Design of COSMIC: a randomized, multi-centre controlled trial comparing conservative or early surgical management of incomplete cervical cord syndrome without spinal instability

This study compares early surgery to conservative treatment for incomplete cervical cord syndrome (ICSCL) without spinal instability, a condition often resulting from trauma. The goal is to determine which approach leads to better functional outcomes and quality of life for patients. The study, named COSMIC, aims to address the ongoing debate about whether early surgical intervention or conservative management is more effective for ICSCL patients without spinal instability. The primary outcome will be measured using the modified Japanese Orthopaedic Association (mJOA) score, assessing motor and sensory function, along with other scales to evaluate overall recovery and well-being.

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  The primary outcome is clinical outcome according to mJOA, which is also measured by ASIA score, DASH score and SCIM III score.
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  Secondary outcomes include duration of stay at a high care department, hospital stay duration, complication rate, mortality rate, rehabilitation type, and quality of life.
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  The study hypothesizes that early surgical intervention will improve functional outcomes compared to conservative treatment in patients with ICSCL without spinal instability.