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

NCT ID: NCT02896439

Last Updated: 2019-03-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-15
• Study Completion Date: 2019-03-07

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

Conditions

Surgery

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Neurophysiological monitoring

Group Type: EXPERIMENTAL

Neurophysiological MONITORING

Intervention Type: DEVICE

The neurophysiology team perform:

• Implementation of the stimulation electrodes and collection (needle electrodes) SEP and EMG as described above.
• Acquisition of data by the machine and the software Protektor® (Natus) in the following format:

A PES stimulation every 10 minutes consistently. Meanwhile, important surgical time and known to be at risk for neurological injury will be noted and their exact schedule specified:

• Establishment of a spacer or forceps in the greater or lesser sciatic notch
• Traction layout

For the ways of Kocher-Langenbeck, a collection of potential nerve sciatic trunk upstream of the critical region:

• At the end of the incision
• On the establishment of a spacer or forceps in the greater or lesser sciatic notch
• When towing layout
• At the end of the intervention

Interventions

Neurophysiological MONITORING

The neurophysiology team perform:

• Implementation of the stimulation electrodes and collection (needle electrodes) SEP and EMG as described above.
• Acquisition of data by the machine and the software Protektor® (Natus) in the following format:

A PES stimulation every 10 minutes consistently. Meanwhile, important surgical time and known to be at risk for neurological injury will be noted and their exact schedule specified:

• Establishment of a spacer or forceps in the greater or lesser sciatic notch
• Traction layout

For the ways of Kocher-Langenbeck, a collection of potential nerve sciatic trunk upstream of the critical region:

• At the end of the incision
• On the establishment of a spacer or forceps in the greater or lesser sciatic notch
• When towing layout
• At the end of the intervention

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fondation Hôpital Saint-Joseph

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guillaume P RIOUALLLON, MD

Role: PRINCIPAL_INVESTIGATOR

Fondation Hôpital Saint-Joseph

Locations

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, France

Countries

France

Other Identifiers

PESCIATIQUE

Identifier Type: -

Identifier Source: org_study_id