Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2026-02-26 @ 12:37 AM
Study NCT ID:
NCT02673320
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-16
First Post:
2016-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Study for Delay in Surgical Treatment of Traumatic Cervical Central Cord Injury in Canal Stenosis
Sponsor:
Nantes University Hospital
Organization:
Study Overview
Official Title:
Prospective Study for Delay in Surgical Treatment of Traumatic Cervical Central Cord Injury in Canal Stenosis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DS3CS
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: