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Completed

NCT Number: NCT07749313

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

* 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)

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Key information

Age range

4 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aswan University Hospitals

Aswān, Aswan Governorate, 32337, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • More than 12 months after injury

Exclusion criteria

  • younger than 4 years
  • older than 50

Treatment and study plan

spinal accessory nerve neurotization

Procedure

neurotizing free Gracilis muscle by Spinal accessory nerve

Intercostal nerve neurotization

Procedure

neurotizing free Gracilis muscle by 3 intercostal nerves

Primary outcomes

  1. British Medical Research Council (BMRC) muscle power

    Time frame: 18 months

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

Secondary outcomes

  1. active and passive range of motion degree

    Time frame: 18 months

    active and passive range of motion degree

  2. first detectable clinical sign of muscle contraction

    Time frame: 18 months

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

  3. time to achieve its maximum possible power following rehabilitation

    Time frame: 18 months

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

Sponsors and collaborators

Lead sponsor

Aswan University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Aug 6, 2026
Registry last updated
Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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