| Objective Testing the security and effectiveness of using collagen-hydroxyatite in clinical trials.To observe the clinical effect of using it and traditional bone repair materials for laminoplasty in spine surgery,and explore the method and advantage of improving laminoplasty.Methods Eliminate elderly, children, suffering from infectious diseases and serious cardiovascular disease patients without controling, and select the clinical files of 90 cases from April.2014 to April.2015 which received surgical treatments in our Neurosurgery department.The patients include 48 males and 42 females aged 20-63 years with averaged 46.7 years. They are divided into two groups randomly.The patients of experimental group were used collagen-hydroxyatite artificial bone repair materials for bone defects of laminoplasty,and the others of control group were used traditional artificial bone in the bone defects.The implantation amount was averaged from 4.0g to 6.0g. All the patients received MRI examination before the operation, and they were diagnosedwith spinal space-occupying lesion and the others were diagnosed with spinal cord vascular malformations(SCVM). The patients with operation ndications were divided into three categories on spinal levels:22 patients for cervical, 39 patients for thoracic,29 patients for lumbar. The vital signs,immune responses,coagulation functions,liver and kidney functions,inflammation indicators,etc were monitored to test the security of them,and clinical and X-ray photograph assessments were performed consecutively during the follow-up of 6 months.Results The result show that the biological safety evaluation is good and it?s effective in animal experiments.All the patients were followed up from 3 to 7 months with the average of 6.1 months. All of the incisions in 30 cases obtained the primary healing.The most of them were operated with a slight rise in ESR in one week,and were recovering during the follow-up of 6 months. No fever was found in the 82 patients during follow-up,and there was no adverse reaction such as HR increased,ABP increased and Anaphylaxis,etc.They were took stiches out in 2weeks after operation.4 patients?wound appear vulvar areas and particulate matterflowed from fluid drainage.The others were no adverse reaction and the fluid drainage is normal too after improving surgery method. Results of X-ray after implantation of CHA were vague bound between the implanted site and bone tissue around defects 3 months after operation; 28 weeks after operation,new bone was found in implanted parts,and the graft material was fused with bone tissue,the bone density was near to normal tissue,the defects were almost repaired.Compared to contol group,its ablity of repairing is stronger more. Clinical healing of bone with the average time of 24-26 weeks.All the patients had no spine instability.Conclusion Implanting artifical bone into spine is safe and effective,can reduce the time of bone healing.CHA is more excellent than traditional material,which is a ideal restoration materiall.It has good prospect in clinical practice.The ability of bone repairing is fit for improving aminoplasty which is good for keeping spine instability recently,but the long-term effect needs long-term follow-up to assess.Its degradation time is long in the soft tissues which may rise infection.The spine defect is different from long bone which is implanted into cavity of bone away from the soft tissues.But the amount of filling materias in the laminoplasty is huge,and they are not separated from the soft tissues.It may lead to flow a powder commonly from the fluid drainage and reduc the amoumt of filling materias,weaken the effect of bone repairing.So it is necessary for us to improve the methods of implanting and reform the technology in production. |
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