Clinical trial NCT01367405: Comparing Surgical Decompression Versus Conservative Treatment in Incomplete Spinal Cord Injury
Official title: COSMIC: Conservative or Early Surgical Management of Incomplete Cervical Cord Syndrome Without Spinal Instability. Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Central Spinal Cord Syndrome
Keywords: Surgical decompression
conservative treatment
incomplete spinal cord lesion
recovery
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2011-06-07
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Eligibility criteria: 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

Primary outcomes:
measure: Dutch translation of mJOA
timeFrame: two years post-injury
Secondary outcomes:
measure: DASH
timeFrame: two years post-injury
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Center
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: Ronald Bartels, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.