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临床试验/NCT06596629
NCT06596629已完成不适用

Nerve Transfers (reinnervation of the Posterior Interosseus Nerve and Anterior Interosseus Nerve) in Patients with Cervical Spinal Cord Injury: Duration Until Effect, Influence of Age and Impact of Time to Surgery on the Effect

Roessingh Research and Development1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2024年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
19
试验地点
1
主要终点
Duration until result of nerve transfers

研究概览

简要总结

The goal of this observational study is to learn about influencing factors on the clinical outcomes of nerve transfers used to restore hand function in patients with cervical spinal cord injury (CSCI). Specifically, the study focuses on the reinnervation of the posterior interosseus nerve (PIN) and the anterior interosseus nerve (AIN).

The main questions it aims to answer are:

  1. What is the duration after nerve transfer surgery until effect is achieved?
  2. What is the influence of the participants age during surgery on the effect of a nerve transfer?
  3. What is the impact of time interval from the date of spinal cord injury to the date of nerve transfer surgery?

Participants are not directly involved in this study since data will be retrospectively collected from the Electronic Patients Records (EPD).

详细描述

Spinal cord injury (SCI) has a profound impact on the quality of life. Patients with a cervical spinal cord injury (CSCI) additionally suffer from upper extremity impairments, leading to increased dependence on others for daily life activities and a further decline in quality of life. For many patients, improvement of hand function is therefore the highest-ranked goal in rehabilitation after CSCI. Conventionally, tendon transfers have been widely used to reconstruct upper extremity function. Over the past decade, there has been growing interest in employing nerve transfer techniques for reconstruction of upper limb function in tetraplegia. Specifically for reconstruction of hand function, reinnervation of the posterior interosseus nerve (PIN) provides restoration of extension of fingers and thumb, while reinnervation of the anterior interosseus nerve (AIN) is intended to restore flexion of thumb, index finger and middle finger.

Since previous studies already reported success rates for the different nerve transfers, this study will mainly focus on the factors influencing the clinical outcomes of the reinnervation of PIN and AIN in patients with cervical spinal cord injury. Specifically, the study will focus on the impact of age during surgery and the interval between spinal cord injury and surgery on clinical outcomes.

In this single-center retrospective case series, data will be collected from patients with a cervical spinal cord injury who underwent single or multiple nerve transfers in one or both upper limbs to reanimate the PIN and/or AIN. Informed consent is not required, as this study involves a retrospective analysis of anonymized data without any direct intervention or interaction with patients.

Data will be extracted from the Electronic Patient Records (EPD) at Roessingh. This data will be anonymized, by using exclusive numbers for all patients. The identifying information will be kept in a separate list only accessible by the lead researcher. In all analyses, only the patient specific codes will be used.

Baseline data will include age, gender and smoking habits. SCI related data compromises the date of injury, mechanism of injury, neurological level, motor level, grade of International Classification of Surgery of the Hand in Tetraplegia (ICSHT) and the American Spinal Injury Association (ASIA) grade. The specific surgeries performed and their dates will be recorded. Patients records will be reviewed to determine the dates of when the effect of nerve transfers were observed. Additionally, the number of treated limbs and the number of patients with limiting spasticity or restricted range of motion in the hands will be documented.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

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

入选标准

  • patients with cervical spinal cord injury
  • single or multiple nerve transfers in one or both upper limbs to reanimate the posterior interosseus nerve (PIN) or anterior interosseus nerve (AIN).
  • Surgery performed in Medical Spectrum Twente (MST) in Enschede.
  • Postoperative treatment in Roessingh, Centre for Rehabilitation (RCR) in Enschede.
  • Surgeries performed between February 2019 and February 2024.

排除标准

  • patients with pre-existing neurological comorbidities

结局指标

主要结局

Duration until result of nerve transfers

时间窗: up to 4 weeks

Defined as the time until 'first result' or 'desired result' is achieved following nerve transfer surgery. First result: defined as the first visible muscle contraction in the reinnervated muscles. For the posterior interosseus nerve (PIN), this includes any contraction of thumb and/or finger extension. For the anterior interosseus nerve (AIN), this refers to any visible flexion of thumb, index finger and middle fingers . Desired result: for reanimation of the posterior interosseus nerve (PIN), this is defined as the patient's ability to extent the thumb and fingers sufficiently to achieve a desirable hand opening. Successful reinnervation of the anterior interosseus nerve (AIN) will be documented when patients are able to flex the thumb and fingers to form a fist. Dates of first result, desired result and date of surgery will be extracted from patient's records. Duration after surgery until 'first result' and 'desired result' will be expressed in months.

次要结局

  • Age during surgery(Up to 4 weeks)
  • Time between spinal cord injury and nerve transfer surgery(Up to 4 weeks)

研究者

发起方
Roessingh Research and Development
申办方类型
Other
责任方
Sponsor

研究点 (1)

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