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Prospective Study for Delay in Surgical Treatment of Traumatic Cervical Central Cord Injury in Canal Stenosis (DS3CS)

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ClinicalTrials.gov Identifier: NCT02673320
Recruitment Status : Not yet recruiting
First Posted : February 3, 2016
Last Update Posted : February 4, 2016
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

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.


Condition or disease Intervention/treatment Phase
Acute Traumatic Cervical Central Cord Syndrom Injury Procedure: Early surgery within 48 hours Procedure: Delayed surgery at 15 days Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Prospective Study for Delay in Surgical Treatment of Traumatic Cervical Central Cord Injury in Canal Stenosis
Study Start Date : March 2016
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Arm Intervention/treatment
Experimental: Early surgery
Early surgery within 48 hours
Procedure: 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
Delayed surgery at 15 days
Procedure: 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.




Primary Outcome Measures :
  1. Score ASIA (American Spinal Injury Association) [ Time Frame: 2 years ]

    Assessment of the motor skills of upper and lower limbs using the score ASIA (American Spinal Injury Association). The primary outcome measure is the Total Motor Score (Score ASIA) at 2 years : difference between the initial score ASIA at the inclusion visit and the score ASIA at 2 years. This is a functional scale divided into four assessment parameters (motor assessment, perineal assessment, functional assessment - neurological level and sensory evaluation.

    The realization of the ASIA score evaluates functional disability of a patient.



Secondary Outcome Measures :
  1. Score ASIA (American Spinal Injury Association) [ Time Frame: Day 0, Day 7, Month 3, Year 1 and Year 2 ]
    Assessment of the motor skills of upper and lower limbs using the score ASIA. Differences between the score ASIA at the different follow-up visits (D0, D7, M3, Y1 and Y2).

  2. Score WISCI II (Walking Index of Spinal Cord Injury) [ Time Frame: Day 0, Day 7, Month 3, Year 1 and Year 2 ]
    Assessment of the walking index of spinal cord injury using the WISCI II. Differences between the score WISCI II at the different follow-up visits (D0, D7, M3, Y1 and Y2).

  3. Score SCIM III (Spinal Cord Independence Measure) [ Time Frame: Day 0, Day 7, Month 3, Year 1 and Year 2 ]
    Assessment of the overall functional abilities of Spinal Cord Injury using the score SCIM III (Spinal Cord Independence Measure). Differences between the score SCIM III at the different follow-up visits (D0, D7, M3, Y1 and Y2).

  4. Score CUE (Capabilities of Upper Extremities) [ Time Frame: Day 0, Day 7, Month 3, Year 1 and Year 2 ]
    Assessment of the capabilities of upper extremities using the score CUE. Differences between the score CUE at the different follow-up visits (D0, D7, M3, Y1 and Y2).

  5. Score SF-36 [ Time Frame: Day 0, Day 7, Month 3, Year 1 and Year 2 ]
    Assessment of the quality of life using the SF-36 questionnaire. Differences between the score SF-36 at the different follow-up visits (D0, D7, M3, Y1 and Y2).

  6. Score EVA (visual analog scale) [ Time Frame: Day 0, Day 7, Month 3, Year 1 and Year 2 ]
    Assessment of cervical pains using a visual analog scale. Differences between the score EVA at the different follow-up visits (D0, D7, M3, Y1 and Y2).

  7. Score DN4 [ Time Frame: Day 0, Day 7, Month 3, Year 1 and Year 2 ]
    Assessment of neuropathic pains using the score DN4. Differences between the score DN4 at the different follow-up visits (D0, D7, M3, Y1 and Y2). It is a questionnaire with ten items (seven of them are issued from the patient interview and three are established by clinical examination). The DN4 questionnaire is based on the analysis of the words proposed by patients to describe their pain.

  8. Urinary status [ Time Frame: Day 0, Day 7, Month 3, Year 1 and Year 2 ]
    This assessment characterizes the patient's urinary status under 4 generic items (Spontaneous micturition, reflex micturition, intermittent poll and other).

  9. Defecation status [ Time Frame: Day 0, Day 7, Month 3, Year 1 and Year 2 ]
    This assessment characterizes the patient's defecation status under 4 generic items (Spontaneous defecation, reflex defecation, rectal touch and other).

  10. Cervical spinal cord injury [ Time Frame: Day 0, Day 7, Month 3, Year 1 and Year 2 ]
    The data collected for each patient will be as follows : Decrease of the lesions (yes / no), disappearance of the lesions (yes / no), presence of radiological spinal cord lesion sequelae (yes / no), size of the lesion and other. The reference imaging will be the cervical spinal MRI.

  11. Resuscitation complications [ Time Frame: Day 0, Day 7, Month 3, Year 1 and Year 2 ]
    Adverse events occurring during resuscitation

  12. Decubitus complications [ Time Frame: Day 0, Day 7, Month 3, Year 1 and Year 2 ]
    Adverse events related to the extended position and immobility



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02673320


Contacts
Contact: Kévin BUFFENOIR-BILLET, PU-PH 02.40.08.37.65 kevin.buffenoirbillet@chu-nantes.fr

Locations
France
CHU d'Angers Not yet recruiting
Angers, France, 49933
Contact: Philippe MENEI, PU-PH    02.41.35.48.288    phmenei@chu-angers.fr   
Principal Investigator: Philippe MENEI, PU-PH         
CHU de Marseille Not yet recruiting
Marseille, France, 13915
Contact: Pierre-Hugues ROCHE, PU-PH    04.91.96.86.20    pierre-hugues.roche@ap-hm.fr   
Principal Investigator: Pierre-Hugues ROCHE, PU-PH         
CHU de Nantes Not yet recruiting
Nantes, France, 44000
Contact: Kévin BUFFENOIR-BILLET, PU-PH    02.40.08.34.58    kevin.buffenoirbillet@chu-nantes.fr   
Principal Investigator: Kévin BUFFENOIR-BILLET, PU-PH         
Sub-Investigator: Brigitte PERROUIN-VERBE, PU-PH         
Sub-Investigator: Luc TERREAUX, Doctor         
Sub-Investigator: Eric BORD, Doctor         
CHU de Rennes Not yet recruiting
Rennes, France, 35033
Contact: Xavier MORANDI, PU-PH    02.99.28.42.77    xavier.morandi@chu-rennes.fr   
Principal Investigator: Xavier MORANDI, PU-PH         
Sponsors and Collaborators
Nantes University Hospital

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT02673320     History of Changes
Other Study ID Numbers: RC15_0040
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: February 4, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Nantes University Hospital:
Acute Traumatic Cervical Central Cord Syndrom Injury
Delay of Surgery
Decompressive Surgery
Canal Stenosis
Schneider Syndrom
Quality of life
Functional Outcome

Additional relevant MeSH terms:
Wounds and Injuries
Constriction, Pathologic
Pathological Conditions, Anatomical