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Functional and Quality-of-Life Outcomes in Geriatric Patients with Type-II Dens Fracture
Alexander R. Vaccaro, MD, PhD1; Christopher K. Kepler, MD, MBA1; Branko Kopjar, MD, PhD, MS2; Jens Chapman, MD3; Christopher Shaffrey, MD4; Paul Arnold, MD5; Ziya Gokaslan, MD6; Darrel Brodke, MD7; John France, MD8; Mark Dekutoski, MD9; Rick Sasso, MD10; S. Tim Yoon, MD11; Christopher Bono, MD12; James Harrop, MD13; Michael G. Fehlings, MD, PhD14
1 Rothman Institute, Thomas Jefferson University, 925 Chestnut Street, 5th Floor, Philadelphia, PA 19107. E-mail address for A.R. Vaccaro: alexvaccaro3@aol.com
2 University of Washington, Box 359455, 4333 Brooklyn Avenue N.E., Room 14-315, Seattle, WA 98195-9455
3 University of Washington, 325 Ninth Avenue, Seattle, WA 98104
4 University of Virginia, P.O. Box 800386, Charlottesville, VA 22908-0386
5 University of Kansas, 3901 Rainbow Boulevard, Mail Stop 3021, Kansas City, KS 66160
6 Johns Hopkins University, Meyer 7-109, 600 North Wolfe Street, Baltimore, MD 21287
7 University of Utah, 590 Wakara Way, Salt Lake City, UT 84108
8 West Virginia University, One Medical Center Drive, Morgantown, WV 26506
9 Mayo Clinic, 200 First Avenue S.W., Rochester, MN 55902
10 Indiana Spine Group, 8402 Harcourt Road, Suite 400, Indianapolis, IN 46260
11 Emory University, 59 Executive Park South, Atlanta, GA 30329
12 Brigham and Women’s Hospital, 75 Francis Street, Boston, MA 02115
13 Thomas Jefferson University, 909 Walnut Street, 2nd Floor, Philadelphia, PA 19107
14 Toronto Western Hospital, West Wing, 4th Floor, Room 4WW449, 399 Bathurst Street, Toronto, ON M5T 2S8, Canada
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Disclosure: One or more of the authors received payments or services, either directly or indirectly (i.e., via his or her institution), from a third party in support of an aspect of this work. In addition, one or more of the authors, or his or her institution, has had a financial relationship, in the thirty-six months prior to submission of this work, with an entity in the biomedical arena that could be perceived to influence or have the potential to influence what is written in this work. No author has had any other relationships, or has engaged in any other activities, that could be perceived to influence or have the potential to influence what is written in this work. The complete Disclosures of Potential Conflicts of Interest submitted by authors are always provided with the online version of the article.

Copyright © 2013 by The Journal of Bone and Joint Surgery, Inc.
J Bone Joint Surg Am, 2013 Apr 17;95(8):729-735. doi: 10.2106/JBJS.K.01636
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Abstract

Background: 

Dens fractures are relatively common in the elderly. The treatment of Type-II dens fractures remains controversial. The aim of this multicenter prospective cohort study was to compare outcomes (assessed with use of validated clinical measures) and complications of nonsurgical and surgical treatment of Type-II dens fractures in patients sixty-five years of age or older.

Methods: 

One hundred and fifty-nine patients with a Type-II dens fracture were enrolled in a multicenter prospective study. Subjects were treated either surgically (n = 101) or nonsurgically (n = 58) as determined by the treatment preferences of the treating physicians and the patients. The subjects were followed at six and twelve months with validated outcome measures, including the Neck Disability Index (NDI) and Short Form-36v2 (SF-36v2). Treatment complications were prospectively recorded. Statistical analysis was performed to compare outcome measures before and after adjustment for confounding variables.

Results: 

The two groups were similar with regard to baseline characteristics. The most common surgical treatment was posterior C1-C2 arthrodesis (eighty of 101, or 79%) while the most common nonsurgical treatment was immobilization with use of a hard collar (forty-seven of fifty-eight, or 81%). The overall mortality rate was 18% over the twelve-month follow-up period. At twelve months, the NDI had increased (worsened) by 14.7 points in the nonsurgical cohort (p < 0.0001) compared with a nonsignificant increase (worsening) of 5.7 points in the surgical group (p = 0.0555). The surgical group had significantly better outcomes as measured by the NDI and SF-36v2 Bodily Pain dimension compared with the nonsurgical group, and these differences persisted after adjustment. There was no difference in the overall rate of complications, but the surgical group had a significantly lower rate of nonunion (5% versus 21% in the nonsurgical group; p = 0.0033). Mortality was higher in the nonsurgical group compared with the surgical group (annual mortality rates of 26% and 14%, respectively; p = 0.059).

Conclusions: 

We demonstrated a significant benefit with surgical treatment of dens fractures as measured by the NDI, a disease-specific functional outcome measure. As a result of the nonrandomized nature of the study, the results are vulnerable to the effects of possible residual confounding. We recommend that elderly patients with a Type-II dens fracture who are healthy enough for general anesthesia be considered for surgical stabilization to improve functional outcome as well as the union and fusion rates.

Level of Evidence: 

Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

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    References

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    Alexander R. Vaccaro MD, PhD, Christopher K. Kepler, MD, MBA, Branko Kopjar, MD, PhD, MS, Michael G. Fehlings. MD, PhD
    Posted on June 03, 2013
    Response to Dr. Paul Levin
    Thomas Jefferson University & Rothman Institute, Thomas Jefferson University & Rothman Institute, University of Washington, Toronto Western Hospital

    We appreciate the critical appraisal by Dr. Levin of our paper regarding the treatment of the elderly with type II odontoid fractures. Dr. Levin describes multiple concerns regarding the validity of our study, concerns that revolve largely around the design of our study.

    Our study uses an observational prospective design. The study was conceived specifically for the purpose of evaluating the results of surgical and non-surgical treatment of type II odontoid fractures in the elderly and is not a retrospective analysis in any way, as described by Dr. Levin. Our study was designed to be observational because of the wide diversity of treatment practices for odontoid fractures and as such does not dictate “…uniformity in either surgical approach or non-operative management.” Protocol driven treatment will require a different, experimental study design which was not the goal of our investigation.

    Dr. Levin further calls for a sub-group analysis of non-operative treatment approaches in our study. Such analysis, due to the small number of patients, would lack statistical power.

    Dr. Levin’s objection that complications are not divided into “minor” and “major” is a valid point. However at this time there is no accepted classification system of complications into those categories. The assertion that previously published studies have used such complication stratification is not compelling in light of the low level of evidence in previously published papers on this subject. Dr. Levin’s own analysis of our data by grouping complications into “major” and “minor” using his own criteria argues that the rate of major complications is higher in the surgical compared to the non-operative group. This calculation, however, fails to account for surgery itself following failed non-operative treatment as a major complication of a non-operative treatment.

    Our study provides Level II evidence of superiority of surgical over conservative treatment in the management of Type II odontoid fracture and we have acknowledged its limitations. We agree with Dr. Levin that an RCT would be desirable to produce Level I evidence. In the meantime, clinicians should use the best available evidence to support clinical decision making.

    Paul E. Levin, MD
    Posted on May 06, 2013
    The heterogeneity of the surgical and nonsurgical study ARMs invalidates conclusions. What is the significance of an odontoid nonunion?
    Montefiore Medical Center, The University Hospital for Albert Einstein College of Medicine, Bronx, NY, USA

    In the investigation “Functional and Quality-of-Life Outcomes in Geriatric Patients with Type-II Dens Fractures” the authors have attempted to identify the optimal treatment for geriatric patients with these challenging injuries. The authors conclude that “We recommend that elderly patients with type-II dens fractures…be considered for surgical stabilization to improve functional outcome as well as union and fusion rates”. 

    I have a number of concerns with the study design, conclusions and recommendations. The study is a multicenter, multiple surgeon, and retrospective analysis of the data. There is no uniformity in either surgical approach or non-operative management. The authors do not describe specific criteria which lead to the diagnosis of an “odontoid nonunion”. In addition, while the authors list numerous different “complications”, in their final analysis they do not consider whether the complications are major or minor. This lack of consistency in treatment protocols ultimately results in an evaluation of a variety of non-operative management protocols and a variety of operative interventions based on the surgeon's treatment philosophy at the time of intervention and it isn’t possible to draw any firm conclusions or recommendations other than the treatment of type-II dens fractures in the elderly warrants further study.

    The authors readily acknowledge that “The clinical relevance of dens nonunion in elderly patients is not clear”.  Despite the unknown clinical relevance, nonunion is considered a complication and by far the most common complication of nonsurgical management. The inclusion of nonunion dramatically alters the final impression of the balance of complications in the author’s analysis. The review also reports that thirteen patients treated nonsurgically crossed over to surgery due to “symptomatic” nonunion or fracture displacement. The authors do not describe the specific criteria to diagnose a nonunion (x-ray finding, CT finding, interval of time for radiographic union). The lack of uniformity in the diagnosis of nonunion in the investigation likely results in a wide spectrum of clinical scenarios ultimately diagnosed as nonunion. The authors surmise that because 13 patients crossed over for treatment of a nonunion or fracture displacement that there is a “suggestion” that nonunion is not a desirable endpoint.  I do not believe that this is a valid conclusion. The authors do not report any neurologic events secondary to these radiographic findings and without having an understanding of the significance of nonunion and fracture displacement we may simply be treating a radiographic finding which may or may not be clinically significant and could possibly cause pain.

    In attempting to create two groups to compare the authors have actually created two very general groups consisting of numerous surgical and nonsurgical treatments. The surgical group consisted of five different approaches of which 79% were a C1-C2 segmental instrumentation. The non-operative arm of the investigation initially included a group of 58 patients: 5 treated with a soft collar, 47 treated with a hard collar and 6 treated with a halo. Thirteen patients crossed over to the operative group leaving only 45 treated non-operatively.  The interval of time to cross over and the reasons for the decision to proceed with operative intervention were not specified other than for “symptomatic nonunion”. The period of immobilization, criteria for discontinuing immobilization, the protocol followed during the period of immobilization and specific problems with each form of immobilization were not described.  Essentially, there truly wasn’t a nonsurgical protocol to use for comparison in this investigation. The grouping of all nonsurgical methods of treatment, including halo versus orthosis, could significantly affect the final analysis and our ability to understand the effect of a specific non-operative treatment on the NDI and SF-36v2 scores.

    Finally, I also have concerns over how the authors elected to evaluate and group the complications related to the two treatment arms. Clinical studies often divide complications into major and minor occurrences. The overall analysis in this manuscript failed to differentiate complications. Table III outlines all of the complications and in the text the authors state that “Although there was a tendency toward a higher proportion of subjects with any complication in the non-surgically treated group, the difference was not significant”. I believe that grouping all complications together minimizes the significance and risk of major complications, which were usually surgical. The primary complications listed in the nonsurgical group were fracture displacement and nonunion. The criteria utilized to diagnosis nonunion are not standardized, and the consequences of fracture displacement/ nonunion in this study group are not described. The authors report that some investigators believe that a fibrous nonunion is an acceptable outcome, and therefore, nonunion may be a “complication” with no clinical relevance. Review of the complications associated with operative management include a far greater number of what most would consider major complications including acute airway compromise, dysphagia, PE, pneumonia, respiratory failure, meningitis, stroke and CSF leak.  This analysis would result in 26 major complications in the surgical group and 11 in the nonsurgical group. In addition, some of the complications in the surgical group (anterior versus posterior) and nonsurgical group (halo versus orthosis) may be treatment specific and not group specific.

    Undoubtedly, all of our patients with these injuries will benefit if we can identify the optimal method of management and learn the significance of an odontoid nonunion. The authors of this manuscript represent a group of highly respected spine surgeons at multiple centers. It would be very exciting if they were able continue their investigation with a prospective randomized trial comparing a specific non-operative protocol with a specific operative protocol.  This will be the best way to learn how to manage these challenging injuries and to understand the significance of an odontoid nonunion.

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