Clinical trial NCT02673320: Prospective Study for Delay in Surgical Treatment of Traumatic Cervical Central Cord Injury in Canal Stenosis
Official title: Prospective Study for Delay in Surgical Treatment of Traumatic Cervical Central Cord Injury in Canal Stenosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Traumatic Cervical Central Cord Syndrom Injury
Keywords: Acute Traumatic Cervical Central Cord Syndrom Injury
Delay of Surgery
Decompressive Surgery
Canal Stenosis
Schneider Syndrom
Quality of life
Functional Outcome
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2016-02-03
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The studied pathology concerns post traumatic cervical spinal cord contusion on narrow spinal canal.

The pathophysiology remains controversial. This pathology does not enjoy consensus support. Many questions remain regarding the surgical care and its delay.

The purpose of the study was to demonstrate non-inferiority of early surgical treatment compared to the same surgery performed with a delay among patients identified as having a cervical spinal cord contusion on posttraumatic narrowed cervical canal.

In the current state of knowledge and practices, the treatment of post traumatic spinal cord contusions on narrow spinal canal spinal decompression is performed remote diagnosis. The generally accepted delay is 15 days.

The surgical technique is a conventional cervical spinal decompression surgery. The type of decompression (anterior or posterior) is dependent on the compression and therefore the clinical radiological analysis. The choice of the technique and the surgical approach are therefore left to the discretion of the surgeon.

After completion of the clinical and radiological diagnosis of post-traumatic spinal cord contusion on narrow spinal canal, the patient was hospitalized in intensive care or in the Neurosurgery Service of the University Hospital concerned.

After anesthetic consultation determining the feasibility or not of surgery and in the absence of other vital injury or involving life-threatening, early surgery within 48 hours of diagnosis is then considered (according to the assigned group).

The surgical technique is a conventional cervical spinal decompression surgery. Way posterior surgery, laminectomy for spinal stenosis significant if greater than or equal to 3 floors will be preferred. In other cases, the type of surgery will be at the discretion of the surgeon and the opinion of the Staff Neurosurgery.

The surgical procedure is identical in the two groups. Alone, the delay of the surgery varies : less than 48 hours for the first group and 15 days for the second.

During the different monitoring visits (D0 (surgery), D7, M3, Y1 and Y2), the following criteria will be assessed : the quality and quickness of the motor and sensory recovery, the early post-operative evolution and the long and medium term evolution but also disability and functional sequelaes.


Eligibility criteria: Inclusion Criteria:

* Man or woman,
* Aged from 18 years old or over,
* Initial glasgow score ≥ 13,
* Initial ASIA score grade A-D,
* Scan of the cervical spine in bone windows
* Posttraumatic cervical spinal cord contusion on narrow cervical canal confirmed by MRI,
* Complete or incomplete tetraplegia on whiplash on narrow cervical canal,
* Patient's consent form (or, if appropriate, by an third party independent of the sponsor and the investigator in the case of physical disability to sign)
* Location of the stepped spinal cord injury C2 to t1,
* Affiliation to a social security system.

Exclusion Criteria:

* Nontraumatic narrow cervical canal,
* Nontraumatic not acute cervical myelopathy,
* Cervico brachial neuralgia,
* Contraindication to one of the methods studied, of a functional exploration, subject on exclusion period,
* Penetrating cervical-spinal wounds,
* Lesions threatening the vital prognosis and preventing the emergency decompression,
* Contraindications to MRI : Pacemaker or implantable defibrillator or pacemaker neurosensory, cochlear implants, ocular or cerebral ferromagnetic foreign body close to the nerve structures, metal prostheses, agitation of the patient : not cooperating or agitated patients, claustrophobic subjects, valves of neurosurgical ventriculoperitoneal shunt, dental braces,
* Pregnant women,
* Unconscious patients whose score ASIA is not feasible,
* Adults under a legal protection regime (guardianship, trusteeship, safeguard justice).

Primary outcomes:
measure: Score ASIA (American Spinal Injury Association)
timeFrame: 2 years
Secondary outcomes:
measure: Score ASIA (American Spinal Injury Association)
timeFrame: Day 0, Day 7, Month 3, Year 1 and Year 2
measure: Score WISCI II (Walking Index of Spinal Cord Injury)
timeFrame: Day 0, Day 7, Month 3, Year 1 and Year 2
measure: Score SCIM III (Spinal Cord Independence Measure)
timeFrame: Day 0, Day 7, Month 3, Year 1 and Year 2
measure: Score SF-36
timeFrame: Day 0, Day 7, Month 3, Year 1 and Year 2
measure: Score EVA (visual analog scale)
timeFrame: Day 0, Day 7, Month 3, Year 1 and Year 2
measure: Score DN4
timeFrame: Day 0, Day 7, Month 3, Year 1 and Year 2
measure: Urinary status
timeFrame: Day 0, Day 7, Month 3, Year 1 and Year 2
measure: Defecation status
timeFrame: Day 0, Day 7, Month 3, Year 1 and Year 2
measure: Cervical spinal cord injury
timeFrame: Day 0, Year 1
measure: Resuscitation complications
timeFrame: Day 0, Day 7, Month 3, Year 1 and Year 2
measure: Decubitus complications
timeFrame: Day 0, Day 7, Month 3, Year 1 and Year 2
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU d'Angers
city: Brest
country: France
facility: CHU de Brest
city: Marseille
country: France
facility: Hospital LA TIMONE
city: Nantes
country: France
facility: CHU de Nantes
city: Rennes
country: France
facility: CHU de Rennes
Study officials:
References: