Acute Traumatic Cervical Central Cord Syndrom InjuryDS3CSNCT02673320
Prospective Study for Delay in Surgical Treatment of Traumatic Cervical Central Cord Injury in Canal Stenosis
A study testing Early surgery within 48 hours and Delayed surgery at 15 days in people with Acute Traumatic Cervical Central Cord Syndrom Injury, run by Nantes University Hospital at 5 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Traumatic Cervical Central Cord Syndrom Injury
- What is being tested?
- Early surgery within 48 hours and Delayed surgery at 15 days
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 5 sitesFrance
- Study dates
- Jul 2016to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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,
Show all 10Show fewer
- 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).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHU d'Angers
Angers, 49933
CHU de Brest
Brest
Hospital LA TIMONE
Marseille
CHU de Nantes
Nantes, 44000
CHU de Rennes
Rennes, 35033
About this study
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.
Read more
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.
- Being tested
- Early surgery within 48 hours, Delayed surgery at 15 days
- Keywords
- Acute Traumatic Cervical Central Cord Syndrom Injury, Delay of Surgery, Decompressive Surgery, Canal Stenosis, Schneider Syndrom, Quality of life, Functional Outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early surgery within 48 hoursProcedure or surgery
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 daysProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Early surgery | Experimental | Early surgery within 48 hours Receives: Procedure: Early surgery within 48 hours |
| Delayed surgery | Other | Delayed surgery at 15 days Receives: Procedure: Delayed surgery at 15 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (11)
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).
Measured: Day 0, Day 7, Month 3, Year 1 and Year 2
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).
Measured: Day 0, Day 7, Month 3, Year 1 and Year 2
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).
Measured: Day 0, Day 7, Month 3, Year 1 and Year 2
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).
Measured: Day 0, Day 7, Month 3, Year 1 and Year 2
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).
Measured: Day 0, Day 7, Month 3, Year 1 and Year 2
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.
Measured: Day 0, Day 7, Month 3, Year 1 and Year 2
Urinary status
This assessment characterizes the patient's urinary status under 4 generic items (Spontaneous micturition, reflex micturition, intermittent poll and other).
Measured: Day 0, Day 7, Month 3, Year 1 and Year 2
Defecation status
This assessment characterizes the patient's defecation status under 4 generic items (Spontaneous defecation, reflex defecation, rectal touch and other).
Measured: Day 0, Day 7, Month 3, Year 1 and Year 2
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.
Measured: Day 0, Year 1
Resuscitation complications
Adverse events occurring during resuscitation
Measured: Day 0, Day 7, Month 3, Year 1 and Year 2
Decubitus complications
Adverse events related to the extended position and immobility
Measured: Day 0, Day 7, Month 3, Year 1 and Year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Traumatic Cervical Central Cord Syndrom InjuryStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02673320
- Sponsor's protocol ID
- RC15_0040
- Acronym
- DS3CS
- Status last verified
- Jul 2025
- First submitted
- 1 Feb 2016
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study for Delay in Surgical Treatment of Traumatic Cervical Central Cord Injury in Canal Stenosis
- ClinicalTrials.gov ID
- NCT02673320
- Acronym / sponsor ID
- DS3CS / RC15_0040
- Keywords
- Acute Traumatic Cervical Central Cord Syndrom Injury, Delay of Surgery, Decompressive Surgery, Canal Stenosis, Schneider Syndrom, Quality of life, Functional Outcome
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 3 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early surgery | Experimental | Procedure: Early surgery within 48 hoursEarly surgery within 48 hours |
| Delayed surgery | Other | Procedure: Delayed surgery at 15 daysDelayed surgery at 15 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early surgery within 48 hoursAfter 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. | Procedure or surgery | Early surgery |
| Delayed surgery at 15 daysAfter 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. | Procedure or surgery | Delayed surgery |
Primary outcome
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.
11 secondary outcomes
Score ASIA (American Spinal Injury Association)
Time frame: Day 0, Day 7, Month 3, Year 1 and Year 2
Score WISCI II (Walking Index of Spinal Cord Injury)
Time frame: Day 0, Day 7, Month 3, Year 1 and Year 2
Score SCIM III (Spinal Cord Independence Measure)
Time frame: Day 0, Day 7, Month 3, Year 1 and Year 2
Score SF-36
Time frame: Day 0, Day 7, Month 3, Year 1 and Year 2
Score EVA (visual analog scale)
Time frame: Day 0, Day 7, Month 3, Year 1 and Year 2
Score DN4
Time frame: Day 0, Day 7, Month 3, Year 1 and Year 2
Urinary status
Time frame: Day 0, Day 7, Month 3, Year 1 and Year 2
Defecation status
Time frame: Day 0, Day 7, Month 3, Year 1 and Year 2
Cervical spinal cord injury
Time frame: Day 0, Year 1
Resuscitation complications
Time frame: Day 0, Day 7, Month 3, Year 1 and Year 2
Decubitus complications
Time frame: Day 0, Day 7, Month 3, Year 1 and Year 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early surgery within 48 hours and Delayed surgery at 15 days in people with Acute Traumatic Cervical Central Cord Syndrom Injury, run by Nantes University Hospital at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score ASIA (American Spinal Injury Association) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.