Two-Year Results of a Randomized Placebo-Controlled Trial of Vertebroplasty for Acute Osteoporotic Vertebral Fractures

Abstract

We previously reported the results of a randomized controlled trial that found no benefit of vertebroplasty over a sham procedure for acute osteoporotic vertebral fractures up to 6 months. We report here the 12-month and 24-month clinical outcomes of this trial. Eligible participants (n ¼ 78) were randomly assigned to receive either vertebroplasty (n ¼ 38) or a sham procedure (n ¼ 40). Randomization was stratified by treatment center, sex, and symptom duration (<6 weeks or !6 weeks). Participants, investigators (except the treating radiologists), and outcome assessors were blinded to group assignments. Enrolment occurred between April 2004 and October 2008 with follow-up completed October 2010. The primary outcome was overall pain measured on a scale of 0 (no pain) to 10 (maximal imaginable pain). Secondary outcomes included pain at rest and at night, disability, quality of life, perceived recovery, and adverse events, including incident clinically apparent vertebral fractures. At 12 and 24 months, complete data were available for 67 (86%) and 57 (73%) participants, respectively. At 12 months participants in the active group improved by 2.4 AE 2.7 (mean AE SD) units in overall pain compared with 1.9 AE 2.8 units in the sham group, adjusted between-group mean difference (MD) 0.3 (95% confidence interval [CI], -0.9 to 1.5), whereas at 24 months participants in the active group had improved by 3.0 AE 3.1 units compared with 1.9 AE 3.0 units in the sham group, MD 1.1 (95% CI, -0.3 to 2.4). No significant between-group differences were observed for any of the secondary efficacy outcomes at 12 or 24 months. There were no between-group differences in incident clinical vertebral fractures up to 24 months (active: n ¼ 14, sham: n ¼ 13), although the study had inadequate power for this outcome. These results provide further evidence that the use of this treatment in routine care is unsupported.

Complications of percutaneous vertebroplasty

“…It must be also pointed out that studies that put in doubts the effectiveness of PVP based on a very limited group of patients—up to 40 patients in each analyzed group. [36–38] …”

“…Some articles revealed no efficacy of PVP in comparison with sham-operated patients. [36–38] Later studies of the same authors showed no or limited value of vertebroplasty in long-term follow-up studies. [38–40] …”

Treatment of multiple osteoporotic vertebral compression fractures by percutaneous cement augmentation

“…Some randomised trials put into doubt the efficiency of vertebroplasty in osteoporotic fractures [9][10][11], but many more publications show significant relief of pain after performing this procedure [2,4,5,14,16,17]. With multiple fractures some authors suggest an increase in the number of new fractures after performing vertebroplasty [3,17], especially in vertebrae adjacent to the augmented ones [3,17].…”

“…This method of treatment is relatively safe, causing minimal operative trauma, and the complications are rare [5], mainly caused by extravertebral leakage of the cement [5,7] or osteitis [8]. In 2009, two randomised trials of vertebroplasty for acute osteoporotic spinal fractures did not find a beneficial effect of vertebroplasty as compared to conservative treatment [9,10], with the same conclusion during a two year follow-up [11]. However, both trials had a small number of patients; the first one, from Australia [9], included 71 participants, 35 treated by vertebroplasty and 36 without cement augmentation, and the second one, from the Mayo Clinic [10], included 131 patients, 68 treated by vertebroplasty and 63 without surgery.…”

Percutaneous vertebroplasty does not reduce pain and disability from osteoporotic vertebral compression fracture

“…The original protocol of Buchbinder1 stipulates 3–4 ml injection, however the substantial SD of ±1.2 mL from the original publication, which indicates very minimal volume application in some cases, is not mentioned. A subsequent publication on the same patient group indicates at least 16 patients having received 2.5 mL or less 5. Unsurprisingly, little clinical difference was seen when comparing groups with volumes under 2.5 ml (the comparison should be with those receiving close to 4 mL for thoracolumbar vertebra).…”