ArticlesVertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trial
Introduction
Vertebral compression fractures in osteoporosis are common in the elderly population, with an estimated 1·4 million new fractures occurring every year worldwide.1 About a third of new fractures come to medical attention, suggesting that most are either asymptomatic or have tolerable symptoms.2 Patients with an acute vertebral fracture can present with severe back pain lasting for weeks to months. Until recently, bed rest, analgesia, and cast and physical support were the only treatment options. Vertebroplasty, involving percutaneous injection of bone cement into the fractured vertebral body, was introduced as an alternative option for treatment of pain. Since its introduction, this minimally invasive technique has gained widespread recognition, effectively reducing pain both in the short and long term.3, 4, 5, 6, 7, 8, 9, 10, 11, 12 Two randomised studies with a sham control intervention have reported clinical outcomes 1 month and 6 months after percutaneous vertebroplasty in patients with osteoporotic vertebral fractures up to a year old.13, 14 Results of both studies seem to show that vertebroplasty and sham treatment are equally effective. However, clinical interpretation of these studies is hampered by inclusion of patients with subacute and chronic fractures instead of acute fractures, absence of a control group without intervention, inconsistent use of bone oedema on MRI as an inclusion criterion, and other methodological issues.15 We aimed to clarify whether percutaneous vertebroplasty has additional value compared with optimum pain treatment in a well defined group of patients with acute vertebral compression fractures.
Section snippets
Study design and patients
The methods of this study, including the protocol, patient selection, and clinical outcome measures, have been described in detail elsewhere;16 in this Article, we mainly report on evolution of pain and cost-effectiveness of vertebroplasty. In short, we undertook an open-label randomised controlled trial in five large teaching hospitals in the Netherlands and one in Belgium. Patients were recruited at the radiology departments of the participating centres. All patients aged 50 years or older
Results
Between Oct 1, 2005, and June 30, 2008, 934 patients were screened for eligibility, of whom 202 were randomly allocated to treatment (101 percutaneous vertebroplasty, 101 conservative treatment). Figure 1 shows the trial profile. Patients allocated to vertebroplasty were treated at a mean of 9·4 (SD 8·1) days after randomisation. Table 1 shows baseline characteristics of both groups. Informed consent was withdrawn after randomisation by six patients assigned to conservative treatment and by two
Discussion
Our results show that in patients with acute osteoporotic vertebral fractures who have persistent severe pain, vertebroplasty done at a mean 5·6 weeks after onset of symptoms resulted in quicker and greater pain relief than did conservative treatment. Notably, in more than half of the patients who initially qualified for the study, pain spontaneously decreased to bearable levels, with a VAS score lower than 5 thereby precluding inclusion. After vertebroplasty, patients had significant pain
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