Skip to content

Comparing Surgical Decompression Versus Conservative Treatment in Incomplete Spinal Cord Injury

COSMIC: Conservative or Early Surgical Management of Incomplete Cervical Cord Syndrome Without Spinal Instability. Randomized Controlled Trial

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01367405
Acronym
COSMIC
Enrollment
1
Registered
2011-06-07
Start date
2013-10-31
Completion date
2015-06-30
Last updated
2016-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Spinal Cord Syndrome

Keywords

Surgical decompression, conservative treatment, incomplete spinal cord lesion, recovery

Brief 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. 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)

Interventions

Surgical decompression within 24 hour postinjury

PROCEDUREConservative treatment

Usual conservative treatment without surgery

Sponsors

Radboud University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

\- all patients with a history of a traumatic event to the cervical spine fulfilling the criteria of incomplete cervical spinal cord lesion. -

Exclusion criteria

* 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) * not speaking Dutch language fluently * not willing to participate * participating in another trial

Design outcomes

Primary

MeasureTime frameDescription
Dutch translation of mJOAtwo years post-injuryfunctional outcome at two years measured by Dutch translation of mJOA

Secondary

MeasureTime frameDescription
DASHtwo years post-injuryarm/hand function assessed by the disability of the arm, shoulder and hand questionnaire (DASH)

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026