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

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.

Study Overview

• Status: Terminated
• Conditions: Surgery
• Intervention / Treatment: Device: Neurophysiological MONITORING

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

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Ile-de-France
    • Paris, Ile-de-France, France, 75014
      • Groupe Hospitalier Paris Saint Joseph

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Neurophysiological monitoring

Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the score of electrophysiological intraoperative event	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)	Day -1 before surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Groupe Hospitalier Paris Saint Joseph
• Investigators: Principal Investigator: Guillaume P RIOUALLLON, MD, Groupe Hospitalier Paris Saint Joseph

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2015
• Primary Completion (Actual): March 7, 2019
• Study Completion (Actual): March 7, 2019

Study Registration Dates

• First Submitted: August 25, 2016
• First Submitted That Met QC Criteria: September 9, 2016
• First Posted (Estimate): September 12, 2016

Study Record Updates

• Last Update Posted (Actual): March 8, 2019
• Last Update Submitted That Met QC Criteria: March 7, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Traumatic; Acetabular
• Other Study ID Numbers: PESCIATIQUE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No