Abstract

Nowadays the loss of bone due to congenital defects, diseases, injuries and trauma, is the most common cause of reconstructive orthopedic surgery; it accounts, just in the maxillo-facial district, hundreds of thousand cases each year worldwide. Furthermore, bone cancers and sarcomas (for example Ewing’s disease), even if very often prematurely diagnosed and treated, request relevant bone tissue excise and this kind of operations are criticai not only for aesthetical issues but especially for the residuai anatomica) functionality for the patients
Very often there is a need to fill/rebuild the defect or the eliminated district and, for self-evident reasons, the use of autologous bone is strongly not recommended; moreover if the site involved is quite large, it is very difficult to get the right amount of bone from the patient. Nevertheless, autologous bone graft still plays the role of gold standard in criticai sized and non-union bone defects, the main reason being the Jack of adequate industriai substitutes (synthetic and xenograft materials). Hence, today’s most commonly used solution today stil! remains the cadaveric bone graft, which is sometimes the only one available. Beside all known criticai issues of these grafts (e.g. ethical, availability and costs), the deep washing, deantigenation and sterilization processes make allograft materials very fragile bone substitutes, unable to withstand typical heavy surgical manoeuvres.
Industrie Biomediche Insubri SA (IBI) developed a new technology to improve the properties of natural materials. Indeed, IBI produces Smartbone®, a bone substitute specifically developed for orthopaedic reconstructive surgery. This innovative scaffold has a composite structure based on a bovine derived bone matrix reinforced with biodegradable polymers and bioactive agents. The bovine derived matrix allows maintaining an adequate 3D-structure, with an open-porosity and a biomimetic chemistry (Ca and P based), biopolymers pennit to achieve good mechanical properties (in the range of healthy human cortical bone), while bioactive agents promote cell adhesion, proliferation and high hydrophilicity ( essenti al also for blood absorption and thus sparkling chemical signals cascade for regeneration). Smartbonéì is produced according to GMP (Good Manufacturing Practice) standards, applying only human-use approved components and CE mark is under obtainment for both conventional and unconventional shapes.
Thanks to the very high performances of Smartbone”, particularly its irnpressively higher mechanical prope1ties with respect to other bone substitutes, !BI developed and launched custom­rnade products, ‘·SmartBone”‘ on demandTM”, solving single specific cases of bone reconstruction: stmting from a comrnon CT scan, !BI can provi de the adequate substitute for every kind of defect.