Brachial Plexus PalsyNCT07749313
Evaluating Elbow Flexion After Free Functional Gracilis Muscle Transfer in Adult Brachial Plexus Lnjury
A study testing spinal accessory nerve neurotization and Intercostal nerve neurotization in people with Brachial Plexus Palsy, run by Aswan University at 1 site in Egypt.
Trial summary
Study Overview This single-arm prospective clinical trial evaluates the efficacy of gracilis free functional muscle transfer (FFMT) for restoring elbow flexion in patients with late-presenting brachial plexus injuries (≥12 months post-injury) or failed prior reconstructive surgery. Read more about this study
- Who is it for?
- Ages 4 to 50 years
- Conditions the study is for
- Brachial Plexus Palsy
- What is being tested?
- spinal accessory nerve neurotization and Intercostal nerve neurotization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2024to 15 May 2026
- Phase
- Interventional
- 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 4 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- More than 12 months after injury
Who cannot join
- younger than 4 years
- older than 50
Trial locations and contacts
1 site in 1 country.
About this study
- Study Overview This single-arm prospective clinical trial evaluates the efficacy of gracilis free functional muscle transfer (FFMT) for restoring elbow flexion in patients with late-presenting brachial plexus injuries (≥12 months post-injury) or failed prior reconstructive surgery. The gracilis muscle is the preferred donor due to its reliable vascular pedicle, adequate excursion, long motor nerve, and minimal donor-site morbidity .
- Primary Objective To assess postoperative elbow flexion strength using the British Medical Research Council (BMRC) grading system following gracilis FFMT neurotized by intercostal nerves (ICN) or spinal accessory nerve (SAN).
- Secondary Objectives
- Evaluate active range of motion (AROM)
- Measure time to first detectable muscle contraction and time to maximum power
- Assess functional improvement via DASH scores
- Compare outcomes between ICN and SAN neurotization groups
- Compare outcomes between pediatric and adult patients
- Document complications, particularly elbow flexion contracture
- Key Inclusion Criteria
- Age 4-50 years
- Elbow flexion loss or severe weakness for >12 months following brachial plexus injury (obstetric or traumatic)
- Weak ipsilateral latissimus dorsi and pectoralis major (<M3), unsuitable for local muscle transfer
- Key Exclusion Criteria
- Age <4 years (microvascular anastomosis feasibility concerns)
- Age >50 years (diminished regenerative capacity)
- Presentation within 12 months of injury
- Reconstructable by local muscle or nerve transfer
- Elbow joint stiffness or contracture
- Uncontrolled comorbidities or inability to comply with rehabilitation
- Intervention
Gracilis FFMT harvested from the contralateral thigh with:
- Neurotization: ICNs (50%) or SAN (50%)
- Vascular anastomosis: Thoracoacromial artery (77%), thoracodorsal artery (13.6%), or subscapular artery (9.2%)
- Muscle tensioning: Elbow flexed 90-110° during inset
- Primary Outcome Measure Postoperative elbow flexion power (BMRC grade) at 24-month follow-up
- Secondary Outcome Measures
- Active range of motion (goniometry)
- Time to first clinical contraction
- Time to maximum power achievement
- DASH score
- Complication rate (flap loss, flexion contracture, scarring)
- Sample Size 22 patients (17 male, 5 female; mean age 13.4±8.7 years)
- Statistical Considerations
- Paired t-test for continuous outcomes
- Wilcoxon signed-rank test for non-parametric data
- Fisher's exact test for categorical comparisons
- Significance threshold: p<0.05
- Expected Outcomes Based on existing literature, 68-76% of patients achieve functionally useful elbow flexion (≥M3) following gracilis FFMT, with significant improvements in AROM and DASH scores . ICN neurotization may offer faster recovery to maximum power (approximately 9 months vs. 14 months for SAN) without compromising final strength .
- Trial Registration:** Not reported (retrospective/prospective case series design)
- Conditions
- Brachial Plexus Palsy
- Being tested
- spinal accessory nerve neurotization, Intercostal nerve neurotization
- Keywords
- Free Functional Muscle Transfer, Brachial Plexus Injury, Spinal Accessory Nerve.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal accessory nerve neurotizationProcedure or surgery
neurotizing free Gracilis muscle by Spinal accessory nerve
Intercostal nerve neurotizationProcedure or surgery
neurotizing free Gracilis muscle by 3 intercostal nerves
| Study group | Role | What they receive |
|---|---|---|
| Spinal acessory nerve neurotisation | Experimental | necrotizing the free Gracilis by spinal accessory nerve Receives: Procedure: spinal accessory nerve neurotization |
| Intercostal nerve group | Experimental | necrotizing the free Gracilis by 3 intercostal nerve Receives: Procedure: Intercostal nerve neurotization |
What is being measured
The primary outcome is the main question the study is designed to answer.
British Medical Research Council (BMRC) muscle power
elbow flexion power using the British Medical Research Council (BMRC)
Measured: 18 months
Secondary outcomes (3)
active and passive range of motion degree
active and passive range of motion degree
Measured: 18 months
first detectable clinical sign of muscle contraction
he time interval from surgery to the first detectable clinical sign of muscle contraction
Measured: 18 months
time to achieve its maximum possible power following rehabilitation
the time required for the transferred muscle to achieve its maximum possible power following rehabilitation
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start15 Jan 2024
- Primary completion15 Jan 2025
- Study completion15 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brachial Plexus PalsyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aswan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osama Hassan Elbanna, Aswan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07749313
- Sponsor's protocol ID
- Asw.Uni. / 889 I L I 24
- Status last verified
- Aug 2026
- First submitted
- 1 Aug 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Armangil M, Unsal SS, Yildirim T, Bezirgan U, Keremov A, Adiyaman S, Bilgin SS. Outcome of free gracilis muscle transfer for the restoration of elbow flexion in traumatic brachial plexus palsy. Jt Dis Relat Surg. 2021;32(3):633-641. doi: 10.52312/jdrs.2021.225. Epub 2021 Nov 19.
PubMed 34842095
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Elbow Flexion After Free Functional Gracilis Muscle Transfer in Adult Brachial Plexus Lnjury
- ClinicalTrials.gov ID
- NCT07749313
- Acronym / sponsor ID
- Asw.Uni. / 889 I L I 24
- Conditions
- Brachial Plexus Palsy
- Keywords
- Free Functional Muscle Transfer, Brachial Plexus Injury, Spinal Accessory Nerve.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Aswan UniversityUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 15 May 2026 (actual)
- First posted
- 6 Aug 2026 (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.
- Study Overview This single-arm prospective clinical trial evaluates the efficacy of gracilis free functional muscle transfer (FFMT) for restoring elbow flexion in patients with late-presenting brachial plexus injuries (≥12 months post-injury) or failed prior reconstructive surgery. The gracilis muscle is the preferred donor due to its reliable vascular pedicle, adequate excursion, long motor nerve, and minimal donor-site morbidity .
- Primary Objective To assess postoperative elbow flexion strength using the British Medical Research Council (BMRC) grading system following gracilis FFMT neurotized by intercostal nerves (ICN) or spinal accessory nerve (SAN).
- Secondary Objectives
- Evaluate active range of motion (AROM)
- Measure time to first detectable muscle contraction and time to maximum power
- Assess functional improvement via DASH scores
- Compare outcomes between ICN and SAN neurotization groups
- Compare outcomes between pediatric and adult patients
- Document complications, particularly elbow flexion contracture
- Key Inclusion Criteria
- Age 4-50 years
- Elbow flexion loss or severe weakness for >12 months following brachial plexus injury (obstetric or traumatic)
- Weak ipsilateral latissimus dorsi and pectoralis major (<M3), unsuitable for local muscle transfer
- Key Exclusion Criteria
- Age <4 years (microvascular anastomosis feasibility concerns)
- Age >50 years (diminished regenerative capacity)
- Presentation within 12 months of injury
- Reconstructable by local muscle or nerve transfer
- Elbow joint stiffness or contracture
- Uncontrolled comorbidities or inability to comply with rehabilitation
- Intervention
Gracilis FFMT harvested from the contralateral thigh with:
- Neurotization: ICNs (50%) or SAN (50%)
- Vascular anastomosis: Thoracoacromial artery (77%), thoracodorsal artery (13.6%), or subscapular artery (9.2%)
- Muscle tensioning: Elbow flexed 90-110° during inset
- Primary Outcome Measure Postoperative elbow flexion power (BMRC grade) at 24-month follow-up
- Secondary Outcome Measures
- Active range of motion (goniometry)
- Time to first clinical contraction
- Time to maximum power achievement
- DASH score
- Complication rate (flap loss, flexion contracture, scarring)
- Sample Size 22 patients (17 male, 5 female; mean age 13.4±8.7 years)
- Statistical Considerations
- Paired t-test for continuous outcomes
- Wilcoxon signed-rank test for non-parametric data
- Fisher's exact test for categorical comparisons
- Significance threshold: p<0.05
- Expected Outcomes Based on existing literature, 68-76% of patients achieve functionally useful elbow flexion (≥M3) following gracilis FFMT, with significant improvements in AROM and DASH scores . ICN neurotization may offer faster recovery to maximum power (approximately 9 months vs. 14 months for SAN) without compromising final strength .
- Trial Registration:** Not reported (retrospective/prospective case series design)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal acessory nerve neurotisation | Experimental | Procedure: spinal accessory nerve neurotizationnecrotizing the free Gracilis by spinal accessory nerve |
| Intercostal nerve group | Experimental | Procedure: Intercostal nerve neurotizationnecrotizing the free Gracilis by 3 intercostal nerve |
Who may qualify
- Ages
- 4 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- More than 12 months after injury
Key exclusion criteria (2 listed)
- younger than 4 years
- older than 50
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 |
|---|---|---|
| spinal accessory nerve neurotizationneurotizing free Gracilis muscle by Spinal accessory nerve | Procedure or surgery | Spinal acessory nerve neurotisation |
| Intercostal nerve neurotizationneurotizing free Gracilis muscle by 3 intercostal nerves | Procedure or surgery | Intercostal nerve group |
Primary outcome
British Medical Research Council (BMRC) muscle power
Time frame: 18 months
elbow flexion power using the British Medical Research Council (BMRC)
3 secondary outcomes
active and passive range of motion degree
Time frame: 18 months
first detectable clinical sign of muscle contraction
Time frame: 18 months
time to achieve its maximum possible power following rehabilitation
Time frame: 18 months
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 6 Aug 2026.
- Results publication: PubMed 34842095Armangil M, Unsal SS, Yildirim T, Bezirgan U, Keremov A, Adiyaman S, Bilgin SS. Outcome of free gracilis muscle transfer for the restoration of elbow flexion in traumatic brachial plexus palsy. Jt Dis Relat Surg. 2021;32(3):633-641. doi: 10.52312/jdrs.2021.225. Epub 2021 Nov 19.
- free gracilis for brachial plexus palsyLink provided by the sponsor.
- 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.
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?
A study testing spinal accessory nerve neurotization and Intercostal nerve neurotization in people with Brachial Plexus Palsy, run by Aswan University at 1 site in Egypt.
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 2 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 6 Aug 2026. 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 Egypt. 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?
British Medical Research Council (BMRC) muscle power (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07749313, which also lists 1 linked publication.
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 6 Aug 2026.