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NCT03359330 Clinical Trial

Mid-term Effect Observation of Biodegradable Conduit Small Gap Tublization Repairing Peripheral Nerve Injury

Peripheral Nerve Injuries Clinical Trial

Official title:
A Multi-center Study on Mid-term Effect Observation of Biodegradable Conduit Small Gap Tublization Repairing Peripheral Nerve Injury

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03359330
Other study ID # PKUPH-PNI
Secondary ID
Status Not yet recruiting
Phase N/A
First received November 26, 2017
Last updated November 30, 2017
Start date January 1, 2018
Est. completion date December 31, 2021

Study information
Verified date November 2017
Source Peking University People's Hospital
Contact Peixun Zhang, MD
Phone 0118613611237628
Email zhangpeixun@126.comb
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To observe the Mid-term clinical effect of biodegradable conduit small gap tublization to repair peripheral nerve injury in multi-center．

Description:

In the study，150 cases of fresh peripheral nerve injury in the upper extremities are recruited in multi-center． After formally informed and obtaining the consent，the biodegradable conduit small gap tublization are used to repair the nerve．Their nerve functional recovery conditions are clinically observed according to the standard score methods provided by SHEN Ning-jiang and British Medical Research Council at 3 years after surgery．The excellent and good rates of the overall nerve functional recovery are calculated．

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 150
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- fresh peripheral nerve injury in the upper extremities

Exclusion Criteria:

- acute myocardial infarction history within 6 months,

- old and pathological peripheral nerve injury,

- acute and chronic infection,

- various consumptive diseases

- unable to tolerate surgery

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Degradable Conduit Small Gap Tublization
Degradable Conduit Small Gap Tublization Repairing Peripheral Nerve Injury

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Peking University People's Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Nerve function 1 standard score methods provided by British Medical Research Council 3 years after surgery
Secondary Nerve function 2 standard score methods provided by Shen Ningjiang Using MSA system 3 years after surgery
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