Vertebroplasty Augmentation Procedures: Examining the Controversy

Abstract

Background: Vertebral compression fractures are a common pathology affecting primarily the elderly, postmenopausal women, and those with metastatic vertebral disease. Vertebral augmentation procedures are popular treatment options for stability and pain relief. Preliminary studies have suggested that such procedures are adequately efficacious. However, the first randomized controlled trials (RCTs) published in the New England Journal of Medicine in 2009 showed that these procedures were not significantly different than placebo with regards to pain relief and quality of life. These studies were met with considerable criticism. The matter was further complicated when The Lancet published an RCT of its own that demonstrated the superiority of vertebroplasty over conservative management. The conflicting evidence has sparked ongoing debate in the medical community. All sides have provided arguments supported by evidence of varying strength and validity. Objective: To provide a concise and comprehensive presentation of the controversy surrounding vertebral augmentation procedures and the evidence cited by proponents on both sides of the debate. Methods: We began by researching the major randomized controlled trials both for and against vertebroplasty. These articles were already known to us, and were used as a starting point. We then performed a literature search in PubMed for articles dated from 2000 through 2012. The bibliographies of major articles and reviews were also cross-referenced for additional sources. Results: A number of articles that included comprehensive and systematic reviews, metaanalyses, and commentaries about noted studies were found. These provided a broad, detailed overview of the subject. Many of the common themes of these articles included limitations in the design, methods, and patient selection with regard to the RCTs and other available studies. Limitations: This review does not analyze the quality of evidence available nor does it provide an opinion in this regard. The conclusions of the present article are, therefore, general and descriptive in nature. Conclusions: The arguments presented by proponents of both sides of the debate appear to have validity. All of the major studies cited as evidence for or against vertebral augmentation procedures have limitations in their quality. Consequently, the debate cannot be concluded, convincingly, until more elaborate studies are conducted involving larger numbers of patients with clear procedure methods agreed upon by the major authorities in the field. Key words: Vertebroplasty, kyphoplasty, vertebral augmentation procedures, controversy of vertebroplasty, vertebral cancer, vertebral pain, compression fractures, back pain, vertebral fractures.