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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07749313
Enrollment
22
Registered
2026-08-06
Start date
2024-01-15
Completion date
2026-05-15
Last updated
2026-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brachial Plexus Palsy

Keywords

Free Functional Muscle Transfer, Brachial Plexus Injury, Spinal Accessory Nerve.

Brief 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)

Interventions

PROCEDUREspinal accessory nerve neurotization

neurotizing free Gracilis muscle by Spinal accessory nerve

PROCEDUREIntercostal nerve neurotization

neurotizing free Gracilis muscle by 3 intercostal nerves

Sponsors

Aswan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
4 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

* More than 12 months after injury

Exclusion criteria

* younger than 4 years * older than 50

Design outcomes

Primary

MeasureTime frameDescription
British Medical Research Council (BMRC) muscle power18 monthselbow flexion power using the British Medical Research Council (BMRC)

Secondary

MeasureTime frameDescription
active and passive range of motion degree18 monthsactive and passive range of motion degree
first detectable clinical sign of muscle contraction18 monthshe time interval from surgery to the first detectable clinical sign of muscle contraction
time to achieve its maximum possible power following rehabilitation18 monthsthe time required for the transferred muscle to achieve its maximum possible power following rehabilitation

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 7, 2026