Vertos II, a study published in August 2010 in The Lancet, finds that vertebroplasty is safe, effective and at an acceptable cost for patients with acute osteoporotic vertebral compression fractures.
It also finds that vertebroplasty gives greater pain relief than regular conservative treatment. Authors of the study, Caroline A H Klazen and Paul N M Lohle, St Elisabeth Ziekenhuis, Tilburg, The Netherlands, and colleagues write that this study contradicts previous findings which have shown that vertebroplasty does not increase pain relief.
In two previous randomised studies with a sham control intervention, the results seemed to show that vertebroplasty and sham treatment are equally effective. However, the authors of this new work say clinical interpretation of these previous studies is hampered by inclusion of patients with subacute and chronic fractures instead of acute fractures only, absence of a control group without intervention, inconsistent use of bone oedema on MRI as an inclusion criterion, and other methodological issues.
In this new study, the authors aimed to clarify whether vertebroplasty has additional value compared with optimal pain treatment in patients with acute vertebral fractures. Patients were recruited to this randomised trial from the radiology departments of six hospitals in the Netherlands and Belgium. Patients were aged 50 years or older, had vertebral compression fractures on spine radiograph with bone oedema on MRI, had experienced back pain for six weeks or less, and a visual analogue scale (VAS) score of five or more. The primary outcome was pain relief at one month and one year as measured by VAS score. VAS scores ranged from 0 (no pain) to 10 (worst pain ever). The authors defined clinically significant pain relief as a decrease in VAS score from baseline of three points or more. Pain-free days were defined as days with a VAS score of three or lower.
Between 1 October 2005, and 30 June 2008, 431 patients were identified who were eligible for randomisation. Two hundred and twenty nine (53%) patients had spontaneous pain relief during assessment (their VAS score dropped below five without intervention), and the other 202 patients with persistent pain were randomly allocated to treatment (101 vertebroplasty, 101 conservative treatment). Vertebroplasty resulted in greater pain relief than did conservative treatment; difference in mean VAS score between baseline and one month was -5.2 after vertebroplasty and -2.7 after conservative treatment, and between baseline and one year was -5.7 after vertebroplasty and -3.7 after conservative treatment. The difference between groups in reduction of mean VAS score from baseline was 2.6 at one month and 2.0 at one year. No serious complications or adverse events were reported.
The authors note that the main drawback of their study was that treatment could not be masked. Knowledge of the treatment assignment might have affected patient responses to questions or radiologist assessments.
They conclude: “In a selected subgroup of patients with acute osteoporotic vertebral fractures and persistent pain, vertebroplasty is effective and safe. Pain relief after the procedure is immediate, sustained for one year, and is significantly better than that achieved with conservative treatment and at acceptable costs.”
In a linked comment, Douglas Wardlaw, Woodend Hospital, NHS Grampian, Aberdeen, UK, and Jan Van Meirhaege, Algemeen Ziekenhuis St Jan, Brugge, Belgium, say: “Vertos II lends support to the large body of medical opinion that vertebroplasty has a part to play in management of the pain of vertebral compression fractures.”
Commenting on the study, Kieran Murphy, professor, neurointerventional radiology, University Health Network, Canada said: “Vertos II is a great step in debunking the flawed science of the two NEJM papers, the ramifications of which continue to deny patients care globally. We still need a prospective randomised three-arm trial of vertebroplasty kyphoplasty and sham arm, however, to once and for all put these NEJM papers behind us. At that point perhaps I could paraphrase Voltaire and say to those authors, I am reading your papers in the smallest room in the house, that which is before me shall soon be behind me!”
Brian F Stainken, adjunct professor of Radiology at Boston University School of Medicine, Massachusetts, department chair at Roger Williams Hospital in Providence, Rhode Island, USA who is also one of the editors-in-chief of Interventional News says, “The robust debate involving the relative merit of vertebral augmentation has entered a new stage. It is a relief to now have such strong data affirming our individual experience. In the aggregate, these trials will us help refine the approach to patient selection, counselling, and imaging evaluation. But these trials are much more important as an example of what must happen throughout IR. We must lead in questioning, refining, and validating everything we do. It is not sufficient to rest on individual experience. Each of us must do everything we can to support IR research. We must re-commit to support academic IR practice, contribute to research foundations, and encourage young IRs toward research careers. Our future depends on it.”