Central Spinal Cord SyndromeCOSMICNCT01367405
Comparing Surgical Decompression Versus Conservative Treatment in Incomplete Spinal Cord Injury
A study testing Surgical decompression and Conservative treatment in people with Central Spinal Cord Syndrome, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Traumatic Central Cord Syndrome (TCCS) was until recent recognized as a separate clinical entity. The most characteristic feature is the disproportionate more motor impairment of the arms and especially the hands than the legs, bladder dysfunction and sensory. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Spinal Cord Syndrome
- What is being tested?
- Surgical decompression and Conservative treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2013to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- all patients with a history of a traumatic event to the cervical spine fulfilling the criteria of incomplete cervical spinal cord lesion. -
Who cannot join
- cognitive impairments
- a preexistent neurologic deficit of arms and/or legs
- psychiatric illness
- significant comorbidity interfering with the indication to perform surgery or not
- use of anticoagulating drugs
- addiction to drugs or alcohol (more than five units daily)
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- not speaking Dutch language fluently
- not willing to participate
- participating in another trial
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Nijmegen Medical Center
Nijmegen, Gelderland, 6500 HB
About this study
Official title: COSMIC: Conservative or Early Surgical Management of Incomplete Cervical Cord Syndrome Without Spinal Instability. Randomized Controlled Trial
Traumatic Central Cord Syndrome (TCCS) was until recent recognized as a separate clinical entity. The most characteristic feature is the disproportionate more motor impairment of the arms and especially the hands than the legs, bladder dysfunction and sensory.
Recently, it has been shown that the distinction of TCCS with an incomplete cervical spinal cord lesion (ICSCL) is artificial. It is the most frequent incomplete traumatic spinal cord lesion. It accounts for up to 70 % of all incomplete cervical spinal cord lesions. The exact incidence is not known.
Read more
Uncertainty about the treatment exists. A good recovery has been described after conservative treatment. Conservative treatment was usually considered when a fracture or dislocation of the spine were absent. It is often seen in hyperextension trauma in the elderly with degenerative spondylotic stenotic cervical spine. However, some reports suggest a better outcome after surgical decompression. Randomized trials have not been performed. To avoid discussion about possible confounding or effect modification related to the mechanism of trauma, this study will focus on ICSCL in patients without fracture or instability of the cervical spine on radiological examination. Also the problem of crossover from the conservative group to the surgical one due to the nature of spinal instability will be reduced.
Goal of the study: To compare the efficacy of early decompressive surgery to improve functional outcome in patients with ICSCL without a fracture or instability of the cervical spine compared to those receiving conservative treatment.
Definition of ICSCL in this study: ICSCL is an incomplete spinal cord lesion due to a cervical spine trauma. At CT scanning with reconstruction and at MRI signs are not seen that could indicate a fracture of the cervical spine or instability. An overt sequestrated herniated disc should not be present since this will always necessitate immediate surgery. Involvement of the cervical spinal cord should be established at physical examination (symptomatic arm or hand dysfunction is obligatory).
Read the detailed description
See Above. Further information in this registration ( Randomized controlled trial (RCT), sample size etc)
- Conditions
- Central Spinal Cord Syndrome
- Being tested
- Surgical decompression, Conservative treatment
- Keywords
- Surgical decompression, conservative treatment, incomplete spinal cord lesion, recovery
- Medical subject headings
- Central Cord Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical decompressionProcedure or surgery
Surgical decompression within 24 hour postinjury
Conservative treatmentProcedure or surgery
Usual conservative treatment without surgery
| Study group | Role | What they receive |
|---|---|---|
| surgical decompression | Experimental | surgical decompression within 24 hours post-injury Receives: Procedure: Surgical decompression |
| Conservative treatment | Active comparator | Normal conservative treatment without surgical intervention Receives: Procedure: Conservative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dutch translation of mJOA
functional outcome at two years measured by Dutch translation of mJOA
Measured: two years post-injury
Secondary outcomes (1)
DASH
arm/hand function assessed by the disability of the arm, shoulder and hand questionnaire (DASH)
Measured: two years post-injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2011 (estimated)
- Study startOct 2013
- Primary completionJun 2015
- Study completionJun 2015
Why it stopped: only 1 inclusion in 1.5 years due to strict exclusion criteria
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Central Spinal Cord SyndromeStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ronald Bartels, M.D.,Ph.D., Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01367405
- Sponsor's protocol ID
- NL36977.091.11
- Acronym
- COSMIC
- Status last verified
- Nov 2013
- First submitted
- 6 Jun 2011
- Last updated
- 13 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Bartels RH, Hosman AJ, van de Meent H, Hofmeijer J, Vos PE, Slooff WB, Oner FC, Coppes MH, Peul WC, Verbeek AL. Design of COSMIC: a randomized, multi-centre controlled trial comparing conservative or early surgical management of incomplete cervical cord syndrome without spinal instability. BMC Musculoskelet Disord. 2013 Jan 31;14:52. doi: 10.1186/1471-2474-14-52.
PubMed 23369169
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COSMIC: Conservative or Early Surgical Management of Incomplete Cervical Cord Syndrome Without Spinal Instability. Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01367405
- Acronym / sponsor ID
- COSMIC / NL36977.091.11
- Conditions
- Central Spinal Cord Syndrome
- Keywords
- Surgical decompression, conservative treatment, incomplete spinal cord lesion, recovery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: only 1 inclusion in 1.5 years due to strict exclusion criteria
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 7 Jun 2011 (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.
Traumatic Central Cord Syndrome (TCCS) was until recent recognized as a separate clinical entity. The most characteristic feature is the disproportionate more motor impairment of the arms and especially the hands than the legs, bladder dysfunction and sensory.
Recently, it has been shown that the distinction of TCCS with an incomplete cervical spinal cord lesion (ICSCL) is artificial. It is the most frequent incomplete traumatic spinal cord lesion. It accounts for up to 70 % of all incomplete cervical spinal cord lesions. The exact incidence is not known.
Uncertainty about the treatment exists. A good recovery has been described after conservative treatment. Conservative treatment was usually considered when a fracture or dislocation of the spine were absent. It is often seen in hyperextension trauma in the elderly with degenerative spondylotic stenotic cervical spine. However, some reports suggest a better outcome after surgical decompression. Randomized trials have not been performed. To avoid discussion about possible confounding or effect modification related to the mechanism of trauma, this study will focus on ICSCL in patients without fracture or instability of the cervical spine on radiological examination. Also the problem of crossover from the conservative group to the surgical one due to the nature of spinal instability will be reduced.
Goal of the study: To compare the efficacy of early decompressive surgery to improve functional outcome in patients with ICSCL without a fracture or instability of the cervical spine compared to those receiving conservative treatment.
Definition of ICSCL in this study: ICSCL is an incomplete spinal cord lesion due to a cervical spine trauma. At CT scanning with reconstruction and at MRI signs are not seen that could indicate a fracture of the cervical spine or instability. An overt sequestrated herniated disc should not be present since this will always necessitate immediate surgery. Involvement of the cervical spinal cord should be established at physical examination (symptomatic arm or hand dysfunction is obligatory).
Detailed description
See Above. Further information in this registration ( Randomized controlled trial (RCT), sample size etc)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surgical decompression | Experimental | Procedure: Surgical decompressionsurgical decompression within 24 hours post-injury |
| Conservative treatment | Active comparator | Procedure: Conservative treatmentNormal conservative treatment without surgical intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patients with a history of a traumatic event to the cervical spine fulfilling the criteria of incomplete cervical spinal cord lesion. -
Key exclusion criteria (9 listed)
- cognitive impairments
- a preexistent neurologic deficit of arms and/or legs
- psychiatric illness
- significant comorbidity interfering with the indication to perform surgery or not
- use of anticoagulating drugs
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 |
|---|---|---|
| Surgical decompressionSurgical decompression within 24 hour postinjury | Procedure or surgery | surgical decompression |
| Conservative treatmentUsual conservative treatment without surgery | Procedure or surgery | Conservative treatment |
Primary outcome
Dutch translation of mJOA
Time frame: two years post-injury
functional outcome at two years measured by Dutch translation of mJOA
1 secondary outcome
DASH
Time frame: two years post-injury
Results and safety
The study was stopped early (reason given: only 1 inclusion in 1.5 years due to strict exclusion criteria). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2016.
- Derived from this study: PubMed 23369169Bartels RH, Hosman AJ, van de Meent H, Hofmeijer J, Vos PE, Slooff WB, Oner FC, Coppes MH, Peul WC, Verbeek AL. Design of COSMIC: a randomized, multi-centre controlled trial comparing conservative or early surgical management of incomplete cervical cord syndrome without spinal instability. BMC Musculoskelet Disord. 2013 Jan 31;14:52. doi: 10.1186/1471-2474-14-52.
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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.
Ronald Bartels, M.D.,Ph.D. principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical decompression and Conservative treatment in people with Central Spinal Cord Syndrome, run by Radboud University Medical Center at 1 site in Netherlands.
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 1 inclusion and 9 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: stopped early, as of the sponsor's last update on 13 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
The study was stopped early (reason given: only 1 inclusion in 1.5 years due to strict exclusion criteria). Results are not available in the source record.
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?
Dutch translation of mJOA (time frame: two years post-injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01367405, which also lists 1 linked publication.
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 13 Oct 2016.