Clinical Research Directory
Browse clinical research sites, groups, and studies.
Prospective Study for Delay in Surgical Treatment of Traumatic Cervical Central Cord Injury in Canal Stenosis
Sponsor: Nantes University Hospital
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
72
Start Date
2016-07
Completion Date
2027-07
Last Updated
2025-07-16
Healthy Volunteers
No
Interventions
Early surgery within 48 hours
After completion of the clinical and radiological diagnosis of post-traumatic spinal cord contusion on narrow spinal canal, the patient was hospitalized. After obtaining the signed consent form, the patient was included in the protocol. After anesthetic consultation determining the feasibility or not of surgery and in the absence of other vital injury or involving life-threatening, early surgery is then realised within 48 hours. The surgical technique is a conventional cervical spinal decompression surgery. Surgery by way posterior surgery, by laminectomy in case of significant spinal stenosis 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. Then, the follow-up visits are D7, M3, Y1 and Y2.
Delayed surgery at 15 days
After completion of the clinical and radiological diagnosis of post-traumatic spinal cord contusion on narrow spinal canal, the patient was hospitalized. After obtaining the signed consent form, the patient was included in the protocol. After anesthetic consultation determining the feasibility or not of surgery and in the absence of other vital injury or involving life-threatening, delayed surgery is then realised at 15 days. The surgical technique is a conventional cervical spinal decompression surgery. Surgery by way posterior surgery, by laminectomy in case of significant spinal stenosis 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. Then, the follow-up visits are D7, M3, Y1 and Y2.
Locations (5)
CHU d'Angers
Angers, France
CHU de Brest
Brest, France
Hospital LA TIMONE
Marseille, France
CHU de Nantes
Nantes, France
CHU de Rennes
Rennes, France