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Spine Implants: Porous Coatings vs. Porous Materials vs. Additive Manufacturing

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Spine implant materials and surface characteristics are popular topics among engineers and surgeons. How do surface technologies relate to spine implants and bone integration and fusion? What are the pros and cons of various materials and surfaces? In this interactive session, members of industry and academia reviewed and presented research related to use of
• porous plasma spray coating,
• porous PEEK, and
• additive manufactured titanium in spinal devices.

Published in: Health & Medicine
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Spine Implants: Porous Coatings vs. Porous Materials vs. Additive Manufacturing

  1. 1. Jason Cianfrani, VP of Product Development Camber Spine and The Institute of Musculoskeletal Science and Education BSME Clemson University Additive Manufactured Titanium Geometric and Surface Design Considerations
  2. 2. Electron Beam Melting • More parts per build, less detail Direct Metal Laser Sintering / Melting • Less parts per build, more detail Additive Manufactured Titanium Types of Manufacturing Osseointegration of Coarse and Fine Textured Implants Manufactured by Electron Beam Melting and Direct Metal Laser Sintering, Ruppert et al. Surface roughness and directional fatigue behavior of as-built EBM and DMLS Ti6Al4V, Nicoletto et al
  3. 3. Open Geometric Matrix – macro pores with optimized surface texture; graft can be packed throughout the cage. SPIRA surface topography is modelled using software, centered around 500 microns. Additive manufacturing advantages as compared to traditional PEEK and machined metal cages: • More boney ongrowth and ingrowth • Maybe faster mechanical fusion? • Bone doesn’t have to grow completely through the implant • Concept of ‘grip growth’ • Better patient outcomes! Pain free faster!! Additive Manufactured Titanium Commercially Available Styles of Implant Geometry CAD input vs machine type vs layer thickness
  4. 4. Additive Manufactured Titanium Commercially Available Styles of Implant Geometry – Design Considerations Easy to Model in CAD IP Risk Utilizes complex additive capabilities Larger Graft Bed - More Graft Fatigue and Impact Strength Micropore Size Control Surface Topography Control Modulus Control Trabecular Matrix Yes Medium Yes No ? Yes No Yes Honeycomb Lattice Structure Yes Low No No ? Yes No No Open Geometric Matrix No High Yes Yes Yes No Yes Yes Optimization
  5. 5. IMSE Studies in Progess: Effects of surface topography on cell characterization and gene expression • Looking at 6 different surface designs Sheep Study – in progress, SPIRA cages vs. PEEK control • Early timepoints – 6 weeks, 12 weeks Additive Manufactured Titanium Active Studies – IMSE with Camber Spine
  6. 6. • Additive manufactured titanium offers a variety of design options to designers and clinicians • Two types of additive manufacturing to choose from depending on design and production requirements • Current IP can be a limitation for new designs • We are in the early days of development and there is significant room for optimization • More studies are required to validate current hypotheses and move implant development to the next level Additive Manufactured Titanium Summary and Conclusions
  7. 7. Thank You
  8. 8. Porous PEEK Ken Gall, PhD Professor and Chair Mechanical Engineering and Materials Science Financial Conflict:
  9. 9. Porous PEEK Interbody Devices For ACDF and TLIF/PLIF Mimics Bone1,2 • Fully interconnected • ~1mm in-growth depth • >60% porosity • 300-400µm pore size Bone Porous PEEK 1Evans NT, Torstrick FB, Lee CSD, et al. High-strength, surface-porous poly-ether-ether-ketone for load-bearing orthopedic implants. Acta Biomater 2015;13:159-67 2Evans NT, Torstrick FB, Safranski DL, et al. Local deformation behavior of surface porous polyether-ether-ketone. J Mech Behav Biomed Mater 2017;65:522-32. Wicking Capability The only interbody Porous PEEK devices to achieve FDA clearance, promote bone in-growth, and maintain mechanical and imaging properties of PEEK.1,2
  10. 10. Investigations into Effect of Topography on PEEK – All Data on Smooth PEEK Smooth PEEK Porous Titanium Smooth PEEK Rough Titanium
  11. 11. 1 cm Implant Side View Top View Surgery 8 weeks0 Timeline Smooth PorousRough µCT (n = 12) Histology (n = 4) Biomechanics (n = 8) PEEKTitanium Surface Topography SurfaceMaterial Nano-scale TiO2 coating • ~30 nm thickness • Atomic Layer Deposition (ALD) • All titanium implants have TiO2 surface Torstrick BF et al. In vivo effect of surface topography and chemistry on PEEK and titanium implant osseointegration. Proc of Ortho Res Soc. 2018. What is more important? Surface architecture or material?
  12. 12. Porous PEEK Osseointegration is Equivalent to Porous Titanium *p < 0.05; ^p < 0.01 versus all smooth and rough groups. (2-Way ANOVA, Tukey, n = 6-8). Mean ± SE. Effect Effect Size (ω2) p-value Topography 65% <0.001 Chemistry 6% <0.01 Interaction 1% 0.17 Smooth Rough Porous 0 20 40 60 PEEK Titanium Force(N) ^ ^ * Pull-out StrengthSmooth PorousRough PEEKTitanium Bone Nuclei Osteoid / Soft tissue Sanderson’s Rapid Bone Stain + Van Gieson Torstrick BF et al. In vivo effect of surface topography and chemistry on PEEK and titanium implant osseointegration. Proc of Ortho Res Soc. 2018.
  13. 13. 1Evans NT, Torstrick FB, Lee CS, et al. High strength surface-porous polyether-ether-ketone for load bearing applications. Acta Biomater 2015;13:159-67. Torstrick FB, Lin ASP, Gall K, et al. Porous PEEK improves the bone-implant interface compared to plasma-sprayed titanium coating in PEEK: in vitro and in vivo analysis. Orthopaedic Research Society (ORS) Annual Meeting; March 2017; San Diego, CA. Rat Femoral Segmental Defect1 Smooth PEEK Porous PEEK Fibrous Tissue Bony In-growth Bone Smooth PEEK Histology at 6 Wks Post-op1 Bone Porous PEEK X-ray at 6 Wks Post-op1 Smooth PEEK Porous PEEK Smooth PEEKPorous PEEK Smooth PEEK Porous PEEK MicroCT at 6 Wks Post-op1 Porous PEEK Promotes Bone In-growth as Strong as Bone
  14. 14. Porous PEEK Promotes Bone In-growth as Strong as Bone 1Evans NT, Torstrick FB, Lee CS, et al. High strength surface-porous polyether-ether-ketone for load bearing applications. Acta Biomater 2015;13:159-67. Torstrick FB, Lin ASP, Gall K, et al. Porous PEEK improves the bone-implant interface compared to plasma-sprayed titanium coating in PEEK: in vitro and in vivo analysis. Orthopaedic Research Society (ORS) Annual Meeting; March 2017; San Diego, CA. Rat Femoral Segmental Defect1 Torsional Strength at 12 Wks Post-op2 X-ray at 6 Wks Post-op1 Smooth PEEK Porous PEEK Smooth PEEKPorous PEEK
  15. 15. Porous PEEK Clinical Study
  16. 16. Porous Titanium Enhanced PEEK Implants In Vitro & In Vivo Biomedical Evaluation 15th Annual OMTEC Conference Byron Masi, PhD: Associate Director R&D, Aesculap June 12, 2019
  17. 17. Confidential and Proprietary http://www.mun.ca/biology/desmid/brian/BIOL2060/CBhome.html Overview Transcription Translation & Phenotype Implant:Tissue Interface Pull-out Strength
  18. 18. Plasmapore® XP Marriage of PEEK material properties, radiolucency & titanium osseointegration PEEK Optima® Provides device structure, appropriate elastic modulus and radiolucency PVD Titanium 3-5 µm Adhesion layer to facilitate bonding of VPS Titanium to PEEK VPS Titanium 60-150 µm Porous osseoconductive substrate Plasmapore ® XP : PEEK interbody devices coated with a composite Titanium layer
  19. 19. Surface Characterization Plasmapore ® XP presents complex nano & micro features 60 to 150 µm; determined by cross-sectional imaging at 50xThickness 35 to 60% & 25 to 150 µm; determined by cross-sectional imaging at 50x Porosity 22.94 µm with a Standard Deviation of 0.98 µmRa 136.49 µm with a Standard Deviation of 6.25 µmRz
  20. 20. Cell & Biochemical Evaluation Plasmapore ® XP enables cell adhesion, differentiation & improved osteogenic expression Adhesion Proliferation Differentiation TCP PEEK Plasmapore ® XP MG-63 Cytometry RT-qPCR BMP ELISA ALP Assay
  21. 21. Implant:Tissue Interface Biochemical & cellular activity result in improved new bone formation & apposition PEEK Plasmapore® XP H&E Straining Inflammation New Bone Fibrosis Bony Apposition
  22. 22. Ex Vivo Pull Out Strength Evaluation Plasmapore XP demonstrates significantly improved fixation at 12 & 24 weeks PEEK Plasmapore® XP
  23. 23. Summary Plasmapore® XP enables osseointegration behavior from biochemical to tissue processes Plasmapore XP drives increase in markers for osteogenic differentiation in vitro Plasmapore XP increases expression of osteogenic growth factors in vitro Plasmapore XP increases new bone growth and apposition in vivo Plasmapore XP significantly increases fixation strength ex vivo

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