INTRODUCTION. A new class of soybean-based bio-materials has been presented to the scientific community (patent PCT/GB01/03464) which shows good mechanical properties and an intrinsic anti-inflammatory potential, probably related to the phyto-hormone Genistein. This plant isoflavone is also reported to inhibit osteo-clastic activity.

MATERIALS AND METHODS. De-fatted soybean curd was prepared into granules which were subsequently implanted in a cylindrical cavity drilled into the femural canal of New Zealand White rabbits. Retrieved femurs were embedded in poly-methyl-meta-acrylate and samples were analyzed by back-scattered electron microscopy (BSEM).

RESULTS. Retrieved operated femurs showed a macroscopic appearance similar to the non-operated controls. BSEM showed that granules were still present at the site of implantation after 8 weeks, but a clear progressive degradation took place from the periphery to the centre of the femural canal already after 3 weeks. The degradation of the granule was accompanied by the production of new trabeculae apposed to the surface of the material.

CONCLUSIONS. It can be hyothesised that the released Genistein shifts the metabolic balance towards bone production by inhibiting the macrophagic and osteo-clastic activities and that the material degrading surface supports the apposition and mineralization of the newly-formed bone.

A new class of soybean-based biomaterials has been presented to the scientific community (patent PCT/GB01/03464) that shows good mechanical properties and an intrinsic anti-inflammatory potential, probably related to the phyto-hormone Genistein. This plant iso-flavone is also reported to inhibit osteoclastic activity.

De-fatted soybean curd was prepared into granules which were subsequently implanted in a cylindrical cavity drilled into the femoral canal of New Zealand White rabbits. Retrieved femurs were embedded in polymethyl-meta-acrylate and samples were analysed by back-scattered electron microscopy (BSEM). Retrieved, operated femurs showed a macroscopic appearance similar to the non-operated controls. BSEM showed that granules were still present at the site of implantation after 8 weeks, but a clear progressive degradation took place from the periphery to the centre of the femural canal already after 3 weeks. The degradation of the granule was accompanied by the production of new trabeculae apposed to the surface of the material.

It can be hypothesised that the released Genistein shifts the metabolic balance towards bone production by inhibiting the macrophagic and osteoclastic activities and that the material degrading surface supports the apposition and mineralisation of the newly formed bone.

Aims: Both partial and total functional disorders of spine are one of the most disabling, common and costly problem of current surgery. The surgical treatment may involve the partial or total resection of the Intervertebral Disc (IVD). Thus, implants for vertebral fusion are often required in order to immobilize the diseased column.

Cage implants are designed in order to separate contiguous vertebrae allowing an adequate stress transfer and favoring bone growth. In this paper the biomechanical and histological properties of novel composite cages and commercial titanium implants have been in vitro and in vivo investigated.

Materials: Novel composite lumbar cages were designed by F.E.M., manufactured and implanted in porcine spine at the L4-L5 lumbar zone of five pigs (large white-duroc race of 50–55 Kg by weight and 1.9–2.1 months old). Each composite cage was prepared by filament winding technology by using PEI (PolyEtherImmide – GE Polymerland ULTEM 1000/1000) as matrix and Carbon fibre (Torayca T400-B 6000-50B) as reinforcement with a winding angle of 45A1 degree. Mechanical properties were investigated according to ASTM standard on composite material, novel composite cage, titanium cage and the natural disc. The device was coated with PEI – HA (hydroxyapatite) solution in order to improve the bone interaction. The behaviour of the composite cage was compared to titanium lumbar cages (SOFAMOR Danek) through biomechanical and histological tests.

Results: Tensile test performed on composite material have showed a Young’s Modulus equal to 40,1 GPa, maximum tensile strength equal to 602 MPa. Compressive test on the composite cage showed an Elastic Modulus value of 22 GPa. The comparison among the three systems displayed comparable compliance for titanium (0,0014mm/mm) and composite cage (0,0031mm/mm) while an higher compliance in the case of natural disc (0,0521mm/mm). All pigs showed good health up to the sacrificing date. Particularly, histological tests after two months from the implantation already showed abundant the presence of new-formed tissue around the composite cage.

Conclusions:. The results demonstrate that PEI reinforced with Carbon fibres composite cages coated with HA show excellent performance. Mechanical properties of the composite cages are closer to the properties of cortical bone than those of titanium cages, thus reducing the effect of stress concentration and stress shielding and as observed for stiff metal implants.