title: 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.
abstract: OBJECTIVE
  Despite many years of research, there is currently no treatment available that results in major neurological or functional recovery after traumatic spinal cord injury (tSCI). In particular, no conclusive data related to the role of the timing of decompressive surgery, and the impact of injury severity on its benefit, have been published to date. This paper presents a protocol that was designed to examine the hypothesized association between the timing of surgical decompression and the extent of neurological recovery in tSCI patients.
  
  
  METHODS
  The SCI-POEM study is a Prospective, Observational European Multicenter comparative cohort study. This study compares acute (<12 h) versus non-acute (>12 h, <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.
  
  
  CONCLUSIONS
  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 tSCI patients.
authors.affiliation: Stoke Mandeville Spinal Foundation, National Spinal Injuries Centre, Stoke Mandeville Hospital, Buckinghamshire Healthcare NHS Trust, Aylesbury, Buckinghamshire, UK. jvanmiddendorp@gmail.com
authors.forename: J J
authors.initials: JJ
authors.lastname: van Middendorp
authors.forename: G
authors.initials: G
authors.lastname: Barbagallo
authors.forename: M
authors.initials: M
authors.lastname: Schuetz
authors.forename: A J F
authors.initials: AJ
authors.lastname: Hosman
mesh_terms: D015331:Cohort Studies; D019299:Decompression, Surgical / Q000379:methods*; D005060:Europe / Q000453:epidemiology; D005500:Follow-Up Studies; D006801:Humans; D018579:Patient Selection; D011446:Prospective Studies; D020127:Recovery of Function / Q000502:physiology; D013119:Spinal Cord Injuries / Q000453:epidemiology* / Q000601:surgery*; D013997:Time Factors; D016896:Treatment Outcome