Vertebroplasty appears no better than placebo for painful osteoporotic spinal fractures, and has potential to cause harm
Author: Kevin D Pile
Published online: 1 February 2010
To the Editor: Clinical trials study a restricted patient group, so their results may not be generalisable to a different population subgroup or the population as a whole. The editorial by Buchbinder, Osborne and Kallmes1 about their recent vertebroplasty studies2,3 concludes that vertebroplasty offers no benefit over placebo. They suggest that, in light of their trials, the decision to list vertebroplasty on the Medical Benefits Schedule will be reviewed later this year. I understood the review to have been part of the original listing on the benefits schedule and not as a result of their studies, and I suggest that their editorial generalises results to a subpopulation of early acute vertebral fractures that they did not study.
The duration of symptoms in osteoporotic vertebral fracture is critical, as most fractures heal quickly with a good outcome by 3 months, and only a very small group of patients continue to experience pain.4 A fracture that is still painful months after the event is not a “normal fracture”, and I suggest is less likely to respond to the same management concepts as an acute fracture.
In the study by Buchbinder and colleagues, patients had persistent pain and were recruited up to 1 year after their vertebral fracture.2 Nearly three-quarters had significant ongoing pain for at least a month after their fracture, and most for at least 2 months. The study by Kallmes and colleagues also included symptomatic fractures up to 1 year old, with the interquartile range (8–38 weeks) suggesting that they had an even longer period between fracture and inclusion in the trial.3
While vertebroplasty appears to be unhelpful for patients who continue to have chronic pain months after an acute osteoporotic fracture, the authors have not robustly excluded vertebroplasty as improving quality of life and pain management in those who undergo vertebroplasty within days to a month of the fracture. Such an outcome is suggested by Rousing et al, who showed that vertebroplasty within 2 weeks of fracture led to a rapid reduction in pain within 12–24 hours, similar to the result of conservative management at 3 months.4
Any review of the role for vertebroplasty should consider the populations studied and, hence, should define the characteristics of patients in whom to intervene or not intervene.
References
- Buchbinder R, Osborne RH, Kallmes D. Vertebroplasty appears no better than placebo for painful osteoporotic spinal fractures, and has potential to cause harm [editorial]. Med J Aust 2009; 191: 476-477. 0_CHDJJGCB
- Buchbinder R, Osborne R, Ebeling P, et al. A randomised trial of vertebroplasty for painful osteoporotic vertebral fractures. N Engl J Med 2009; 361: 557-568. 0_i1091867
- Kallmes DF, Comstock BA, Heagerty PJ, et al. A randomised trial of vertebroplasty for osteoporotic spinal fractures. N Engl J Med 2009; 361: 569-579. 0_i1091869
- Rousing R, Andersen M, Jespersen S, et al. Percutaneous vertebroplasty compared with conservative treatment in patients with painful acute or subacute osteoporotic vertebral fractures: three-months follow-up in a clinical randomized study. Spine 2009; 34: 1349-1354. 0_i1091873