The VERTOS II trial, published online Aug 9 in Lancet, has refuted earlier studies by demonstrating that vertebroplasty is safe, effective and available at an acceptable cost for patients with acute osteoporotic vertebral fractures. Vertebroplasty also provided greater pain relief than conservative treatment.
Although vertebroplasty is increasingly used for pain treatment in the 1.4 million osteoporotic vertebral compression fractures occurring annually worldwide, data about the efficacy, cost-effectiveness and safety of the minimally invasive treatment are uncertain.
Two previous studies that seemed to indicate vertebroplasty and sham treatment were equally effective were hampered by the inclusion of patients with subacute and chronic fractures instead of acute fractures only, absence of a control group without intervention, inconsistent use of bone edema on MRI as a consistent inclusion criterion and other issues, wrote VERTOS II lead authors Caroline A.H. Klazen, MD, and Paul N.M. Lohle, MD, of St. Elisabeth Ziekenhuis in Tilburg, the Netherlands, and colleagues.
To clarify whether vertebroplasty provided additional value compared with conventional conservative treatment in patients with acute vertebral fractures Klazen and Lohle recruited patients aged 50 years or older with vertebral compression fractures on a spine x-ray who reported back pain for six weeks or less and presented with a visual analogue scale (VAS) of five or more from six hospitals in the Netherlands and Belgium. The primary outcome was pain relief at one month and one year as measured by VAS score. The secondary outcome was cost-effectiveness at one month and one year.
The authors identified 431 patients eligible for participation in the randomized trial between Oct. 1, 2005 and June 30, 2008--202 of whom who had persistent pain were randomly allocated to treatment with 101 referred to vertebroplasty and 101 referred to conservative treatment.
Patients were clinically assessed at baseline, one day, one week, one month, three months, six months and one year after vertebroplasty or randomization to conservative treatment. Researchers measured VAS on a score ranging from 0 (no pain) to 10 (worst pain ever) and defined clinically significant pain relief as a decrease in VAS from baseline of three points or more. Pain-free days were defined as days with a VAS score of three or lower.
“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 at one year,” wrote the authors. In addition, no serious complications or adverse events were reported.
The difference in mean total medical costs per patient was roughly equivalent to the cost of vertebroplasty and amounted to €2,474 ($3,277) at one month and €2,450 ($3,246) at one year in favor of conservative treatment. After results were processed to produce a cost-effectiveness acceptability curve, researchers determined that if society were willing to spend €30,000 ($39,745) or more per quality of adjusted life years gained, vertebroplasty is acceptable with more than 70 percent certainty.
The primary drawback of the study was that treatment could not be masked, which might have affected patient responses to questions or radiologic assessments.
"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," concluded Klazen and Lohle.
In an accompanying commentary, Douglas Wardlaw, MD, form Woodend Hospital, NHS Grampian in Aberdeen, Scotland, and Jan Van Meirhaege, MD, from Algemeen Ziekenhuis St Jan in Brugge, Belgium, wrote: "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."