Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
COMPLETED
NCT07749313
NA

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

Sponsor: Aswan University

View on ClinicalTrials.gov

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)

Key Details

Gender

All

Age Range

4 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

22

Start Date

2024-01-15

Completion Date

2026-05-15

Last Updated

2026-08-06

Healthy Volunteers

No

Interventions

PROCEDURE

spinal accessory nerve neurotization

neurotizing free Gracilis muscle by Spinal accessory nerve

PROCEDURE

Intercostal nerve neurotization

neurotizing free Gracilis muscle by 3 intercostal nerves

Locations (1)

Aswan University Hospitals

Aswān, Aswan Governorate, Egypt