Comparing Surgical Decompression Versus Conservative Treatment in Incomplete Spinal Cord Injury

NCT01367405 | Terminated

• 1 other identifier: NL36977.091.11
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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).

Conditions

Central Spinal Cord Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Dutch translation of mJOA

  functional outcome at two years measured by Dutch translation of mJOA

  two years post-injury

Secondary Outcomes (1)

• DASH

  two years post-injury

Study Arms (2)

surgical decompression

EXPERIMENTAL

surgical decompression within 24 hours post-injury

Procedure: Surgical decompression

Conservative treatment

ACTIVE COMPARATOR

Normal conservative treatment without surgical intervention

Procedure: Conservative treatment

Interventions

Surgical decompression PROCEDURE

Surgical decompression within 24 hour postinjury

surgical decompression

Conservative treatment PROCEDURE

Usual conservative treatment without surgery

Conservative treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboud University Nijmegen Medical Center

Nijmegen, Gelderland, 6500 HB, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 23369169 DERIVED

MeSH Terms

Conditions

Central Cord Syndrome

Interventions

Decompression, Surgical; Conservative Treatment

Condition Hierarchy (Ancestors)

Spinal Cord Injuries; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Therapeutics

Study Officials

• Ronald Bartels, M.D.,Ph.D.

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2011
• First Posted: June 7, 2011
• Study Start: October 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: October 13, 2016

Record last verified: 2013-11

Locations

NL (1)