Brachial Plexus InjuryNCT06237270
A Multicenter External Validation of a Novel Prediction Model for Elbow Flexion Recovery After Nerve Transfer Surgery in Brachial Plexus Injuries
An observational study of Brachial Plexus Injury, run by Siriraj Hospital at 1 site in Thailand.
Trial summary
The goal of this observational study is to validate a risk prediction model developed for unsuccessful elbow flexion recovery after nerve transfer surgery in patients with brachial plexus injury. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Brachial Plexus Injury
- What is being tested?
- Nerve transfer surgery for elbow flexion
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteThailand
- Study dates
- 18 Mar 2023to 1 May 2024
- 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Traumatic brachial plexus injury patients underwent nerve transfer operation
Who may be able to join
- Traumatic brachial plexus injury patients underwent nerve transfer operation for re-innervation of elbow flexion at Siriraj Hospital between 2018 and 2020 and Lerdsin General Hospital between 2008 and 2022
- Patients had follow-up duration at least 24 months after surgery
Who cannot join
- Incomplete medical records
- Patients underwent free functioning muscle transfer as primary surgery for elbow flexion
- Obstetric brachial plexus injury
- Radiation-induced brachial plexopathy
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkoknoi, Bangkok, 10700
About this study
The goal of this observational study is to validate a risk prediction model developed for unsuccessful elbow flexion recovery after nerve transfer surgery in patients with brachial plexus injury. The main question it aims to answer is how well a risk prediction model perform in a different dataset, which are patients with brachial plexus injury who underwent surgery in a different time period or a different hospital.
- Conditions
- Brachial Plexus Injury
- Being tested
- Nerve transfer surgery for elbow flexion
- Keywords
- nerve transfer, neurotization, brachial plexus injury, predictive factors, external validation, risk prediction model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve transfer surgery for elbow flexionProcedure or surgery
A functioning but less important nerve (e.g. spinal accessory nerve, phrenic nerve, fascicle of median nerve, or fascicle of ulnar nerve) was transferred to nerves innervating biceps or brachialis muscle to restore elbow flexion.
| Study group | Role | What they receive |
|---|---|---|
| Successful biceps recovery | Motor power more than or equal to grade 3 at 24 months after surgery Receives: Procedure: Nerve transfer surgery for elbow flexion | |
| Failure of biceps recovery | Motor power less than grade 3 at 24 months after surgery Receives: Procedure: Nerve transfer surgery for elbow flexion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with failure of biceps recovery at 24 months
Medical research council motor grading system of less than 3 at 24 months after surgery
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start18 Mar 2023
- Primary completion1 May 2024
- Study completion1 May 2024
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.
- 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
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siriraj Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Lerdsin General Hospital
- Responsible party
- Principal investigator, Panai Laohaprasitiporn, MD, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06237270
- Sponsor's protocol ID
- 123/2566(IRB1), LH671009
- Status last verified
- Jun 2024
- First submitted
- 23 Jan 2024
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Need a consensus from institute and colleagues
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter External Validation of a Novel Prediction Model for Elbow Flexion Recovery After Nerve Transfer Surgery in Brachial Plexus Injuries
- ClinicalTrials.gov ID
- NCT06237270
- Acronym / sponsor ID
- 123/2566(IRB1), LH671009
- Conditions
- Brachial Plexus Injury
- Keywords
- nerve transfer, neurotization, brachial plexus injury, predictive factors, external validation, risk prediction model
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Siriraj HospitalUniversity, hospital or other
- Collaborators
- Lerdsin General Hospital
- Study start
- 18 Mar 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 1 Feb 2024 (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.
The goal of this observational study is to validate a risk prediction model developed for unsuccessful elbow flexion recovery after nerve transfer surgery in patients with brachial plexus injury. The main question it aims to answer is how well a risk prediction model perform in a different dataset, which are patients with brachial plexus injury who underwent surgery in a different time period or a different hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Successful biceps recovery | – | Procedure: Nerve transfer surgery for elbow flexionMotor power more than or equal to grade 3 at 24 months after surgery |
| Failure of biceps recovery | – | Procedure: Nerve transfer surgery for elbow flexionMotor power less than grade 3 at 24 months after surgery |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Traumatic brachial plexus injury patients underwent nerve transfer operation
Key inclusion criteria (2 listed)
- Traumatic brachial plexus injury patients underwent nerve transfer operation for re-innervation of elbow flexion at Siriraj Hospital between 2018 and 2020 and Lerdsin General Hospital between 2008 and 2022
- Patients had follow-up duration at least 24 months after surgery
Key exclusion criteria (4 listed)
- Incomplete medical records
- Patients underwent free functioning muscle transfer as primary surgery for elbow flexion
- Obstetric brachial plexus injury
- Radiation-induced brachial plexopathy
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 surgery for elbow flexionA functioning but less important nerve (e.g. spinal accessory nerve, phrenic nerve, fascicle of median nerve, or fascicle of ulnar nerve) was transferred to nerves innervating biceps or brachialis muscle to restore elbow flexion. | Procedure or surgery | Failure of biceps recovery, Successful biceps recovery |
Primary outcome
Number of participants with failure of biceps recovery at 24 months
Time frame: 24 months
Medical research council motor grading system of less than 3 at 24 months after surgery
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 26 Jun 2025.
- Individual participant dataSharing planned: No. Need a consensus from institute and colleagues
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brachial Plexus Injury, run by Siriraj Hospital at 1 site in Thailand.
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 2 inclusion and 4 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 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Number of participants with failure of biceps recovery at 24 months (time frame: 24 months). 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 26 Jun 2025.