Clinical trial NCT02896439: Protocol for Evaluation Effectiveness Monitoring Neurophysiological Per-operative in Surgery Traumatic Acetabular
Official title: Protocol for Evaluation Effectiveness Monitoring Neurophysiological Per-operative in Surgery Traumatic Acetabular
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Surgery
Keywords: Traumatic
Acetabular
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2016-09-12
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: 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.

Detailed description: 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

Frequency of neurophysiological changes on the interventions of the acetabulum.

An anomaly being retained as:

* Interval prolongation N8-P15\> 10%
* And / or decrease in the amplitude ratio P15 / N22\> 50%
* And / or elongation of the latency of nerve potential\> 10% of the value-operative Opré
* And / or reducing the amplitude of the nerve potential\> 50% Correlation between the impact of changes neurophysiological intraoperative and
* The occurrence of postoperative neurological deficit:

  * motor deficit
  * and / or sensory deficit
  * territory of the sciatic trunk

Correlation between the incidence of intraoperative neurophysiological modifications and:

* The type of surgery
* The type of fracture

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Assessment of the score of electrophysiological intraoperative event
timeFrame: Day -1 before surgery
Secondary outcomes:
measure: Assessment of change of sensitivity: according to the quotation of the ASIA score
timeFrame: Day 2, Month 3, Month 6 et Month 12
measure: Assessment of change of Pain (VAS) Visual Assessment Scale
timeFrame: Day 2, Month 3, Month 6 et Month 12
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
affiliation: Fondation Hôpital Saint-Joseph
name: Guillaume P RIOUALLLON, MD
role: PRINCIPAL_INVESTIGATOR
References: