Evaluating Elbow Flexion After Free Functional Gracilis Muscle Transfer in Adult Brachial Plexus Lnjury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- British Medical Research Council (BMRC) muscle power
研究概览
简要总结
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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 .
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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).
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Secondary Objectives
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Evaluate active range of motion (AROM)
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Measure time to first detectable muscle contraction and time to maximum power
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Assess functional improvement via DASH scores
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Compare outcomes between ICN and SAN neurotization groups
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Compare outcomes between pediatric and adult patients
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Document complications, particularly elbow flexion contracture
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Key Inclusion Criteria
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Age 4-50 years
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Elbow flexion loss or severe weakness for >12 months following brachial plexus injury (obstetric or traumatic)
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Weak ipsilateral latissimus dorsi and pectoralis major (<M3), unsuitable for local muscle transfer
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Key Exclusion Criteria
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Age <4 years (microvascular anastomosis feasibility concerns)
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Age >50 years (diminished regenerative capacity)
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Presentation within 12 months of injury
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Reconstructable by local muscle or nerve transfer
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Elbow joint stiffness or contracture
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Uncontrolled comorbidities or inability to comply with rehabilitation
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Intervention
Gracilis FFMT harvested from the contralateral thigh with:
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**Neurotization:** ICNs (50%) or SAN (50%)
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**Vascular anastomosis:** Thoracoacromial artery (77%), thoracodorsal artery (13.6%), or subscapular artery (9.2%)
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**Muscle tensioning:** Elbow flexed 90-110° during inset
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Primary Outcome Measure Postoperative elbow flexion power (BMRC grade) at 24-month follow-up
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Secondary Outcome Measures
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Active range of motion (goniometry)
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Time to first clinical contraction
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Time to maximum power achievement
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DASH score
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Complication rate (flap loss, flexion contracture, scarring)
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Sample Size 22 patients (17 male, 5 female; mean age 13.4±8.7 years)
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Statistical Considerations
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Paired t-test for continuous outcomes
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Wilcoxon signed-rank test for non-parametric data
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Fisher's exact test for categorical comparisons
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Significance threshold: p<0.05
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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 .
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Trial Registration:** Not reported (retrospective/prospective case series design)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 50 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •More than 12 months after injury
排除标准
- •younger than 4 years
- •older than 50
研究组 & 干预措施
Spinal acessory nerve neurotisation
necrotizing the free Gracilis by spinal accessory nerve
干预措施: spinal accessory nerve neurotization (Procedure)
Intercostal nerve group
necrotizing the free Gracilis by 3 intercostal nerve
干预措施: Intercostal nerve neurotization (Procedure)
结局指标
主要结局
British Medical Research Council (BMRC) muscle power
时间窗: 18 months
elbow flexion power using the British Medical Research Council (BMRC)
次要结局
- 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)
研究者
Osama Hassan Elbanna
Lecturer of plastic surgery
Aswan University
