NEW YORK (Reuters Health) – Vertebroplasty does not improve the pain or disability associated with osteoporotic spinal fractures, according to the results of two randomized trials appearing in The New England Journal of Medicine for August 6.
Despite only limited evidence supporting its use, vertebroplasty has become a popular treatment for painful osteoporotic spinal fractures, Dr. Rachelle Buchbinder, from Monash University, Malvern, Australia, and colleagues note. The few controlled studies that have examined the procedure have yielded conflicting results.
In the first study, Dr. Buchbinder’s team assessed the outcomes of patients with painful osteoporotic vertebral fractures who were randomized to undergo vertebroplasty or a sham procedure. The subjects were evaluated at 1 week and at 1, 3, and 6 months with the primary endpoint being overall pain at 3 months.
Of the 78 patients who started the study, 71 had complete follow-up through 6 months (91%).
The average reduction in overall pain scores in both groups at 3 months were not significantly different: 2.6 in the vertebroplasty group vs. 1.9 in the control group. Likewise, vertebroplasty offered no advantage over the sham procedure in reducing pain at night or improving physical functioning or quality of life.
By 6 months, 3 incident vertebral fractures had occurred in the vertebroplasty group, while 4 were seen in the control group, the report indicates.
The second study was similar in design to the first and involved 131 patients with one to three painful osteoporotic vertebral compression fractures. The main outcome measures were scores on the modified Roland-Morris Disability Questionnaire (RDQ) and the patients’ rating of pain on a 10-point scale at 1 month. The subjects, who were randomized to vertebroplasty or a sham procedure, were permitted to cross-over to the other study group at 1 month or later if pain relief was not adequate.
Neither the RDQ score, nor pain ratings differed significantly between the groups at 1 month, lead author Dr. David F. Kallmes, from the Mayo Clinic, Rochester, and colleagues note.
Vertebroplasty was, however, associated with a trend toward a higher rate of clinically meaningful improvement in pain (64% vs. 48%), although the difference was not statistically significant (p = 0.06). The crossover rate from sham treatment to vertebroplasty was higher than the opposite (43% vs. 12%, p < 0.001).
Both groups reported improvement in pain and disability immediately after the intervention. One patient in each group experienced a serious adverse event.
While the findings of both studies provide strong evidence that vertebroplasty offers little benefit for painful spinal fractures, the impact the results will have on clinical practice is unclear,” editorialist Dr. James N. Weinstein, from Dartmouth-Hitchcock Medical Center, Hanover, New Hampshire, writes.
Although the current studies “provide the best available scientific evidence for an informed choice,” he noted, “it remains to be seen whether there will be a paradigm shift in the treatment of vertebral compression fractures with vertebroplasty or similar procedures.
N Engl. J Med 2009;361:557-579,619-621.