Comparing early versus delayed surgery for traumatic cervical spinal cord injury
Prospective Study for Delay in Surgical Treatment of Traumatic Cervical Central Cord Injury in Canal Stenosis
This study is testing whether having surgery within 48 hours is just as good as waiting 15 days for people with a specific type of spinal cord injury.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nantes University Hospital Academic / other |
| Locations | 5 sites (Angers and 4 other locations) |
| Trial ID | NCT02673320 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of timing on surgical treatment for patients with acute traumatic cervical central cord syndrome caused by a narrow spinal canal. It aims to demonstrate that early surgical intervention within 48 hours is not inferior to surgery performed after a delay of 15 days. The study will involve patients who have sustained a cervical spinal cord contusion, with the surgical approach determined by clinical and radiological assessments. The goal is to provide clarity on the optimal timing for surgical intervention in this complex condition.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with acute traumatic cervical spinal cord contusion and a Glasgow score of 13 or higher.
Not a fit: Patients with non-traumatic cervical canal issues or those with contraindications to MRI or the surgical methods studied may not benefit from this trial.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and recovery for patients with traumatic cervical spinal cord injuries.
How similar studies have performed: While the approach of comparing surgical timing is not widely tested, similar studies in spinal surgery have shown varying results, indicating the need for further investigation.
Eligibility criteria
Show full 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).
Where this trial is running
Angers and 4 other locations
- CHU d'Angers — Angers, France (Recruiting)
- CHU de Brest — Brest, France (Recruiting)
- Hospital LA TIMONE — Marseille, France (Recruiting)
- CHU de Nantes — Nantes, France (Recruiting)
- CHU de Rennes — Rennes, France (Recruiting)
Study contacts
- Study coordinator: Kévin BUFFENOIR-BILLET, PU-PH
- Email: kevin.buffenoirbillet@chu-nantes.fr
- Phone: 02.40.08.37.65
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.