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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nerve scaffold group | Experimental | the experimental group of cases with peripheral sensory nerve injuries will be treated with nerve scaffold. |
|
| non-nerve scaffold group | No Intervention | the control group of cases will be treated without nerve scaffold. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nerve scaffold | Device | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Observing 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. | 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. | 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. | 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. | 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing h Huang, MD | Contact | 13572066464 | huangjh@fmmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Zhuo j Luo, MD | Xijing Hospital | Study Chair |
| Rui Cong, MD | Xijing Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospital | Recruiting | Xi'an | Shaanxi | 710032 | China |
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| ID | Term |
|---|---|
| D059348 | Peripheral Nerve Injuries |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| 2 weeks after operation |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 6 months after operation |
| D014947 | Wounds and Injuries |