Skip Navigation LinksHome > August 2013 - Volume 60 - Issue > Guidelines for the Management of Acute Cervical Spine and Sp...
Neurosurgery:
doi: 10.1227/01.neu.0000430319.32247.7f
GENERAL SCIENTIFIC SESSION IV: OUR FUTURE IS NOW!: Chapter 15

Guidelines for the Management of Acute Cervical Spine and Spinal Cord Injuries: 2013 Update

Walters, Beverly C. MD, MSc, FRCSC; Hadley, Mark N. MD; Hurlbert, R. John MD, PhD, FRCSC; Aarabi, Bizhan MD, FRCSC; Dhall, Sanjay S. MD; Gelb, Daniel E. MD; Harrigan, Mark R. MD; Rozelle, Curtis J. MD; Ryken, Timothy C. MD, MS; Theodore, Nicholas MD

Free Access

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.

Back to Top | Article Outline

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.

Back to Top | Article Outline

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.

Back to Top | Article Outline

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).32

TABLE-a Comparison o...
TABLE-a Comparison o...
Image Tools

The 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.

TABLE-b Comparison o...
TABLE-b Comparison o...
Image Tools
TABLE-c Comparison o...
TABLE-c Comparison o...
Image Tools
TABLE-d Comparison o...
TABLE-d Comparison o...
Image Tools
TABLE-e Comparison o...
TABLE-e Comparison o...
Image Tools
TABLE-f Comparison o...
TABLE-f Comparison o...
Image Tools
TABLE-g Comparison o...
TABLE-g Comparison o...
Image Tools
TABLE-h Comparison o...
TABLE-h Comparison o...
Image Tools

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.

Back to Top | Article Outline

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

Back to Top | Article Outline
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.

Back to Top | Article Outline

REFERENCES

1. Guidelines for management of acute cervical spinal injuries: introduction. Neurosurgery. 2002;50(suppl 3):S1.

2. Methodology of guideline development. Neurosurgery. 2002;50(suppl 3):S2–S6.

3. Cervical spine immobilization before admission to the hospital. Neurosurgery. 2002;50(suppl 3):S7–S17.

4. Transportation of patients with acute traumatic cervical spine injuries. Neurosurgery. 2002;50(suppl 3):S18–S20.

5. Clinical assessment after acute cervical spinal cord injury. Neurosurgery. 2002;50(suppl 3):S21–S29.

6. Radiographic assessment of the cervical spine in symptomatic trauma patients. Neurosurgery. 2002;50(suppl 3):S36–S43.

7. Initial closed reduction of cervical spine fracture-dislocation injuries. Neurosurgery. 2002;50(suppl 3):S44–S50.

8. Management of acute spinal cord injuries in an intensive care unit or other monitored setting. Neurosurgery. 2002;50(suppl 3):S51–S57.

9. Blood pressure management after acute spinal cord injury. Neurosurgery. 2002;50(suppl 3):S58–S62.

10. Pharmacological therapy after acute cervical spinal cord injury. Neurosurgery. 2002;50(suppl 3):S63–S72.

11. Deep venous thrombosis and thromboembolism in patients with cervical spinal cord injuries. Neurosurgery. 2002;50(suppl 3):S73–S80.

12. Nutritional support after spinal cord injury. Neurosurgery. 2002;50(suppl 3):S81–S84.

13. Management of pediatric cervical spine and spinal cord injuries. Neurosurgery. 2002;50(suppl 3):S85–S99.

14. Spinal cord injury without radiographic abnormality. Neurosurgery. 2002;50(suppl 3):S100–S104.

15. Diagnosis and management of traumatic atlanto-occipital dislocation injuries. Neurosurgery. 2002;50(suppl 3):S105–S113.

16. Occipital condyle fractures. Neurosurgery. 2002;50(suppl 3):S114–S119.

17. Isolated fractures of the atlas in adults. Neurosurgery. 2002;50(suppl 3):S120–S124.

18. Isolated fractures of the axis in adults. Neurosurgery. 2002;50(suppl 3):S125–S139.

19. Management of combination fractures of the atlas and axis in adults. Neurosurgery. 2002;50(suppl 3):S140–S147.

20. Os odontoideum. Neurosurgery. 2002;50(suppl 3):S148–S155.

21. Treatment of subaxial cervical spinal injuries. Neurosurgery. 2002;50(suppl 3):S156–S165.

22. Management of acute central cervical spinal cord injuries. Neurosurgery. 2002;50(suppl 3):S166–S172.

23. Management of vertebral artery injuries after nonpenetrating cervical trauma. Neurosurgery. 2002;50(suppl 3):S173–S178.

24. Walters BC. Methodology of the guidelines for the management of acute cervical spine and spinal cord injuries. Neurosurgery. 2013;72(suppl 2):17–21.

25. Centre for Evidence-based Medicine. Oxford Centre for Evidence-based Medicine: Levels of Evidence (March 2009). http://www.cebm.net/index.aspx?o=1025. Accessed December 31, 2012.

26. Fehlings 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):e32037.

27. Dididze M, Green BA, Dalton Dietrich W, et al.. Systemic hypothermia in acute cervical spinal cord injury: a case-controlled study [published online ahead of print]. Spinal Cord. 2012;51(5):395–400.

28. Cadotte DW, Stroman PW, Mikulis D, Fehlings MG. A systematic review of spinal fMRI research: outlining the elements of experimental design. J Neurosurg Spine. 2012;17(suppl 1):102–118.

29. Fehlings MG, Theodore N, Harrop J, et al.. A phase I/IIa clinical trial of a recombinant Rho protein antagonist in acute spinal cord injury. J Neurotrauma. 2011;28(5):787–796.

30. Nakamura M, Okano H. Cell transplantation therapies for spinal cord injury focusing on induced pluripotent stem cells. Cell Res. 2013;23(1):70–80.

31. Walters BC. Oscillating field stimulation in the treatment of spinal cord injury. PM R. 2010;2(12 suppl 2):S286–S291.

32. Hadley MN, Walters BC. Introduction to the Guidelines for the Management of Acute Cervical Spine and Spinal Cord Injuries. Neurosurg. 2013;72(Suppl 2):5–16.

33. Bracken MB, Shepard MJ, Hellenbrand KG, et al.. Methylprednisolone and neurological function 1 year after spinal cord injury: results of the National Acute Spinal Cord Injury Study. J Neurosurg. 1985;63(5):704–713.

34. Bracken MB, Shepard MJ, Collins WF Jr, et al.. Methylprednisolone or naloxone treatment after acute spinal cord injury: 1-year follow-up data: results of the second National Acute Spinal Cord Injury Study. J Neurosurg. 1992;76(1):23–31.

35. Bracken MB, Shepard MJ, Holford TR, et al.. Administration of methylprednisolone for 24 or 48 hours or tirilazad mesylate for 48 hours in the treatment of acute spinal cord injury: results of the Third National Acute Spinal Cord Injury Randomized Controlled Trial: National Acute Spinal Cord Injury Study. JAMA. 1997;277(20):1597–1604.

36. Coleman WP, Benzel D, Cahill DW, et al.. A critical appraisal of the reporting of the National Acute Spinal Cord Injury Studies (II and III) of methylprednisolone in acute spinal cord injury. J Spinal Disord. 2000;13(3):185–199.

37. Benzel EC. Commentary on National Acute Spinal Cord Injury Study III. J Neurosurg. 2002;96(suppl 3):257; discussion 257-258.

38. Hugenholtz H. Methylprednisolone for acute spinal cord injury: not a standard of care. CMAJ. 2003;168(9):1145–1146.

39. Hurlbert RJ, Moulton R. Why do you prescribe methylprednisolone for acute spinal cord injury? A Canadian perspective and a position statement. Can J Neurol Sci. 2002;29(3):236–239.

40. Nicholas JS, Selassie AW, Lineberry LA, Pickelsimer EE, Haines SJ. Use and determinants of the methylprednisolone protocol for traumatic spinal cord injury in South Carolina acute care hospitals. J Trauma. 2009;66(5):1446–1450; discussion 1450.

41. Pandya KA, Weant KA, Cook AM. High-dose methylprednisolone in acute spinal cord injuries: proceed with caution. Orthopedics. 2010;33(5):327–331.

42. Eck JC, Nachtigall D, Humphreys SC, Hodges SD. Questionnaire survey of spine surgeons on the use of methylprednisolone for acute spinal cord injury. Spine (Phila Pa 1976). 2006;31(9):E250–E253.

43. Hurlbert RJ, Hamilton MG. Methylprednisolone for acute spinal cord injury: 5-year practice reversal. Can J Neurol Sci. 2008;35(1):41–45.

Copyright © by the Congress of Neurological Surgeons

Login

Article Tools

Images

Share