Brachial Plexus InjuryNCT03162393
The Surgical Treatment of Total Brachial Plexus Avulsion Injury-A Retrospective Study of 73 Patients
An observational study of Brachial Plexus Injury, run by Huashan Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 60 years
- Conditions the study is for
- Brachial Plexus Injury
- What is being tested?
- nerve transfer
- Type of treatment
- Surgery or procedure
- How many people
- 73 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 31 Dec 2016
- 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 12 to 60 years
- All sexes
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- diabetes, Volkmann contracture, fracture on the affected limb, rib fracture, brain trauma.
About this study
Official title: 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.
Read the 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.
- Conditions
- Brachial Plexus Injury
- Being tested
- nerve transfer
- Keywords
- brachial plexus; avulsion injury
- Medical subject headings
- Fractures, Avulsion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nerve transferProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Procedure: nerve transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
physical examination
the motor and sensory function recovery of the recipient nerves
Measured: at least 3 years post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start1 Jan 2016
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brachial Plexus InjuryStudies of the same condition, open and under way.
- More trials run by Huashan 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kaiming Gao, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03162393
- Sponsor's protocol ID
- NSFC-H0605/81501871
- Status last verified
- May 2017
- First submitted
- 19 May 2017
- Last updated
- 22 May 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Optimal Surgical Strategy for the Treatment of Total Brachial Plexus Avulsion Injury Patients
- ClinicalTrials.gov ID
- NCT03162393
- Acronym / sponsor ID
- NSFC-H0605/81501871
- Conditions
- Brachial Plexus Injury
- Keywords
- brachial plexus; avulsion injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 22 May 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.
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.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | Procedure: nerve transferphrenic 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 | – | Procedure: nerve transferphrenic 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 | – | Procedure: nerve transferspinal 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 | – | Procedure: nerve transferspinal 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 | – | Procedure: nerve transferspinal 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 | – | Procedure: nerve transferspinal accessory transfer to suprascapular nerve; intercostal nerve transfer to musculocutaneous nerve and radial nerve; contralateral C7 nerve transfer to median nerve and triceps branch |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- diabetes, Volkmann contracture, fracture on the affected limb, rib fracture, brain trauma.
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 |
|---|---|---|
| nerve transfer | Procedure or surgery | group 1, group 2, group 3, group 4, group 5, group 6 |
Primary outcome
physical examination
Time frame: at least 3 years post-operative
the motor and sensory function recovery of the recipient nerves
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Brachial Plexus Injury, run by Huashan 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 1 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: finished, as of the sponsor's last update on 22 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
physical examination (time frame: at least 3 years post-operative). 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 22 May 2017.