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Custom Endoprotesi: Design e stampa 3D di protesi personalizzate per la caviglia


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Il progetto Custom Implants si inserisce nel campo della chirurgia personalizzata di precisione e in particolare:

Custom-Endoprotesi: realizzazione in stampa 3D di protesi in leghe metalliche e in polietilene per la chirurgia protesica sostitutiva
Le superfici articolari affette da gravi degenerazioni sono sostituite da endoprotesi artificiali. L’attuale limitatissimo numero di taglie disponibili ingenera importanti problemi tra la protesi e l’osso ospitante, che porta spesso al fallimento della sostituzione. Con i nuovi strumenti a disposizione (immagini biomedicali, software di ricostruzione, modelli biomeccanici, ecc.) e la recente tecnologia di stampa-3D si vogliono progettare nuove protesi articolari personalizzate per la caviglia.

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Custom Endoprotesi: Design e stampa 3D di protesi personalizzate per la caviglia

  1. 1. 19/07/2017 1 Design e stampa 3D di protesi  personalizzate per la cavigliapersonalizzate per la caviglia  Ing. Alberto LEARDINI e Ing. Paolo CARAVAGGI Laboratorio Analisi del Movimento Istituto Ortopedico Rizzoli  Total Ankle Replacement Severe pain (*2M), end‐stage osteoarthritis with motion limitation (*50K) Ankle Fusion Total Ankle Replacement (TAR) CUSTOM IMPLANTS 2 Both ankle fusion and current day TARs are inadequate in addressing the problem * Numbers refer to USA market only, not worldwide
  2. 2. 19/07/2017 2 Total Ankle ReplacementGeneration: Pioneers ‘70 Classics ‘80 Modern ‘90 Current 2000 Smith ICLH Newton TPR Mayo TNK Agility Bue‐Papp STAR ESKA AES Salto Alpha Hintegra Mobility Topez Eclipse SaltoTal Taric CCIevol Cement fixation Bone resection Original CoR changed Osteolysis Impingement Loosening (90 Edge loading Salvage/revision Malleolar fracture Polyethylene wear and dislocation Subsidence Instability Long pegs, cortical window Screw-based fixation Stress-shielding Still Flat-Ti & Nat- Ta? Back to conforming 2-comp?! Lateral access?! Back to constrained?! Back to cement?! Cumbersome CUSTOM IMPLANTS 3 Loosening (90- 95%) Subsidence Infection Instability Instability Impingement Infection Vascularity Bone removal Syndesmosis fusion Non- delay-union Groove at articulat Earlier complications Sizing operative technique! Leardini et al. GIOT 2007; Giannini et al. Foot Ankle Surg 2000 Disegno anatomo-funzionale Post Ant CUSTOM IMPLANTS 4 Plantarflexion DorsiflexionNeutral Leardini Clin Biomech 2001; Med Bio Eng Comp 2001, 2002
  3. 3. 19/07/2017 3 Disegno anatomo-funzionale CaFi ICMax Pl TiCa CUSTOM IMPLANTS 5 Max Do In 6 in‐vitro implantation (‘99–’02), and in  about 1200 patients (Jul ‘03 – May ‘16) Disegno funzionale A1 A2 Tibia/Fibula Segment A B F CL CM B1 B2 Lateral Sphere Medial Sphere Talus/Calcaneus Segment Fixed Sphere CaFiL TiCaL C CUSTOM IMPLANTS 6Parenti‐Castelli, Leardini et al., Med Bio Eng Comp 2007; J Biomech 2009  Two ligament fibres  Three rigid contacts:  A. 2 sph‐pla at Ti‐Ta, 1 sph‐pla at Ta‐Fi B. 3 sph‐sph  3D mathematical description of passive kinematics
  4. 4. 19/07/2017 4 Disegno funzionale CUSTOM IMPLANTS 7 Disegno anatomico • A  new TAR design with articulating surface geometry  representing a paradigm shift from the “Common knowledge”. • Main features: 2. Lateral apex 1. Truncated non‐symmetric cone Claims, close to normal:  • Joint Kinematics • Load Transfer CUSTOM IMPLANTS 8 3. Saddle shaped • Loading of ligaments • Behavior under functional  and extreme loads Expected benefits: • Reduced wear • Reduced rates of failure
  5. 5. 19/07/2017 5 Disegno anatomico Image‐ and experimental‐ based study of the morphology of the articular surfaces,  in natural and prosthetic ankle joint CT Imaging 3D G t i l CUSTOM IMPLANTS 9 Segmentation &  3D Renderings 3D Geometrical  Analysis Design & Manufacturing of Artificial Surfaces Testing: 3D Kinematics and Kinetics Analyses CAOS & EFAS Best Paper Awards!, June 2016ankles (vitro/vivo) Progettazione personalizzata Imaging Biomech. MODELS: anatomical Bones Li t D D E S I D E S…modelling Motion analysis funct/anat functional Ligaments Kinematics  D E S I G N G N d i m e s n Surgical/clinical options: • position  • shoulder/gutter • fixation elements • material I G N f i n a l both ankles?! CUSTOM IMPLANTS 10 e d • cement / coating • transverse plane • chamfers • insert • cutting blocks? both ankles?! Liverani et al. Materials and Design 2016
  6. 6. 19/07/2017 6 Scansioni ed immagini  Best selection, including possible combinations, among imaging devices at IOR: CT based tech: ‐ Standard CT (no soft tissue)‐ Standard CT (no soft tissue) ‐ Dual‐Energy CT (enhancement of soft tissues) ‐ ConeBeam CT (new technology, 3D and soft tissue, … loading!) CUSTOM IMPLANTS 11 MRI based tech: ‐ 1.5 T MRI ‐ 3.0 T MRI Scansioni ed immagini to create reference markers well detectable in CT & MRI via material combination  rigidly fixed on relevant anatomical structures via plaster HARD MARKER with centered cavity…. ….Filled with a CRYSTAL JELLY BALL…. ….and hermetically closed CUSTOM IMPLANTS 12 to avoid possible drying.
  7. 7. 19/07/2017 7 Scansioni ed immagini Regular CT Tissue 1Regular CT Tissue 1 MRI 3T T2 FSMRI 1.5T cartilage new CBCT Dual Energy CT Basal 1Dual Energy CT Basal 1 CUSTOM IMPLANTS 13 Modellazione e registrazione CUSTOM IMPLANTS 14
  8. 8. 19/07/2017 8 Disegno e progettazione CUSTOM IMPLANTS 15 Disegno e progettazione CUSTOM IMPLANTS 16
  9. 9. 19/07/2017 9 Interfaccia impianto-osso Polyethylene component CUSTOM IMPLANTS 17 titolo Topography  Bone‐implant interface material Core material  ‐ metals (e.g. CoCr, Ti alloys, Mg alloys) ‐ ceramics (Zr and Al based) ‐ metals (CoCr, Ti alloy, Tantalum) ‐ Calcium‐phosphate based  (biomimetic coating, e.g. hydroxyapatite) ‐ surface roughness (10‐50 micron) ‐ micron‐scale and nano‐scale (1 – 100nm) Surface treatments ‐ sand‐blasting ‐ plasma sprying ‐ electropolishing Chemistry & biocompatibility ‐ biotolerant (distance osteogenesis) ‐ bioinert (contact osteogenesis) ‐ bioreactive (stimulating bone ingrowth) CUSTOM IMPLANTS 18Osseointegration “A direct structural and functional connection between ordered, living bone and the surface of a load‐carrying implant.” Branemark (1985) Stress‐shielding
  10. 10. 19/07/2017 10 Interfaccia impianto-osso CUSTOM IMPLANTS 19 CUSTOM IMPLANTS 20
  11. 11. 19/07/2017 11 Metallo-trabecolare - Zimmer CUSTOM IMPLANTS 21 ‘Trabecular bone model’ microCT – femoral bone Acknowledgement : Laboratorio di Tecnologia Medica (IOR) Top vieww CUSTOM IMPLANTS 22 Side view Density = 17% Trabecular thickness = 150um Trabecular Separation = 670um
  12. 12. 19/07/2017 12 Modelli interfaccia impianto-osso ew Acknowledgement: CIRI‐MAM (UniBO) Top vieiew CUSTOM IMPLANTS 23 Side v SPHERICAL NEW geometries – density‐matched ROUND DIAGONAL Existing geometry ‐ Control Dal .STL al modello CrCo CUSTOM IMPLANTS 24 Selective Laser Melting
  13. 13. 19/07/2017 13 Test tossicità e osteogenesi T0: 24 h T2: 2 weeks und Acknolwedgement: laboratorio BITTA (IOR)roudiagonalecular CUSTOM IMPLANTS 25 trabespherical top sidetop Indagine SEM: campione “round” CUSTOM IMPLANTS 26
  14. 14. 19/07/2017 14 Indagine SEM: campione “round” + cellule CUSTOM IMPLANTS 27 Indagine SEM: campione “trabecolare” CUSTOM IMPLANTS 28
  15. 15. 19/07/2017 15 Indagine SEM: campione “trabecolare” + cellule CUSTOM IMPLANTS 29 Prototipo di interfaccia impianto-osso: protesi di caviglia CUSTOM IMPLANTS 30 Selective Laser Melting (CIRI‐MAM, UniBO)
  16. 16. 19/07/2017 16 Sviluppi futuri … Specialised Research / Design Centre #iSpecialised Research / Design Centre #1 Trad. Fabrication #N Cloud Services Specialised Research / Design Centre #N Trad. Fabrication #1 Trad. Fabrication #j CUSTOM IMPLANTS 31 3DP Fabrication! g Grazie per l’attenzione Ing. Alberto Leardini [] Ing. Claudio Belvedere [] CUSTOM IMPLANTS 32 Ing. Paolo Caravaggi [] Laboratorio Analisi del Movimento, Istituto Ortopedico Rizzoli