Prospective Study for Delay in Surgical Treatment of Traumatic Cervical Central Cord Injury in Canal Stenosis

Last updated: June 27, 2024
Sponsor: Nantes University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Delayed surgery at 15 days

Early surgery within 48 hours

Clinical Study ID

NCT02673320
RC15_0040
  • Ages > 18
  • All Genders

Study 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

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 byMRI,

  • Complete or incomplete tetraplegia on whiplash on narrow cervical canal,

  • Patient's consent form (or, if appropriate, by an third party independent of thesponsor 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

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, subjecton exclusion period,

  • Penetrating cervical-spinal wounds,

  • Lesions threatening the vital prognosis and preventing the emergency decompression,

  • Contraindications to MRI : Pacemaker or implantable defibrillator or pacemakerneurosensory, cochlear implants, ocular or cerebral ferromagnetic foreign body closeto the nerve structures, metal prostheses, agitation of the patient : notcooperating or agitated patients, claustrophobic subjects, valves of neurosurgicalventriculoperitoneal shunt, dental braces,

  • Pregnant women,

  • Unconscious patients whose score ASIA is not feasible,

  • Adults under a legal protection regime (guardianship, trusteeship, safeguardjustice).

Study Design

Total Participants: 72
Treatment Group(s): 2
Primary Treatment: Delayed surgery at 15 days
Phase:
Study Start date:
July 01, 2016
Estimated Completion Date:
July 31, 2027

Connect with a study center

  • CHU d'Angers

    Angers, 49933
    France

    Active - Recruiting

  • CHU de Besançon

    Besançon,
    France

    Site Not Available

  • CHU de Brest

    Brest,
    France

    Active - Recruiting

  • Hospital LA TIMONE

    Marseille,
    France

    Active - Recruiting

  • CHU de Nantes

    Nantes, 44000
    France

    Active - Recruiting

  • Chu Poitiers

    Poitiers,
    France

    Site Not Available

  • CHU de Rennes

    Rennes, 35033
    France

    Active - Recruiting

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