Abstract
Introduction
Traumatic 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 Methods
This 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.
Results
The 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.
Conclusion
In 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.
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