Biomechanical behavior of a novel composite intervertebral body fusion device

Purpose: Low back pain related to intervertebral disc (IVD) degeneration represents a socio-economic problem which affects quality of life. In order to solve this problem the current gold standard techniques such as spinal arthroplasty and arthrodesis (or fusion) are considered. As for spinal arthroplasty, over the past 40 yrs, IVD prostheses have been designed to maintain the correct IVD spacing and to allow for motion, while providing stability. However, there are many difficulties in incorporating important features such as viscoelastic and shock absorber behavior of natural IVDs in a prosthetic disc design. Moreover, in some cases, the use of IVD prostheses does not represent the ideal solution. Consequently, the aim of this study was to improve the design of alternative devices for spinal fusion, which overcome the problems related to metal ones currently available on the market, such as stress shielding, stress concentration effects and eventual bone corrosive or inflammatory reaction. Methods: Accordingly, a novel polyetherimide (PEI)-based cage reinforced with carbon fibers through filament winding and compression molding technologies was realized. Results: The characterization through a porcine model has produced very interesting results. The small values obtained from local compression tests have suggested that a reduction in mobility occurred, whereas distributed compression tests on IVDs prosthesized by employing the PEI-based cage reinforced with carbon fibers have highlighted a compressive stiffness of 100 MPa. This stiffness is lower than that of the IVD prosthesized through the titanium cage (146 MPa), and closer to the stiffness of natural porcine IVDs (90 MPa). Conclusions: Through a suitable composite cage design it is possible to control stress-strain distributions and the mechanical signals to bone, thus avoiding the stress-shielding phenomena, but also corrosion and metal ions release which are typical of the metallic implants.