Elsevier

The Lancet

Volume 376, Issue 9746, 25 September–1 October 2010, Pages 1085-1092
The Lancet

Articles
Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trial

https://doi.org/10.1016/S0140-6736(10)60954-3Get rights and content

Summary

Background

Percutaneous vertebroplasty is increasingly used for treatment of pain in patients with osteoporotic vertebral compression fractures, but the efficacy, cost-effectiveness, and safety of the procedure remain uncertain. We aimed to clarify whether vertebroplasty has additional value compared with optimum pain treatment in patients with acute vertebral fractures.

Methods

Patients were recruited to this open-label prospective 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 (minimum 15% height loss; level of fracture at Th5 or lower; bone oedema on MRI), with back pain for 6 weeks or less, and a visual analogue scale (VAS) score of 5 or more. Patients were randomly allocated to percutaneous vertebroplasty or conservative treatment by computer-generated randomisation codes with a block size of six. Masking was not possible for participants, physicians, and outcome assessors. The primary outcome was pain relief at 1 month and 1 year as measured by VAS score. Analysis was by intention to treat. This study is registered at ClinicalTrials.gov, number NCT00232466.

Findings

Between Oct 1, 2005, and June 30, 2008, we identified 431 patients who were eligible for randomisation. 229 (53%) patients had spontaneous pain relief during assessment, and 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 1 month was −5·2 (95% CI −5·88 to −4·72) after vertebroplasty and −2·7 (−3·22 to −1·98) after conservative treatment, and between baseline and 1 year was −5·7 (−6·22 to −4·98) after vertebroplasty and −3·7 (−4·35 to −3·05) after conservative treatment. The difference between groups in reduction of mean VAS score from baseline was 2·6 (95% CI 1·74–3·37, p<0·0001) at 1 month and 2·0 (1·13–2·80, p<0·0001) at 1 year. No serious complications or adverse events were reported.

Interpretation

In a subgroup of patients with acute osteoporotic vertebral compression fractures and persistent pain, percutaneous vertebroplasty is effective and safe. Pain relief after vertebroplasty is immediate, is sustained for at least a year, and is significantly greater than that achieved with conservative treatment, at an acceptable cost.

Funding

ZonMw; COOK Medical.

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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