The Surgical Treatment of Total Brachial Plexus Avulsion Injury-A Retrospective Study of 73 Patients

May 19, 2017 updated by: Kaiming Gao, Huashan Hospital

The Optimal Surgical Strategy for the Treatment of Total Brachial Plexus Avulsion Injury Patients

Brachial plexus avulsion injury (BPAI) caused by traction injury, especially total root avulsion, represents a severe handicap for the patient. Despite recent progress in diagnosis and microsurgical repair, the prognosis in such cases remains unfavorable. We need to find an relatively optimal surgical treatment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Brachial plexus avulsion injury (BPAI) caused by traction injury, especially total root avulsion, represents a severe handicap for the patient. Despite recent progress in diagnosis and microsurgical repair, the prognosis in such cases remains unfavorable. Nerve transfer is the most successful method for repairing cases of brachial plexus root avulsion. Phrenic nerve transfer, accessory nerve transfer, intercostal nerve transfer and contralateral C7 transfer are all well-established technique in the treatment of certain severe brachial plexus lesions in adults. As reported in previous articles, shoulder function, elbow flexion, elbow extension, and wrist and finger function have been restored successfully by spinal accessory, phrenic, intercostal, and contralateral C7 nerve transfers . However, the results of just one function reconstruction were evaluated in those articles. Few studies were found that focused on the whole function reconstructions of the affected limb. In different medical organizations even in our department, many different surgical strategies were used in treating total BPAI patients and the results differed significantly. Here, we investigated the results of different commonly used nerve transfer in order to determine a relatively optimal surgical strategy for treatment of total BPAI patients.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
73

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Between 1999 and 2006, a total of approximately 200 patients with posttraumatic total BPAI underwent surgical exploration and reconstruction of the brachial plexus and 109 agreed to participate in our study. Seventy-three patients were enrolled and 36 were excluded.

Description

Inclusion Criteria:

  • global root avulsion brachial plexus injury, a minimum postoperative interval of 3 years, all operations performed by the same medical team, nerve transfer was the only reconstruction method.

Exclusion Criteria:

  • diabetes, Volkmann contracture, fracture on the affected limb, rib fracture, brain trauma.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
group 1
phrenic nerve transfer to musculocutaneous nerve; spinal accessory transfer to suprascapular nerve; intercostal nerve transfer to triceps branch, radial nerve and axillary nerve; contralateral C7 nerve transfer to median nerve
Procedure: nerve transfer
group 2
phrenic nerve transfer to musculocutaneous nerve; spinal accessory transfer to suprascapular nerve; intercostal nerve transfer to triceps branch and radial nerve; contralateral C7 nerve transfer to median nerve
Procedure: nerve transfer
group 3
spinal accessory transfer to suprascapular nerve; intercostal nerve transfer to triceps branch, radial nerve and axillary nerve; contralateral C7 nerve transfer to median nerve and musculocutaneous nerve
Procedure: nerve transfer
group 4
spinal accessory transfer to suprascapular nerve; intercostal nerve transfer to triceps branch and radial nerve; contralateral C7 nerve transfer to median nerve and musculocutaneous nerve
Procedure: nerve transfer
group 5
spinal accessory transfer to suprascapular nerve; intercostal nerve transfer to musculocutaneous nerve, radial nerve and axillary nerve; contralateral C7 nerve transfer to median nerve and triceps branch
Procedure: nerve transfer
group 6
spinal accessory transfer to suprascapular nerve; intercostal nerve transfer to musculocutaneous nerve and radial nerve; contralateral C7 nerve transfer to median nerve and triceps branch
Procedure: nerve transfer

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
physical examination
Time Frame: at least 3 years post-operative
the motor and sensory function recovery of the recipient nerves
at least 3 years post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Huashan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 19, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 22, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NSFC-H0605/81501871

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Brachial Plexus Injury

Clinical Trials on nerve transfer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings