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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
It is a new kind of nerve scaffold with the microstructure of longitudinally oriented microchannels. It's made of collagen as the main raw material.
Xijing Hospital
Xi'an, Shaanxi, China
RECRUITINGObserving the condition of the healing of local wound with the naked eye at 2 weeks after operation，including redness, exudation and ulceration.
The condition of the healing of local wound will be observed by the designated doctor with the naked eye to see if there is redness, exudation or ulceration. And then the condition will be recorded.
Time frame: 2 weeks after operation
Learning about patients' systemic reactions by asking them at 2 weeks after operation, including fever, nausea, vomiting and skin itching.
The patients will be asked if there is systemic discomfort or any other bad reactions during the 2 weeks, including fever, nausea, vomiting and skin itching. And then the condition will be recorded.
Time frame: 2 weeks after operation
Test of white blood cell count at 2 weeks after operation
Blood routine test will be conducted in our hospital. And then the value of white blood cell count will be recorded.
Time frame: 2 weeks after operation
Test of lymphocyte count at 2 weeks after operation
Blood routine test will be conducted in our hospital. And then the value of lymphocyte count will be recorded.
Time frame: 2 weeks after operation
Test of red blood cell count at 2 weeks after operation
Blood routine test will be conducted in our hospital. And then the value of red blood cell count will be recorded.
Time frame: 2 weeks after operation
Test of hemoglobin concentration at 2 weeks after operation
Blood routine test will be conducted in our hospital. And then the value of hemoglobin concentration will be recorded.
Time frame: 2 weeks after operation
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Test of platelet count at 2 weeks after operation
Blood routine test will be conducted in our hospital. And then the value of platelet count will be recorded.
Time frame: 2 weeks after operation
Test of alanine aminotransferase at 2 weeks after operation
Liver function test will be conducted in our hospital. And then the value of alanine aminotransferase will be recorded.
Time frame: 2 weeks after operation
Test of aspartate aminotransferase at 2 weeks after operation
Liver function test will be conducted in our hospital. And then the value of aspartate aminotransferase will be recorded.
Time frame: 2 weeks after operation
Test of serum creatinine at 2 weeks after operation
Kidney function test will be conducted in our hospital. And then the value of serum creatinine will be recorded.
Time frame: 2 weeks after operation
Test of blood urea nitrogen at 2 weeks after operation
Kidney function test will be conducted in our hospital. And then the value of blood urea nitrogen will be recorded.
Time frame: 2 weeks after operation
Test of prothrombin time at 2 weeks after operation
Hemagglutination series test will be conducted in our hospital. And then the value of prothrombin time will be recorded.
Time frame: 2 weeks after operation
Test of activated partial thromboplastin time at 2 weeks after operation
Hemagglutination series test will be conducted in our hospital. And then the value of activated partial thromboplastin time will be recorded.
Time frame: 2 weeks after operation
Test of thrombin time at 2 weeks after operation
Hemagglutination series test will be conducted in our hospital. And then the value of thrombin time will be recorded.
Time frame: 2 weeks after operation
Examination of the position sense at 3 months after operation
The position sense of the area innervated by the repaired nerve will be examined by the designated doctor, which is a kind of deep sense.
Time frame: 3 months after operation
Examination of the movement sense at 3 months after operation
The movement sense of the area innervated by the repaired nerve will be examined by the designated doctor, which is another kind of deep sense.
Time frame: 3 months after operation
Examination of the sense of light touch at 3 months after operation
The sense of light touch of the area innervated by the repaired nerve will be examined by the designated doctor, which is one of the superficial sense categories.
Time frame: 3 months after operation
Examination of the sense of pain at 3 months after operation
The sense of pain of the area innervated by the repaired nerve will be examined by the designated doctor, which is another one of the superficial sense categories.
Time frame: 3 months after operation
Examination of the sense of temperature at 3 months after operation
The sense of temperature of the area innervated by the repaired nerve will be examined by the designated doctor, which also belongs to the superficial sense categories.
Time frame: 3 months after operation
Examination of static two-point discrimination at 3 months after operation
The static two-point discrimination of the area innervated by the repaired nerve will be examined by the designated doctor.
Time frame: 3 months after operation
Test of white blood cell count at 3 months after operation
Blood routine test will be conducted in our hospital. And then the value of white blood cell count will be recorded.
Time frame: 3 months after operation
Test of lymphocyte count at 3 months after operation
Blood routine test will be conducted in our hospital. And then the value of lymphocyte count will be recorded.
Time frame: 3 months after operation
Test of red blood cell count at 3 months after operation
Blood routine test will be conducted in our hospital. And then the value of red blood cell count will be recorded.
Time frame: 3 months after operation
Test of hemoglobin concentration at 3 months after operation
Blood routine test will be conducted in our hospital. And then the value of hemoglobin concentration will be recorded.
Time frame: 3 months after operation
Test of platelet count at 3 months after operation
Blood routine test will be conducted in our hospital. And then the value of platelet count will be recorded.
Time frame: 3 months after operation
Test of alanine aminotransferase at 3 months after operation
Liver function test will be conducted in our hospital. And then the value of alanine aminotransferase will be recorded.
Time frame: 3 months after operation
Test of aspartate aminotransferase at 3 months after operation
Liver function test will be conducted in our hospital. And then the value of aspartate aminotransferase will be recorded.
Time frame: 3 months after operation
Test of serum creatinine at 3 months after operation
Kidney function test will be conducted in our hospital. And then the value of serum creatinine will be recorded.
Time frame: 3 months after operation
Test of blood urea nitrogen at 3 months after operation
Kidney function test will be conducted in our hospital. And then the value of blood urea nitrogen will be recorded.
Time frame: 3 months after operation
Test of prothrombin time at 3 months after operation
Hemagglutination series test will be conducted in our hospital. And then the value of prothrombin time will be recorded.
Time frame: 3 months after operation
Test of activated partial thromboplastin time at 3 months after operation
Hemagglutination series test will be conducted in our hospital. And then the value of activated partial thromboplastin time will be recorded.
Time frame: 3 months after operation
Test of thrombin time at 3 months after operation
Hemagglutination series test will be conducted in our hospital. And then the value of thrombin time will be recorded.
Time frame: 3 months after operation
Examination of the position sense at 6 months after operation
The position sense of the area innervated by the repaired nerve will be examined by the designated doctor, which is a kind of deep sense.
Time frame: 6 months after operation
Examination of the movement sense at 6 months after operation
The movement sense of the area innervated by the repaired nerve will be examined by the designated doctor, which is another kind of deep sense.
Time frame: 6 months after operation
Examination of the sense of light touch at 6 months after operation
The sense of light touch of the area innervated by the repaired nerve will be examined by the designated doctor, which is one of the superficial sense categories.
Time frame: 6 months after operation
Examination of the sense of pain at 6 months after operation
The sense of pain of the area innervated by the repaired nerve will be examined by the designated doctor, which is another one of the superficial sense categories.
Time frame: 6 months after operation
Examination of the sense of temperature at 6 months after operation
The sense of temperature of the area innervated by the repaired nerve will be examined by the designated doctor, which also belongs to the superficial sense categories.
Time frame: 6 months after operation
Examination of static two-point discrimination at 6 months after operation
The static two-point discrimination of the area innervated by the repaired nerve will be examined by the designated doctor.
Time frame: 6 months after operation
Test of white blood cell count at 6 months after operation
Blood routine test will be conducted in our hospital. And then the value of white blood cell count will be recorded.
Time frame: 6 months after operation
Test of lymphocyte count at 6 months after operation
Blood routine test will be conducted in our hospital. And then the value of lymphocyte count will be recorded.
Time frame: 6 months after operation
Test of red blood cell count at 6 months after operation
Blood routine test will be conducted in our hospital. And then the value of red blood cell count will be recorded.
Time frame: 6 months after operation
Test of hemoglobin concentration at 6 months after operation
Blood routine test will be conducted in our hospital. And then the value of hemoglobin concentration will be recorded.
Time frame: 6 months after operation
Test of platelet count at 6 months after operation
Blood routine test will be conducted in our hospital. And then the value of platelet count will be recorded.
Time frame: 6 months after operation
Test of alanine aminotransferase at 6 months after operation
Liver function test will be conducted in our hospital. And then the value of alanine aminotransferase will be recorded.
Time frame: 6 months after operation
Test of aspartate aminotransferase at 6 months after operation
Liver function test will be conducted in our hospital. And then the value of aspartate aminotransferase will be recorded.
Time frame: 6 months after operation
Test of serum creatinine at 6 months after operation
Kidney function test will be conducted in our hospital. And then the value of serum creatinine will be recorded.
Time frame: 6 months after operation
Test of blood urea nitrogen at 6 months after operation
Kidney function test will be conducted in our hospital. And then the value of blood urea nitrogen will be recorded.
Time frame: 6 months after operation
Test of prothrombin time at 6 months after operation
Hemagglutination series test will be conducted in our hospital. And then the value of prothrombin time will be recorded.
Time frame: 6 months after operation
Test of activated partial thromboplastin time at 6 months after operation
Hemagglutination series test will be conducted in our hospital. And then the value of activated partial thromboplastin time will be recorded.
Time frame: 6 months after operation
Test of thrombin time at 6 months after operation
Hemagglutination series test will be conducted in our hospital. And then the value of thrombin time will be recorded.
Time frame: 6 months after operation