Study finds vertebroplasty safe and clinically effective for patients with acute osteoporotic vertebral compression fractures

According to a study published in the online version of the Lancet, the injection of bone cement into the vertebrae is safe, effective, and at an acceptable cost for patients with acute osteoporotic vertebral compression fractures.

Injection of bone cement into the vertebrae (vertebroplasty) also gives greater pain relief than regular conservative treatment, the authors found. The article, written by Caroline A.H. Klazen, MD, and Paul N.M. Lohle, MD, PhD, of the Netherlands, and colleagues, is part of the Vertos II trial, a randomized controlled trial designed to assess the cost-effectiveness of percutaneous vertebroplasty compared to conservative therapy in patients with acute osteoporotic vertebral compression fractures (VCFs).

According to a press release, this study contradicts previous findings that showed vertebroplasty does not decrease pain. In two previous randomized studies with a sham control intervention, results seemed to show that vertebroplasty and sham treatment are equally effective, the authors noted. However, they said clinical interpretation of those studies is hampered by the following factors: 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 methodological issues.

Randomized trial

In this new study, the authors stated they aimed to clarify whether vertebroplasty has additional value compared with optimal pain treatment in patients with acute vertebral fractures.

Patients were recruited to this randomized trial from the radiology departments of six hospitals in the Netherlands and Belgium, the press release noted. Patients were aged 50 years or older, had VCFs verified on spinal radiographs, had experienced back pain for 6 weeks or less, and had a Visual Analog 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.

The investigators reported that between Oct. 1, 2005, and June 30, 2008, 431 patients were identified who were eligible for randomization. Two hundred and twenty-nine (53%) patients had spontaneous pain relief during assessment when their VAS score dropped below 5 without intervention, and the remaining 202 patients with persistent pain were evenly randomly allocated to vertebroplasty or conservative treatment.

Pain relief

The authors wrote that vertebroplasty resulted in greater pain relief than did conservative treatment; the 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.

They noted 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.

“In a selected subgroup of patients with acute osteoporotic vertebral fractures and persistent pain, vertebroplasty is effective and safe,” the authors stated in the press release. “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.”

Reference:
Klazen CAH, Lohle PNM, de Vries J, et al. Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trial. Lancet. Early Online Publication, 10 August 2010; doi:10.1016/S0140-6736(10)60954-3

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.

– Prof. Douglas Wardlaw
Woodend Hospital, NHS Grampian, Aberdeen, UK

–Dr Jan Van Meirhaege
Algemeen Ziekenhuis St Jan, Brugge, Belgium
Published commentary to the study

Follow OrthoSuperSite.com on Twitter