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临床试验/NCT04653129
NCT04653129Unknown不适用

Use of Autologous Fat to Improve Functional Outcomes After Upper Limb Nerve Injuries

Assiut University0 个研究点目标入组 44 人开始时间: 2021年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
44
主要终点
Modified British Medical Research Council, sensory grading

研究概览

简要总结

The aim of this study is to assess the efficacy of autologous fat graft in enhancing peripheral nerve regeneration. The investigators hypothesize that fat grafting will allow for faster and greater recovery of motor and sensory function following surgical repair of injured peripheral nerves.

详细描述

Traumatic injuries to peripheral nerves are a frequent finding after hand trauma. High morbidity after nerve injuries mainly affects the younger and working population, with consequent decrease in life quality and productivity .

Even in direct nerve repair and microsurgical nerve coaptation, regeneration is often suboptimal with incomplete target reinnervation. Suboptimal outcome is attributed to axonal degeneration, fibrotic scar formation, and neuromas at the site of injury.

The use of adipose tissue has become very popular in tissue engineering and reconstructive surgery in recent years. It is proposed as a "regenerative tool" for various tissues, including peripheral nerves, because it offers an effective and minimally invasive procedure for obtaining stem cells.

Unprocessed fat grafting can provide a simple approach to improve peripheral nerve regeneration by means of neoangiogenesis & inflammatory response modulation. Furthermore, it serves as a good protective barrier in peripheral nerve surgery, reducing fibrosis and adhesions.

A recent study advocated by Tuncel et al, concluded that combined use of autologous fat graft with surgical repair methods induced significantly better regeneration in rats [3]. In another study by Kilic et al, using adipose tissue flap in a crush injury model in rats was found to be superior to other groups in myelin thickness, nerve fiber density, axon count, and functional recovery at 4 weeks. They concluded that fat tissue seems to promote nerve regeneration because of its stem cell content.

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
Single (Outcomes Assessor)

盲法说明

the assessment of outcome measures will be performed by a dedicated surgeon not involved in the surgery or preoperative patient evaluation

入排标准

年龄范围
16 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Acute median or ulnar nerve lacerations below elbow

排除标准

  • Old Nerve lacerations > 48 hours
  • Nerve gap which requires nerve grafting
  • Psychosocial issues that would limit participation and compliance

结局指标

主要结局

Modified British Medical Research Council, sensory grading

时间窗: 6-12 months

standardized clinical assessment of sensory function using two-point discrimination and monofilament testing by a score from S0 to S4; the higher score indicates better sensation

Modified British Medical Research Council, motor grading

时间窗: 6-12 months

standardized clinical assessment of motor function on a scale from M0 to M5; the higher score indicates better strength.

次要结局

  • Nerve conduction study(6-12 months)
  • Disability of the Arm, Shoulder, and Hand (DASH) score(6-12 months)

研究者

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

Ahmed ElSayed Sharaf Ahmed

Assistant Lecturer

Assiut University

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Autologous Fat in Peripheral Nerve Injury | 临床试验