NCT02896439: PESCIATIQUE

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

Terminated NA Last updated 8 March 2019

What this trial tests

NA trial testing Neurophysiological MONITORING in Surgery in 35 participants. Terminated before completion.

Timeline

15 May 2015

Primary endpoint
7 March 2019

7 March 2019

Quick facts

Lead sponsor	Fondation Hôpital Saint-Joseph
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	screening
Enrollment	35
Start date	15 May 2015
Primary completion	7 March 2019
Estimated completion	7 March 2019
Sites	1 location across France

Drugs / interventions tested

• Neurophysiological MONITORING

Conditions studied

• Surgery — all drugs for Surgery →

Sponsor

Fondation Hôpital Saint-Joseph — full company profile →

Who can join

Adults 18 to 60, any sex, with Surgery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.