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

NCT02896439 | Terminated

• 1 other identifier: PESCIATIQUE
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery

Keywords

Traumatic; Acetabular

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (1)

Neurophysiological monitoring

EXPERIMENTAL

Device: Neurophysiological MONITORING

Interventions

Neurophysiological MONITORING 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

Neurophysiological monitoring

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

MeSH Terms

Interventions

Neurophysiological Monitoring

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Guillaume P RIOUALLLON, MD

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2016
• First Posted: September 12, 2016
• Study Start: May 15, 2015
• Primary Completion: March 7, 2019
• Study Completion: March 7, 2019
• Last Updated: March 8, 2019

Record last verified: 2019-03

Locations

FR (1)