SurgeryPESCIATIQUENCT02896439
Protocol for Evaluation Effectiveness Monitoring Neurophysiological Per-operative in Surgery Traumatic Acetabular
A study testing Neurophysiological MONITORING in people with Surgery, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Surgery
- What is being tested?
- Neurophysiological MONITORING
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 15 May 2015to 7 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Known diabetes treated
- Previous history of spine surgery
- Sick antecedent the peripheral or central nervous system known
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
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.
Read the 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
- Being tested
- Neurophysiological MONITORING
- Keywords
- Traumatic, Acetabular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurophysiological MONITORINGDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Neurophysiological monitoring | Experimental | Not described Receives: Device: Neurophysiological MONITORING |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- 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)
Measured: Day -1 before surgery
Secondary outcomes (2)
Assessment of change of sensitivity: according to the quotation of the ASIA score
Measured: Day 2, Month 3, Month 6 et Month 12
Assessment of change of Pain (VAS) Visual Assessment Scale
Measured: Day 2, Month 3, Month 6 et Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study start15 May 2015
- Primary completion7 Mar 2019
- Study completion7 Mar 2019
Why it stopped: The principal investigator decided to stop the research.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume P RIOUALLLON, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02896439
- Sponsor's protocol ID
- PESCIATIQUE
- Acronym
- PESCIATIQUE
- Status last verified
- Mar 2019
- First submitted
- 25 Aug 2016
- Last updated
- 8 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for Evaluation Effectiveness Monitoring Neurophysiological Per-operative in Surgery Traumatic Acetabular
- ClinicalTrials.gov ID
- NCT02896439
- Acronym / sponsor ID
- PESCIATIQUE / PESCIATIQUE
- Conditions
- Surgery
- Keywords
- Traumatic, Acetabular
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The principal investigator decided to stop the research.
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 15 May 2015 (actual)
- Primary completion
- 7 Mar 2019 (actual)
- Study completion
- 7 Mar 2019 (actual)
- First posted
- 12 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neurophysiological monitoring | Experimental | Device: Neurophysiological MONITORING |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Known diabetes treated
- Previous history of spine surgery
- Sick antecedent the peripheral or central nervous system known
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurophysiological MONITORINGThe 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 | Device | Neurophysiological monitoring |
Primary outcome
Assessment of the score of electrophysiological intraoperative event
Time frame: Day -1 before surgery
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)
2 secondary outcomes
Assessment of change of sensitivity: according to the quotation of the ASIA score
Time frame: Day 2, Month 3, Month 6 et Month 12
Assessment of change of Pain (VAS) Visual Assessment Scale
Time frame: Day 2, Month 3, Month 6 et Month 12
Results and safety
The study was stopped early (reason given: The principal investigator decided to stop the research.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume P RIOUALLLON, MD principal investigator
Fondation Hôpital Saint-Joseph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurophysiological MONITORING in people with Surgery, run by Fondation Hôpital Saint-Joseph at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The principal investigator decided to stop the research.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the score of electrophysiological intraoperative event (time frame: Day -1 before surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2019.