ClinicalTrials.gg
Status unknownNCT03359330Updated Dec 2, 2017

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

An observational study in Peripheral Nerve Injuries, sponsored by Peking University People's Hospital. Status unknown. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-12-02.

Sponsored by Peking University People's Hospital · Observational

The sponsor has not verified this record recently (last verified Nov 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

Read the detailed 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.

02

Conditions studied

  • Peripheral Nerve Injuries

Keywords

  • Peripheral nervous system diseases
  • Wounds and injuries
  • Nerve regeneration
  • Biocompatible materials
  • Surgical procedures
03

In context

Peripheral Nerve Injuries

90 studies on the registry are indexed under Peripheral Nerve Injuries; 24 are open to participants now.

This study's planned enrollment of 150 is above the median of 63 across 24 observational studies indexed under Peripheral Nerve Injuries.

Browse Peripheral Nerve Injuries studies →

Lead sponsor

Peking University People's Hospital is the lead sponsor of 609 studies on the registry; 247 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • fresh peripheral nerve injury in the upper extremities

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • OtherDegradable Conduit Small Gap Tublization

    Degradable Conduit Small Gap Tublization Repairing Peripheral Nerve Injury

06

What researchers measure

Primary outcomes

  1. Nerve function 1

    standard score methods provided by British Medical Research Council

    Time frame: 3 years after surgery

Secondary outcomes

  1. Nerve function 2

    standard score methods provided by Shen Ningjiang Using MSA system

    Time frame: 3 years after surgery

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jan 2018; primary completion for Dec 2021, 47 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 26, 2017
First posted
Dec 2, 2017
StartEst.
Jan 1, 2018
Primary completionEst.
Dec 31, 2021
CompletionEst.
Dec 31, 2021
Last update
Dec 2, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 2, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03359330
Responsible party
Zhang Peixun (Department of orthopaedics and trauma, Peking University People's Hospital) — Principal investigator
First posted
Dec 2, 2017
Start date
Jan 1, 2018 (estimated)
Primary completion
Dec 31, 2021 (estimated)
Completion
Dec 31, 2021 (estimated)
Last update
Dec 2, 2017

Study contacts

Peixun Zhang, MD
Contact
zhangpeixun@126.comb
0118613611237628
Peixun Zhang, MD
principal investigator · Department of orthopaedics and trauma

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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