Back to resultsPreliminary Evaluation of the Clinical Safety and Effectiveness of the Bionic Nerve Scaffold
Primary Purpose
Peripheral Nerve Injuries
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
nerve scaffold
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Nerve Injuries focused on measuring scaffold, Peripheral nerve injures, repair, safety, effectiveness
Eligibility Criteria
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
Sites / Locations
- Xijing HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
nerve scaffold group
non-nerve scaffold group
Arm Description
the experimental group of cases with peripheral sensory nerve injuries will be treated with nerve scaffold.
the control group of cases will be treated without nerve scaffold.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03780855
Brief Title
Preliminary Evaluation of the Clinical Safety and Effectiveness of the Bionic Nerve Scaffold
Official Title
Preliminary Evaluation of the Safety and Effectiveness of the Bionic Nerve Scaffold With Longitudinally Oriented Microchannels in Clinical Application
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 14, 2017 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Nerve Injuries
Keywords
scaffold, Peripheral nerve injures, repair, safety, effectiveness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
nerve scaffold group
Arm Type
Experimental
Arm Description
the experimental group of cases with peripheral sensory nerve injuries will be treated with nerve scaffold.
Arm Title
non-nerve scaffold group
Arm Type
No Intervention
Arm Description
the control group of cases will be treated without nerve scaffold.
Intervention Type
Device
Intervention Name(s)
nerve scaffold
Intervention Description
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.
Primary Outcome Measure Information:
Title
Observing the condition of the healing of local wound with the naked eye at 2 weeks after operation，including redness, exudation and ulceration.
Description
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
Title
Learning about patients' systemic reactions by asking them at 2 weeks after operation, including fever, nausea, vomiting and skin itching.
Description
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
Title
Test of white blood cell count at 2 weeks after operation
Description
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
Title
Test of lymphocyte count at 2 weeks after operation
Description
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
Title
Test of red blood cell count at 2 weeks after operation
Description
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
Title
Test of hemoglobin concentration at 2 weeks after operation
Description
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
Title
Test of platelet count at 2 weeks after operation
Description
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
Title
Test of alanine aminotransferase at 2 weeks after operation
Description
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
Title
Test of aspartate aminotransferase at 2 weeks after operation
Description
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
Title
Test of serum creatinine at 2 weeks after operation
Description
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
Title
Test of blood urea nitrogen at 2 weeks after operation
Description
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
Title
Test of prothrombin time at 2 weeks after operation
Description
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
Title
Test of activated partial thromboplastin time at 2 weeks after operation
Description
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
Title
Test of thrombin time at 2 weeks after operation
Description
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
Title
Examination of the position sense at 3 months after operation
Description
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
Title
Examination of the movement sense at 3 months after operation
Description
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
Title
Examination of the sense of light touch at 3 months after operation
Description
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
Title
Examination of the sense of pain at 3 months after operation
Description
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
Title
Examination of the sense of temperature at 3 months after operation
Description
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
Title
Examination of static two-point discrimination at 3 months after operation
Description
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
Title
Test of white blood cell count at 3 months after operation
Description
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
Title
Test of lymphocyte count at 3 months after operation
Description
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
Title
Test of red blood cell count at 3 months after operation
Description
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
Title
Test of hemoglobin concentration at 3 months after operation
Description
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
Title
Test of platelet count at 3 months after operation
Description
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
Title
Test of alanine aminotransferase at 3 months after operation
Description
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
Title
Test of aspartate aminotransferase at 3 months after operation
Description
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
Title
Test of serum creatinine at 3 months after operation
Description
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
Title
Test of blood urea nitrogen at 3 months after operation
Description
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
Title
Test of prothrombin time at 3 months after operation
Description
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
Title
Test of activated partial thromboplastin time at 3 months after operation
Description
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
Title
Test of thrombin time at 3 months after operation
Description
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
Title
Examination of the position sense at 6 months after operation
Description
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
Title
Examination of the movement sense at 6 months after operation
Description
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
Title
Examination of the sense of light touch at 6 months after operation
Description
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
Title
Examination of the sense of pain at 6 months after operation
Description
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
Title
Examination of the sense of temperature at 6 months after operation
Description
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
Title
Examination of static two-point discrimination at 6 months after operation
Description
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
Title
Test of white blood cell count at 6 months after operation
Description
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
Title
Test of lymphocyte count at 6 months after operation
Description
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
Title
Test of red blood cell count at 6 months after operation
Description
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
Title
Test of hemoglobin concentration at 6 months after operation
Description
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
Title
Test of platelet count at 6 months after operation
Description
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
Title
Test of alanine aminotransferase at 6 months after operation
Description
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
Title
Test of aspartate aminotransferase at 6 months after operation
Description
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
Title
Test of serum creatinine at 6 months after operation
Description
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
Title
Test of blood urea nitrogen at 6 months after operation
Description
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
Title
Test of prothrombin time at 6 months after operation
Description
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
Title
Test of activated partial thromboplastin time at 6 months after operation
Description
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
Title
Test of thrombin time at 6 months after operation
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing h Huang, MD
Phone
13572066464
Email
huangjh@fmmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhuo j Luo, MD
Organizational Affiliation
Xijing Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Rui Cong, MD
Organizational Affiliation
Xijing Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Xijing Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing h Huang, MD
Phone
13572066464
Email
huangjh@fmmu.edu.cn
12. IPD Sharing Statement
Learn more about this trial
Preliminary Evaluation of the Clinical Safety and Effectiveness of the Bionic Nerve Scaffold
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