跳至主要内容
临床试验/NCT07046247
NCT07046247已完成不适用

Effect of Teflon Implant on Nerve Tissue and Its Relationship With Recurrences in the Treatment of Trigeminal Neuralgia by Microvascular Decompression, With Special Attention to the Method of Application: A Retrospective Clinical Study

University of Valencia1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年1月1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
150
试验地点
1
主要终点
Modified Ranking scale

研究概览

简要总结

The study aims to see if shredded Teflon placed away from the trigeminal nerve is equally effective in pain control in Trigeminal Neuralgia while minimizing the risks of pain recurrence due to granuloma formation when this material is placed immediately close to the nerve in a pledget form.

详细描述

Complications associated with Teflon implants in the treatment of Trigeminal Neuralgia have been reported, including granuloma formation and persistent neuroinflammation, which can mimic tumor recurrence or lead to renewed symptoms. These concerns underscore the importance of precise implant positioning and accurate volume control. At the reporting institution, the investigators have consistently used a technique involving minimal amounts of shredded Teflon placed around the offending vessel, positioned at a distance from the trigeminal nerve itself. The goal of this technique is to elicit localized arachnoiditis to stabilize the artery and prevent re-compression. To date, no published studies have directly correlated the amount and form of Teflon used with subsequent inflammation and recurrence, particularly with imaging-based validation. The present study seeks to address this gap by retrospectively analyzing the outcomes of microvascular decompression procedures performed using this specific Teflon application method, correlating clinical outcomes with MRI findings to assess the degree of inflammatory response and the likelihood of symptom recurrence.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

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

入选标准

  • •Trigeminal Neuralgia refractory to medical therapy and treated via microvascular decompression

排除标准

  • •Other craniofacial neuralgias, atypical facial pain, trigeminal neuralgia (TN) due to non-vascular causes (e.g., multiple sclerosis), and those with posterior fossa pathology, such as tumors, infarctions, hematomas, infections, or inflammatory lesions
  • •Patients treated by alternative methods, including percutaneous radiofrequency thermocoagulation, glycerol injection, balloon compression, or radiosurgery

研究组 & 干预措施

Teflon pledgets group

Is the group of patients submitted to microvascular decompression for trigeminal neuralgia in whom the material to separate the trigeminal nerve from the offending vessel will be Teflon, placed in the form of one or more pledgets between the nerve and the vessel.

干预措施: Microvascular decompression for trigeminal neuralgia (Procedure)

Shredded Teflon group

Is the group of patients submitted to microvascular decompression for trigeminal neuralgia in whom the material to separate the trigeminal nerve from the offending vessel will be shredded Teflon, placed around the displaced vessel away from the trigeminal nerve, aiming to induce a localized arachnoiditis away from the nerve that will fix the vessel in its new position, without any contact between the nerve and the vessel or the Teflon implant.

干预措施: Microvascular decompression for trigeminal neuralgia (Procedure)

结局指标

主要结局

Modified Ranking scale

时间窗: 5 years

The Modified Rankin Scale (mRS) will be used to evaluate neurological disability, ranging from 0 (no symptoms) to 6 (death)

Barrow Neurological Institute Pain Intensity Scale

时间窗: 5 years

The Barrow Neurological Institute (BNI) Pain Intensity Scale will be used to assess pain control, ranging from 1 (no pain, no medication) to 5 (severe pain without relief)

次要结局

未报告次要终点

研究者

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

Vicente Vanaclocha

University Professor

University of Valencia

研究点 (1)

Loading locations...

相似试验