore be to extend it to using
cadaveric specimens. This would allow the appropriate environment considering
both temperature and humidity to be simulated providing a more realistic in vitro
test.

The issue of continuous measurement of subsidence while providing the capacity for
distal migration measurement could be achieved using a multi-axial materials testing
machine. A biaxial testing machine would allow the experimental procedure to be
conducted in such a way that the issues of discontinuous subsidence measurement in
a test involving the use of a torsional diagnostic of the specimen would be removed.
With some modification it is possible that the test devices designed for this project
could be adapted to a biaxial testing machine to provide more reliable distal
migration data for a cyclically loaded specimen.

An important modification to the experimental program would be to achieve more
accurate measurement of the torsional stiffness by redesign of the coupling arm to
eliminate frictional misalignment torques. This would allow measurements of not
only the torsional stiffness, but also energy dissipation of the specimen. This
additional data may provide information that will enable distinctions to be made
between an initially implanted and revision reimplanted stem.

10.2 Recommendations for future FEM work
An in depth analysis of the geometry of the femur (especially surrounding the second
rosette position) is required given the results of the FEM validation. The variation in
the geometry between the FEM and the physical model 3303 femurs is the most
likely reason behind the variation in the strain measured at the second rosette. This
could result in modification of the Papini model (Papini 2003) or the generation of a
new CAD femur model.


312
Of immediate interest to this project would be a FE investigation of the effects of the
position of the stem relative to the femur, and the effect of varus implantation on the
mechanics of the femur.

Most of the current finite element modelling investigations that are undertaken
within the current literature would be reproducible using the model presented here.

10.3 Conclusions
The experimental and finite element models developed within the scope of this
project have provided a powerful analysis tool for the investigation of the femoral
component mechanics of a THA. Application of the model to clinically relevant
problems has given valuable insight into the mechanisms behind the success of the
Exeter femoral component. Models such as this will provide information on implant
failure modes that will further lead to an increased implant life expectancy and
reduction in the number of revision operations performed.

In particular this thesis has:
1. Designed and developed experimental rigs and defined an experimental protocol,
2. Identified and quantified the temperature dependence of Sawbones femurs,
3. Identified the effect of the orientation of the Exeter stem on the strains of the
proximal femur,
4. Identified the torsional stability of the Exeter stem in the initial implanted and
revision reimplanted states,
5. Generated a geometrically accurate model of the proximal femur implanted with
a cemented Exeter stem for FE modelling,
6. Developed an FEM of the Exeter femoral stem implanted in a Sawbones femur
7. Validated the FEM against experimental data,
8. Used the FEM to evaluate fixed and reimplanted stems under a static resultant
hip contact load,
9. Validated the FEM in a torsional loading case.


313


314


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Appendix A: Protocol for the Subsidence and Rotational Stability of the Exeter
Femoral Hip Component
329
Appendix A: Protocol for the Subsidence
and Rotational Stability of the Exeter

A.1 Nomenclature
Specimen: A specimen is a Sawbones femur implanted with an Exeter femoral stem.
Secure Specimen: A secure specimen is a specimen that has a complete cement
mantle.
Unstable Specimen: A loose specimen is a specimen that has been destabilized and
does not possess a complete cement mantle.
Component: Refers to the Exeter femoral stem Number 1 37.5mm stem.

A.2 Equipment
Femur clamp: The anatomical clamp for the femur is set at a constant angle. The
angle of the clamp is such that the femur is positioned at an angle of 10 in the
frontal plane and 11 in the sagittal plane.


330
Torsional clamp: Torsional loading device has been designed to accept a modified
Exeter implant and hold the implant in such a way that the rotation of the implant is
about the long axis of the implant.

Hounsfield: Torsion is applied using the Hounsfield testing machine. The torque
arm is 0.1m in length.

Patient warmer: Heating the specimen to 37C2C is achieved using a patient
warmer.

Stem position device: This device is used to ensure that every stem is implanted in
the same position. The stem position device possesses two components; the support
column and the tri-planar head mount.

Data acquisition: Data acquisition is through an IOtech DBK207/CJ C board.
Channels are conditioned using 5B modules. Data is gathered for 9 strain, 3 LVDT,
2 temperature and 1 pressure channels.

Data analysis: Data is gathered using DaqView 2000 software. Data in analysed
using a program within MatLab.

A.3 Loading regimes
Anatomical loading: Refers to a load applied to the head of the implant when the
femur is clamped in the specially designed femoral clamp. A load of 650N will be
applied to the head of the implant when loading anatomically. A Torque wrench is
to be used to secure the femur into the femur clamp. The wrench is to be set to a
torque of 0.30 Nm for the hex nuts on the mid-shaft clamping block.


331
Torsional loading: Refers to a load applied to the head of the implant when the
femur is clamped in the specially designed torsional loading device. A torque of
4Nm will be applied to the head of the implant during torsional loading, requiring a
40N load from the Hounsfield.

Condition Value
Load 40N
Displacement rate 10mm/min
Number of cycles 15
Limit displacement with: Load

Zeroing of the force needs to be undertaken to ensure that drift of the hysteresis loop
does not occur. Force is to be zeroed prior to the femur being positioned, once the
torque arm is horizontal. The specimen is then to be attached to the torque arm at the
head of the femur. Fixation of the femur is to be achieved using the following
protocol:
7. Insert head of implant into the taper of the torque arm.
8. Fix collar to the torque arm leaving some play in the screws.
9. Tighten the screws of the torque arm to bring the locking block into position
ensuring that the locking block is flush with the machined flat on the head of
the implant.
10. Tighten the screws of the collar until firm.
11. Adjust the distal epicondylar clamps using only the lateral and medial blocks
until there is contact on all points of the epicondyles.
12. Tighten the grub screws of the epicondylar clamps using a torque wrench set
to 0.20 Nm.


332
A.4 Materials
1. Sawbones #3303 analogue femurs are to be used as the femur substitute.
2. Exeter stems are to be implanted into the Sawbones femurs using the stem
positioning equipment. Implanted femurs are henceforward denoted as
specimens.
3. TSM strain rosettes model #2/350/PC11/TRI/A1m8. Gauges are at 45,
active gauge length of 3mm, total rosette size 5 by 5mm.
4. Linear variable differential transformer (LVDT). Solartron DC spring return
displacement transducer model #DG/5.0, calibrated range of 5mm.

A.5 Destabilisation protocol
Each femur tested while the component is initially stable, the component is then to be
destabilised and the testing protocol is to be repeated for the destabilised specimen.
Destabilisation is to be carried out by removing the component from the cement
mantle and the replacement of the component within the mantle to the original
position (to the second marker).
Removal of the component is to be undertaken while the specimen is at 37C to
minimise pullout force and limit damage to the component. The component is to be
cleaned and coupled to the torque arm of the torsional loading device. The femur is
then replaced to the point of the second marker. The femur is then secured into the
torsional loading device and the torsional stability of the system is measured. The
relevant loading protocol is then repeated for the specimen.


333
A.6 Femoral instrumentation
Relative displacement
Relative displacement between the femur and the component is to be carried out
using two LVDTs. The LVDTs are to be placed on the medial edge of the femur in
positions that are medial-proximal and mesial-distal.

Holes are to be drilled through the bone at the locations of the existing holes drilled
into the component. A pin is secured to the component that will mate with the
LVDT in order to measure the relative displacement. The actual displacement of the
component relative to the bone will be calculated from the measurement taken by the
LVDT.

Strain
Three strain rosettes will be placed on the femur. The positions of the rosettes are
Lateral edge between the LVDTs, anterior edge transversely level with the lateral
rosette and on the medial neck in line with the distal ridge of the lesser trochanter.
These positions are shown in Figure A-1.


334

Figure A-1. Strain gauge positioning on the proximal femur

Instrumentation of the specimen is to occur during the curing process, every attempt
is to be made to keep the specimen at body temperature (37C).

A.7 Data acquisition channel allocation
Data will be gathered over 15 channels. Table A-1 shows the data recorded and the
associated channel.
Table A-1. Data Channel
allocation
Channel Data recorded
00-08 Strain
09-010 Temperature
1-3 Displacement
6 Pressure


335
A.8 Finite Element Validation
Secure specimens only are to be used for the finite element validation. Validation is
based on the strains produced from static loads. The finite element validation
protocol is to be carried out before the torsional stability investigation protocol.

Phase 1
Static anatomical loading
1. Heat specimen to achieve 37C for 1 hour prior to testing.
2. Apply a static anatomical load using a square wave with a period of
15minutes.

Phase 2
Static torsional loading
1. Remove specimen from femur clamp and place in torsion clamp.
2. Apply a static torsional load using a square wave with a period of 15
minutes.

Suggested sampling at 2Hz for 15 mins (total of 1800 samples)

A.9 Torsional stability investigation
Group 1: 24 hour loading
1. Measure the rotational stability of the femoral component using the torsional
load.


336
2. Apply anatomical loading cyclically with a frequency of 1Hz for 6 hours.
load.
4. Apply anatomical loading at 1Hz for 18 hours.
5. Measure the rotational stability with the torsional loading regime.
6. Repeat 2-4 to allow for 4 days of testing. Total loading cycles will be 345,600.

Data acquisition for the constant loading protocol
Data will be acquired every 10 minutes for the anatomical loading regime and during
rest periods. Data will be acquired at 10Hz for 4 second bursts.
Data will be acquired during the torsional loading component. Every attempt will be
made to gather data over the entire torsional loading period. Suggested sampling
rate of 2Hz for 4 mins

Group 2: 6 hour loading with 18 hour relaxation
load.
2. Apply anatomical loading cyclically with a frequency of 1Hz for 6 hours.
3. Acquire data for the specimen once the load has been turned off. This is to
measure the position of LVDT 1 and strain.
4. Measure the rotational stability of the femoral component using the torsional load
immediately after removal from the femoral clamp.
5. Let the specimen rest for 18 hours.
6. Replace specimen and acquire data with the bearing plate in position with NO
LOAD to measure LVDT 1 position and strain.
7. Repeat 2-6 to allow for 4 days of testing. Total loading cycles will be 36,000.


337


Appendix B: Element Verification
338


339
B.1 Element verification: Bending
The second order modified tetrahedral elements were verified in bending by
comparing results obtained from a model of cantilever beam with theoretical
calculations of the beam. A theoretical steel cantilever beam with dimensions of
2040600mm with a 100N load applied to the free end was used as the true solution
of the model. The nodes of the beam at end A were constrained in all directions to
simulate the encastre end of the beam. The corner nodes of the beam at end B were
each given a load of 25N to distribute the 100N load. The model boundary
conditions are given in Figure B-1.

Figure B-1. Boundary conditions of the cantilever beam. .
Nodes were constrained in all directions on the elements of the face at end A. 25N was placed on
each corner node of the face at end B in the X-direction to distribute the 100N load.


340

The beam was meshed in terms of number of elements through the width with values
of 2, 3, 4, 5, 6 elements used.

B.1.2 Results
The theoretical maximum stress of this beam will have a value of 22.5MPa in the Z-
direction and will occur at the constrained end of the beam. The theoretical
maximum deflection will be 1.35mm in the X-direction and will occur at the free end
of the beam. Model results were expressed in terms of nodal values for comparison
with the theoretical solution. For this system the maximum displacement of the
beam is 1.356mm at end B. Displacement results, expressed in terms of percent error
from the theoretical solution, for all of the models are given in Figure B-2.
0
0.2
0.4
0.6
0.8
1
1.2
1 2 3 4 5 6 7
Number of elements through the width of the beam
P
E
R
C
E
N
T

E
R
R
O
R

Figure B-2. Convergence of the deflection expressed in terms of percent error
with increasing numbers of elements trough the width of the beam

All of the models produced valid results for displacement with only one model
predicting a displacement greater than 1% error. All models with three or more


341
elements through the width of the beam have an error of less than 1% with the model
of two elements through the width predicting a solution with an error of only 1.1%.

Stress in the Z direction was then obtained from the model. For this system the
maximum stress of the beam was 23.95MPa, obtained from the central node of the
tensile side at end A. Stress results, expressed in terms of percent error from the
theoretical solution, for all of the models are given in Figure B-3.

0
2
4
6
8
10
12
14
1 2 3 4 5 6 7
Number of elements through the width of the beam
P
E
R
C
E
N
T

E
R
R
O
R
Figure B-3. Convergence of the stress expressed in terms of percent error with
increasing numbers of elements through the width of the beam

The stress values appear to converge to a value of stress with an asymptote of
approximately 3%. Models with three or more elements through the thickness
predict stress values with error less than 10%, with models containing five and six
elements through the width predict stresses with an error of 3.2%.


342
B.1.3 Discussion and Conclusion
The models display good convergence characteristics for both displacement and
stress. Using three or more elements through the width will produce results with
expected error of less than 1% and 10% in displacement and stress respectively.
Increasing the number of elements from five to six through the width does not
increase the accuracy of the model in terms of either displacement or stress. If an
error of less than 10% is considered acceptable for the predicted stress then a model
with more than three elements through the width of the beam will provide a suitable
model.

The error in the stress values will be greater than the error in the displacement values
for the following reason. The theoretical calculation of stress does not consider the
encastre end. The stress in the model at the constrained end accounts for the
constraint. Stress at an arbitrary length from the applied load at a distance from the
constrained end will not have as great en error as the maximum stress at the
constraint. Considering this, a model that converges to 3% error using the maximum
stress as a criterion is an excellent model.

B.2 Element Verification: Contact
A model of two contacting cylinders was generated to assess the ability of the
modified second order tetrahedral element to accurately predict contact pressure.
The size of the cylinders was chosen so that elements of the same seed length and
size as would be used in the femur model could be used for the cylinders Figure B-4.


343

Figure B-4. Two cylinders used for the contact analysis.
Note that there is a displacement separating the cylinders before the *ADJ UST parameter has been
enforced.

Table B-1 gives the results of the analysis of the two contacting cylinders.

Table B-1. Results for the contact of two cylinders
Element Length Applied Pressure
Nodal contact pressure
Mean(SD)
3mm 100Pa 97.3(12)
2mm 100Pa 96.5(12)
1.5mm 100Pa 96.3(14)


344

B.3 Element Verification: Discussion
All of the models produced suitable results in terms of the mean and standard
deviation when considering the expected 100Pa at the interface. Edge effects are not
considered in the theoretical calculations and as such some variation between the
theory and modelled results is to be expected. Any of the element lengths
investigated could be used to provide accurate contact results given the mean and
standard deviations produced from this analysis.

A Finite Element and Experimental Investigation of The Femoral Component Mechanics in A Total Hip Arthroplasty - Cameron Gordon Bell - Thesis - 2005

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A Finite Element and Experimental Investigation of The Femoral Component Mechanics in A Total Hip Arthroplasty - Cameron Gordon Bell - Thesis - 2005

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A finite element and experimental

investigation of the femoral

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