A Long-term Clinical Observation Of The Artificial Bone With Nanocrystalline And Collagen Materials In Spinal Fusion Surgery

Objective:Spinal fusion has played an important role in the reconstruction of spinal stability, restoration of normal sequence and relief of the spinal pain. Autologous bone graft is the best material to promote bone fusion, but its resources are limited. To solve the problem, we have been looking for other solutions in recent years:bone graft substitutes. The materials used in this study, which is Nano-Hydroxyapaptite/Collagen (nHAC), made by the development of Materials Science and Engineering of the Tsi-nghua University. The material has been carried out in the animal models and preliminary clinical trials, confirmed that having clinical efficacy and can be applied. The purpose of this study is to observe the long-term clinical effects of the material in spinal fusion surgery.Methods:These patients came from the spine surgery of the Guangzhou Military hospital, from March 2008 to February 2009, including 32 male and 14 female, aged 23-62 years (average 38.45±10.04), which were randomly divided into the nHAC artificial bone and autogenous bone mixed group and the autograft group (23 cases each). Spinal fusion used a mixture of the nHAC artificial bone and the autogenous bone by 1:1 in the experimental group, the control group with the autogenous bone graft. Bony union, volumes of fusion mass, and bone absorption rates were postoperatively evaluated using simple radiographs and 2D-CT scans. The X-ray studies performed at 3,6 and up to 15 months postoperatively and CT perfoming at 2 weeks and 15 month postoperatively. Results:1.The X-ray studies of all cases showed:the fusion rates of the experimental group and the control group were 27.27% and 55.56% at 3 months postoperatively, and were 78.95% and 82.35% at 6 months postoperatively. The result of analysis of variance showed:the fusion rates between the two groups have no significant difference (P> 0.05).2. CT scan showed:the fusion rates between the two groups were great, but the bone graft have been absorbed after surgery. Measuring the volumes of fusion mass and calculating the bone absorption rates postoperatively, the results showed there was no significant difference between the two groups.Conclusion:The complexed bone of collagen and nanocrystalline materials, as a new type of the substituted materials of artificial bone, which was used in spinal surgery and the clinical effect was significant. It coude be applied widely in the spinal surgery.