J. A.

Simoes
Department of Mechanical Engineering, University of Aveiro, Aveiro, Portugal

NumericalExperimental Method for the Validation of a Controlled Stiffness Femoral Prosthesis

The aim of this paper is to describe a new numericalexperimental method to determine the stiffness of a conceptual proximal femoral prototype. The methodology consists of the comparison of the numerical and experimental displacement distributions of the prosthesis loaded as a cantilever beam to validate a design concept: controlled stiffness prosthesis. The manufactured prototype used to test the applicability of the numerical experimental procedure integrates a stiff metal core bonded to a composite material made of an epoxy resin reinforced with carbon-glass braided pre-forms. The prosthesis with an embedded controlled stiffness concept was obtained by varying the geometry of the core with the composite layer thickness. DOI: 10.1115/1.1375162 Keywords: Femoral Prosthesis, Stiffness, Holography, Displacement, Composite Material

J. Monteiro M. A. Vaz
Department of Mechanical Engineering and Industrial Management, University of Porto, Porto, Portugal

Introduction
The design of a hip prosthesis is a challenging problem that has stimulated many investigators. The femoral component of a hip prosthesis is essentially composed of a stem incorporating a ball and is characterized by its geometry and material s , what is known as stiffness elastic modulus multiplied by the second moment of area . Stiffness is an important design parameter and many authors have addressed its inuence on the prosthesis performance. Stiffness is known to play a key role in the stress shielding phenomena and on the relative interface bone-implant micromotion, the predominant causes for long-term failure of total hip replacements 1 . Stress shielding depends on the design of the intramedullary reconstruction and mainly on the material of the femoral component, which inuences the mechanism of load transfer from implant to the surrounding bone and can have an alarming effect on a revision procedure. Interface micromotion can lead to a premature failure of the implant and is design and material dependent. Therefore, two important design goals have to be addressed in the design cycle of a hip prosthesis to balance the advantages of exible and stiff materials concerning stress shielding and micromotion. These design objectives are strongly affected by the prosthesis material s . Flexible stems provoke less stress shielding in the surrounding bone, but higher proximal interface stresses: cement stresses for cemented designs. Thus, excessive bone resorption is more likely to occur around stiff stems, but proximal interface failure is more likely to occur around exible stems 1 . Having this in mind, a suitable compromise has to be achieved because the femoral component cannot be stiff and exible at the same time. The design problem is to know how to minimize stress shielding keeping interface stresses and interface micromotions at acceptable levels 1,2 . Conventional proximal femoral prostheses are manufactured with a single constant modulus material. Such prostheses can address either the stress shielding effect or the interface stresses, but not both simultaneously. However, with optimized controlled stiffness, it is possible to obtain a compromise between the two conicting design factors to attenuate the problems described above. There has been substantial active research with composites for total hip replacement applications 310 , namely for his prostheses. The possibilities of stress shielding reduction, and therefore bone resorption minimization, leading to thigh pain alleviaContributed by the Bioengineering Division for publication in the JOURNAL OF BIOMECHANICAL ENGINEERING. Manuscript received by the Bioengineering Division June 26, 2000; revised manuscript received December 13, 2000. Associate Editor: V. K. Goel.

tion, have stimulated the development of compliant and tailored prosthesis designs made from composite materials. Due to the anisotropic nature of composite materials, they offer to the designer the possibility to tailor the desired optimized stiffness and strength and are potentially excellent materials for hip prostheses applications. However, it is necessary to prove the benets of these composites clearly, namely those properties related to biocompatibility and biofunctionality performance. Published reports suggest that composite prostheses perform no better than similarly shaped titanium alloy prostheses with regard to maintaining bone stock. Further, unpublished reports from clinical trials have shown early failure of femoral components made from composite materials 9 . One of the major problems in the design procedure of femoral components when these materials are used is the degree of design complexity. Laminated composite technology has been widely developed by the aerospace and aeronautic industry. The design concepts developed do not seem to be appropriate for femoral component design, and have been ignored by many authors. Previous studies have suggested that a controlled stiffness prosthesis is required to address the conicting design requirements of minimizing stress shielding and interface stresses 2,11 . A preliminary investigation of a novel controlled stiffness proximal femoral prosthesis was performed by Simoes et al. 11,12 . A conceptual prototype of a novel prosthesis consisting of a cobalt chrome core surrounded by a exible composite material was developed and manufactured embedding a controlled stiffness concept, based on optimized elastic modulus data of a cementless prosthesis design 2,13 . The aim of this work was to carry out an appropriate experimental analytically validated procedure to determine the variation of the prototype prosthesis stiffness and to validate a concept.

Materials and Methods

To determine the variation of the prosthesis stiffness, the method idealized and implemented consisted of the comparison of the prosthesis lateral displacement eld measured using a noncontact experimental technique, namely ESPI Electronic Speckle Pattern Interferometry with the one obtained with an analytical model. The study was performed with a modied Freemans femoral prosthesis, whose front orthographic projection is shown in Fig. 1. The conceptual prosthesis was manufactured using a composite technology, which allowed the implementation of the concept 12 . The prototype was studied and developed based on ndings of material stiffness optimization of a femoral component 13 . These ndings suggest that an optimized femoral component Transactions of the ASME

234 Vol. 123, JUNE 2001

Copyright 2001 by ASME

Fig. 3 Prosthesis load as a cantilever beam Fig. 1 Orthographic projection of the test model prosthesis

must have a relatively high proximalmedial modulus and a low distal modulus matching cortical bone modulus at the prosthesis tip 2,14 . The model used in this study was manufactured to have a modulus of 80 GPa at the proximal lateral part of the prosthesis varying to 20 GPa distally. The modulus of the proximal medial wedge was varied from 150 to 100 GPa at the intersection with

Fig. 2 Manufactured composite proximal femoral prosthesis

the straight-backed stem 12 . Using a single modulus material geometry cannot be deeply changed , it is not possible to physically materialize the optimized numerical results. Even using composite materials, it seems difcult to achieve, within the same structure, such highly differentiated modulus. To overcome this manufacturing design obstacle, the prototype prosthesis was manufactured combining the geometry of an inner cobaltchrome core E 200 GPa with the thickness of a relatively exible composite outer layer E 12 GPa 11,12 . The core was modeled and machined with Powershape CAD/CAM software Delcam, plc., Birmingham . For the composite structure, hybrid commercial braided pre-forms A&P Technology, KY of glasscarbon ber reinforcement were used. The composite layer modulus and Poissons ratios were obtained experimentally testing tubular specimens with internal pressure. Axial and circumferential strains and therefore the axial circumferential stiffness properties were obtained (E 8.9 GPa; E z 12.7 GPa; v z 0.461 and v z 0.323) 12 . The prototype was manufactured localizing and bonding sequentially carbonglass pre-forms around a stiff metal core with different number of layers from distal to proximal. A mean thickness of 0.35 mm was considered for each layer and therefore, the total number of layers was calculated at different locations on the prosthesis. The composite structure material was impregnated with an epoxy resin, placed in a mold, and left to cure at room temperature for 24 hours. The prototype was then submitted to a curing cycle during 24 hours at 80C. Figure 2 shows the prototype manufactured used to test the controlled stiffness concept. The controlled stiffness concept has shown its adequacy for the design of a proximal femoral prosthesis considering the compromise between the strain energy distribution a parameter used to determine the stress shielding effect and therefore the degree of bone resorption and the cancellous bone stresses parameter to determine the prosthesis migration 11,12,15,16 . By combining a stiff material with a more exible one, it is possible to obtain a prosthesis with controlled stiffness, which meets the requirements of the compromise between the two parameters mentioned: stress shielding and migration. Following Simoes et al. 12 , the controlled stiffness prosthesis showed a very similar numerical behavior to that observed with an identical cemented one. To determine the prosthesis stiffness, an experimental numerical procedure was idealized and its applicability studied. JUNE 2001, Vol. 123 235

Journal of Biomechanical Engineering

The method consisted of the comparison of the lateral displacement eld measured using ESPI and the same data resulting from an analytical model. In both the numerical and experimental models the prosthesis was loaded as a cantilever beam Fig. 3 . No torsional force due to the anterior loading component of the hip joint force was taken into account within the experimental setup. The objective within the study was to validate a controlled stiffness concept, by determining an optimal variation composite thickness, assuming that the bending stiffness Elyy Youngs modulus x second moment area of the optimized prosthesis is the same as the bending stiffness of a prosthesis composed of a metal core and a composite layer 12 . For an equivalent torsional stiffness, the variation of the optimal composite layer thickness was inferior to the one obtained for the equivalent bending stiffness, therefore playing a second-order effect concerning the study hereby presented. Analytical Model. An easily understood analytical model was developed to obtain the numerical solution for the lateral displacements of the prosthesis loaded as a cantilever beam. The displacement distribution of a beam can be obtained by integrating the equation: d2y z dz 2 M z E z Iyy z (1)

where R(z) is the radius of a circular section A as a function of coordinate z as follows: R z 60 17 z for 0 z 96 17 (3)

For the proximal part of the model prosthesis, the geometry section B was considered as a sum of four elementary geometries Fig. 1 . Therefore, the second moment of area function for this part of the prosthesis was obtained by
4

Iyy z

i 1

yyi

I yy1 z

I yy2 z

I yy3 z

I yy4 z (4)

for 96 z 162 where I yy1 z R4 4 sin 2 8 rR 3 cos3 18 4 sin2 9 R2 2R sin 3

G z (5)
2

I yy2 z I yy3 z I yy4 z and L z r4

rR cos

2R cos 3

G z G z 4r 3
2

(6) (7)
2

where y(z) is the displacement function, E(z) the Youngs modulus, M (z) the moment due to the loading, and I y y (z) the second moment of area, respectively, all functions of the z coordinate. The second moment of area function was analytically obtained having in consideration the prosthesis geometry and dimensions Fig. 1 . Considering the prosthesis main sections section A and B on the coronal plane, the function characterizing the second moment of area was obtained for each of them. For the middledistal part of the prosthesis, this function was determined using the equation: R z 4 Iyy z (2) 4

rB 3 2rL z 6 8 8 9

L z R cos 2 R cos

r2 L z 2

G z (8)

r ztg30 R cos 180 arcsin R

(9)

The variable G(z), center of mass of section B, was determined by the equation:

G z

2 3 R sin 3

2 2 2 rR cos 3

rL z R
2

2rL z R cos 2rL z

rR cos

r2 R cos 2 r2 2

L z r2

2 3 r 3

(10)

Finally, the analytical solution for the displacement distribution was obtained replacing the function of the variability of the optimized Youngs modulus E(z) and the function for the second moment of area I y y (z) approximated to a second-degree function in Eq. 1 . The applicability of the second moment of area function to be used within Eq. 1 was tested using a nite element model. The lateral displacements of a constant Youngs modulus prosthesis, loaded as a cantilever beam, were obtained by integrating Eq. 1 and using the nite element method and data obtained by both methods compared. For the nite element analysis, the prosthesis was modeled with SolidWorks 99 computer aided design software and simulated with Cosmos/Works 5.0 nite element analysis

software. The nite element model was composed of 2139 tetrahedral four-node elements and 702 nodes. The numerical integration of Eq. 1 was performed with Mathematica software 17 . The prosthesis was loaded with a load of P 700 N. To determine the numerical displacement eld of the prototype, a linear relationship between the optimal elastic modulus and the axial prosthesis coordinate was used: 130 z GPa (11) 162 for z 0,160 . Replacing Eq. 11 in Eq. 1 , the following equation was numerically integrated to determine the displacements along the lateral side of the controlled stiffness prosthesis: E z 20

d2y z dz
2

Pz 20 130 z 162 103 0.00092z 2 2.24 10

5

(12) z 7.25 10
8

where P was the load applied. 236 Vol. 123, JUNE 2001 Transactions of the ASME

Fig. 4 ESPI setup to measure in-plane displacements

Experimental Model. To perform the experimental measurements, the electronic speckle pattern interferometry ESPI technique was used. With this technique, the assessment of the displacement led of the prototype was possible with no need of contact or surface preparation and with very high resolution, the order of magnitude of the laser wavelength. The experimental displacements were obtained with a manufactured prosthesis prototype to determine the variation of its stiffness by comparing with identical results derived from the analytical model. The prosthesis was xed and loaded as assumed in the analytical model, as a cantilever beam. A stiff support was used to hold the prosthesis 30 mm from its distal end. The magnitude of the displacement eld measured was of the order of the micron, therefore a very low load of P 0.2 N was used, which allowed us to obtain a reasonable number of fringes to calculate the displacements values easily. The experimental setup used Fig. 4 is a ESPI setup. The interferometer arms were oriented in such a way that the sensitivity vector was coincident with the direction of the displacements measured, that is, perpendicular to the lateral surface of the prosthesis. The displacement eld obtained resulted from the phase map calculation by using an image-processing algorithm based on phase stepping techniques. The 2 phase difference corresponds to a /2 displacement; therefore, the displacement of a point on the prosthesis surface was obtained by: y z fringe_order 2 (13)

second moment of area function in Eq. 1 to obtain the displacements of the controlled stiffness prosthesis prototype analytically. Table 1 shows the displacement values measured experimentally and those obtained analytically. Relative to the ESPI experiment, Fig. 5 shows phase map a , ltered phase map b , and unwrapped phase map c obtained for the prototype model prosthesis. It is a typical phase map of cantilever-loaded beam. Figure 6 shows the graphic comparison of the ESPI and numerical integration displacement elds. A relatively good correlation between the displacement elds was obtained using the method described, and so we can state with some certainty that the manufactured prosthesis prototype had embedded equivalent optimized stiffness. This means that the prosthesis was manufactured with an equivalent Youngs modulus as stated in the materials and methods sec-

Table 1 Displacement eld determined analytical and measured experimental on a controlled stiffness femoral prosthesis

For the laser used, 632 nm, and replacing this value in Eq. 13 , the displacements were obtained along the lateral side of prosthesis.

Results and Discussion

The applicability of the second moment of area function of the prosthesis model was veried by comparison of the displacements calculated with the nite element method and the numerical integration of Eq. 1 . The results obtained for both methods were similar along the prosthesis length. The maximum displacement observed was 1.704 mm for the numerical integration of the analytical model and 1.720 mm for the nite element method. This observation gave the necessary condence to use the analytical Journal of Biomechanical Engineering JUNE 2001, Vol. 123 237

technique was 4.3 m; for the analytical model, the maximum displacement was 4.1 m, a relative difference of 5 percent.

Conclusions
The methodology idealized and described within this paper proved to be suitable to validate the purpose of the study. Having developed a conceptual novel prosthesis with an objective to materialize numerical optimized modulus data, there was a necessity to validate experimentally the variability of the prototypes stiffness and therefore the concept. The experimental method based on ESPI was revealed to be suitable to determine the prosthesis displacements and the comparison with the ones obtained with the analytical model proved the adequacy of the procedure implemented. Relative to the conceptual prosthesis, it is shown that it is possible to materialize optimized Youngs modulus data by overcoming possible composite manufacturing difculties.

Acknowledgments
The authors would like to thank Carlos Relvas from the Department of Mechanical Engineering of the University of Aveiro and Jose Carlos from Norcam-Engenharia e Design Industrial for the machining of the mold and core for the prototype.

References
1 Huiskes, R., 1993, Failed Innovation in Total Hip Replacement. Diagnosis and Proposals for a Cure, Acta Orthop. Scand., 64, No. 6, pp. 699716. 2 Kuiper, J. H., and Huiskes, R., 1993, Numerical Optimization of HipProsthetic Stem Material, in: Computer Methods in Biomechanics and Biomedicine, Middleton et al., eds., Gordon and Breach, New York, pp. 7884. 3 Blake, T. A., Davy, D. T., Saravanos, D. A., and Hopkins, D. A., 1992, Numerical Optimization of Composite Hip Endoprostheses, in: Proc. 4th AIAA/USAF/NASA/OAI Symposium on Multidisciplinary Analysis and Optimization, pp. 119129. 4 Chang, F., Perez, J. L., and Davidson, J. A., 1990, Stiffness and Strength Tailoring of a Hip Prosthesis Made of Advanced Composite Materials, J. Biomed. Mater. Res., 24, pp. 873899. 5 Claes, I., Burri, C., Neugebauer, R., and Gruber, U., 1983, Experimental Investigations on Hip Prostheses With Carbon Fibre Reinforced Carbon Shafts and Ceramic Heads, in: Ceramics in Surgery, P. Vincenzini, ed., Amsterdam, pp. 243250. 6 Christel, P., Meunier, A., and Leclerq, S., 1987, Development of a Carbon Carbon Hip Prosthesis, J. Biomed. Mater. Res., Applied Biomaterials, 21, No. A2, pp. 191218. 7 Davidson, R., Brabon, S., Lee, R. J., Nelson, K., Unwin, P., and Roughley, P., 1996, The Development of CFRP Based Hip Stems, Proc. 7th European Conference on Composite Materials, ECCM-7, London, pp. 513517. 8 Devanathan, D., 1991, Orthopadic Composites International Encyclopedia of Composites, Stuart M. Lee, ed., New York, 4, pp. 7486. 9 Fu, W., 1998, Design Optimization of a Laminated Composite Femoral Component for Total Hip Joint Arthroplasty, Ph.D. thesis, Graduate School of Clemson University. 10 Widmer, M., Callenbach, T., Isler, J., Frohlich, M., Meier, D., Mayer, J., Wintermantel, E., Tschanz, P., Luthi, H., Matzenauer, K., and Klostermann, L., 1995, Injection Moulding of Carbon Fibre Reinforced PEEK for Anisotropic Hip-Prostheses: Preliminary Results, Proc. III Portuguese Congress in Biomedical Engineering, Porto, Portugal. 11 Simoes, J. A. O., Taylor, M., Marques, A. T., and Jeronimidis, G., 1998, Preliminary Investigation of a Novel Controlled Stiffness Proximal Femoral Prosthesis Proc. Inst. Mech. Eng., 212, Part H, pp. 165175. 12 Simoes, J. A., Marques, A. T., and Jeronimidis, G., 2000, Design of a Controlled-Stiffness Composite Proximal Femoral Prosthesis, Comput. Sci. Eng., 60, pp. 559567. 13 Kuiper, J. H., 1993, Numerical Optimization of Articial Hip Joint Designs, Ph.D. thesis, University of Nijmegen, The Netherlands. 14 Simoes, J. A. O., Antonio, C. A. C., and Marques, A. T., 1996, Material Stiffness Optimization for a Composite Hip Prosthesis, in: Proc. 1st International Conference on Composite Science and Technology, S. Adali and V. E. Verijienko, eds., Durban, pp. 477482. 15 Taylor, N., Tanner, K. E., Freeman, M. A. R., and Yettram, A. L., 1995, Cancellous Bone Stresses Surrounding the Femoral Component of a Hip Prosthesis: an ElasticPlastic Finite Element Analysis, Med. Eng. Phys., 79B, pp. 544550. 16 Taylor, M., and Tanner, K. E., 1997, Fatigue Failure of Cancellous Bone: a Possible Cause of Implant Migration and Loosening, J. Bone Jt. Surg., Br. Vol., 79B, pp. 181182. 17 Wolfram, S., 1991, MathematicaA System for Doing Mathematics by Computer, Addison-Wesley Publishing Company, Inc., 2nd ed.

Fig. 5 Phase map of the measured displacement eld

Fig. 6 Comparison between the experimental and numerical displacements

tion. However, at the distal part of the prosthesis where it was rigidly xed, the highest displacement difference was observed, essentially due to the natural experimental perturbing region. The displacement difference near the prosthesis xation device was 400 percent and gradually diminished up to a difference of 2.5 percent at the last observed fringe, which was localized at a distance of 15 mm from the applied load. The higher differences observed at the xation region of the prosthesis may have resulted from a less efcient xation of the prosthesis. In the analytical numerical model, the xation of the prosthesis was considered ideally. We must say that the measuring displacements are of the order of a micron and can easily be inuenced by the experimental setup. The maximum displacement obtained with the ESPI

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