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

Primary Purpose

Acute Traumatic Cervical Central Cord Syndrom Injury

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Early surgery within 48 hours
Delayed surgery at 15 days
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Acute Traumatic Cervical Central Cord Syndrom Injury focused on measuring Acute Traumatic Cervical Central Cord Syndrom Injury, Delay of Surgery, Decompressive Surgery, Canal Stenosis, Schneider Syndrom, Quality of life, Functional Outcome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • CHU d'AngersRecruiting
  • CHU de BrestRecruiting
  • Hospital LA TIMONERecruiting
  • CHU de NantesRecruiting
  • CHU de RennesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Early surgery

Delayed surgery

Arm Description

Early surgery within 48 hours

Delayed surgery at 15 days

Outcomes

Primary Outcome Measures

Score ASIA (American Spinal Injury Association)
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

Score ASIA (American Spinal Injury Association)
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).
Score WISCI II (Walking Index of Spinal Cord Injury)
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).
Score SCIM III (Spinal Cord Independence Measure)
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).
Score SF-36
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).
Score EVA (visual analog scale)
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).
Score DN4
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.
Urinary status
This assessment characterizes the patient's urinary status under 4 generic items (Spontaneous micturition, reflex micturition, intermittent poll and other).
Defecation status
This assessment characterizes the patient's defecation status under 4 generic items (Spontaneous defecation, reflex defecation, rectal touch and other).
Cervical spinal cord injury
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.
Resuscitation complications
Adverse events occurring during resuscitation
Decubitus complications
Adverse events related to the extended position and immobility

Full Information

First Posted
February 1, 2016
Last Updated
June 10, 2022
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02673320
Brief Title
Prospective Study for Delay in Surgical Treatment of Traumatic Cervical Central Cord Injury in Canal Stenosis
Acronym
DS3CS
Official Title
Prospective Study for Delay in Surgical Treatment of Traumatic Cervical Central Cord Injury in Canal Stenosis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 2016 (Actual)
Primary Completion Date
July 2026 (Anticipated)
Study Completion Date
July 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Traumatic Cervical Central Cord Syndrom Injury
Keywords
Acute Traumatic Cervical Central Cord Syndrom Injury, Delay of Surgery, Decompressive Surgery, Canal Stenosis, Schneider Syndrom, Quality of life, Functional Outcome

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early surgery
Arm Type
Experimental
Arm Description
Early surgery within 48 hours
Arm Title
Delayed surgery
Arm Type
Other
Arm Description
Delayed surgery at 15 days
Intervention Type
Procedure
Intervention Name(s)
Early surgery within 48 hours
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Delayed surgery at 15 days
Intervention Description
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 Measure Information:
Title
Score ASIA (American Spinal Injury Association)
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Score ASIA (American Spinal Injury Association)
Description
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).
Time Frame
Day 0, Day 7, Month 3, Year 1 and Year 2
Title
Score WISCI II (Walking Index of Spinal Cord Injury)
Description
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).
Time Frame
Day 0, Day 7, Month 3, Year 1 and Year 2
Title
Score SCIM III (Spinal Cord Independence Measure)
Description
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).
Time Frame
Day 0, Day 7, Month 3, Year 1 and Year 2
Title
Score SF-36
Description
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).
Time Frame
Day 0, Day 7, Month 3, Year 1 and Year 2
Title
Score EVA (visual analog scale)
Description
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).
Time Frame
Day 0, Day 7, Month 3, Year 1 and Year 2
Title
Score DN4
Description
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.
Time Frame
Day 0, Day 7, Month 3, Year 1 and Year 2
Title
Urinary status
Description
This assessment characterizes the patient's urinary status under 4 generic items (Spontaneous micturition, reflex micturition, intermittent poll and other).
Time Frame
Day 0, Day 7, Month 3, Year 1 and Year 2
Title
Defecation status
Description
This assessment characterizes the patient's defecation status under 4 generic items (Spontaneous defecation, reflex defecation, rectal touch and other).
Time Frame
Day 0, Day 7, Month 3, Year 1 and Year 2
Title
Cervical spinal cord injury
Description
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.
Time Frame
Day 0, Year 1
Title
Resuscitation complications
Description
Adverse events occurring during resuscitation
Time Frame
Day 0, Day 7, Month 3, Year 1 and Year 2
Title
Decubitus complications
Description
Adverse events related to the extended position and immobility
Time Frame
Day 0, Day 7, Month 3, Year 1 and Year 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kévin BUFFENOIR-BILLET, PU-PH
Phone
02.40.08.37.65
Email
kevin.buffenoirbillet@chu-nantes.fr
Facility Information:
Facility Name
CHU d'Angers
City
Angers
ZIP/Postal Code
49933
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe MENEI, PU-PH
Phone
02.41.35.48.288
Email
phmenei@chu-angers.fr
First Name & Middle Initial & Last Name & Degree
Philippe MENEI, PU-PH
Facility Name
CHU de Brest
City
Brest
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandre SIMON
Email
alexandre.simon@chu-brest.fr
First Name & Middle Initial & Last Name & Degree
Alexandre SIMON
Facility Name
Hospital LA TIMONE
City
Marseille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphane FUENTES
Email
sfuentes@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
Stéphane FUENTES
Facility Name
CHU de Nantes
City
Nantes
ZIP/Postal Code
44000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kévin BUFFENOIR-BILLET, PU-PH
Phone
02.40.08.34.58
Email
kevin.buffenoirbillet@chu-nantes.fr
First Name & Middle Initial & Last Name & Degree
Kévin BUFFENOIR-BILLET, PU-PH
First Name & Middle Initial & Last Name & Degree
Brigitte PERROUIN-VERBE, PU-PH
First Name & Middle Initial & Last Name & Degree
Luc TERREAUX, Doctor
First Name & Middle Initial & Last Name & Degree
Eric BORD, Doctor
Facility Name
CHU de Rennes
City
Rennes
ZIP/Postal Code
35033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean LEFEBVRE, PH
Phone
02.99.28.42.77
Email
Jean.LEFEBVRE@chu-rennes.fr
First Name & Middle Initial & Last Name & Degree
Jean LEFEBVRE, PH

12. IPD Sharing Statement

Plan to Share IPD
No

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

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