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COSMIC: Conservative or early Surgical Management of Incomplete cervical Cord syndrome without spinal instability. Randomized controlled trial

COSMIC: Conservative or early Surgical Management of Incomplete cervical Cord syndrome without spinal instability. Randomized controlled trial - COSMIC

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON39722
Enrollment
72
Registered
2011-08-02
Start date
2014-01-02
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

spinal cord lesion

Interventions

Conservative treatment or surgical decompression of the spinal cord

Sponsors

Universitair Medisch Centrum Sint Radboud
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: all patients with a history of a traumatic event to the cervical spine with 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.

Exclusion criteria

Exclusion criteria: ASIA A at neurologic examination,mental 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 frame
Primary outcome: functional outcome at two years measured by Dutch translation of mJOA.

Secondary

MeasureTime frame
Secondary outcomes: motor and sensory scores according to the ASIA standards at six weeks, 12 weeks, 12 months, stay at a high care department (medium care, intensive care), stay at the hospital, complication rate, mortality rate, sort of rehabilitation and kind of rehabilitation, quality of life, and arm/hand function assessed by the disability of the arm, shoulder and hand questionnaire (DASH),SCIM III .

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)