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CompletedNCT07749313Updated Aug 6, 2026

Evaluating Elbow Flexion After Free Functional Gracilis Muscle Transfer in Adult Brachial Plexus Lnjury

An interventional study of spinal accessory nerve neurotization and Intercostal nerve neurotization in Brachial Plexus Palsy, sponsored by Aswan University. Completed at 1 site in Egypt. Open to participants aged 4 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-08-06.

Sponsored by Aswan University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 6 months after the study started (first participant enrolled Jan 2024, registered Aug 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
4 Years to 50 Years
Sex
All
01

Study 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. 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)
02

Conditions studied

  • Brachial Plexus Palsy

Keywords

  • Free Functional Muscle Transfer
  • Brachial Plexus Injury
  • Spinal Accessory Nerve.
03

In context

Lead sponsor

Aswan University is the lead sponsor of 47 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • More than 12 months after injury

Exclusion criteria

Exclusion Criteria:

  • younger than 4 years
  • older than 50
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    Spinal acessory nerve neurotisation

    necrotizing the free Gracilis by spinal accessory nerve

    Procedure: spinal accessory nerve neurotization

  • Experimental
    Intercostal nerve group

    necrotizing the free Gracilis by 3 intercostal nerve

    Procedure: Intercostal nerve neurotization

Interventions

  • Procedurespinal accessory nerve neurotization

    neurotizing free Gracilis muscle by Spinal accessory nerve

  • ProcedureIntercostal nerve neurotization

    neurotizing free Gracilis muscle by 3 intercostal nerves

06

What researchers measure

Primary outcomes

  1. British Medical Research Council (BMRC) muscle power

    elbow flexion power using the British Medical Research Council (BMRC)

    Time frame: 18 months

Secondary outcomes

  1. active and passive range of motion degree

    active and passive range of motion degree

    Time frame: 18 months

  2. first detectable clinical sign of muscle contraction

    he time interval from surgery to the first detectable clinical sign of muscle contraction

    Time frame: 18 months

  3. time to achieve its maximum possible power following rehabilitation

    the time required for the transferred muscle to achieve its maximum possible power following rehabilitation

    Time frame: 18 months

07

Study locations

1 site
  • Aswan University Hospitals
    Aswān, Aswan Governorate 32337, Egypt
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07749313
Lead sponsor
Aswan University
Responsible party
Osama Hassan Elbanna (Lecturer of plastic surgery, Aswan University) — Principal investigator
First posted
Aug 6, 2026
Start date
Jan 15, 2024
Primary completion
Jan 15, 2025
Completion
May 15, 2026
Last update
Aug 6, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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