8th Combined Meeting of Orthopaedic Research Societies – October 13-16, 2013, Venice, Italy BIOACTIVE TRABECULAR-LIKE COATINGS TO IMPROVE THE OSTEOINTEGRATION OF CERAMIC PROSTHETIC DEVICES www.match-euproject.com Chiara Vitale-Brovarone1, Francesco Baino1, Enrica Verné1, Polytimi Perdika1, Feza Korkusuz2, Maria Angeles Montealegre3, Joaquim Minguella4 Contact: [email protected] ; [email protected] 1Institute of Materials Physics & Engineering, Department of Applied Science and Technology, Politecnico di Torino , Italy MEDICAL Ltd, Ankara, Turkey 3 AIMEN Tecnology Centre, Porriño, Spain 4 Fundacio Privada CIM, Barcelona, Spain 2 FAME-MED Basic concepts: The potential of bioactive glasses Since the invention of 45S5 Bioglass® by Larry Hench and associates in 1969 [1], bioactive glasses have been considered ideal biomaterials for bone repair, as they exhibit the unique property to bond to bone and to stimulate bone regeneration while dissolving over time. Today, biomedical glasses are commercialized and clinically used mainly as bone fillers or bioactive thin coatings on prosthetic metal stems to promote implant osteointegration, but in the experimental research they are often designed and processed to act as porous scaffolds to support tissue growth and remodelling in 3-D [2]. New perspectives and aim of the activity Hip joint prosthesis (HJP): state of the art Acetabular element Metal Back Advantages [3,4]: Improved osteointegration No risk of elements malpositioning No risk of elements mobility Easier fabrication of small-sized prostheses (children) Easier coupling with high-diameter femur heads CHALLENGE: “biological” fixation by using POROUS BIOACTIVE GLASS DIRECT BOND between acetabular cup and pelvic bone Cup Prosthetic femur head PATENT: E. Verné, C. Vitale-Brovarone, L. Robiglio, F. Baino. Monoblock ceramic prosthetic members. WO 2008/146322 A2. Prosthetic femur neck Composite cup machining Analogous concepts can be applied for knee prosthesis Dense coating manufacturing Starting materials: Al2O3 and ZrO2 powders mixed according to a 75/25 weigth ratio (as BIOLOX Delta ® by CeramTec) The intermediate coatings were manufactured by using powdered glasses (oxide systems: SiO2-CaO-Na2O-P2O5-B2O3-Al2O3) as starting materials. Press into a mould to obtain Al2O3/ZrO2 composite cylinders Surface machining (subtractive manufacturing) Pre-sintering phase Slurry preparation (glass powders sieved below 32 µm + PVA + water) Soaking of the ceramic composite cup into the slurry Final coatings on cups of different size obtained by high-temperature thermal treatment. Manual rotation to avoid unwanted accumulation and coating inhomogeneity Cutting and fine surface machining Sintering SEM micrograph of the coating (thickness ~150 µm) Two prototypes were finally obtained: - small cups with a 29.5-mm external diameter - large cups with a 39.5-mm external diameter EDS analysis showing the chemical joining between cup and coating: Al3+ migrates from the cup into the coating and Na+ migrates from the coating into the cup. Micro-CT investigation demonstraing the homogeneity of the coating. Microindenations at the coating/cup interface: the cracks do not propagate along the interface. ADHESION STRENGTH: 30 MPa Full prototype fabrication First approach: sponge replication method PU sponge preforming by thermal shaping Dipping of the system into a glass slurry, so that glass particles can adhere to polymer struts Squeezing of the impregnated sponge to remove the exceeding slurry out of the sponge pores Final sintered 3-layer prototype: alumina/zirconia composite cup + dense glass layer + trabecular coating «Green» full prototype (glass–impregnated sponge joined to the glass-coated cup) Thermal treatment (polymer burning-out and glass particles sintering) In vitro bioactivity: the osteointegration potential Second approach: laser cladding Intermediate glass layer manufactured by laser cladding Dense coating by laser cladding Pre-coating by a glass slurry (PVA as porogen agent) + laser beam Final 3-layer prototype after laser cladding 7 days in SBF 28 days in SBF Ca P Conclusions • Al2O3/ZrO2 composite cups were successfully obtained by subtractive manufacturing • The intermediate dense coating was successfully manufactured by using two different techniques, i.e. dipping method and laser cladding • Different prototypes of the whole ceramic cup with the trabecular-like coating were successfully obtained • The trabecular-like coating mimicked the 3-D porous architecture of cancellous bone and was highly bioactive in SBF enhanced osteointegration potential Globular CaP agglomerate, typical of the HA formed on bioactive glasses, are well distiguishable and forms a 20-µm thick layer visible in the cross-section. References [1] Hench LL, J Mater Sci: Mater Med 17 (2006) 967-978. [3] Baino F & Vitale-Brovarone C, J Biomed Mater Res A 97 (2011) 514-535. [4] Verné E et al., Single-piece ceramic prosthesis elements. WO 2008/146322 A2. [4] Vitale-Brovarone C et al., J Mater Sci: Mater Med 23 (2012) 2369-2380. Funding EC-funded project MATCh (“Monoblock acetabular cup with trabecular-like coating”) – EU Seventh Framework Programme (FP7/2007-2013) under grant agreement no. [286548].
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