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

NCT07749313 | Completed

• 1 other identifier: Asw.Uni. / 889 I L I 24
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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)

Conditions

Brachial Plexus Palsy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• British Medical Research Council (BMRC) muscle power

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

  18 months

Secondary Outcomes (3)

• active and passive range of motion degree

  18 months

• first detectable clinical sign of muscle contraction

  18 months

• time to achieve its maximum possible power following rehabilitation

  18 months

Study Arms (2)

Spinal acessory nerve neurotisation

EXPERIMENTAL

necrotizing the free Gracilis by spinal accessory nerve

Procedure: spinal accessory nerve neurotization

Intercostal nerve group

EXPERIMENTAL

necrotizing the free Gracilis by 3 intercostal nerve

Procedure: Intercostal nerve neurotization

Interventions

spinal accessory nerve neurotization PROCEDURE

neurotizing free Gracilis muscle by Spinal accessory nerve

Spinal acessory nerve neurotisation

Intercostal nerve neurotization PROCEDURE

neurotizing free Gracilis muscle by 3 intercostal nerves

Intercostal nerve group

Eligibility Criteria

• Age: 4 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• More than 12 months after injury

You may not qualify if:

• younger than 4 years
• older than 50

Sponsors & Collaborators

• Aswan University: lead

Study Sites (1)

Aswan University Hospitals

Aswān, Aswan Governorate, 32337, Egypt

Location

Related Publications (1)

• 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.

  PMID: 34842095 RESULT

Related Links

• free gracilis for brachial plexus palsy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of plastic surgery

Study Record Dates

• First Submitted: August 1, 2026
• First Posted: August 6, 2026
• Study Start: January 15, 2024
• Primary Completion: January 15, 2025
• Study Completion: May 15, 2026
• Last Updated: August 6, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)