- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03162393
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
Completed
Conditions
Intervention / Treatment
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
Observational
Enrollment (Actual)
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
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 |
Intervention / Treatment |
---|---|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
What is the study measuring?
Primary Outcome Measures
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
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)
January 1, 2016
Primary Completion (Actual)
December 31, 2016
Study Completion (Actual)
December 31, 2016
Study Registration Dates
First Submitted
May 19, 2017
First Submitted That Met QC Criteria
May 19, 2017
First Posted (Actual)
May 22, 2017
Study Record Updates
Last Update Posted (Actual)
May 22, 2017
Last Update Submitted That Met QC Criteria
May 19, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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.
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