Acute Spinal Cord Injury of Traumatic Origin (tSCI) Clinical Trial
Official title:
Prognostic Factors and Therapeutic Effects of Surgical Treatment for Traumatic Spinal Column Injury With Spinal Cord Injury: A Prospective, Observational European Multi-center Study.
Despite many years of research, an incomprehensible amount of scientific efforts worldwide and billions of dollars invested, no effective therapy resulting in major neurological or functional recovery is available to date for traumatic spinal cord injury (tSCI). Although there is increasing experimental evidence from animal models that surgical decompression of the spinal cord improves recovery after tSCI, clinical studies have not shown conclusive data yet. The main explanations for this lack of convincing evidence are relatively small sample sizes in previous studies, their predominantly retrospective nature, suboptimal measurement methods for the assessment of neurological deficits, and inappropriate recording and documentation of potential confounding factors.
Although injuries to the spinal column represent a relatively small proportion of all
traumatic injuries, spinal injuries have one of the highest impacts on functional outcomes
and employment status. Even more than an injury of the spinal column, traumatic spinal cord
injury (tSCI) is a devastating disorder severely affecting patients' physical and
psychosocial well-being. The incidence of tSCI is estimated to be 11 to 53 new cases per
million population per year.
This is a multi-center, prospective, observational cohort study to evaluate if early (≤ 12
hours after the tSCI) surgical decom¬pression is superior to late (> 12 hours and < 14 days
after the tSCI) in improving neurologic motor outcomes in patients with acute traumatic
spinal cord injury.
The study will enroll 300 patients with anticipated 1:2 ratio of early vs. late surgery. This
CIP is not limited to cervical spinal cord injuries, does not consider a diagnostic MRI as
mandatory and will be conducted in a European setting where patients are generally
transported more swiftly to the treating institution when compared to other geographic
regions in the world.
Patients will be evaluated according to the schedule set forth in this CIP. The schedule
includes evaluations at pre-surgery, post-surgery, 72 hours post injury, 12 weeks ± 2 weeks;
6 months ± 30 days; 1 year ± 30 days. The enrollment period is expected to be approximately
36 months and subjects will be followed-up for 12 months for the evaluation of the primary
endpoint. The study duration is approximately 48 months.
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