Traumatic Spinal Cord Injury: the Impact of Timing. A Prospective Cohort Study to Evaluate Outcomes after Early Surgery (and Reasons for Delays)

Abstract

IntroductionTraumatic spinal cord injury (tSCI) is a devastating condition affecting mostly young adults.1 Unfortunately, to date there are no standardized guidelines for treating these patients in the early phase and initial management can vary widely.2 Surgical decompression is considered to be a valid approach, however conclusive data regarding the best timing to perform it are still missing.3 The STASCIS trial evaluated the effect of surgical decompression pre- or 24 hours post-injury,4 however some aspects of its design have been criticized. The clinical study SCI-POEM aims to fill the gap of missing evidence by comparing the effect of early (<12 hour after injury) versus delayed (12 hour to 14 days after injury) surgical treatment.5 Material and MethodsThis is a prospective, multicenter, cohort study to test the superiority of early versus late surgery measured by the American Spinal Injury Association (ASIA) lower extremity motor score (ASIALEMS) pre-surgery and after 1 year. Inclusion criteria: Patients > 18 years old with tSCI, AIS grade A-D and indication of surgical management by the treating physician. To detect 6 points of difference in ASIALEMS with a power of 80%, a total of 300 patients are planned to be recruited in 17 clinics in 12 European countries within 3 years, assuming a 1:2 ratio of early vs delayed surgeries. Secondary outcome measures include different functional outcome scores and adverse events. Details about work, injury, main reason associated with a delayed surgery and steroid use are also collected. ResultsThe study started recruitment in March 2013 and until August 2015, 137 eligible patients had been enrolled: 112 (81.8%) men and 25 (18.2%) woman with ages ranging from 18 to 89. Mechanism of injury was low energy trauma in 42 (30.7%) cases and high energy trauma in 95 (69.3%) cases. In 67 (48.9%) patients, traumatic lesion occurred at a single level. One third of cases suffered a complete spinal cord injury (ASIA A, postsurgery measurement). About 50% of decompression surgeries were performed within 12 hour after injury. Unwanted delays for tSCI treatment (as judged by the local investigator) occurred in 36 (26.3%) cases, of which 25 (69.5%) were caused by logistical issues (bed or imaging availability, transfer, etc) and 11 (30.5%) were due to medical reasons. ConclusionIn our study, nearly two third of the cases had an incomplete spinal cord lesion (ASIA B-D), which highlights the relevance of appropriate and timely treatment to improve this situation. Strikingly, the actual rate of early vs delayed surgery is better than the anticipated 1:2 ratio. Even though 50% of the patients underwent early decompression, there was a considerable number of unwanted delays in the treatment of tSCI patients. The reasons for these delays are in most cases due to circumstances beyond the physician's control, such as time for transfer, availability of material resources or the medical condition of the patient. This information is important for future resource planning and suggests that improvements in material resources are needed across Europe.ReferencesLopez AD, Mathers CD, Ezzati M, Jamison DT, Murray CJL. Global Burden of Disease and Risk Factors. New York: Oxford University Press; 2006Fransen BL, Hosman AJ, van Middendorp JJ, Edwards M, van Grunsven PM, van de Meent H. Pre-hospital and acute management of traumatic spinal cord injury in the Netherlands: survey results urge the need for standardisation. Spinal Cord 2016;54(1):34–38van Middendorp JJ, Hosman AJ, Doi SA. The effects of the timing of spinal surgery after traumatic spinal cord injury: a systematic review and meta-analysis. J Neurotrauma 2013;30(21):1781–1794Fehlings MG, Vaccaro A, Wilson JR, et al. Early versus delayed decompression for traumatic cervical spinal cord injury: results of the Surgical Timing in Acute Spinal Cord Injury Study (STASCIS). PLoS ONE 2012;7(2):e32037van Middendorp JJ, Barbagallo G, Schuetz M, Hosman AJ. 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 2012;50(9):686–694