ABBREVIATIONS: CCR, Canadian C-Spine Rule CCT, cervical computed tomography CSR, cervical spine radiographs EAST, Eastern Association for the Surgery of Trauma NEXUS, National Emergency X-Radiography Utilization Study Group NLC, NEXUS low risk category NPV, negative predictive value PPV, positive predictive value
✓ This 44-year-old man presented with a 4-year history of progressive spastic weakness of his legs. He was found to have epidural lipomatosis behind the thoracic spinal cord, and the nerve roots exited from the posterior and anterior midline planes of the dura, indicating a 90° rotation of the thoracic cord. Magnetic resonance images clearly demonstrated the segmental thoracic nerve roots exiting from the dorsal midline of the dura, a finding confirmed at surgery. The authors found only one previously published case of rotation of the spinal cord. Directed mechanical stress caused by deformation of the rotated spinal cord, rather than compression from adipose tissue, is proposed as the mechanism of the myelopathy. The extent, location, and thickness of the associated extradural adipose tissue is suggestive of epidural lipomatosis. The lipomatous tissue might have been an epiphenomenon and cord rotation an isolated congenital anomaly. Alternatively, asymmetrical growth of epidural fat may have exerted torque, rotating the thecal sac.
In 2002, an author group selected and sponsored by the Joint Section on Spine and Peripheral Nerves of the American Association of Neurological Surgeons and Congress of Neurological Surgeons published the first evidence-based guidelines for the management of patients with acute cervical spinal cord injuries (SCIs).1-23 In the spirit of keeping up with changes in information available in the medical literature that might provide more contemporary and more robust medical evidence, another author group was recruited to revise and update the guidelines. The review process has been completed and is published and can be once again found as a supplement to Neurosurgery. The purpose of this article is to provide an overview of the changes in the recommendations as a result of new evidence or broadened scope. CHANGES IN METHODOLOGY In accordance with the established practice of guideline development within organized neurosurgery, a thorough review of the medical literature was undertaken for each subject chosen for evaluation. Although literature outside the English language was excluded, a sample of non-English abstracts that could be found in the database of the National Library of Medicine failed to reveal any data significantly different from what we found in the English literature. Each chapter of recommendations contained in the new guidelines uses standard search techniques fully described in each chapter. After articles appropriate to each review question were identified, a rigorous critical evaluation was undertaken to establish the strength (quality) of the evidence and the level (certainty) of the recommendations. As in previous guidelines, published evidence was divided into Class I (well-designed and -executed randomized controlled trials), Class II (comparative studies, including randomized controlled trials with significant flaws, nonrandomized cohort studies, or case-control studies), and Class III (case series and expert opinion). Different from previous recommendations, the levels that used to be called standards, guidelines, and options are now referred to as Level I, Level II, and Level III, bringing them more in line with other neurosurgical and medical specialty paradigms and allowing the use of the term guidelines to denote the broader scope of the overall recommendations.24 Our author group universally felt that further stratification of guidelines into additional subsets (1a, 1b, 1c, 2a, 2b, 2c, etc)25 would not denote improved certainty or strength but instead would undermine consensus building and promote confusion among the readership. NOTABLE EXCLUSIONS FROM THE GUIDELINES Topical areas not included in the current guidelines pertain to the timing of surgery and use of hypothermia. The published evidence for these clinical strategies is so sparse that recommendations cannot be made with any degree of confidence pending further study. A single prospective study on surgical timing has subsequently been published since completion of our SCI guidelines review. Although designed as a prospective, nonrandomized comparative study (Class II), methodological flaws downgrade it to Class III evidence, rendering it unhelpful for establishing quality and certainty in the case of acute surgical intervention in SCI.26 Systemic hypothermia has been studied in animal models of SCI but only anecdotally in humans by way of a single Class II study also published after the current guidelines went to press. Again, in this instance, the evidence is early and cannot support a practice recommendation.27 The use of intraoperative somatosensory evoked potentials in the setting of trauma as a warning of SCI has not been addressed in the current guidelines. Those studies that our author group was able to find were carried out in nonacute (elective) spinal surgical situations. Although we felt that inferences might be made to acute SCI surgery, our supervising Joint Guidelines Committee of the American Association of Neurological Surgeons and Congress of Neurological Surgeons preferred to minimize such extrapolations. Hence, recommendations with respect to intraoperative electrophysiological monitoring will be made under a different (nontraumatic) guidelines initiative. Functional magnetic resonance imaging may potentially contribute to SCI research, but to date, there are no clinical studies that establish its usefulness in human SCI. Thus, it has been excluded from the current guidelines.28 Similarly, there are no recommendations on the use of drugs,29 biologicals,30 or devices31 aimed at neural regeneration of the spinal cord because of the absence of clinical evidence. It is our hope that such evidence will be forthcoming in time for the next SCI guidelines review. SCOPE OF THE REVISED GUIDELINES In this 2013 iteration of the cervical SCIs guidelines, the scope has been broadened, as have the recommendations. In 2002, the guidelines featured 76 recommendations in contrast to 112 recommendations in the present version. Among the new guidelines are 19 Level I recommendations supported by Class I medical evidence. These include assessment of functional outcomes (1); assessment of pain after SCI (1); radiographic assessment (1); pharmacology (2); diagnosis of atlanto-occipital dislocation (1); cervical subaxial injury classification schemes (2); pediatric spinal injuries (1); vertebral artery injuries (1); and venous thromboembolism (1). In addition, there are 11 Level II recommendations, based on Class II evidence, with the remaining 77 recommendations qualifying as Level III recommendations from a variety of Class III medical evidence. The Table highlights these differences between the 2 SCI guidelines processes (used with permission from the published guidelines).32TABLE-a: Comparison of Cervical Spine and Spinal Cord Injury Guidelines Recommendations Between 2 Iterations Where Differences in Recommendations Have Occurred (All Other Recommendations Remain as Previously Stated) a 32TABLE-b: Comparison of Cervical Spine and Spinal Cord Injury Guidelines Recommendations Between 2 Iterations Where Differences in Recommendations Have Occurred (All Other Recommendations Remain as Previously Stated) a 32TABLE-c: Comparison of Cervical Spine and Spinal Cord Injury Guidelines Recommendations Between 2 Iterations Where Differences in Recommendations Have Occurred (All Other Recommendations Remain as Previously Stated) a 32TABLE-d: Comparison of Cervical Spine and Spinal Cord Injury Guidelines Recommendations Between 2 Iterations Where Differences in Recommendations Have Occurred (All Other Recommendations Remain as Previously Stated) a 32TABLE-e: Comparison of Cervical Spine and Spinal Cord Injury Guidelines Recommendations Between 2 Iterations Where Differences in Recommendations Have Occurred (All Other Recommendations Remain as Previously Stated) a 32TABLE-f: Comparison of Cervical Spine and Spinal Cord Injury Guidelines Recommendations Between 2 Iterations Where Differences in Recommendations Have Occurred (All Other Recommendations Remain as Previously Stated) a 32TABLE: g Comparison of Cervical Spine and Spinal Cord Injury Guidelines Recommendations Between 2 Iterations Where Differences in Recommendations Have Occurred (All Other Recommendations Remain as Previously Stated) a 32TABLE: h Comparison of Cervical Spine and Spinal Cord Injury Guidelines Recommendations Between 2 Iterations Where Differences in Recommendations Have Occurred (All Other Recommendations Remain as Previously Stated) a 32The most contentious of the present recommendations likely pertains to the use of methylprednisolone in acute SCI and therefore deserves special comment. Methylprednisolone has been used for decades as a standard of care to improve neurological and functional outcome in SCI; however, careful examination, particularly of randomized clinical trials expected to produce Class I data,33-35 reveals many methodological flaws in study design and data analysis that refute the conclusions of the authors.36-38 As these limitations have come to light, there has also been a change in the perception of frontline surgeons treating SCI with respect to the necessity of steroids at all.39-43 In the case of the present guidelines, our author group downgraded them from Class I to Class III because the primary (a priori) outcome measures were all negative. Any positive results reported from either National Acute Spinal Cord Injury Study (NASCIS) II or NASCIS III came from post hoc analysis rather than being preplanned. In a randomized clinical trial, comparison of data defined by protocol (ie, before data are accrued) is considered Class I evidence, including both primary and secondary outcomes. All other queries within the data set are Class III, whether they are published at the time of initial analysis or 10 years later. Class II is reserved for a priori comparisons within a prospective study in which the study population is nonrandomized but still comparative (eg, cohort studies, case-control studies, or before-and-after studies). This is fundamentally important and explains why retrospective mining of a prospective database still yields Class III evidence (unless in the format of a case-control study). Class of evidence pertains to how the research question was asked (study design). It does not pertain to how the data were accrued. The underlying tenet is that retrospective examination of prospective data is still a “fishing expedition” or essentially a retrospective exercise unless clearly stated as part of the prospective research question(s). Outside of a priori analyses, any number of post hoc comparisons can be made within a data set (retrospective or prospective) until an interesting result is found. In a perfect world, authors should report how many post hoc comparisons they make and apply a correction to their statistical testing (eg, Bonferroni) before reporting claims of positive results. However, in reality, we know that this rarely happens, including in the case of the NASCIS studies. SUMMARY The 2013 update on the “Guidelines for the Management of Acute Cervical Spine and Spinal Cord Injuries” is meant to help the practicing neurosurgeon in his or her efforts to provide up-to-date, evidence-based care to patients with acute SCIs. They are based on a formal critical evaluation of the evidence, with a well-developed relationship between the strength of the evidence and the level of recommendations. This time-consuming and extensive process produces the best estimate of scientific foundation for current SCI care. For related video content, please access the Supplemental Digital Content: http://www.youtube.com/watch?v=KB1NBEDkw9c Disclosures Funding was provided by the Joint Section on Spine and Peripheral Nerves of the American Association of Neurological Surgeons and the Congress of Neurological Surgeons for author travel and accommodation. The authors have no personal financial or institutional interest in any of the drugs, materials, or devices described in this article.
Abstract BACKGROUND: Adjuncts for pain management in lumbar decompressive surgery are needed to reduce narcotic consumption and promote early mobility. OBJECTIVE: To evaluate the efficacy and active components of a previously described epidural analgesic paste in controlling postoperative pain and facilitating early discharge from hospital after lumbar decompressive surgery. METHODS: A randomized double-blind controlled trial was conducted. Two-hundred and one patients were randomized to 1 of 4 analgesic epidural pastes at the time of lumbar spinal surgery: combination paste (morphine + methylprednisolone), steroid paste (methylprednisolone alone), morphine paste (morphine alone), or placebo. The primary outcome measures used were analgesic consumption and the McGill Pain Questionnaire (MPQ). Secondary outcome measures were: modified American Spinal Cord Injury Association (ASIA) score, Short Form 36 General Health Survey (SF-36), Aberdeen Pain Index (ABPI), time to ambulation and time to discharge from hospital. RESULTS: Administration of combination and steroid paste, but not morphine paste, resulted in a statistically significant reduction in mean pain rating index (PRI) and present pain intensity (PPI) components of the MPQ in the first 3 days after surgery. Likewise, postoperative in-patient narcotic analgesic consumption was reduced in the combination paste and steroid paste group, but not in the morphine paste group. No difference in time to ambulation or discharge, SF-36 scores, ABPI scores, or neurologic recovery was observed. CONCLUSION: An analgesic paste containing methylprednisolone acetate is effective at reducing postoperative pain after lumbar decompressive surgery. Mixing effective doses of morphine sulfate in the paste abrogates the expected analgesic effects of epidural morphine.
Hurlbert, R. John MD, PhD, FRCSC, FACS; Alexander, David MD, FRCSC; Bailey, Stewart MD, FRCSC; Mahood, James MD, FRCSC; Abraham, Ed MD, FRCSC; McBroom, Robert MD, FRCSC; Jodoin, Alain MD, FRCSC; Fisher, Charles MD, FRCSC, MSc Author Information
In Brief Study Design. The Thoracolumbar Injury Severity Score (TLISS) and the Thoracolumbar Injury Classification and Severity Score (TLICS) were prospectively evaluated. Objectives. To compare the reliability and validity of the TLISS and TLICS schemes to determine the importance of injury mechanism and morphology to the identification and treatment of thoracolumbar fractures. Summary of Background Data. Two novel algorithms have been developed for the categorization and management of thoracolumbar injuries: the TLISS system emphasizing injury mechanism and the TLICS scheme involving injury morphology. Methods. The clinical and radiographic findings of 25 patients with thoracolumbar fractures were prospectively presented to 5 groups of surgeons with disparate levels of training and experience with spinal trauma. These injuries were consecutively scored, first using the TLISS and then 3 months later with the TLICS. The recommended treatments proposed by the 2 schemes were compared with the actual management of each patient. Results. For both algorithms, the interrater kappa statistics of all subgroups (mechanism/morphology, status of the posterior ligaments, total score, predicted management) were within the range of moderate to substantial reproducibility (0.45–0.74), and there were no statistically significant differences noted between the respective kappa values. Interrater correlation was higher for the TLISS paradigm on mechanism/morphology, integrity of the posterior ligaments, and proposed management (P ≤ 0.01). The TLISS and TLICS schemes both exhibited excellent overall validity. Conclusions. Although both schemes were noted to have substantial reproducibility and validity, our results indicate the TLISS is more reliable than the TLICS, suggesting that the mechanism of trauma may be a more valuable parameter than fracture morphology for the classification and treatment thoracolumbar injuries. Since these injury characteristics are interrelated and are critical to the maintenance of spinal stability, we think that both concepts should be considered during the assessment and management of these patients. The reliability and validity of 2 thoracolumbar injury classification systems were prospectively compared. The TLISS system, which emphasizes injury mechanism, was shown to be slightly more reliable than the TLICS scheme, which emphasizes injury morphology. However, both TLISS and TLICS algorithms exhibited excellent overall reproducibility and validity.
Clinical trials of therapies for acute traumatic spinal cord injury (tSCI) have failed to convincingly demonstrate efficacy in improving neurologic function. Failing to acknowledge the heterogeneity of these injuries and under-appreciating the impact of the most important baseline prognostic variables likely contributes to this translational failure. Our hypothesis was that neurological level and severity of initial injury (measured by the American Spinal Injury Association Impairment Scale [AIS]) act jointly and are the major determinants of motor recovery. Our objective was to quantify the influence of these variables when considered together on early motor score recovery following acute tSCI. Eight hundred thirty-six participants from the Rick Hansen Spinal Cord Injury Registry were analyzed for motor score improvement from baseline to follow-up. In AIS A, B, and C patients, cervical and thoracic injuries displayed significantly different motor score recovery. AIS A patients with thoracic (T2-T10) and thoracolumbar (T11-L2) injuries had significantly different motor improvement. High (C1-C4) and low (C5-T1) cervical injuries demonstrated differences in upper extremity motor recovery in AIS B, C, and D. A hypothetical clinical trial example demonstrated the benefits of stratifying on neurological level and severity of injury. Clinically meaningful motor score recovery is predictably related to the neurological level of injury and the severity of the baseline neurological impairment. Stratifying clinical trial cohorts using a joint distribution of these two variables will enhance a study's chance of identifying a true treatment effect and minimize the risk of misattributed treatment effects. Clinical studies should stratify participants based on these factors and record the number of participants and their mean baseline motor scores for each category of this joint distribution as part of the reporting of participant characteristics. Improved clinical trial design is a high priority as new therapies and interventions for tSCI emerge.
