(Burr Ridge, IL) – The North American Spine Society (NASS) today released comments on two new studies on vertebroplasty and their significance to patient care. NASS’ comments, published in The Spine Journal online, were issued in response to two randomized controlled trials on vertebroplasty published on August 6, 2009 in the New England Journal of Medicine – A Randomized Trial of Vertebroplasty for Painful Osteoporotic Vertebral Fractures and A Randomized Trial of Vertebroplasty for Osteoporotic Spinal Fractures. Both studies examined the benefit of vertebroplasty when compared to sham procedures.

“Evidence and experience related to use of vertebroplasty have been overwhelmingly positive, prior to the publication of the studies by Buchbinder et al. and Kallmes et al. Spine care providers are now faced with a large chasm between the previous data and experiences and these latest studies. The data from these two new studies must be considered carefully and thoughtfully. The findings are not surprising or dissimilar from previous data; however, the conclusions drawn by the authors may not be as decisive as they appear. Practical conclusions should be made based on a thorough and systematic review of all the literature in order to better define the subgroup of patients for which vertebroplasty might be most appropriate,” said Christopher Bono, MD, orthopedic surgeon at Brigham & Women's Hospital in Boston, Massachusetts and NASS Board member and Evidence-based Guideline Development Committee Chair.

NASS’ primary concerns were about the studies’ patient selection, including issues related to fracture acuity, patient enrollment, control group management and outcomes.

“Both groups of authors should be congratulated for undertaking the difficult task of performing high-level studies on an important clinical disorder in our aging population.  The intent of this analysis is not to in any way defame the studies or question the integrity of the authors.  Instead, it is to perhaps help explore why there is such a seeming disconnect between the conclusions of these two prospective randomized controlled trials (PRCTs) and previous experience and data,” said Dr. Bono.

The entire text of the NASS response can be found on the NASS Web site.

The North American Spine Society (NASS) is a multidisciplinary medical organization dedicated to fostering the highest quality, evidence‐based, and ethical spine care by promoting education, research, and advocacy. NASS is comprised of more than 5,500 members from several disciplines including orthopedic surgery, neurosurgery, physiatry, neurology, radiology, anesthesiology, research, physical therapy and other spine care professionals. For more information, visit www.spine.org.

The Spine Journal, the official journal of NASS, is an international and multidisciplinary journal that publishes original, peer-reviewed articles on research and treatment related to the spine and high-quality, ethical, evidence-based spine care, including basic science and clinical investigations. For more information, visit www.thespinejournalonline.com.

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