Additively manufactured porous tantalum implants.

The medical device industry's interest in open porous, metallic biomaterials has increased in response to additive manufacturing techniques enabling the production of complex shapes that cannot be produced with conventional techniques. Tantalum is an important metal for medical devices because of its good biocompatibility. In this study selective laser melting technology was used for the first time to manufacture highly porous pure tantalum implants with fully interconnected open pores. The architecture of the porous structure in combination with the material properties of tantalum result in mechanical properties close to those of human bone and allow for bone ingrowth. The bone regeneration performance of the porous tantalum was evaluated in vivo using an orthotopic load-bearing bone defect model in the rat femur. After 12 weeks, substantial bone ingrowth, good quality of the regenerated bone and a strong, functional implant-bone interface connection were observed. Compared to identical porous Ti-6Al-4V structures, laser-melted tantalum shows excellent osteoconductive properties, has a higher normalized fatigue strength and allows for more plastic deformation due to its high ductility. It is therefore concluded that this is a first step towards a new generation of open porous tantalum implants manufactured using selective laser melting.

[1]  M. Fernández-Fairen,et al.  Anterior Cervical Fusion With Tantalum Implant: A Prospective Randomized Controlled Study , 2008, Spine.

[2]  G. Gronowicz,et al.  Porous tantalum stimulates the proliferation and osteogenesis of osteoblasts from elderly female patients , 2011, Journal of orthopaedic research : official publication of the Orthopaedic Research Society.

[3]  J Kenwright,et al.  The influence of induced micromovement upon the healing of experimental tibial fractures. , 1985, The Journal of bone and joint surgery. British volume.

[4]  J. Dawson,et al.  Host Bone Response to Polyetheretherketone Versus Porous Tantalum Implants for Cervical Spinal Fusion in a Goat Model , 2012, Spine.

[5]  J. Howard,et al.  Early results of the use of tantalum femoral cones for revision total knee arthroplasty. , 2011, The Journal of bone and joint surgery. American volume.

[6]  H Van Oosterwyck,et al.  The effect of pore geometry on the in vitro biological behavior of human periosteum-derived cells seeded on selective laser-melted Ti6Al4V bone scaffolds. , 2012, Acta biomaterialia.

[7]  Ke Yang,et al.  Tantalum coating on porous Ti6Al4V scaffold using chemical vapor deposition and preliminary biological evaluation. , 2013, Materials science & engineering. C, Materials for biological applications.

[8]  G. Tsakotos,et al.  Osseous integration in porous tantalum implants , 2012, Indian journal of orthopaedics.

[9]  V. Traynelis,et al.  Failure of Porous Tantalum Cervical Interbody Fusion Devices: Two-year Results From a Prospective, Randomized, Multicenter Clinical Study , 2013, Journal of spinal disorders & techniques.

[10]  M. Foss,et al.  Morphology, proliferation, and osteogenic differentiation of mesenchymal stem cells cultured on titanium, tantalum, and chromium surfaces. , 2008, Journal of biomedical materials research. Part A.

[11]  A. A. Zadpoor,et al.  Enhanced bone regeneration of cortical segmental bone defects using porous titanium scaffolds incorporated with colloidal gelatin gels for time- and dose-controlled delivery of dual growth factors. , 2013, Tissue engineering. Part A.

[12]  S. Scully,et al.  Direct tendon attachment and healing to porous tantalum: an experimental animal study. , 2007, The Journal of bone and joint surgery. American volume.

[13]  C. Bignardi,et al.  Autologous cartilage fragments in a composite scaffold for one stage osteochondral repair in a goat model. , 2013, European cells & materials.

[14]  Hongyi Li,et al.  Study on the anticorrosion, biocompatibility, and osteoinductivity of tantalum decorated with tantalum oxide nanotube array films. , 2012, ACS applied materials & interfaces.

[15]  S. M. Ahmadi,et al.  Mechanical behavior of regular open-cell porous biomaterials made of diamond lattice unit cells. , 2014, Journal of the mechanical behavior of biomedical materials.

[16]  Joshua J Jacobs,et al.  Experimental and clinical performance of porous tantalum in orthopedic surgery. , 2006, Biomaterials.

[17]  R. Bader,et al.  Oxygen consumption, acidification and migration capacity of human primary osteoblasts within a three-dimensional tantalum scaffold , 2011, Journal of materials science. Materials in medicine.

[18]  Vamsi Krishna Balla,et al.  Direct laser processing of a tantalum coating on titanium for bone replacement structures. , 2010, Acta biomaterialia.

[19]  L. Vavruch,et al.  Clinical and radiological evaluation of Trabecular Metal and the Smith–Robinson technique in anterior cervical fusion for degenerative disease: a prospective, randomized, controlled study with 2-year follow-up , 2009, European Spine Journal.

[20]  Michiel Mulier,et al.  Bone regeneration performance of surface-treated porous titanium. , 2014, Biomaterials.

[21]  A. Hanssen,et al.  Use of porous tantalum metaphyseal cones for severe tibial bone loss during revision total knee replacement. , 2008, The Journal of bone and joint surgery. American volume.

[22]  L. Fedrizzi,et al.  Porous metallic structures for orthopaedic applications: a short review of materials and technologies , 2010 .

[23]  T Albrektsson,et al.  Qualitative interfacial study between bone and tantalum, niobium or commercially pure titanium. , 1990, Biomaterials.

[24]  A. A. Zadpoor,et al.  Mechanical properties of open-cell metallic biomaterials manufactured using additive manufacturing , 2013 .

[25]  Eric A Nauman,et al.  Effect of porosity on the fluid flow characteristics and mechanical properties of tantalum scaffolds. , 2005, Journal of biomedical materials research. Part B, Applied biomaterials.

[26]  Harumoto Yamada,et al.  Mid-term results of total knee arthroplasty with a porous tantalum monoblock tibial component. , 2014, The Knee.

[27]  Michael Tanzer,et al.  Fibrous tissue ingrowth and attachment to porous tantalum. , 2000, Journal of biomedical materials research.

[28]  Y. Huang,et al.  Porous Tantalum Coatings Prepared by Vacuum Plasma Spraying Enhance BMSCs Osteogenic Differentiation and Bone Regeneration In Vitro and In Vivo , 2013, PloS one.

[29]  Gui Wang,et al.  High strength bulk tantalum with novel gradient structure within a particle fabricated by spark plasma sintering , 2011 .

[30]  J. Bellemans,et al.  Clinical and radiological evaluation of modular trabecular metal acetabular cups. Short-term results in 64 hips. , 2009, Acta orthopaedica Belgica.

[31]  Y. Missirlis,et al.  Biomaterials: A Tantalus Experience , 2010 .

[32]  D. Howie,et al.  Primary human osteoblasts grow into porous tantalum and maintain an osteoblastic phenotype. , 2008, Journal of biomedical materials research. Part A.

[33]  B. Nigg,et al.  Can Porous Tantalum Be Used to Achieve Ankle and Subtalar Arthrodesis?: A Pilot Study , 2010, Clinical orthopaedics and related research.

[34]  Evaluation of the mechanical behavior of a direct compression molded porous tantalum-UHMWPE construct: a microstructural model. , 2009, Journal of applied biomaterials & biomechanics : JABB.

[35]  Y. Kwong,et al.  The use of a tantalum-based Augmentation Patella in patients with a previous patellectomy. , 2008, The Knee.

[36]  A. Rıos-Luna,et al.  A Review of the Treatment of Pelvic Discontinuity , 2008, HSS Journal.

[37]  F. Klocke,et al.  Consolidation phenomena in laser and powder-bed based layered manufacturing , 2007 .

[38]  E R Valstar,et al.  Model-based Roentgen stereophotogrammetry of orthopaedic implants. , 2001, Journal of biomechanics.

[39]  Matthew J. Silva,et al.  What's new in orthopaedic research. , 2005, The Journal of bone and joint surgery. American volume.

[40]  Rik Huiskes,et al.  Effects of mechanical forces on maintenance and adaptation of form in trabecular bone , 2000, Nature.

[41]  M. McKee,et al.  Survivorship analysis and radiographic outcome following tantalum rod insertion for osteonecrosis of the femoral head. , 2006, The Journal of bone and joint surgery. American volume.

[42]  A. Yokoyama,et al.  Biocompatibility and osteogenesis of refractory metal implants, titanium, hafnium, niobium, tantalum and rhenium. , 2001, Biomaterials.

[43]  B. Levine,et al.  Porous metals in orthopedic applications – A review , 2010 .

[44]  A. A. Zadpoor,et al.  Osteostatin-coated porous titanium can improve early bone regeneration of cortical bone defects in rats. , 2015, Tissue engineering. Part A.

[45]  J. Blanco,et al.  Titanium and tantalum as mesenchymal stem cell scaffolds for spinal fusion: an in vitro comparative study , 2011, European Spine Journal.

[46]  Michael Tanzer,et al.  Characteristics of bone ingrowth and interface mechanics of a new porous tantalum biomaterial , 1999 .

[47]  D. Howie,et al.  The proliferation and phenotypic expression of human osteoblasts on tantalum metal. , 2004, Biomaterials.

[48]  A. A. Zadpoor,et al.  Fatigue behavior of porous biomaterials manufactured using selective laser melting. , 2013, Materials science & engineering. C, Materials for biological applications.

[49]  J. Jacobs,et al.  Applications of porous tantalum in total hip arthroplasty. , 2006, The Journal of the American Academy of Orthopaedic Surgeons.

[50]  J. Parvizi,et al.  What's new in total hip arthroplasty. , 2010, The Journal of bone and joint surgery. American volume.

[51]  Lie Liu,et al.  Preliminary study of the biomechanical behavior and physical characteristics of tantalum (Ta)-coated prostheses , 2012, Journal of orthopaedic science : official journal of the Japanese Orthopaedic Association.

[52]  Kevin Ong,et al.  The epidemiology of revision total hip arthroplasty in the United States. , 2009, The Journal of bone and joint surgery. American volume.

[53]  K. Takaoka,et al.  Comparison of bone mineral density between porous tantalum and cemented tibial total knee arthroplasty components. , 2010, The Journal of bone and joint surgery. American volume.

[54]  Johan H. C. Reiber,et al.  The use of Roentgen stereophotogrammetry to study micromotion of orthopaedic implants , 2002 .

[55]  Peter Thomsen,et al.  Aseptic loosening, not only a question of wear: A review of different theories , 2006, Acta orthopaedica.

[56]  H. M. Kim,et al.  Bioactive tantalum metal prepared by NaOH treatment. , 2000, Journal of biomedical materials research.

[57]  P. Papagelopoulos,et al.  Radiological evaluation of the metal-bone interface of a porous tantalum monoblock acetabular component. , 2006, The Journal of bone and joint surgery. British volume.

[58]  E. Morgan,et al.  Mechanotransduction and fracture repair. , 2008, The Journal of bone and joint surgery. American volume.

[59]  D G Lewallen,et al.  Clinical validation of a structural porous tantalum biomaterial for adult reconstruction. , 2004, The Journal of bone and joint surgery. American volume.

[60]  C. Rorabeck,et al.  The operation of the century: total hip replacement , 2007, The Lancet.

[61]  J. Kruth,et al.  Strong morphological and crystallographic texture and resulting yield strength anisotropy in selective laser melted tantalum , 2013 .

[62]  A. Gross,et al.  Acetabular revision using an anti-protrusion (ilio-ischial) cage and trabecular metal acetabular component for severe acetabular bone loss associated with pelvic discontinuity. , 2009, The Journal of bone and joint surgery. British volume.

[63]  P. Paschen,et al.  Tantalum—processing, properties and applications , 1989 .

[64]  L D Zardiackas,et al.  Structure, metallurgy, and mechanical properties of a porous tantalum foam. , 2001, Journal of biomedical materials research.

[65]  A. C. Jayasuriya,et al.  An overview of recent advances in designing orthopedic and craniofacial implants. , 2012, Journal of biomedical materials research. Part A.

[66]  J Kärrholm,et al.  Radiostereometry of hip prostheses. Review of methodology and clinical results. , 1997, Clinical orthopaedics and related research.

[67]  D. Davy,et al.  Evaluation of machining methods for trabecular metal implants in a rabbit intramedullary osseointegration model. , 2007, Journal of biomedical materials research. Part B, Applied biomaterials.

[68]  B. Rys,et al.  Hedrocel trabecular metal monoblock acetabular cups: mid-term results. , 2006, Acta orthopaedica Belgica.

[69]  S. M. Ahmadi,et al.  Mechanical analysis of a rodent segmental bone defect model: the effects of internal fixation and implant stiffness on load transfer. , 2014, Journal of biomechanics.

[70]  A. Lovy,et al.  Histologic retrieval analysis of a porous tantalum metal implant in an infected primary total knee arthroplasty. , 2012, The Journal of arthroplasty.

[71]  H. M. Kim,et al.  Effect of thermal treatment on apatite-forming ability of NaOH-treated tantalum metal , 2001, Journal of materials science. Materials in medicine.

[72]  J. Day,et al.  Bone ingrowth in well-fixed retrieved porous tantalum implants. , 2013, The Journal of arthroplasty.

[73]  M. Dunbar,et al.  Fixation of a trabecular metal knee arthroplasty component. A prospective randomized study. , 2009, The Journal of bone and joint surgery. American volume.

[74]  Vamsi Krishna Balla,et al.  Tantalum—A bioactive metal for implants , 2010 .

[75]  Gunnar Flivik,et al.  Guidelines for standardization of radiostereometry (RSA) of implants , 2005, Acta orthopaedica.

[76]  T. Schildhauer,et al.  Activation of human leukocytes on tantalum trabecular metal in comparison to commonly used orthopedic metal implant materials. , 2009, Journal of biomedical materials research. Part A.

[77]  P. Issack Use of porous tantalum for acetabular reconstruction in revision hip arthroplasty. , 2013, The Journal of bone and joint surgery. American volume.

[78]  J. Kärrholm,et al.  The history and future of radiostereometric analysis. , 2006, Clinical orthopaedics and related research.

[79]  B. Levine,et al.  A New Era in Porous Metals: Applications in Orthopaedics , 2008 .

[80]  C. Ohtsuki,et al.  Mechanism of bonelike apatite formation on bioactive tantalum metal in a simulated body fluid. , 2002, Biomaterials.

[81]  Christopher J. Sutcliffe,et al.  Interface interactions between porous titanium/tantalum coatings, produced by Selective Laser Melting (SLM), on a cobalt–chromium alloy , 2008 .

[82]  A. A. Zadpoor,et al.  Selective laser melting‐produced porous titanium scaffolds regenerate bone in critical size cortical bone defects , 2013, Journal of orthopaedic research : official publication of the Orthopaedic Research Society.

[83]  W. Hozack,et al.  Management of acetabular bone loss in revision total hip arthroplasty. , 2011, The Journal of bone and joint surgery. American volume.

[84]  Vamsi Krishna Balla,et al.  Porous tantalum structures for bone implants: fabrication, mechanical and in vitro biological properties. , 2010, Acta biomaterialia.

[85]  J. Kruth,et al.  Selective laser melting of biocompatible metals for rapid manufacturing of medical parts , 2006 .

[86]  M. Niinomi,et al.  Development of new metallic alloys for biomedical applications. , 2012, Acta biomaterialia.

[87]  J. Black Biological performance of tantalum. , 1994, Clinical materials.

[88]  R. Ritchie Mechanisms of fatigue-crack propagation in ductile and brittle solids , 1999 .

[89]  Anne Simmons,et al.  Monitoring cell adhesion on tantalum and oxidised polystyrene using a quartz crystal microbalance with dissipation. , 2006, Biomaterials.

[90]  M. Foss,et al.  Spatial and temporal changes in the morphology of preosteoblastic cells seeded on microstructured tantalum surfaces. , 2009, Journal of biomedical materials research. Part A.

[91]  K. Saleh,et al.  Treatment options and allograft use in revision total hip arthroplasty the acetabulum. , 2007, The Journal of arthroplasty.

[92]  B. Masri,et al.  Enhanced gap filling and osteoconduction associated with alendronate-calcium phosphate-coated porous tantalum. , 2008, The Journal of bone and joint surgery. American volume.

[93]  S. Galanakos,et al.  The Trabecular Metal Monoblock acetabular component in patients with high congenital hip dislocation: a prospective study. , 2010, The Journal of bone and joint surgery. British volume.