[en] The study aimed to evaluate and discuss the use of an innovative PSI made of porous hydroxyapatite, with interconnected porosity promoting osteointegration, called MyBone Custom® implant (MBCI), for maxillofacial bone reconstruction. A multicentric cohort of 13 patients underwent maxillofacial bone reconstruction surgery using MBCIs for various applications, from genioplasty to orbital floor reconstruction, including zygomatic and mandibular bone reconstruction, both for segmental defects and bone augmentation. The mean follow-up period was 9 months (1-22 months). No infections, displacements, or postoperative fractures were reported. Perioperative modifications of the MBCIs were possible when necessary. Additionally, surgeons reported significant time saved during surgery. For patients with postoperative CT scans, osteointegration signs were visible at the 6-month postoperative follow-up control, and continuous osteointegration was observed after 1 year. The advantages and disadvantages compared with current techniques used are discussed. MBCIs offer new bone reconstruction possibilities with long-term perspectives, while precluding the drawbacks of titanium and PEEK. The low level of postoperative complications associated with the high osteointegration potential of MBCIs paves the way to more extensive use of this new hydroxyapatite PSI in maxillofacial bone reconstruction.
Disciplines :
Dentistry & oral medicine Surgery
Author, co-author :
Systermans, Simon ; Centre Hospitalier Universitaire de Liège - CHU > > Service de chirurgie plastique et maxillo-faciale
Cobraiville, Elisabeth ; CERHUM SA, Liège, Belgium. Electronic address: Elisabeth.cobraiville@cerhum.com
CAMBY, Séverine ; Centre Hospitalier Universitaire de Liège - CHU > > Service de chirurgie plastique et maxillo-faciale
Meyer, Christophe; Chirurgie Maxillo-Faciale, Stomatologie et Odontologie Hospitalière, CHU, Université de Franche-Comté, Besançon, France
Louvrier, Aurélien ; Chirurgie Maxillo-Faciale, Stomatologie et Odontologie Hospitalière, CHU, Université de Franche-Comté, Besançon, France
Lie, Suen An ; Department of Cranio-Maxillofacial Surgery, Maastricht University Medical Center, Maastricht, the Netherlands
Schouman, Thomas ; Department of Maxillofacial Surgery, Groupe Hospitalier Pitié-Salpêtrière Charles Foix, Assistance Publique des Hôpitaux de Paris, Sorbonne Université, Paris, France
Siciliano, Sergio; Department of Stomatology and Maxillofacial Surgery, Clinique Sainte Elisabeth, Brussels, Belgium
Beckers, Olivier; Department of Oral and Maxillofacial Surgery, ZOL Genk, Genk, Belgium
Poulet, Vinciane ; Department of Maxillofacial Surgery, Toulouse Purpan University Hospital, Toulouse, France
Ullmann, Nicolas ; Service de Chirurgie Maxillo-faciale et Stomatologie, Hôpital de Villeneuve Saint Georges, France
Nolens, Grégory ; CERHUM SA, Liège, Belgium
Biscaccianti, Vincent ; Research Institute of Civil Engineering and Mechanics (GeM), CNRS, Nantes, France
Nizet, Jean-Luc ; Université de Liège - ULiège > Département des sciences cliniques > Chirurgie réparatrice
Hascoët, Jean-Yves; Research Institute of Civil Engineering and Mechanics (GeM), CNRS, Nantes, France
Gilon, Yves ; Université de Liège - ULiège > Département des sciences cliniques > Chirurgie orale et maxillo-faciale
Vidal, Luciano ; Research Institute of Civil Engineering and Mechanics (GeM), CNRS, Nantes, France, Department of Plastic and Reconstructive Surgery, Clinique Bretéché - ELSAN, Nantes, France. Electronic address: lucianovidal75@gmail.com
Alasseri, N., Alasraj, A., Patient-specific implants for maxillofacial defects: challenges and solutions. Maxillofac. Plast. Reconstr. Surg., 42(1), 2020, 10.1186/s40902-020-00262-7.
Alonso-Rodriguez, E., Cebri, J.L., Nieto, M.J., Del Castillo, J.L., Hern Andez-Godoy, J., Burgueño, M., Polyetheretherketone custom-made implants for craniofacial defects: report of 14 cases and review of the literature. J. Cranio-Maxillo-Fac. Surg. 43:7 (2015), 1232–1238, 10.1016/j.jcms.2015.04.028.
Atef, M., Mounir, M., Shawky, M., Mounir, S., Gibaly, A., Polyetheretherketone patient-specific implants (PPSI) for the reconstruction of two different mandibular contour deformities. Oral Maxillofac. Surg. 26:2 (2022), 299–309, 10.1007/s10006-021-00984-6.
Bedogni, A., Bettini, G., Bedogni, G., Menapace, G., Sandi, A., Michelon, F., Di Carlo, R., Franco, P., Saia, G., Safety of boneless reconstruction of the mandible with a CAD/CAM designed titanium device: the replica cohort study. Oral Oncol., 112, 2021, 10.1016/j.oraloncology.2020.105073.
Beuriat, P.A., Szathmari, A., Grassiot, B., Di Rocco, F., Mottolese, C., Pourquoi peut-on utiliser une plastie en hydroxyapatite pour réparer une perte de substance osseuse de la boîte crânienne chez les enfants: expérience à propos de 19 cas. Neurochirurgie 62:5 (2016), 251–257, 10.1016/j.neuchi.2016.04.003.
Biscaccianti, V., Fragnaud, H., Hascoët, J.Y., Crenn, V., Vidal, L., Digital chain for pelvic tumor resection with 3D-printed surgical cutting guides. Front. Bioeng. Biotechnol., 10, 2022, 991676, 10.3389/FBIOE.2022.991676/BIBTEX.
Blume, O., Back, M., Dinya, E., Palkovics, D., Windisch, P., Efficacy and volume stability of a customized allogeneic bone block for the reconstruction of advanced alveolar ridge deficiencies at the anterior maxillary region: a retrospective radiographic evaluation. Clin. Oral Invest. 27:7 (2023), 3927–3935, 10.1007/s00784-023-05015-0.
Bouakaz, I., Drouet, C., Grossin, D., Cobraiville, E., Nolens, G., Hydroxyapatite 3D-printed scaffolds with gyroid-TPMS porous structure: fabrication and in vivo pilot study in the sheep. Acta Biomater. 170 (2023), 580–595, 10.2139/SSRN.4426865.
Brie, J., Chartier, T., Chaput, C., Delage, C., Pradeau, B., Caire, F., Boncoeur, M.P., Moreau, J.J., A new custom made bioceramic implant for the repair of large and complex craniofacial bone defects. J. Cranio-Maxillofacial Surg. 41:5 (2013), 403–407, 10.1016/j.jcms.2012.11.005.
Castrisos, G., Matheus, I.G., Sparks, D., Lowe, M., Ward, N., Sehu, M., Wille, M.-L., Phua, Y., Savi, F.M., Hutmacher, D., Wagels, M., Regenerative matching axial vascularisation of absorbable 3D-printed scaffold for large bone defects: a first in human series. J. Plast. Reconstr. Aesthetic Surg. 75 (2022), 2108–2118, 10.1016/j.bjps.2022.02.057.
Chamrad, J., Marcián, P., Cizek, J., Beneficial osseointegration effect of hydroxyapatite coating on cranial implant — FEM investigation. PLoS One, 16(7), 2021, 10.1371/JOURNAL.PONE.0254837.
Chan, D., Ducic, Y., A simplified, reliable approach for advancement genioplasty. JAMA Fac. Plast. Surg. 18:2 (2016), 114–118, 10.1001/jamafacial.2015.1818.
Charbonnier, B., Hadida, M., Marchat, D., Additive manufacturing pertaining to bone: hopes, reality and future challenges for clinical applications. Acta Biomater. 121 (2021), 1–28, 10.1016/J.ACTBIO.2020.11.039.
Charbonnier, B., Manassero, M., Bourguignon, M., Decambron, A., El-Hafci, H., Morin, C., Leon, D., Bensidoum, M., Corsia, S., Petite, H., Marchat, D., Potier, E., Custom-made macroporous bioceramic implants based on triply-periodic minimal surfaces for bone defects in load-bearing sites. Acta Biomater. 109 (2020), 254–266, 10.1016/J.ACTBIO.2020.03.016.
Chepurnyi, Y., Kustro, T., Chernogorskyi, D., Zhukovtseva, O., Kanura, O., Kopchak, A., Application of patient-specific implants as alternative approach to zygoma defect management — a retrospective study. Ann. Maxillofac. Surg. 11:1 (2021), 91–96, 10.4103/ams.ams_294_20.
Le Clerc, N., Baudouin, R., Carlevan, M., Khoueir, N., Verillaud, B., Herman, P., 3D titanium implant for orbital reconstruction after maxillectomy. J. Plast. Reconstr. Aesthetic Surg. 73:4 (2020), 732–739, 10.1016/j.bjps.2019.11.014.
Doi, K., Kubo, T., Makihara, Y., Oue, H., Morita, K., Oki, Y., Kajihara, S., Tsuga, K., Osseointegration aspects of placed implant in bone reconstruction with newly developed block-type interconnected porous calcium hydroxyapatite. J. Appl. Oral Sci., 24(4), 2016, 325, 10.1590/1678-775720150597.
Dondani, J.R., Iyer, J., Tran, S.D., Surface treatments of PEEK for osseointegration to bone. Biomolecules, 13(3), 2023.
Düzgün, S., Sirkeci, B.K., Comparison of post-operative outcomes of graft materials used in reconstruction of blow-out fractures. Ulusal Travma ve Acil Cerrahi Dergisi 26:4 (2020), 538–544, 10.14744/tjtes.2020.80552.
Falkhausen, R., Mitsimponas, K., Adler, W., Brand, M., Von Wilmowsky, C., Clinical outcome of patients with orbital fractures treated with patient specific CAD/CAM ceramic implants — a retrospective study. J. Cranio-Maxillofacial Surg. 49:6 (2021), 468–479, 10.1016/j.jcms.2021.02.021.
French, K.E.M., Gormley, M., Kana, A., Deacon, S., Revington, P.J., Outcomes and complications associated with malar onlays: literature review and case series of 119 implants. Br. J. Oral Maxillofac. Surg. 58:9 (2020), 1110–1115, 10.1016/j.bjoms.2020.06.008.
Gebel, A., Eichhorn, S., Kim, J., Park, J.J., Midface reconstruction using customized Bioverit implant. P. S223 in Abstract- und Posterband — 93. Jahresversammlung der Deutschen Gesellschaft für HNO-Heilkunde, Kopf- und Hals-Chirurgie e.V., Bonn Interface — Fokus Mensch im Zeitalter der technisierten Medizin. Vol. 101, Abstract- und Posterband — 93. Jahresversammlung der Deutschen Gesellschaft für HNO-Heilkunde, Kopf- und Hals-Chirurgie e.V. 2022, Bonn Interface — Fokus Mensch im Zeitalter der technisierten Medizin.
Ghantous, Y., Nashef, A., Mohanna, A., Abu-El-naaj, I., Three-dimensional technology applications in maxillofacial reconstructive surgery: current surgical implications. Nanomaterials 10:12 (2020), 1–17, 10.3390/NANO10122523.
Goodson, A.M.C., Parmar, S., Ganesh, S., Zakai, D., Shafi, A., Wicks, C., O'Connor, R., Yeung, E., Khalid, F., Tahim, A., Gowrishankar, S., Hills, A., Williams, E.M., Printed titanium implants in UK craniomaxillofacial surgery. Part I: access to digital planning and perceived scope for use in common procedures. Br. J. Oral Maxillofac. Surg. 59:3 (2021), 312–319, 10.1016/j.bjoms.2020.08.087.
Gosau, M., Draenert, F.G., Ihrler, S., Facial augmentation with porous polyethylene (Medpor®) — histological evidence of intense foreign body reaction. J. Biomed. Mater. Res. B Appl. Biomater. 87B:1 (2008), 83–87, 10.1002/JBM.B.31072.
Gunatillake, P.A., Adhikari, R., Nondegradable synthetic polymers for medical devices and implants. Biosynthet. Polym. Med. Appl., 2016, 33–62, 10.1016/B978-1-78242-105-4.00002-X.
Haas Junior, O.L., Guijarro-Martínez, R., de Sousa Gil, A.P., da Silva Meirelles, L., de Oliveira, R.B., Hernández-Alfaro, F., Stability and surgical complications in segmental Le Fort I osteotomy: a systematic review. Int. J. Oral Maxillofac. Surg. 46:9 (2017), 1071–1087.
Habraken, W., Habibovic, P., Epple, M., Bohner, M., Calcium phosphates in biomedical applications: materials for the future?. Mater. Today 19:2 (2016), 69–87.
Hardy, H., Tollard, E., Derrey, S., Delcampe, P., Péron, J.M., Fréger, P., Proust, F., [Clinical and ossification outcome of custom-made hydroxyapatite prothese for large skull defect]. Neurochirurgie 58:1 (2012), 25–29, 10.1016/J.NEUCHI.2011.09.006.
Haroun, F., Benmoussa, N., Bidault, F., Lassau, N., Moya-Plana, A., Leymarie, N., Honart, J.F., Kolb, F., Qassemyar, Q., Gorphe, P., Outcomes of mandibular reconstruction using three-dimensional custom-made porous titanium prostheses. J. Stomatol. Oral Maxillofac. Surg., 124(1), 2023, 10.1016/j.jormas.2022.09.002.
Van Hede, D., Liang, B., Anania, S., Barzegari, M., Verlée, B., Nolens, G., Pirson, J., Geris, L., Lambert, F., 3D-printed synthetic hydroxyapatite scaffold with in silico optimized macrostructure enhances bone formation in vivo. Adv. Funct. Mater., 32(6), 2022, 10.1002/adfm.202105002.
Hou, X., Zhang, L., Zhou, Z., Luo, X., Wang, T., Zhao, X., Lu, B., Chen, F., Zheng, L., Calcium phosphate-based biomaterials for bone repair. J. Funct. Biomater., 13(4), 2022.
Järvinen, S., Suojanen, J., Kormi, E., Wilkman, T., Kiukkonen, A., Leikola, J., Stoor, P., The use of patient specific polyetheretherketone implants for reconstruction of maxillofacial deformities. J. Cranio-Maxillofacial Surg. 47:7 (2019), 1072–1076, 10.1016/j.jcms.2019.03.018.
Kattimani, V.S., Kondaka, S., Lingamaneni, K.P., Hydroxyapatite — past, present, and future in bone regeneration. Bone Tissue Regen. Insights, 7(4), 2016, 9, 10.4137/btri.s36138.
Kerkfeld, V., Schorn, L., Depprich, R., Lommen, J., Wilkat, M., Kübler, N., Rana, M., Meyer, U., Simultaneous PSI-based orthognathic and PEEK bone augmentation surgery leads to improved symmetric facial appearance in craniofacial malformations. J. Personalized Med., 12(10), 2022, 10.3390/jpm12101653.
Khorasani, M., Janbaz, P., Rayati, F., Maxillofacial reconstruction with Medpor porous polyethylene implant: a case series study. J. Korean Asso. Oral Maxillofac. Surg. 44:3 (2018), 128–135, 10.5125/jkaoms.2018.44.3.128.
Kim, K.T., Eo, M.Y., Nguyen, T.T.H., Min Kim, S.M., General review of titanium toxicity. Int. J. Implant Dent., 5(1), 2019, 10.1186/s40729-019-0162-x.
Kim, M.M., Boahene, K.D.O., Byrne, P.J., Use of customized polyetheretherketone (PEEK) implants in the reconstruction of complex maxillofacial defects. Arch. Facial Plast. Surg. 11:1 (2009), 53–57.
Kwarcinski, J., Boughton, P., Ruys, A., Doolan, A., van Gelder, J., Cranioplasty and craniofacial reconstruction: a review of implant material, manufacturing method and infection risk. Appl. Sci., 7(3), 2017.
Landry, M., Hankins, M., Berkovic, J., Nathan, C.A., Delayed infection of porous polyethylene implants after oncologic maxillectomy and reconstruction: 2 case reports and review of literature. Ear Nose Throat J., 100(10_Suppl. l), 2021, 10.1177/0145561320927525 1023S–6S.
Matsushita, K., Inoue, N., Yamaguchi, H.O., Mikoya, T., Tei, K., post-operative stability after bimaxillary surgery in patients with facial asymmetry: comparison of differences among different original skeletal class patterns. J. Maxillofac. Oral Surg. 14:3 (2015), 789–798, 10.1007/s12663-014-0713-x.
Mommaerts, M.Y., Patient- and clinician-reported outcomes of lower jaw contouring using patient-specific 3D-printed titanium implants. Int. J. Oral Maxillofac. Surg. 50:3 (2021), 373–377, 10.1016/j.ijom.2020.07.008.
Moreira Filho, O., Wykrota, F.H.L., Ellen Lobo, S.E., Restoring facial contour and harmony using biphasic calcium phosphate bioceramics. Plast. Reconstr. Surg. — Glob. Open, 9(4), 2021, 10.1097/GOX.0000000000003516.
Morselli, C., Zaed, I., Tropeano, M.P., Cataletti, G., Iaccarino, C., Rossini, Z., Servadei, F., Comparison between the different types of heterologous materials used in cranioplasty: a systematic review of the literature. J. Neurosurg. Sci. 63:6 (2019), 723–736, 10.23736/S0390-5616.19.04779-9.
Nieminen, T., Kallela, I., Wuolijoki, E., Kainulainen, H., Hiidenheimo, I., Rantala, I., Amorphous and crystalline polyetheretherketone: mechanical properties and tissue reactions during a 3-year follow-up. J. Biomed. Mater. Res. 84:2 (2008), 377–383, 10.1002/JBM.A.31310.
Paré, A., Charbonnier, B., Veziers, J., Vignes, C., Dutilleul, M., De Pinieux, G., Laure, B., Bossard, A., Saucet-Zerbib, A., Touzot-Jourde, G., Weiss, P., Corre, P., Gauthier, O., Marchat, D., Standardized and axially vascularized calcium phosphate-based implants for segmental mandibular defects: a promising proof of concept. Acta Biomater. 154 (2022), 626–640, 10.1016/J.ACTBIO.2022.09.071.
Paxton, N.C., Allenby, M.C., Lewis, P.M., Woodruff, M.A., Biomedical applications of polyethylene. Eur. Polym. J. 118 (2019), 412–428, 10.1016/J.EURPOLYMJ.2019.05.037.
Perez, A., Lazzarotto, B., Marger, L., Durual, S., Alveolar ridge augmentation with 3D‐printed synthetic bone blocks: a clinical case series. Clin. Case Rep., 11(4), 2023, 10.1002/ccr3.7171.
Persson, J., Helgason, B., Engqvist, H., Ferguson, S.J., Persson, C., Stiffness and strength of cranioplastic implant systems in comparison to cranial bone. J. Cranio-Maxillo-Fac. Surg. 46:3 (2018), 418–423, 10.1016/J.JCMS.2017.11.025.
Rayess, H.M., Svider, P., Hanba, C., Patel, V.S., Carron, M., Zuliani, G., Adverse events in facial implant surgery and associated malpractice litigation. JAMA Fac. Plast. Surg., 20(3), 2018, 244, 10.1001/JAMAFACIAL.2017.2242.
Ridwan-Pramana, A., Wolff, J., Raziei, A., Ashton-James, C.E., Forouzanfar, T., Porous polyethylene implants in facial reconstruction: outcome and complications. J. Cranio-Maxillofacial Surg. 43:8 (2015), 1330–1334, 10.1016/J.JCMS.2015.06.022.
Rodríguez‐Arias, J.P., Tapia, B., Pampín, M.M., Morán, M.J., Gonzalez, J., Barajas, M., Del Castillo, J.L., Cuéllar, C.N., Cebrian, J.L., Clinical outcomes and cost analysis of fibula free flaps: a retrospective comparison of CAD/CAM versus conventional technique. J. Personalized Med., 12(6), 2022, 10.3390/jpm12060930.
Rubio-Palau, J., Prieto-Gundin, A., Cazalla, A.A., Serrano, M.B., Fructuoso, G.G., Ferrandis, F.P., Baró, A.R., Three-dimensional planning in craniomaxillofacial surgery. Ann. Maxillofac. Surg., 6(2), 2016, 281, 10.4103/2231-0746.200322.
Sarfraz, S., Mäntynen, P.H., Laurila, M., Rossi, S., Leikola, J., Kaakinen, M., Suojanen, J., Reunanen, J., Comparison of titanium and PEEK medical plastic implant materials for their bacterial biofilm formation properties. Polymers, 14(18), 2022, 10.3390/POLYM14183862.
Schlieder, D., Markiewicz, M.R., Craniofacial syndromes: the Le Fort III osteotomy for correction of severe midface hypoplasia. Atlas Oral Maxillofac. Surg. Clin. 30:1 (2022), 85–99, 10.1016/J.CXOM.2021.11.004.
Scolozzi, P., Maxillofacial reconstruction using polyetheretherketone patient-specific implants by “mirroring” computational planning. Aesthetic Plast. Surg. 36:3 (2012), 660–665, 10.1007/s00266-011-9853-2.
Shi, H., Yin, X., Hu, Y., Solitary neurofibroma of the zygoma: three-dimensional virtual resection and patient-specific polyetheretherketone implant reconstruction. J. Craniofac. Surg. 33:8 (2022), 781–783, 10.1097/SCS.0000000000008526.
Shilo, D., Emodi, O., Blanc, O., Noy, D., Rachmiel, A., Printing the future — updates in 3D printing for surgical applications. Rambam Maimonides Med. J., 9(3), 2018, e0020, 10.5041/RMMJ.10343.
Spetzger, U., Vougioukas, V., Schipper, J., Materials and techniques for osseous skull reconstruction materials and techniques for osseous skull reconstruction. Minim Invasive Ther. Allied Technol. 19 (2010), 110–121, 10.3109/13645701003644087.
Staffa, G., Nataloni, A., Compagnone, C., Servadei, F., Custom made cranioplasty prostheses in porous hydroxy-apatite using 3D design techniques: 7 years experience in 25 patients. Acta Neurochir. 149:2 (2007), 161–170, 10.1007/s00701-006-1078-9.
Staffa, G., Barbanera, A., Faiola, A., Fricia, M., Limoni, P., Mottaran, R., Zanotti, B., Stefini, R., Custom made bioceramic implants in complex and large cranial reconstruction: a two-year follow-up. J. Cranio-Maxillofacial Surg., 40(3), 2012, 10.1016/j.jcms.2011.04.014.
Thayaparan, G.K., Lewis, P.M., Thompson, R.G., D'Urso, P.S., Patient-specific implants for craniomaxillofacial surgery: a manufacturer's experience. Ann. Med. Surg., 66, 2021, 102420, 10.1016/J.AMSU.2021.102420.
Trzaskowska, M., Vivcharenko, V., Przekora, A., The impact of hydroxyapatite sintering temperature on its microstructural, mechanical, and biological properties. Int. J. Mol. Sci., 24(6), 2023, 5083, 10.3390/IJMS24065083.
Vidal, L., Biscaccianti, V., Fragnaud, H., Hascoët, J.Y., Crenn, V., Semi-automatic Segmentation of Pelvic Bone Tumors: Usability Testing. Annals of 3D Printed Medicine, vol. 9, 2023, 10.1016/j.stlm.2022.100098.
Vidal, L., Kampleitner, C., Krissian, S., Brennan, M., Hoffmann, O., Raymond, Y., Maazouz, Y., Ginebra, M.P., Rosset, P., Layrolle, P., Regeneration of segmental defects in metatarsus of sheep with vascularized and customized 3D-printed calcium phosphate scaffolds. Sci. Rep., 10(1), 2020, 10.1038/s41598-020-63742-w.
Vollkommer, T., Henningsen, A., Friedrich, R.E., Felthaus, O.H., Eder, F., Morsczeck, C., Smeets, R., Gehmert, S., Gosau, M., Extent of inflammation and foreign body reaction to porous polyethylene in vitro and in vivo. In Vivo, 33(2), 2019, 337, 10.21873/INVIVO.11479.
Wang, W., Yeung, K.W.K., Bone grafts and biomaterials substitutes for bone defect repair: a review. Bioact. Mater. 2:4 (2017), 224–247.
Zhao, R., Yang, R., Cooper, P.R., Khurshid, Z., Shavandi, A., Ratnayake, J., Bone grafts and substitutes in dentistry: a review of current trends and developments. Molecules, 26(10), 2021.