FDA-IDE study finds vertebroplasty with Cortoss has better patient outcomes


Hyun W Bae presented long-term functional results observed in a multicentre FDA-IDE study at the North American Spine Society annual meeting in October 2010.


“Vertebroplasty is the treatment of choice for acute vertebral compression fractures which are non-responsive to conservative care. Long-term comparative data on functional outcomes beyond 12 months are lacking,” he said.


The study is a prospective, randomised, multicentre, non-inferiority trial comparing vertebroplasty with Cortoss (a bioactive composite material from Orthovita) to vertebroplasty with polymethyl methacrylate.


Bae told delegates that vertebroplasty remains an appropriate treatment for patients with subacute fractures and more severe symptoms, and, as demonstrated in this study, leads to significant reduction in pain and functional improvement.


“The beneficial effects of percutaneous vertebroplasty in elderly patients with vertebral compression fractures are durable and can be measured over the long term,” he said.

Bae also noted that, “Patients with vertebral compression fractures who were treated with Cortoss exhibited better long-term functional results than those treated with polymethyl methacrylate. But this finding can be due to the more pronounced effect on pain in the earlier stages following percutaneous vertebroplasty.”


Investigators enroled 256 patients (average age 78 years). One hundred and sixty two of these were in the group treated with Cortoss and 94 in the group treated with polymethyl methacrylate. They collected functional data at baseline and at six postprocedure intervals; seven days, one, three, six, 12 and 24 months postprocedure. These included Visual Analog Scale pain score, Oswestry disability index and SF-12 for quality of life. Bae told delegates that at 24 months, investigators were able to achieve 83% follow-up.


In terms of the early patient outcomes assessed at three months, investigators found that 86.6% of Cortoss patients and 75% of polymethyl methacrylate patients achieved successful pain relief as measured by the visual analogue pain scale. The Cortoss patient group experienced a statistically significant benefit in pain success over the polymethyl methacrylate group.


When it came to long-term patient outcomes assessed at 24 months, 96.7% of Cortoss patients and 88.4% of polymethyl methacrylate patients maintained or improved their function as measured by the Oswestry disability index. The Cortoss patient group experienced a statistically significant benefit in function success over the polymethyl methacrylate group.


In this study, the safety and effectiveness of Cortoss was found to be non-inferior to the control.