Peripheral Nerve InjuriesNCT03359330
Mid-term Effect Observation of Biodegradable Conduit Small Gap Tublization Repairing Peripheral Nerve Injury
An observational study of Peripheral Nerve Injuries, run by Peking University People's Hospital.
Trial summary
To observe the Mid-term clinical effect of biodegradable conduit small gap tublization to repair peripheral nerve injury in multi-center． Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Peripheral Nerve Injuries
- What is being tested?
- Degradable Conduit Small Gap Tublization
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2018to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with fresh peripheral nerve injury in the upper extremities, requiring surgery
Who may be able to join
- fresh peripheral nerve injury in the upper extremities
Who cannot join
- acute myocardial infarction history within 6 months,
- old and pathological peripheral nerve injury,
- acute and chronic infection,
- various consumptive diseases
- unable to tolerate surgery
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multi-center Study on Mid-term Effect Observation of Biodegradable Conduit Small Gap Tublization Repairing Peripheral Nerve Injury
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．
- Conditions
- Peripheral Nerve Injuries
- Being tested
- Degradable Conduit Small Gap Tublization
- Keywords
- Peripheral nervous system diseases, Wounds and injuries, Nerve regeneration, Biocompatible materials, Surgical procedures
- Medical subject headings
- Peripheral Nerve Injuries, Peripheral Nervous System Diseases, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Degradable Conduit Small Gap TublizationOther
Degradable Conduit Small Gap Tublization Repairing Peripheral Nerve Injury
| Study group | Role | What they receive |
|---|---|---|
| Degradable conduit small gap tublization | patients with fresh peripheral nerve injury in the upper extremities,repaired with degradable conduit small gap tublization Receives: Other: Degradable Conduit Small Gap Tublization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nerve function 1
standard score methods provided by British Medical Research Council
Measured: 3 years after surgery
Secondary outcomes (1)
Nerve function 2
standard score methods provided by Shen Ningjiang Using MSA system
Measured: 3 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2017
- Study start1 Jan 2018 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Nerve InjuriesStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Peixun, Peking University People's Hospital
- Investigators
- Peixun Zhang, MD, Principal investigator, Department of orthopaedics and trauma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03359330
- Sponsor's protocol ID
- PKUPH-PNI
- Status last verified
- Nov 2017
- First submitted
- 26 Nov 2017
- Last updated
- 2 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Study on Mid-term Effect Observation of Biodegradable Conduit Small Gap Tublization Repairing Peripheral Nerve Injury
- ClinicalTrials.gov ID
- NCT03359330
- Acronym / sponsor ID
- PKUPH-PNI
- Conditions
- Peripheral Nerve Injuries
- Keywords
- Peripheral nervous system diseases, Wounds and injuries, Nerve regeneration, Biocompatible materials, Surgical procedures
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 2 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To observe the Mid-term clinical effect of biodegradable conduit small gap tublization to repair peripheral nerve injury in multi-center．
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．
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Degradable conduit small gap tublization | – | Other: Degradable Conduit Small Gap Tublizationpatients with fresh peripheral nerve injury in the upper extremities,repaired with degradable conduit small gap tublization |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with fresh peripheral nerve injury in the upper extremities, requiring surgery
Key inclusion criteria (1 listed)
- fresh peripheral nerve injury in the upper extremities
Key exclusion criteria (5 listed)
- acute myocardial infarction history within 6 months,
- old and pathological peripheral nerve injury,
- acute and chronic infection,
- various consumptive diseases
- unable to tolerate surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Degradable Conduit Small Gap TublizationDegradable Conduit Small Gap Tublization Repairing Peripheral Nerve Injury | Other | Degradable conduit small gap tublization |
Primary outcome
Nerve function 1
Time frame: 3 years after surgery
standard score methods provided by British Medical Research Council
1 secondary outcome
Nerve function 2
Time frame: 3 years after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peixun Zhang, MD principal investigator
Department of orthopaedics and trauma
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Nerve Injuries, run by Peking University People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peixun Zhang, MD (0118613611237628, zhangpeixun@126.comb), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nerve function 1 (time frame: 3 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2017.