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Evidence-Based Orthopaedics   |    
American Academy of Orthopaedic Surgeons Clinical Practice Guideline onThe Treatment of Osteoporotic Spinal Compression Fractures
Stephen I. Esses, MD; Robert McGuire, MD; John Jenkins, MD; Joel Finkelstein, MD; Eric Woodard, MD; William C. Watters, III, MD; Michael J. Goldberg, MD; Michael Keith, MD; Charles M. Turkelson, PhD; Janet L. Wies, MPH; Patrick Sluka, MPH; Kevin M. Boyer; Kristin Hitchcock, MLS; Laura Raymond, MA
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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. Also, one or more of the authors has had another relationship, or has engaged in another activity, 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.

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Disclaimer: This clinical guideline was developed by an AAOS physician volunteer Work Group and is provided as an educational tool based on an assessment of the current scientific and clinical information and accepted approaches to treatment. It is not intended to be a fixed protocol as some patients may require more or less treatment. Patient care and treatment should always be based on a clinician's independent medical judgment given the individual clinical circumstances.
The complete AAOS guideline can be found at http://www.aaos.org/research/guidelines/SCFguideline.pdf

Copyright © 2011 by The Journal of Bone and Joint Surgery, Inc.
J Bone Joint Surg Am, 2011 Oct 19;93(20):1934-1936. doi: 10.2106/JBJS.9320ebo
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AAOS Guideline on The Treatment of Osteoporotic Spinal Compression Fractures
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    Christof Birkenmaier, MD
    Posted on October 31, 2011
    'Clear and present danger' to many patients' health and quality of life
    Head of Spine & Osteology, Department of Orthopedic Surgery, University of Munich

    I am an academic spine surgeon from Munich, Germany and I am writing to you in my name and in that of several colleagues, all spine specialists. The current issue of the JBJS American Issue publishes the American Academy of Orthopaedic Surgeons Clinical Practice Guidelines on 'The Treatment of Osteoporotic Spinal Compression Fractures'. While these are generated and primarily issued by the AAOS, the JBJS shares certain responsibilities with the AAOS in the sense that the JBJS is the primary journal to publish these guidelines to the Orthopaedic world at large and because the voice of the JBJS carries a lot of weight. These guidelines contain only one single 'strong recommendation' next to 1 'moderate' and 9 'weak' or 'inconclusive' recommendations. This strong recommendation is against vertebroplasty 'for patients who present with an osteoporotic spinal compression fracture on imaging with correlating clinical signs and symptoms and who are neurologically intact'. At the same time, there is a 'weak' recommendation for kyphoplasty for the same group of patients. The strong recommendation against vertebroplasty is almost exclusively based on 2 RCTs, originally published in the NEJM in 2009. These studies have been widely criticized in the scientific arena, even though – in our opinion – not precisely enough and not to the full depth of their design problems. It is our strong belief, that these 2 studies do in fact not allow for a transfer of their findings to the group of patients which sensible and conscientious spinal specialists would normally indicate for vertebroplasty. In consequence and after thoroughly studying the complete guidelines as they are published on the AAOS website, it is our conviction that in this specific case, the 'absence of evidence' has been misinterpreted for the 'evidence of absence'. After all, it still is the clear clinical experience of Orthopaedic and Neurosurgical spine specialists around the world, that vertebroplasty is an extremely beneficial procedure, when properly indicated and performed. And with no Orthopaedic or Neurosurgical spine specialist being centrally involved in either of the 2 studies in question, it comes as no surprise, that physical examination and clinical differential diagnostics as to the predominant source of back pain were not an inclusion criterion in either study. We do not wish to burden you with too much detail in this initial contact, but if you wish, you may want to look at our attached critique of the 2 trials and at our response to a recent subgroup metaanalysis that was published in the BMJ (http://www.bmj.com/content/343/bmj.d3952.full/reply#bmj_el_269846). Our concern in 2009 was, that a very beneficial (and in specific situations potentially even life saving) procedure might be withheld from patients as a result of these 2 flawed RCTs, especially when these 2 trials are taken as a basis for national guidelines. This risk is certainly greater in the US than in Europe, because of the power which HMOs hold over indications and procedures, but also Europe will certainly see patients go untreated – or instead being indicated for the much more expensive, because still mainly proprietary kyphoplasty procedure. It appears that our concerns will become reality to their full potential. We implore you to appreciate the 'clear and present danger' to many patients' health and quality of life that these guidelines pose, if consumed without further detail knowledge. And we therefore ask you to open a critical and scientifically objective discussion on the background for the 'strong recommendation' against vertebroplasty. We are prepared to put our expertise and analyses on the topic at your disposition. Last, but not least, without suggesting anything and exclusively for the sake of transparency: The readers of the AAOS guidelines deserve to know in specific, whether or whether not any of the guidelines' authors have any financial, business or research ties with Kyphon or any other manufacturer of kyphoplasty equipment.

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