A study published online by the Journal of NeuroInterventional Surgery suggests that vertebroplasty and kyphoplasty are equally effective in reducing pain and disability in patients suffering from vertebral body compression fractures.
Vertebral body compression fractures are a significant cause of disability worldwide and can cause disability secondary to pain, spinal deformity, reduced pulmonary function, impaired mobility and depression. Both conservative and interventional techniques have been used to treat such fractures.
Avery J Evans, University of Virginia, Charlottesville, USA, and colleagues write that “While the overall utilisation rate of kyphoplasty and vertebroplasty has decreased since the publication of negative sham trials in 2009, these procedures are still commonly performed and represent a significant source of healthcare expenditure costs.” Kyphoplasty is performed more frequently than vertebroplasty—nearly 75% of patients undergoing spine augmentation in the USA receive kyphoplasty, the authors write—largely due to the perception that it is safer and more effective. However, studies comparing the two procedures are generally non-randomised or meta-analyses of non-randomised prospective studies. As such, Evans and colleagues carried out this, the third randomised controlled trial on the topic.
The authors enrolled 115 subjects at nine US centres in their trial, who were then randomly assigned to treatment with either vertebroplasty (56, 48.7%) or kyphoplasty (59, 51.3%). Primary endpoints for this study were pain measured on a 0–10 scale and disability assessed using the Roland-Morris Disability Questionnaire. Outcomes were assessed at three days, one month, six months and one year following the procedure. The mean age of the full cohort was 75.6 years, 71% of whom were women. The authors note that “baseline demographic and clinical characteristics were similar by random assignment,” (p>0.05).
Evans et al report that “reductions in average pain, pain frequent and functional limitations due to pain were substantial after surgery, while remarkably similar by treatment assignment.” Mean baseline pain scores were 7.4 for the kyphoplasty group and 7.9 for vertebroplasty. Three days after the treatment, these scores had fallen to 4.1 for kyphoplasty and 3.7 for vertebroplasty. At 30 days the mean pain scores fell to 3.4 for kyphoplasty and 3.6 for vertebroplasty, and at one year the scores were 3.0 for kyphoplasty and 2.3 for vertebroplasty (all time points p>0.05).
In terms of disability scores, a similar improvement across time points was reported. At baseline the scores were 17.3 for the kyphoplasty group and 16.3 in the vertebroplasty. Three days after treatment these scores fell to 11.8 for kyphoplasty and 10.9 for vertebroplasty. At 30 days the kyphoplasty group’s mean disability score was 8.6 compared to 8.8 in the vertebroplasty group, and at one year 7.5 for kyphoplasty and 6.7 for vertebroplasty (all time points p>0.05).
“There was essentially no evidence of a differential response in clinical improvement between treatment with kyphoplasty and with vertebroplasty,” the authors write. They go on to note that the results “could have a significant economic impact as they suggest that the less costly a less utilised procedure—vertebroplasty—is equally effective in all measures when compared with kyphoplasty.” That said, the authors do conclude that the comparative long-term benefits have yet to be clarified, and that the sample size of this study is “modest”.