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

• Register: ClinicalTrials.gov
• Last refreshed on: 15 April 2024
• Main ID: NCT02673320
• Date of registration: 01/02/2016
• Prospective Registration: Yes
• Primary sponsor: Nantes University Hospital
• Public title: Prospective Study for Delay in Surgical Treatment of Traumatic Cervical Central Cord Injury in Canal Stenosis DS3CS
• Scientific title: Prospective Study for Delay in Surgical Treatment of Traumatic Cervical Central Cord Injury in Canal Stenosis
• Date of first enrolment: July 2016
• Target sample size: 72
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT02673320
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Kévin BUFFENOIR-BILLET, PU-PH

Key inclusion & exclusion 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).



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Acute Traumatic Cervical Central Cord Syndrom Injury

Intervention(s)

Procedure: Delayed surgery at 15 days

Procedure: Early surgery within 48 hours

Primary Outcome(s)

Score ASIA (American Spinal Injury Association) [Time Frame: 2 years]

Secondary Outcome(s)

Defecation status [Time Frame: Day 0, Day 7, Month 3, Year 1 and Year 2]

Score SCIM III (Spinal Cord Independence Measure) [Time Frame: Day 0, Day 7, Month 3, Year 1 and Year 2]

Cervical spinal cord injury [Time Frame: Day 0, Year 1]

Score WISCI II (Walking Index of Spinal Cord Injury) [Time Frame: Day 0, Day 7, Month 3, Year 1 and Year 2]

Score ASIA (American Spinal Injury Association) [Time Frame: Day 0, Day 7, Month 3, Year 1 and Year 2]

Score EVA (visual analog scale) [Time Frame: Day 0, Day 7, Month 3, Year 1 and Year 2]

Score DN4 [Time Frame: Day 0, Day 7, Month 3, Year 1 and Year 2]

Urinary status [Time Frame: Day 0, Day 7, Month 3, Year 1 and Year 2]

Resuscitation complications [Time Frame: Day 0, Day 7, Month 3, Year 1 and Year 2]

Score SF-36 [Time Frame: Day 0, Day 7, Month 3, Year 1 and Year 2]

Decubitus complications [Time Frame: Day 0, Day 7, Month 3, Year 1 and Year 2]

Secondary ID(s)

RC15_0040

Source(s) of Monetary Support

Please refer to primary and secondary sponsors