Stepwise Validated Finite Element Model of the Human Lumbar Spine

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1 Stepwise Validated Finite Element Model of the Human Lumbar Spine Simulia Community Conference - May, 2012 Dana Coombs*, Michael Bushelow*, Peter Laz, Milind Rao, Sean Smith, and Paul Rullkoetter *Synthes Spine, West Chester, PA University of Denver, Denver, CO

2 Need for Spine Biomechanics Evaluate Implant Designs Test Intact and Compare to Devices Typical Measures Kinematics Torque vs. Rotation Disc Pressure Facet Forces Etc Challenges Cadaveric Tissue is Costly Time Consuming Variability in Tissue and Implantation Impossible or Difficult Measures

3 Lumbar Spine FEA Model Benefits Eliminate variability of cadaver tissue Measures that are not possible with cadaver tissue Bone Screw Interface Stress/Strain Anywhere in Model Contact Force Etc Fast Design Comparisons Fast Design Improvements Visualization

4 Need for Validation? = Does FE model match cadaveric model? Many models have been validated with in vitro data from literature However, no prior FE models have been created using patient-specific in vitro data involving a stepwise addition of structures

5 Spine Biomechanics Study Two lumbar spine specimens (A) Healthy (B) Mild to moderate degeneration Fiducial Markers to register motion to segmented geometry

6 Spine Biomechanics Study Multi-Segmental Protocol (L1 through L5) Fiducial markers digitized Disc pressure measured with needle transducers Kinematic motion capture (Vicon Motion Systems) Test Number Test Description Loads 1 FE +/- 10Nm 2 LB +/- 10Nm 3 AR +/- 10Nm 4 FE + Right LB +/- 7Nm FE +/- 7Nm LB 5 FE + Left LB +/- 7Nm FE +/- 7Nm LB 6 FE + AR +/- 7Nm FE +/- 7Nm LB 7 LB + AR +/- 7Nm FE +/- 7Nm AR 8 FE with 450N Preload +/- 10Nm 9 FE +/- 10Nm

7 Spine Biomechanics Study Multi-Segmental Protocol (L1 through L5)

8 Spine Biomechanics Study FSU Protocol (L2/L3 and L4/L5) Condition Test Description Tests Performed 1 FCL, LFL, ITL, ALL, PLL, ISL, SSL (Intact) FE, LB, AR (+/- 10Nm) 2 FCL, LFL, ITL, ALL, PLL, ISL (Remove SSL) FE, AR (hybrid to intact angle) 3 FCL, LFL, ITL, ALL, PLL (Remove ISL) FE, AR (hybrid to intact angle) 4 FCL, LFL, ITL, ALL (Remove PLL) FE, AR (hybrid to intact angle) 5 FCL, LFL, ITL (Remove ALL) FE, AR (hybrid to intact angle) 6 FCL, LFL (Remove ITL) FE, LB, AR (hybrid to intact angle) 7 FCL (Remove LFL) FE, LB, AR (hybrid to intact angle) 8 Facet Cartilages (Remove FCL) FE, LB, AR (hybrid to intact angle) 9 Disc Only (Remove Facets) FE, LB, AR (hybrid to intact angle) 10 Disc Only (Remove Facets) Axial Compression 1000 to 1500N

9 Spine Biomechanics Study FSU Protocol (L2/L3 and L4/L5) Condition Test Description Tests Performed 1 FCL, LFL, ITL, ALL, PLL, ISL, SSL (Intact) FE, LB, AR (+/- 10Nm) 2 FCL, LFL, ITL, ALL, PLL, ISL (Remove SSL) FE, AR (hybrid to intact angle) 3 FCL, LFL, ITL, ALL, PLL (Remove ISL) FE, AR (hybrid to intact angle) 4 FCL, LFL, ITL, ALL (Remove PLL) FE, AR (hybrid to intact angle) 5 FCL, LFL, ITL (Remove ALL) FE, AR (hybrid to intact angle) 6 FCL, LFL (Remove ITL) FE, LB, AR (hybrid to intact angle) 7 FCL (Remove LFL) FE, LB, AR (hybrid to intact angle) 8 Facet Cartilages (Remove FCL) FE, LB, AR (hybrid to intact angle) 9 Disc Only (Remove Facets) FE, LB, AR (hybrid to intact angle) 10 Disc Only (Remove Facets) Axial Compression 1000 to 1500N

10 Spine Biomechanics Study FSU Protocol (L2/L3 and L4/L5) Condition Test Description Tests Performed 1 FCL, LFL, ITL, ALL, PLL, ISL, SSL (Intact) FE, LB, AR (+/- 10Nm) 2 FCL, LFL, ITL, ALL, PLL, ISL (Remove SSL) FE, AR (hybrid to intact angle) 3 FCL, LFL, ITL, ALL, PLL (Remove ISL) FE, AR (hybrid to intact angle) 4 FCL, LFL, ITL, ALL (Remove PLL) FE, AR (hybrid to intact angle) 5 FCL, LFL, ITL (Remove ALL) FE, AR (hybrid to intact angle) 6 FCL, LFL (Remove ITL) FE, LB, AR (hybrid to intact angle) 7 FCL (Remove LFL) FE, LB, AR (hybrid to intact angle) 8 Facet Cartilages (Remove FCL) FE, LB, AR (hybrid to intact angle) 9 Disc Only (Remove Facets) FE, LB, AR (hybrid to intact angle) 10 Disc Only (Remove Facets) Axial Compression 1000 to 1500N

11 Spine Biomechanics Study FSU Protocol (L2/L3 and L4/L5) Condition Test Description Tests Performed 1 FCL, LFL, ITL, ALL, PLL, ISL, SSL (Intact) FE, LB, AR (+/- 10Nm) 2 FCL, LFL, ITL, ALL, PLL, ISL (Remove SSL) FE, AR (hybrid to intact angle) 3 FCL, LFL, ITL, ALL, PLL (Remove ISL) FE, AR (hybrid to intact angle) 4 FCL, LFL, ITL, ALL (Remove PLL) FE, AR (hybrid to intact angle) 5 FCL, LFL, ITL (Remove ALL) FE, AR (hybrid to intact angle) 6 FCL, LFL (Remove ITL) FE, LB, AR (hybrid to intact angle) 7 FCL (Remove LFL) FE, LB, AR (hybrid to intact angle) 8 Facet Cartilages (Remove FCL) FE, LB, AR (hybrid to intact angle) 9 Disc Only (Remove Facets) FE, LB, AR (hybrid to intact angle) 10 Disc Only (Remove Facets) Axial Compression 1000 to 1500N

12 Spine Biomechanics Study FSU Protocol (L2/L3 and L4/L5) Condition Test Description Tests Performed 1 FCL, LFL, ITL, ALL, PLL, ISL, SSL (Intact) FE, LB, AR (+/- 10Nm) 2 FCL, LFL, ITL, ALL, PLL, ISL (Remove SSL) FE, AR (hybrid to intact angle) 3 FCL, LFL, ITL, ALL, PLL (Remove ISL) FE, AR (hybrid to intact angle) 4 FCL, LFL, ITL, ALL (Remove PLL) FE, AR (hybrid to intact angle) 5 FCL, LFL, ITL (Remove ALL) FE, AR (hybrid to intact angle) 6 FCL, LFL (Remove ITL) FE, LB, AR (hybrid to intact angle) 7 FCL (Remove LFL) FE, LB, AR (hybrid to intact angle) 8 Facet Cartilages (Remove FCL) FE, LB, AR (hybrid to intact angle) 9 Disc Only (Remove Facets) FE, LB, AR (hybrid to intact angle) 10 Disc Only (Remove Facets) Axial Compression 1000 to 1500N

13 Spine Biomechanics Study FSU Protocol (L2/L3 and L4/L5) Condition Test Description Tests Performed 1 FCL, LFL, ITL, ALL, PLL, ISL, SSL (Intact) FE, LB, AR (+/- 10Nm) 2 FCL, LFL, ITL, ALL, PLL, ISL (Remove SSL) FE, AR (hybrid to intact angle) 3 FCL, LFL, ITL, ALL, PLL (Remove ISL) FE, AR (hybrid to intact angle) 4 FCL, LFL, ITL, ALL (Remove PLL) FE, AR (hybrid to intact angle) 5 FCL, LFL, ITL (Remove ALL) FE, AR (hybrid to intact angle) 6 FCL, LFL (Remove ITL) FE, LB, AR (hybrid to intact angle) 7 FCL (Remove LFL) FE, LB, AR (hybrid to intact angle) 8 Facet Cartilages (Remove FCL) FE, LB, AR (hybrid to intact angle) 9 Disc Only (Remove Facets) FE, LB, AR (hybrid to intact angle) 10 Disc Only (Remove Facets) Axial Compression 1000 to 1500N

14 Spine Biomechanics Study FSU Protocol (L2/L3 and L4/L5) Condition Test Description Tests Performed 1 FCL, LFL, ITL, ALL, PLL, ISL, SSL (Intact) FE, LB, AR (+/- 10Nm) 2 FCL, LFL, ITL, ALL, PLL, ISL (Remove SSL) FE, AR (hybrid to intact angle) 3 FCL, LFL, ITL, ALL, PLL (Remove ISL) FE, AR (hybrid to intact angle) 4 FCL, LFL, ITL, ALL (Remove PLL) FE, AR (hybrid to intact angle) 5 FCL, LFL, ITL (Remove ALL) FE, AR (hybrid to intact angle) 6 FCL, LFL (Remove ITL) FE, LB, AR (hybrid to intact angle) 7 FCL (Remove LFL) FE, LB, AR (hybrid to intact angle) 8 Facet Cartilages (Remove FCL) FE, LB, AR (hybrid to intact angle) 9 Disc Only (Remove Facets) FE, LB, AR (hybrid to intact angle) 10 Disc Only (Remove Facets) Axial Compression 1000 to 1500N

15 Spine Biomechanics Study FSU Protocol (L2/L3 and L4/L5) Condition Test Description Tests Performed 1 FCL, LFL, ITL, ALL, PLL, ISL, SSL (Intact) FE, LB, AR (+/- 10Nm) 2 FCL, LFL, ITL, ALL, PLL, ISL (Remove SSL) FE, AR (hybrid to intact angle) 3 FCL, LFL, ITL, ALL, PLL (Remove ISL) FE, AR (hybrid to intact angle) 4 FCL, LFL, ITL, ALL (Remove PLL) FE, AR (hybrid to intact angle) 5 FCL, LFL, ITL (Remove ALL) FE, AR (hybrid to intact angle) 6 FCL, LFL (Remove ITL) FE, LB, AR (hybrid to intact angle) 7 FCL (Remove LFL) FE, LB, AR (hybrid to intact angle) 8 Facet Cartilages (Remove FCL) FE, LB, AR (hybrid to intact angle) 9 Disc Only (Remove Facets) FE, LB, AR (hybrid to intact angle) 10 Disc Only (Remove Facets) Axial Compression 1000 to 1500N

16 Spine Biomechanics Study FSU Protocol (L2/L3 and L4/L5) Condition Test Description Tests Performed 1 FCL, LFL, ITL, ALL, PLL, ISL, SSL (Intact) FE, LB, AR (+/- 10Nm) 2 FCL, LFL, ITL, ALL, PLL, ISL (Remove SSL) FE, AR (hybrid to intact angle) 3 FCL, LFL, ITL, ALL, PLL (Remove ISL) FE, AR (hybrid to intact angle) 4 FCL, LFL, ITL, ALL (Remove PLL) FE, AR (hybrid to intact angle) 5 FCL, LFL, ITL (Remove ALL) FE, AR (hybrid to intact angle) 6 FCL, LFL (Remove ITL) FE, LB, AR (hybrid to intact angle) 7 FCL (Remove LFL) FE, LB, AR (hybrid to intact angle) 8 Facet Cartilages (Remove FCL) FE, LB, AR (hybrid to intact angle) 9 Disc Only (Remove Facets) FE, LB, AR (hybrid to intact angle) 10 Disc Only (Remove Facets) Axial Compression 1000 to 1500N

17 Spine Biomechanics Study FSU Protocol (L2/L3 and L4/L5) Condition Test Description Tests Performed 1 FCL, LFL, ITL, ALL, PLL, ISL, SSL (Intact) FE, LB, AR (+/- 10Nm) 2 FCL, LFL, ITL, ALL, PLL, ISL (Remove SSL) FE, AR (hybrid to intact angle) 3 FCL, LFL, ITL, ALL, PLL (Remove ISL) FE, AR (hybrid to intact angle) 4 FCL, LFL, ITL, ALL (Remove PLL) FE, AR (hybrid to intact angle) 5 FCL, LFL, ITL (Remove ALL) FE, AR (hybrid to intact angle) 6 FCL, LFL (Remove ITL) FE, LB, AR (hybrid to intact angle) 7 FCL (Remove LFL) FE, LB, AR (hybrid to intact angle) 8 Facet Cartilages (Remove FCL) FE, LB, AR (hybrid to intact angle) 9 Disc Only (Remove Facets) FE, LB, AR (hybrid to intact angle) 10 Disc Only (Remove Facets) Axial Compression 1000 to 1500N

18 Current Simulation Workflow CT scan BoneMat Input: cct, inp Scan IP Input: dicom Output: STL Hypermesh Input: STL Output: inp Abaqus/Explicit Solver Input:.inp Output: odb CAD Implant Input: igs Python Custom Scripts Input: odb Output: txt, xls Abaqus Viewer Input: odb Output: txt, bmp, xls, avi

19 Current Simulation Workflow CT scan BoneMat Input: cct, inp Scan IP Input: dicom Output: STL Hypermesh Input: STL Output: inp Abaqus/Explicit Solver Input: STL Output: odb CAD Implant Input: igs Python Custom Scripts Input: odb Output: txt, xls Abaqus CAE/Post Input: odb Output: txt, bmp, xls, avi

20 Current Simulation Workflow CT scan BoneMat Input: cct, inp Scan IP Input: dicom Output: STL Hypermesh Input: STL Output: inp Abaqus/Explicit Solver Input: STL Output: odb CAD Implant Input: igs Python Custom Scripts Input: odb Output: txt, xls Abaqus CAE/Post Input: odb Output: txt, bmp, xls, avi

21 Current Simulation Workflow CT scan BoneMat Input: cct, inp Scan IP Input: dicom Output: STL Hypermesh Input: STL Output: inp Abaqus/Explicit Solver Input: STL Output: odb CAD Implant Input: igs Python Custom Scripts Input: odb Output: txt, xls Abaqus CAE/Post Input: odb Output: txt, bmp, xls, avi Non Homogeneous Bone Material Properties Bonemat: CT Hounsfeld unit Density of BoneMaterial Property of Bone

22 Force (N) Non Linear Ligaments ALL Tensile Properties ITL Displacement (mm) FCL SSL ISL PLL ALL Axial Connectors (CONN3D2): Non-linear Force Displacement Curve

23 Disc Model Annulus Fibrosus: Anisotropic Hyperelastic Holzapfel Model Fibers at 30 and 150 to Horizontal 4 Quadrants Nucleus Pulposus: Fluid Cavity Left Lateral Posterior Anterior Right Lateral

24 Disc and Model Annulus Fobrosus: Initial material constants C10, D, K1, K2 and kappa were optimized based on the uniaxial experimental data Reference Length [mm] Width [mm] Thickness [mm] Ebara et al., Guerin et al., ± ± ± 0.38 Holzapfel et al., ± ± ± 0.06 Wagner et al.,

25 Facet Model Facet: Rigid Hexahedral Mesh Movable for Optimization 3 Translations DOF 3 Rotation DOF

26 Optimization Data Matching Addition of Structures FSU first, then multi segmental Reverse order from Testing Condition Test Description Tests performed 1 Disc only FE, LB, AR (hybrid to intact ang. disp.) 2 Add facet cartilages FE, LB, AR (hybrid to intact ang. disp.) 3 Add FCL and LFL LB, LB, AR (hybrid to intact ang. disp.) 4 Add FCL, LFL, and ITL FE, AR (hybrid to intact ang. disp.) 5 Add FCL, LFL, ITL, and ALL FE, AR (hybrid to intact ang. disp.) 6 Add FCL, LFL, ITL, ALL, and PLL FE, AR (hybrid to intact ang. disp.) 7 Add FCL, LFL, ITL, ALL, PLL, and ISL FE, AR (hybrid to intact ang. disp.) 8 Add FCL, LFL, ITL, ALL, PLL, ISL, and SSL FE, AR (hybrid to intact ang. disp.) 9 Intact FE, LB, AR (± 10Nm)

27 Optimization Data Matching Isight Workflow Displacement controlled analysis on fiducial markers Output requested: Reaction Moment (RM) Data matching: Model RM vs. Experimental Moment Compute Root Mean Square Error (RMSE) in Data Matching component Optimization component Adaptive simulated annealing optimization Objective function is to minimize RMSE Perturb optimization parameters between upper and lower bounds

28 Optimization Data Matching Isight Workflow Option to weight error

29 Optimization Data Matching Isight Workflow Optimization Parameters Disc only setup: + 5 parameters (C10, D, K1, K1, and Kappa) x 4 quadrants Disc + Facets setup: Disc parameters optimized values retained + 2 parameters (rigid facet pressure-overclosure value) + 3 parameters (translations of facet cartilage) x 2 facets + 3 parameters (rotations of facet cartilage) x 2 facets Disc + Facets + Ligaments setup: Disc + Facet parameters optimized values retained + 1 parameter (ligament stiffness) x 7 ligaments (-1 for ITL) Total

30 Optimization Results FSU Disc Only Results Compression Only

31 Optimization Results FSU Disc Only Results Spine B - FE, LB, AR

32 Optimization Results FSU Disc + Facets Results Spine B - FE, LB, AR

33 Optimization Results FSU Disc + Facets + Ligaments Results Spine B - FE, AR

34 Optimization Results FSU Torque Rotation Results Spine B

35 Optimization Results FSU ICR Results Spine B L4 L4 E D A B C E B D A C L5 L5 FLEXION Spine B A=disc only B=disc and facet cartilages only C=intact FSU without SSL, ISL and PLL D=intact FSU without SSL and ISL E=intact FSU. EXTENSION Spine B

36 Torque [N-m] Torque [N-m] Torque [N-m] Torque [N-m] Optimization Results Multi-Segmental Missing levels used adjacent levels as initial parameter values for optimization Extension EXPERIMENT FE MODEL L1L2 L1-L2 Flexion-Extension w/follower Load Extension -4 L2-L3 L2L3 Flexion-Extension -6 w/ Follower Load Rotation [Deg] Flexion Flexion Extension EXPERIMENT FE MODEL L3-L4 L3L4 Flexion-Extension w/ Follower Load Extension Rotation [Deg] Flexion Flexion L4L5 L4-L5 Flexion-Extension w/ Follower Load

37 Surrogate Spine Model Disc Defined as Ball in Socket with 6DOF Non-Linear Springs Center Located at ICR Based on Fully Deformable Spine Computation with One Deformable Disc < 15% Computation with No Deformable Disc < 1% = Instant centers Fully Deformable Surrogate Spine

38 Typical Results Biomechanics Range of Motion Center of Rotation Annulus Strain Disc Pressure Facet Contact Force Etc Device Stress / Strain Design Optimization Placement / Planning Etc

39 Discussion and Conclusions Validation The purpose of this study was to create validated FE models of the human lumbosacral spine (FSU and multisegmental) using in vitro subject-specific scan and experimental testing data. Patient-specific FE model validation provides improved realism over validation to literature data by considering subject-specific anatomical representations and mechanical behavior. This study utilized a rigorous stepwise structure addition process and applied optimization at each step to match model response to the experimental protocol

40 Discussion and Conclusions Simulation Model: Eliminates Time, Cost, Variability, and Biohazards Create Difficult or Impossible Measures Predict Biomechanics Behavior Predict Implant Performance Large Impact as a Design Tool for Orthopedic Implants to Optimize Designs and Reduce Prototypes and Tests

41 Discussion and Conclusions

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