Comparing Surgical Decompression Versus Conservative Treatment in Incomplete Spinal Cord Injury

Central Spinal Cord Syndrome Clinical Trial

— COSMIC  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01367405
• Other study ID #: NL36977.091.11
• Status: Terminated
• Phase: N/A
• First received: June 6, 2011
• Last updated: October 12, 2016
• Start date: October 2013
• Est. completion date: June 2015

Study information

• Verified date: November 2013
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical 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.

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).

Description:

See Above. Further information in this registration ( Randomized controlled trial (RCT), sample size etc)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Central Cord Syndrome
• Central Spinal Cord Syndrome
• Syndrome

Intervention

Procedure:
• Surgical decompression
Surgical decompression within 24 hour postinjury
• Conservative treatment
Usual conservative treatment without surgery

Locations

Country	Name	City	State
Netherlands	Radboud University Nijmegen Medical Center	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dutch translation of mJOA	functional outcome at two years measured by Dutch translation of mJOA	two years post-injury	No
Secondary	DASH	arm/hand function assessed by the disability of the arm, shoulder and hand questionnaire (DASH)	two years post-injury	No