Preclinical Testing of a Novel, Additive-Manufactured, Three-Dimensional Porous Titanium Structure

When considering orthopedic implants for bone growth, several factors such as porosity, pore size, stiffness, friction, and strength can affect bone growth and contribute to the long-term success of the implant. Additive manufacturing is one tool to help achieve the ideal factors for implant structu...

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Published inStructural Integrity of Additive Manufactured Materials and Parts pp. 322 - 339
Main Authors Woodard, Erik, Post, Zach, Morrison, Mark
Format Book Chapter
LanguageEnglish
Published 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959 ASTM International 01.09.2020
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ISBN9780803177086
0803177089
DOI10.1520/STP163120190139

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Abstract When considering orthopedic implants for bone growth, several factors such as porosity, pore size, stiffness, friction, and strength can affect bone growth and contribute to the long-term success of the implant. Additive manufacturing is one tool to help achieve the ideal factors for implant structures and materials. Smith+Nephew has developed an additive manufactured (AM), Ti-6Al-4V advanced porous structure designed to be similar to cancellous bone with up to 80% porosity. This structure is currently used as part of both acetabular shells and augments. This paper describes the preclinical testing of this advanced porous structure that comprised coupon-level and device-level testing. The critical parameters that can influence bone ingrowth, such as pore size (mean void intercept length, or MVIL) and porosity, were measured. The ability of the three-dimensional porous structure to withstand compressive, tensile, and shear forces was evaluated in static (monotonic) testing. Finally, bone ingrowth was assessed in a load-bearing ovine model. Clinically relevant device-level fatigue testing was conducted in foam blocks with a cavity and adjacent rim defect to simulate the acetabulum. The strength of the locking screw hole features was assessed using static and fatigue cantilever bending and pull-through strength. Acetabular constructs were also fatigue tested in an unsupported model with an adjacent augment and corresponding defect. Constructs completed all clinically relevant fatigue testing with no fractures.
AbstractList When considering orthopedic implants for bone growth, several factors such as porosity, pore size, stiffness, friction, and strength can affect bone growth and contribute to the long-term success of the implant. Additive manufacturing is one tool to help achieve the ideal factors for implant structures and materials. Smith+Nephew has developed an additive manufactured (AM), Ti-6Al-4V advanced porous structure designed to be similar to cancellous bone with up to 80% porosity. This structure is currently used as part of both acetabular shells and augments. This paper describes the preclinical testing of this advanced porous structure that comprised coupon-level and device-level testing. The critical parameters that can influence bone ingrowth, such as pore size (mean void intercept length, or MVIL) and porosity, were measured. The ability of the three-dimensional porous structure to withstand compressive, tensile, and shear forces was evaluated in static (monotonic) testing. Finally, bone ingrowth was assessed in a load-bearing ovine model. Clinically relevant device-level fatigue testing was conducted in foam blocks with a cavity and adjacent rim defect to simulate the acetabulum. The strength of the locking screw hole features was assessed using static and fatigue cantilever bending and pull-through strength. Acetabular constructs were also fatigue tested in an unsupported model with an adjacent augment and corresponding defect. Constructs completed all clinically relevant fatigue testing with no fractures.
Author Post, Zach
Woodard, Erik
Morrison, Mark
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2020
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References KarageorgiouV. and KaplanD. , “Porosity of 3D Biomaterial Scaffolds and Osteogenesis,” Biomaterials 26, no. 27 (2005): 5474–5491.
Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings, ASTM F1147-05(2017)e1 (West Conshohocken, PA: ASTM International, approved May 1, 2017), https://doi.org/10.1520/F1147-05R17E01
Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings, ASTM F1160-14(2017)e1 (West Conshohocken, PA: ASTM International, approved December 1, 2017), https://doi.org/10.1520/F1160-14R17E01
KeavenyT. M. , WachtelE. F. , FordC. M. , and HayesW. C. , “Differences between the Tensile and Compressive Strengths of Bovine Tibial Trabecular Bone Depend on Modulus,” Journal of Biomechanics 27, no. 9 (1994): 1137–1146.
AdlerE. , StuchinS. A. , and KummerF. J. , “Stability of Press-Fit Acetabular Cups,” The Journal of Arthroplasty 7, no. 3 (1992): 295–301.
Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings, ASTM F1044-05(2017)e1 (West Conshohocken, PA: ASTM International, approved December 1, 2017), https://doi.org/10.1520/F1044-05R17E01
HayesW. C. and BouxseinM. L. , “Biomechanics of Cortical and Trabecular Bone: Implications for Assessment of Fracture Risk,” in Basic Orthopaedic Biomechanics, ed. MowV. C. and HayesW. C. (Philadelphia, PA: Lippincott-Raven Publishers, 1997), 69–112.
BobynJ. D. , PilliarR. M. , CameronH. U. and WeatherlyG. C. , “The Optimum Pore Size for the Fixation of Porous-Surfaced Metal Implants by the Ingrowth of Bone,” Clinical Orthopaedics and Related Research 150 (1980):263–270.
BobynJ. D. , PilliarR. M. , CameronH. U. , and WeatherlyG. C. , “The Optimum Pore Size for the Fixation of Porous-Surfaced Metal Implants by the Ingrowth of Bone,” Clinical Orthopaedics and Related Research 150 (1980): 263–270.
WrightJ. M. , PellicciP. M. , SalvatiE. A. , GhelmanB. , RobertsM. M. , and KohJ. L. , “Bone Density Adjacent to Press-Fit Acetabular Components: A Prospective Analysis with Quantitative Computed Tomography,” The Journal of Bone and Joint Surgery 83, no. 4 (2001): 529–536.
BrandlE. , LeyensC. , and PalmF. , “Mechanical Properties of Additive Manufactured Ti-6Al-4V Using Wire and Powder Based Processes,” IOP Conference Series: Materials Science and Engineering 26, no. 1 (2011), https://doi.org/10.1088/1757-899X/26/1/012004
RøhlL. , LarsenE. , LindeF. , OdgaardA. , and JørgensenJ. , “Tensile and Compressive Properties of Cancellous Bone,” Journal of Biomechanics 24, no. 12 (1991): 1143–1149.
JastyM. , BragdonC. , BurkeD. , O'ConnorD. , LowensteinJ. , and HarrisW. H. , “In Vivo Skeletal Responses to Porous-Surfaced Implants Subjected to Small Induced Motions,” The Journal of Bone and Joint Surgery 79, no. 5 (1997): 707–714.
Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants, ASTM F1854-15 (West Conshohocken, PA: ASTM International, approved March 15, 2015), https://doi.org/10.1520/F1854-15
GibsonL. J. and AshbyM. F. , Cellular Solids: Structure and Properties (Cambridge, MA: Cambridge University Press, 1997).
FenwickS. , WilsonD. , WilliamsM. , PenmetsaJ. , EllisK. , SmithM. , DoddJ. , PitcherJ. , and ScottM. , “A Load Bearing Model to Assess Osseointegration of Novel Surfaces—A Pilot Study,” in Proceedings of the Eighth World Biomaterials Congress (Red Hook, NY: Curran Associates, 2008), 1240.
HedayatiR. , Hosseini-ToudeshkyH. , SadighiM. , Mohammadi-AghdamM. , and ZadpoorA. A. , “Computational Prediction of the Fatigue Behavior of Additively Manufactured Porous Metallic Biomaterials,” International Journal of Fatigue 84 (2016): 67–79.
WirtzD. C. , SchiffersN. , PandorfT. , RadermacherK. , WeichertD. , and ForstR. , “Critical Evaluation of Known Bone Material Properties to Realize Anisotropic FE-Simulation of the Proximal Femur,” Journal of Biomechanics 33, no. 10 (2000): 1325–1330.
FrostH. M. , “Wolff's Law and Bone's Structural Adaptations to Mechanical Usage: An Overview for Clinicians,” The Angle Orthodontist 64, no. 3 (1994): 175–188.
Standard Specification for Femoral Prostheses—Metallic Implants, ASTM F2068-15 (West Conshohocken, PA: ASTM International, approved March 15, 2015), https://doi.org/10.1520/F2068-15
PaproskyW. G. , PeronaP. G. , and LawrenceJ. M. , “Acetabular Defect Classification and Surgical Reconstruction in Revision Arthroplasty: A 6-Year Follow-Up Evaluation,” The Journal of Arthroplasty 9, no. 1 (1994): 33–44.
ZargarianA. , EsfahanianM. , KadkhodapourJ. , and Ziaei-RadS. , “Numerical Simulation of the Fatigue Behavior of Additive Manufactured Titanium Porous Lattice Structures,” Materials Science and Engineering: C 60 (2016): 339–347.
MorganE. F. and KeavenyT. M. , “Dependence of Yield Strain of Human Trabecular Bone on Anatomic Site,” Journal of Biomechanics 34, no. 5 (2001): 569–577.
References_xml – reference: JastyM. , BragdonC. , BurkeD. , O'ConnorD. , LowensteinJ. , and HarrisW. H. , “In Vivo Skeletal Responses to Porous-Surfaced Implants Subjected to Small Induced Motions,” The Journal of Bone and Joint Surgery 79, no. 5 (1997): 707–714.
– reference: FrostH. M. , “Wolff's Law and Bone's Structural Adaptations to Mechanical Usage: An Overview for Clinicians,” The Angle Orthodontist 64, no. 3 (1994): 175–188.
– reference: GibsonL. J. and AshbyM. F. , Cellular Solids: Structure and Properties (Cambridge, MA: Cambridge University Press, 1997).
– reference: Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings, ASTM F1160-14(2017)e1 (West Conshohocken, PA: ASTM International, approved December 1, 2017), https://doi.org/10.1520/F1160-14R17E01
– reference: BobynJ. D. , PilliarR. M. , CameronH. U. and WeatherlyG. C. , “The Optimum Pore Size for the Fixation of Porous-Surfaced Metal Implants by the Ingrowth of Bone,” Clinical Orthopaedics and Related Research 150 (1980):263–270.
– reference: Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings, ASTM F1147-05(2017)e1 (West Conshohocken, PA: ASTM International, approved May 1, 2017), https://doi.org/10.1520/F1147-05R17E01
– reference: KeavenyT. M. , WachtelE. F. , FordC. M. , and HayesW. C. , “Differences between the Tensile and Compressive Strengths of Bovine Tibial Trabecular Bone Depend on Modulus,” Journal of Biomechanics 27, no. 9 (1994): 1137–1146.
– reference: Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants, ASTM F1854-15 (West Conshohocken, PA: ASTM International, approved March 15, 2015), https://doi.org/10.1520/F1854-15
– reference: Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings, ASTM F1044-05(2017)e1 (West Conshohocken, PA: ASTM International, approved December 1, 2017), https://doi.org/10.1520/F1044-05R17E01
– reference: HayesW. C. and BouxseinM. L. , “Biomechanics of Cortical and Trabecular Bone: Implications for Assessment of Fracture Risk,” in Basic Orthopaedic Biomechanics, ed. MowV. C. and HayesW. C. (Philadelphia, PA: Lippincott-Raven Publishers, 1997), 69–112.
– reference: WrightJ. M. , PellicciP. M. , SalvatiE. A. , GhelmanB. , RobertsM. M. , and KohJ. L. , “Bone Density Adjacent to Press-Fit Acetabular Components: A Prospective Analysis with Quantitative Computed Tomography,” The Journal of Bone and Joint Surgery 83, no. 4 (2001): 529–536.
– reference: WirtzD. C. , SchiffersN. , PandorfT. , RadermacherK. , WeichertD. , and ForstR. , “Critical Evaluation of Known Bone Material Properties to Realize Anisotropic FE-Simulation of the Proximal Femur,” Journal of Biomechanics 33, no. 10 (2000): 1325–1330.
– reference: BobynJ. D. , PilliarR. M. , CameronH. U. , and WeatherlyG. C. , “The Optimum Pore Size for the Fixation of Porous-Surfaced Metal Implants by the Ingrowth of Bone,” Clinical Orthopaedics and Related Research 150 (1980): 263–270.
– reference: MorganE. F. and KeavenyT. M. , “Dependence of Yield Strain of Human Trabecular Bone on Anatomic Site,” Journal of Biomechanics 34, no. 5 (2001): 569–577.
– reference: AdlerE. , StuchinS. A. , and KummerF. J. , “Stability of Press-Fit Acetabular Cups,” The Journal of Arthroplasty 7, no. 3 (1992): 295–301.
– reference: PaproskyW. G. , PeronaP. G. , and LawrenceJ. M. , “Acetabular Defect Classification and Surgical Reconstruction in Revision Arthroplasty: A 6-Year Follow-Up Evaluation,” The Journal of Arthroplasty 9, no. 1 (1994): 33–44.
– reference: KarageorgiouV. and KaplanD. , “Porosity of 3D Biomaterial Scaffolds and Osteogenesis,” Biomaterials 26, no. 27 (2005): 5474–5491.
– reference: FenwickS. , WilsonD. , WilliamsM. , PenmetsaJ. , EllisK. , SmithM. , DoddJ. , PitcherJ. , and ScottM. , “A Load Bearing Model to Assess Osseointegration of Novel Surfaces—A Pilot Study,” in Proceedings of the Eighth World Biomaterials Congress (Red Hook, NY: Curran Associates, 2008), 1240.
– reference: BrandlE. , LeyensC. , and PalmF. , “Mechanical Properties of Additive Manufactured Ti-6Al-4V Using Wire and Powder Based Processes,” IOP Conference Series: Materials Science and Engineering 26, no. 1 (2011), https://doi.org/10.1088/1757-899X/26/1/012004
– reference: RøhlL. , LarsenE. , LindeF. , OdgaardA. , and JørgensenJ. , “Tensile and Compressive Properties of Cancellous Bone,” Journal of Biomechanics 24, no. 12 (1991): 1143–1149.
– reference: ZargarianA. , EsfahanianM. , KadkhodapourJ. , and Ziaei-RadS. , “Numerical Simulation of the Fatigue Behavior of Additive Manufactured Titanium Porous Lattice Structures,” Materials Science and Engineering: C 60 (2016): 339–347.
– reference: Standard Specification for Femoral Prostheses—Metallic Implants, ASTM F2068-15 (West Conshohocken, PA: ASTM International, approved March 15, 2015), https://doi.org/10.1520/F2068-15
– reference: HedayatiR. , Hosseini-ToudeshkyH. , SadighiM. , Mohammadi-AghdamM. , and ZadpoorA. A. , “Computational Prediction of the Fatigue Behavior of Additively Manufactured Porous Metallic Biomaterials,” International Journal of Fatigue 84 (2016): 67–79.
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Snippet When considering orthopedic implants for bone growth, several factors such as porosity, pore size, stiffness, friction, and strength can affect bone growth and...
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StartPage 322
SubjectTerms Laser Powder Bed Fusion
Manufacturing Engineering
Materials & Manufacturing Processes
Orthopedic Implants
Porous Structure
TableOfContents 22.1 Introduction 22.2 Material and Methods 22.3 Results 22.4 Discussion References
Title Preclinical Testing of a Novel, Additive-Manufactured, Three-Dimensional Porous Titanium Structure
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