Surgical treatment for acute spinal cord injury study pilot study #2: evaluation of protocol for decompressive surgery within 8 hours of injury

Abstract

<jats:p>Acute spinal cord injury (SCI) is a major public health problem for which there is still only limited treatment available. The National Acute Spinal Cord Injury Study-2 (NASCIS-2) and -3 clinical trials demonstrated that the use of acute pharmacotherapy with methylprednisolone can attenuate the secondary injury cascade if administered within 8 hours of acute SCI. However, no trial has been performed to examine whether acute surgical decompressive procedures within this critical 8-hour time window can improve patients' neurological outcome. The purpose of the current prospective Surgical Treatment for Acute Spinal Cord Injury Study (STASCIS) pilot study was to determine the feasibility of obtaining a radiological diagnosis of spinal canal compromise of 25% or more and to perform spinal cord (C3-T1) decompressive procedures by 8 hours postinjury. One of the following three decompressive methods was used: 1) traction alone; 2) traction and surgery; or 3) surgery alone. Twenty-six patients from eight North American centers were entered into the study between 1996 and 1997. Significant difficulties were encountered in many centers in performing immediate magnetic resonance imaging examination in patients with acute SCI. Fewer than 10% of acute cervical SCI patients could be enrolled into this protocol mainly because the combination of the required time for rescue, resuscitation, transport, imaging study, and surgical preparation exceeded the 8-hour injury-to-decompressive surgery window. Eleven patients underwent decompressive procedures initially by being placed in traction at a mean time of 10.9 hours postinjury. Those patients not undergoing this procedure underwent decompressive surgery at a mean time of 40.1 hours. However, the surgical decompressive procedure was completed within 12 hours in seven patients. As a result of these findings, several major changes have been made to the STASCIS protocol for early decompressive therapy.</jats:p>

Does early decompression improve neurological outcome of spinal cord injured patients? Appraisal of the literature using a meta-analytical approach

“…Nevertheless the indication, the timing and even the role of this intervention in improving neurological recovery remains controversial because of the lack of unequivocal evidence. 10,37,42 The objective difficulties in designing and conducting large prospective randomized studies and, at the same time, the urgent necessity to clarify the role of surgery has spurred a reanalysis of the enormous quantity of data produced in the past decades regarding SCI. Fehlings et al 37 recently reviewed the literature using the modern criteria of evidence-based medicine and arrived to a qualitative evaluation of the available data, concluding that there are Class III data suggesting a role for urgent decompression in the setting of bilateral facet dislocation, and in incomplete injuries in patients with neurological deterioration.…”

“…32,34,[40][41][42][43][44][45] Most studies reported on retrospective case series with historical controls (Class III evidence).…”

“…[11][12][13] The limit of 24 h has been used in this study for two practical reasons: (1) very few reports provide data on an earlier treatment; (2) less than 50% of patients can be currently admitted to spinal cord centres within 24 h. 57,58 Analysis of results and limitations of the study The meta-analytic procedure consisted of extraction, pooling and statistical analysis of data from parent studies. Since only one prospective randomized (Class I evidence) 39 and eight prospective nonrandomized case series (Class II evidence) 32,34,40,[41][42][43][44][45] were found from the literature search, the meta-analysis was based on studies reported on retrospective case series with historical controls (Class III evidence). The outcome of patients undergoing a decompressive procedure within 24 h was then compared with that of patients treated through delayed decompressive procedures and that of nonoperatively managed patients.…”

Spinal Cord Injury: A Systematic Review of Current Treatment Options

“…In terms of neurologic outcome, the field of SCI research is torn between substantive evidence from preclinical animal models favoring early surgery [29,31,48] and mixed evidence from human clinical trials. Recent preliminary results from the Surgical Treatment for Acute Spinal Cord Injury Study (STASCIS) suggest decompression of the spinal cord within 24 hours of injury is associated with improved neurologic recovery in persons with cervical injury [45]. A final report from this multicenter prospective cohort study is expected within the next year after longterm followup is complete.…”

Efficacy of Surgical Decompression in the Setting of Complete Thoracic Spinal Cord Injury

“…There are 8 prospective nonrandomized case series (class 2 evidence) (23,25,(31)(32)(33)(51)(52)(53) and several retrospective case series with historical controls (class 3 evidence) that have addressed the role of spinal cord decompression. None has shown an advantage to surgery in the setting of a complete SCI.…”