NCT03359330

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 2, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

December 2, 2017

Status Verified

November 1, 2017

Enrollment Period

4 years

First QC Date

November 26, 2017

Last Update Submit

November 30, 2017

Conditions

Peripheral Nerve Injuries

Keywords

Peripheral nervous system diseasesWounds and injuriesNerve regenerationBiocompatible materialsSurgical procedures

Outcome Measures

Primary Outcomes (1)

  • Nerve function 1

    standard score methods provided by British Medical Research Council

    3 years after surgery

Secondary Outcomes (1)

  • Nerve function 2

    3 years after surgery

Study Arms (1)

Degradable conduit small gap tublization

patients with fresh peripheral nerve injury in the upper extremities,repaired with degradable conduit small gap tublization

Other: Degradable Conduit Small Gap Tublization

Interventions

Degradable Conduit Small Gap TublizationOTHER

Degradable Conduit Small Gap Tublization Repairing Peripheral Nerve Injury

Degradable conduit small gap tublization

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with fresh peripheral nerve injury in the upper extremities, requiring surgery

You may qualify if:

  • fresh peripheral nerve injury in the upper extremities

You may not qualify if:

  • acute myocardial infarction history within 6 months,
  • old and pathological peripheral nerve injury,
  • acute and chronic infection,
  • various consumptive diseases
  • unable to tolerate surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Peripheral Nerve InjuriesPeripheral Nervous System DiseasesWounds and Injuries

Condition Hierarchy (Ancestors)

Neuromuscular DiseasesNervous System DiseasesTrauma, Nervous System

Study Officials

  • Peixun Zhang, MD

    Department of orthopaedics and trauma

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peixun Zhang, MD

CONTACT

0118613611237628zhangpeixun@126.comb

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of orthopaedics and trauma

Study Record Dates

First Submitted

November 26, 2017

First Posted

December 2, 2017

Study Start

January 1, 2018

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

December 2, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share