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

NCT02896439 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2019-03-08

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Fondation Hôpital Saint-Joseph

    lead OTHER

Principal Investigators

  • Guillaume P RIOUALLLON, MD · Fondation Hôpital Saint-Joseph

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-05-15
Primary Completion
2019-03-07
Completion
2019-03-07

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02896439 on ClinicalTrials.gov