The introduction of spinal fusion devices has made a huge advance in the treatment of lower back pain. Currently, a range of devices exists manufactured from either Ti alloy or reinforced PEEK. A four year European Community funded project has researched the benefits of using ceramic materials in spinal surgery. This has resulted in a ceramic composite spinal fusion device with the benefits of

• Faster bone fusion
• No allograft or autologous bone graft
• Anterior and posterior operative procedures
• Optimum biomechanical stability

In Vitro data

In vitro testing was conducted to characterise the implant according to mechanical, biochemical and biocompatible criteria. These include

• Osteoblast cell proliferation testing
• Direct contact cell culture toxicity tests (ISO 10993-5)
• Agar diffusion cell culture screening for cytotoxicity (ASTM F895)
• Modified agar diffusion cytotoxicity (ASTM F895)
• In vitro degradation tests

Results confirmed the device design for clinical testing and that all materials used are biocompatible and therefore suitable for the application.