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临床试验/CTRI/2025/07/090228
CTRI/2025/07/090228尚未招募3 期

Median Nerve Fascicle Transfer Versus Ulnar Nerve Fascicle Transfer to Biceps motor branch of Musculocutaneous nerve for Restoration of Elbow Flexion in Patients with C5 C6 C7 Brachial Plexus Root Injury: A Randomised Controlled Trial

All India Institute of Medical Sciences, Kalyani1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年8月1日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
elbow flexion strength and

研究概览

简要总结

Restoring elbow flexion is the primary goal in treating upper brachial plexus injury, especially when there is a damage to the C5,C6 roots with C7 compromise which results in a loss of brachialis and biceps function. Our study aims to compare median nerve fascicle vs ulnar nerve fascicle transfer to the motor branch of Biceps ( branch of Musculocutaneous nerve) in patients with fair hand function in whom double nerve transfer is not possible to optimize a surgical strategy for such patients.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • 1.Diagnosed with C5, C6, C7 brachial plexus injury (confirmed via clinical, electrodiagnostic, EMG, MRI/CT studies) with intact hand function.
  • 2.Absence of complete brachial plexus avulsion.
  • 3.Presenting to OPD between 3 to 12 months since the time of injury.
  • 4.Willing to follow up.

排除标准

  • Complete brachial plexus injury (C5–T1).
  • 2.Severe comorbidities affecting nerve recovery (like diabetes, peripheral neuropathy).
  • Previous trauma affecting the donor nerves.
  • Elbow joint arthrodesis
  • Displaced/ un displaced fracture of the said upper limb
  • Prior nerve transfer surgery for elbow flexion.

结局指标

主要结局

elbow flexion strength and

时间窗: at 2,4,6 months post operative

recovery of biceps muscle strength

时间窗: at 2,4,6 months post operative

次要结局

  • Rate of nerve growth at 2, 4 & 6th month with NCV study(Electromyographic evidence of reinnervation at 2, 4 & 6th month)

研究者

发起方
All India Institute of Medical Sciences, Kalyani
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Shrimoyee Roy

All India Institute of Medical Sciences, Kalyani

研究点 (1)

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