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临床试验/NCT07749313
NCT07749313已完成不适用

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

Aswan University1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2024年1月15日最近更新:
适应症
干预措施

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

  • 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)

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

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

Experimental

necrotizing the free Gracilis by spinal accessory nerve

干预措施: spinal accessory nerve neurotization (Procedure)

Intercostal nerve group

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Osama Hassan Elbanna

Lecturer of plastic surgery

Aswan University

研究点 (1)

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