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