Design of COSMIC: a randomized, multi-centre controlled trial comparing conservative or early surgical management of incomplete cervical cord syndrome without spinal instability.
BACKGROUND
Incomplete cervical cord syndrome without spinal instability is a very devastating event for the patient and the family. It is estimated that up to 25% of all traumatic spinal cord lesions belong to this category. The treatment for this type of spinal cord lesion is still subject of discussion. From a biological point of view early surgery could prevent secondary damage due to ongoing compression of the already damaged spinal cord. Historically, however, conservative treatment was propagated with good clinical results. Proponents for early surgery as well those favoring conservative treatment are still in debate. The proposed trial will contribute to the discussion and hopefully also to a decrease in the variability of clinical practice.


METHODS
A randomized controlled trial is designed to compare the clinical outcome of early surgical strategy versus a conservative approach. The primary outcome is clinical outcome according to mJOA. This also measured by ASIA score, DASH score and SCIM III score. Other endpoints are duration of the stay at a high care department (medium care, intensive care), duration of the stay at the hospital, complication rate, mortality rate, sort of rehabilitation, and quality of life. A sample size of 36 patients per group was calculated to reach a power of 95%. The data will be analyzed as intention-to-treat at regular intervals, but the end evaluation will take place at two years post-injury.


CONCLUSIONS
At the end of the study, clinical outcomes between treatments attitudes can be compared. Efficacy, but also efficiency can be determined. A goal of the study is to determine which treatment will result in the best quality of life for the patients. This study will certainly contribute to more uniformity of treatment offered to patients with a special sort of spinal cord injury.


BACKGROUND
Gov: NCT01367405.
Department of Neurosurgery, Radboud University Nijmegen Medical Centre, R, Postlaan 4, 6500 HB, Nijmegen, The Netherlands. r.bartels@nch.umcn.nl
Ronald H M A
RH
Bartels
Allard J F
AJ
Hosman
Henk
H
van de Meent
Jeannette
J
Hofmeijer
Pieter E
PE
Vos
Willem Bart
WB
Slooff
F Cumhur
FC
Öner
Maarten H
MH
Coppes
Wilco C
WC
Peul
André L M
AL
Verbeek
D019299:Decompression, Surgical / Q000009:adverse effects / Q000295:instrumentation / Q000401:mortality; D004185:Disability Evaluation; D006801:Humans; D007902:Length of Stay; D009426:Netherlands; D019637:Orthopedic Procedures / Q000009:adverse effects / Q000295:instrumentation / Q000401:mortality; D026741:Physical Therapy Modalities / Q000009:adverse effects / Q000401:mortality; D011788:Quality of Life; D020127:Recovery of Function; D012107:Research Design; D013119:Spinal Cord Injuries / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000523:psychology / Q000601:surgery / Q000628:therapy*; D011795:Surveys and Questionnaires; D013997:Time Factors; D015599:Trauma Severity Indices; D016896:Treatment Outcome