Preliminary Evaluation of the Clinical Safety and Effectiveness of the Bionic Nerve Scaffold

Preliminary Evaluation of the Safety and Effectiveness of the Bionic Nerve Scaffold With Longitudinally Oriented Microchannels in Clinical Application

The objective of the study is to preliminarily evaluate the clinical safety and effectiveness of the bionic nerve scaffold with longitudinally oriented microchannels. 10 patients with peripheral sensory nerve defects will be involved and divided into 2 groups: the experimental group is treated with the nerve scaffold, and the control group without that. Then follow the cases up and draw conclusion according to the results of observation and examination.

The objective of the study is to preliminarily evaluate the clinical safety and effectiveness of the bionic nerve scaffold with longitudinally oriented microchannels developed in the Department of Orthopaedics in Xijing hospital in repairing the peripheral nerve defect. According to the inclusion and exclusion criteria, 10 patients with peripheral sensory nerve defects of 1 to 3 cm in size will be involved. Divided them into 2 groups. The experimental group of 5 cases will be treated with the nerve scaffold, and the control group without that. Then follow the cases up at about 2 weeks, 3 months and 6 months after surgery. Observe the condition of the healing of the local wound and the whole body of the 10 patients. Examine the blood routine and biochemical indexes of the experimental group. Sensory recovery of injured nerves will be tested at about 3 months and 6 months after surgery. Record the results in the case report forms. Analyze the data statistically and draw conclusion.

Inclusion Criteria:

• age from 18-50 yeas old, male or female, course of disease is within one year;
• good heart, liver and kidney function;
• with peripheral sensory nerve defects of 1-3 cm in size, and willing to repair it with the nerve scaffold;
• no significant damage existing in the skin and soft tissue in the operative region
• have signed the informed consent form
• good adherence and willing to return for follow-up visits as required.

Exclusion Criteria:

• with acute or severe infection
• suffering from serious primary diseases of heart, brain, liver and kidney, blood system, endocrine system and so on, and can not tolerate surgery
• with histories of peripheral vascular disease, immunological disorder chronic alcoholism, and drug abuse and so on
• with family history of genetic
• allergic to collagen and chitosan
• pregnancy and lactating women
• serious damage existing in the skin and soft tissue in the operative region
• bad adherence and can not return for follow-up visits on time as required