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• W2022100514 abstract "In 2009, two studies on percutaneous vertebroplasty (PVP) were published in the New England Journal of Medicine (NEJM) ( 1 Kallmes D.F. Comstock B.A. Heagerty P.J. et al. A randomized trial of vertebroplasty for osteoporotic spinal fractures. N Engl J Med. 2009; 361: 569-579 Crossref PubMed Scopus (1093) Google Scholar , 2 Buchbinder R. Osborne R.H. Ebeling P.R. et al. A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. N Engl J Med. 2009; 361: 557-568 Crossref PubMed Scopus (1101) Google Scholar ). These were double-blind, prospective, randomized controlled trials (RCTs) that raised surprising questions regarding the effectiveness of PVP. Both studies showed that, compared with a nonoperative group (what some have termed a controlled intervention, as there was no true placebo group), PVP had no greater benefit in alleviating pain from osteoporotic vertebral compression fractures (OVCFs). Many papers were written identifying perceived flaws in the research methods and results of Kallmes et al ( 1 Kallmes D.F. Comstock B.A. Heagerty P.J. et al. A randomized trial of vertebroplasty for osteoporotic spinal fractures. N Engl J Med. 2009; 361: 569-579 Crossref PubMed Scopus (1093) Google Scholar ) and Buchbinder et al ( 2 Buchbinder R. Osborne R.H. Ebeling P.R. et al. A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. N Engl J Med. 2009; 361: 557-568 Crossref PubMed Scopus (1101) Google Scholar ). Despite these challenges, the two articles nonetheless raised questions regarding the belief in the benefit of vertebral augmentation in the minds of many doctors and changed the fate of many patients with OVCFs. Among the implications, many health care insurance companies, and Washington state and others, no longer cover the cost of PVP or percutaneous kyphoplasty (PKP). Additionally, some physicians stopped recommending PVP and PKP as an alternative treatment for patients with OVCFs. As a result, many patients have had prolonged pain that might have been more quickly addressed with augmentation. Additionally, conservative therapy is not necessarily benign, and complications from the associated immobility, including pneumonia, pulmonary embolism, bed sores, additional bone loss, muscle weakness, depression, and isolation, have been reported ( 3 Jensen M.E. McGraw J.K. Cardella J.F. Hirsch J.A. Position statement on percutaneous vertebral augmentation: a consensus statement developed by the American Society of Interventional and Therapeutic Neuroradiology, Society of Interventional Radiology, American Association of Neurological Surgeons/Congress of Neurological Surgeons, and American Society of Spine Radiology. J Vasc Interv Radiol. 2007; 18: 325-330 Abstract Full Text Full Text PDF PubMed Scopus (41) Google Scholar ). These factors are well known to lead to significantly increased morbidity and mortality ( 4 Lyles K.W. Gold D.T. Shipp K.M. Pieper C.F. Martinez S. Mulhausen P.L. Association of osteoporotic vertebral compression fractures with impaired functional status. Am J Med. 1993; 94: 595-601 Abstract Full Text PDF PubMed Scopus (359) Google Scholar , 5 Kado D.M. Browner W.S. Palermo L. Nevitt M.C. Genant H.K. Cummings S.R. Vertebral fractures and mortality in older women: a prospective study. Study of Osteoporotic Fractures Research Group. Arch Intern Med. 1999; 159: 1215-1220 Crossref PubMed Scopus (882) Google Scholar )." @default.
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• W2022100514 title "Vertebroplasty Trials: The Medium Is the Message" @default.
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