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临床试验/NCT02896439
NCT02896439终止不适用

Protocol for Evaluation Effectiveness Monitoring Neurophysiological Per-operative in Surgery Traumatic Acetabular

Fondation Hôpital Saint-Joseph1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2015年5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
终止
入组人数
35
试验地点
1
主要终点
Assessment of the score of electrophysiological intraoperative event

研究概览

简要总结

Pelvic fractures in which integrate the acetabulum fractures represent a risk of traumatic injury to the sciatic nerve trunk by stretching or section (1): Judet and Letournel reported a complication rate of around 6% (1). Fractures of the acetabulum strictly speaking are also providers of neurological complications with rates, significant, have recently been precisely detailed by a cohort study published by Lehmann et al. (2): In a series of 2073 patients, the authors reported an overall complication rate of neurological related to the initial trauma of the order of 4%. In this series, 1395 patients were operated with a rate of iatrogenic neurological complications of 2 to 3%. Regarding the first routes (and therefore the types of fractures), the Kocher-Langenbeck path is the path that leads to the greatest number of neurological complications: 3 to 4% in this series (2). However, this cohort study does not specify what truncal achievement it is. Obviously violations posterior acetabular are preferentially providers of sciatic injury while violations prior acetabular are more providers of obturator or femoral lesions. But this is not always the case. Moreover, this study does not specify the type or severity of neurological involvement.

详细描述

Methodology Design: This is an interventional study in routine care, prospective, single-center.

Main objective / secondary:

Primary objective :

To evaluate the sensitivity of the neurophysiological monitoring combining two specific new procedures to detect intraoperative complications on the sciatic trunk (by measuring potential with somatosensory storied collection of P15 and electromyographic recording with the potential of sciatic nerve in the popliteal fossa).

secondary objectives

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients sent to the Hospital Group Service Paris Saint Joseph for surgical treatment of fractures of the acetabulum.
  • •Anterior and posterior surgical first Routes
  • •Major Patient
  • •Age <60 years

排除标准

  • •Known diabetes treated
  • •Previous history of spine surgery
  • •Sick antecedent the peripheral or central nervous system known

研究组 & 干预措施

Neurophysiological monitoring

Experimental

干预措施: Neurophysiological MONITORING (Device)

结局指标

主要结局

Assessment of the score of electrophysiological intraoperative event

时间窗: Day -1 before surgery

The Score will be assessed between 1 to 3 (1= negative. 2= average, 3= good): * Potential to be studied subsequent stages, after averaging 500 successive traces to the following story: o popliteal Hollow: bipolar collection * Cathode medial, (1, 2 or 3 Point) * Anode side (1, 2 or 3 Point) * Recording the distal truncal response N8. (1, 2 or 3 Point) * Recorded values: * Latency N8 (1, 2 or 3 Point) * Amplitude o Basin bipolar collection, * Cathode: iliac crest to the stimulated nerve (1, 2 or 3 Point) * Anode: ipsilateral gluteal fold ((1, 2 or 3 Point) * Recording the P15 response. (1, 2 or 3 Point) * Recorded values: * Latency P15 (1, 2 or 3 Point) * P15 Amplitude (1, 2 or 3 Point) * Interval-P15 N8 (1, 2 or 3 Point) o Spinal cord dorsal low Bipolar collection * Cathode level D12 (1, 2 or 3 Point) * Umbilicus anode (1, 2 or 3 Point) * Saving the N22 potential. (1, 2 or 3 Point)

次要结局

  • Assessment of change of sensitivity: according to the quotation of the ASIA score(Day 2, Month 3, Month 6 et Month 12)
  • Assessment of change of Pain (VAS) Visual Assessment Scale(Day 2, Month 3, Month 6 et Month 12)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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