VERTOS IV study uses strict inclusion criteria


An interivew with Paul NM Lohle and Willem Jan van Rooij

The principal investigators of the ongoing VERTOS IV (A randomised sham controlled trial of vertebroplasty for painful acute osteoporotic vertebral fractures) study—Paul NM Lohle and Willem Jan van Rooij (Department of Interventional Radiology and Neuroradiology, St Elisabeth ziekenhuis, Tilburg, The Netherlands)—spoke to Spinal News International about the study and the role of vertebroplasty today

VERTOS IV is an ongoing sham-controlled trial of vertebroplasty. What is its

main objective?

Its main objective is to compare pain relief during one year after vertebroplasty vs. one year after sham intervention in selected patients with an acute osteoporotic vertebral compression fractures using the strict inclusion criteria from VERTOS II: a proven vertebral compression fracture on spinal X-ray, local back pain of ≤6 weeks’ duration, local back pain Visual Analogue Scale (VAS) score of >5, vertebral compression fracture with bone oedema on MRI, proven osteoporosis, and age older than 50 years.

Other objectives of VERTOS IV are secondary vertebral compression fractures, quality of life and function during one year follow up.

Please can you describe the design of the study?

VERTOS IV is a Dutch multicentre study randomised sham-controlled trial. For the study, 142 patients are required. To date (August 2013) inclusion has been completed and we are awaiting final follow-up results.

What do you expect the results will show for vertebroplasty?

We do not speculate about the results because, whatever the outcome, the most important thing is to deliver scientifically sound data from a well-designed and well-executed randomised sham-controlled multicentre trial. We hope to release the results in the last quarter of 2014.

What is your view of the Buchbinder and Kallmes studies, which both suggested vertebroplasty was no more effective than sham treatment for the management of osteoporotic vertebral compression fractures?

These studies mixed “apples with pears” as they included both subacute and chronic vertebral compression fractures. There was no control group without an intervention, and bone oedema on MRI was not an inclusion criterion. Another problem was that in these studies, physical examination was not performed in all cases and follow-up was limited to one to six months. This makes these two studies difficult to interpret clinically and, therefore, the best treatment option remains unclear for the clinician.

Why are sham studies important in vertebroplasty?

Before the Buchbinder and Kallmes studies, we did not have sham treatment arms in studies of vertebroplasty. However as both of these studies had a sham treatment arm, to verify the correctness of their reported results in the N Engl J of Med (2009), we had to come up with the same level of evidence. Therefore, primarily for this reason, we started the randomised sham-controlled trial VERTOS IV, which will provide the highest level of evidence.  

Why do you think vertebroplasty continues to be used today?

All over the world, some interventional radiologists still continue to treat patients with osteoporotic vertebral compression fractures with vertebroplasty.So apparently, the results published by Buchbinder and Kallmes were not convincing enough. Both referring physicians and patients themselves still ask for vertebroplasty because they believe that in most cases, it will provide significant local back pain relief.