Comparing Surgical Decompression Versus Conservative Treatment in Incomplete Spinal Cord Injury

NCT ID: NCT01367405

Last Updated: 2016-10-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2015-06-30

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)

Conditions

Central Spinal Cord Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

surgical decompression

surgical decompression within 24 hours post-injury

Group Type: EXPERIMENTAL

Surgical decompression

Intervention Type: PROCEDURE

Surgical decompression within 24 hour postinjury

Conservative treatment

Normal conservative treatment without surgical intervention

Group Type: ACTIVE_COMPARATOR

Conservative treatment

Intervention Type: PROCEDURE

Usual conservative treatment without surgery

Interventions

Surgical decompression

Surgical decompression within 24 hour postinjury

Intervention Type: PROCEDURE

Conservative treatment

Usual conservative treatment without surgery

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ronald Bartels, M.D.,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

Radboud University Nijmegen Medical Center

Nijmegen, Gelderland, Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 23369169 (View on PubMed)

Other Identifiers

NL36977.091.11

Identifier Type: -

Identifier Source: org_study_id