Prospective Study for Delay in Surgical Treatment of Traumatic Cervical Central Cord Injury in Canal Stenosis
Launched by NANTES UNIVERSITY HOSPITAL · Feb 1, 2016
Trial Information
Current as of July 13, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating the timing of surgery for patients with acute traumatic central cord injuries in a narrow spinal canal. The main goal is to see if having surgery within 48 hours after diagnosis is just as effective as waiting 15 days. The researchers want to understand how the timing of surgery affects recovery in terms of movement and sensation, as well as overall function after the procedure.
To participate in this study, individuals must be at least 18 years old, have a specific type of spinal cord injury confirmed by MRI, and score a certain level on tests that assess their condition. Participants will undergo a standard type of surgery called cervical spinal decompression, and they will be monitored over time to track their recovery. It's important for potential participants to know that they need to provide consent and have no other significant health issues that would prevent them from having the surgery. This trial is currently recruiting participants and aims to improve our understanding of how to best treat this kind of spinal injury.
Gender
ALL
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).
About Nantes University Hospital
Nantes University Hospital, a leading academic medical institution in France, is dedicated to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical studies, the hospital integrates cutting-edge scientific exploration with patient care, fostering collaborations among multidisciplinary teams of healthcare professionals and researchers. With a strong emphasis on ethical standards and patient safety, Nantes University Hospital aims to contribute to the development of effective therapies and interventions that enhance patient outcomes and overall public health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Rennes, , France
Nantes, , France
Brest, , France
Angers, , France
Marseille, , France
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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