Design and rationale of a Prospective, Observational European Multicenter study on the efficacy of acute surgical decompression after traumatic Spinal Cord Injury: the SCI-POEM study
Spinal Cord, 05/11/2012
van Middendorp JJ et al. – In order to minimize bias and reduce the impact of confounders, special attention is paid to key methodological principles in this study protocol. A significant difference in safety and/or efficacy endpoints will provide meaningful information to clinicians, as this would confirm the hypothesis that rapid referral to and treatment in specialized centers result in important improvements in traumatic spinal cord injury (tSCI) patients.Methods
- The SCI-POEM study is a Prospective, Observational European Multicenter comparative cohort study.
- This study compares acute (<12h) versus non-acute (>12h, <2 weeks) decompressive surgery in patients with a traumatic spinal column injury and concomitant spinal cord injury.
- The sample size calculation was based on a representative European patient cohort of 492 tSCI patients.
- During a 4-year period, 300 patients will need to be enrolled from 10 trauma centers across Europe.
- The primary endpoint is lower-extremity motor score as assessed according to the ‘International standards for neurological classification of SCI’ at 12 months after injury.
- Secondary endpoints include motor, sensory, imaging and functional outcomes at 3, 6 and 12 months after injury.