Kyphoplasty Safe and Effective for VCFs
BY LAUREN UZDIENSKI, NOVEMBER 24, 2009
This month JBJS reprinted data from the Fracture Reduction Evaluation (FREE) study that had been published in the Lancet earlier this year (and discussed at NASS two weeks ago.) FREE researchers found that patients randomized to undergo kyphoplasty for the treatment of a VCF reported greater improvement in pain and function than patients who received non-surgical care. Outcomes were measured by the SF-36, where patients receiving kyphoplasty improved an average of five points more than the non-surgical group one month following treatment. Benefits were maintained through six months.
With 300 patients enrolled at 21 European sites, the study featured a fairly broad cohort. Patients were suffering from acute VCFs, which is relevant as the age of the fracture has been considered a factor contributing to mixed results for VCF treatments noted in other studies. FREE was not blinded. There were two serious adverse events in the kyphoplasty group, which did not differ significantly from the group treated non-surgically.
FREE contributes to the ongoing dialogue on VCF treatments, which were questioned over the summer with the release of a controversial study on vertebroplasty. While not addressing the vertebroplasty study directly, commentary accompanying the Lancet data stressed the importance of growing the evidence on VCF treatments and highlighted some of the research activity that is ongoing in this field. Beyond demonstrating efficacy for a single treatment compared to non-surgical treatment, data comparing vertebroplasty and kyphoplasty is forthcoming from the OSTEO+6, KAVIAR, and Cost Effectiveness and Efficacy of Kypho and Vertebroplasty (CEEP) studies.
