Aswan University Hospitals
Aswān, Aswan Governorate, 32337, Egypt
NCT Number: NCT07749313
* 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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Notify Me4 year–50 year
All sexes
Interventional
Not applicable
Aswān, Aswan Governorate, 32337, Egypt
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
neurotizing free Gracilis muscle by Spinal accessory nerve
neurotizing free Gracilis muscle by 3 intercostal nerves
Time frame: 18 months
elbow flexion power using the British Medical Research Council (BMRC)
Time frame: 18 months
active and passive range of motion degree
Time frame: 18 months
he time interval from surgery to the first detectable clinical sign of muscle contraction
Time frame: 18 months
the time required for the transferred muscle to achieve its maximum possible power following rehabilitation
Aswan University
Other
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