Injection of bone cement (vertebroplasty) is safe, effective, and at an acceptable cost for patients with acute osteoporotic vertebral compression fractures. Vertebroplasty also gives greater pain relief than regular conservative treatment. This study contradicts previous findings that showed vertebroplasty does not increase pain relief. The Article is published Online First in The Lancet, and written by Dr Caroline A H Klazen and Dr Paul N M Lohle, St Elisabeth Ziekenhuis, Tilburg, Netherlands, and colleagues.
In two previous randomised studies with a sham control intervention, 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 a consistent 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, had experienced back pain for 6 weeks or less, and a visual analogue scale (VAS) score of 5 or more. The primary outcome was pain relief at 1 month and 1 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 3 points or more. Pain-free days were defined as days with a VAS score of 3 or lower.
Between Oct 1, 2005, and June 30, 2008, 431 patients were identified who were eligible for randomisation. 229 (53%) patients had spontaneous pain relief during assessment (their VAS score dropped below 5 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 1 month was -5•2 after vertebroplasty and -2•7 after conservative treatment, and between baseline and 1 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 1 month and 2•0 at 1 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 1 year, and is significantly better than that achieved with conservative treatment and at acceptable costs.”
In a linked Comment, Dr Douglas Wardlaw, Woodend Hospital, NHS Grampian, Aberdeen, UK, and Dr 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.”
“Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trial”
Caroline A H Klazen, Paul N M Lohle, Jolanda de Vries, Frits H Jansen, Alexander V Tielbeek, Marion C Blonk, Alexander Venmans, Willem Jan J van Rooij, Marinus C Schoemaker, Job R Juttmann, Tjoen H Lo, Harald J J Verhaar, Yolanda van der Graaf, Kaspar J van Everdingen, Alex F Muller, Otto E H Elgersma, Dirk R Halkema, Hendrik Fransen, Xavier Janssens, Erik Buskens, Willem P Th M Mali
The Lancet. August 10, 2010. DOI:10.1016/S0140-6736(10)60954-3