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news.Orthopedic biomaterials developer Orthovita has announced that the FDA has approved further changes to the protocol for its Cortoss IDE pivotal study. The changes will shorten the study's enrollment period and increase the randomization of Cortoss to control patients.
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The changes include a reduction in the number of total patients to be enrolled from 300 down to 243, as well as an increase in the randomization ratio of patients treated with Cortoss to patients in the control group treated with an approved PMMA bone cement. The protocol now provides for the enrollment of 162 patients in the Cortoss arm of the study and 81 patients in the control group, for an overall randomization of 2:1.
The prospective randomized controlled multi-center IDE study is underway in the US and is designed to demonstrate that Cortoss is safe and effective for the treatment of osteoporotic vertebral compression fractures. Patients in the study are being treated minimally invasively with Cortoss using the vertebroplasty technique, where Cortoss is injected directly into the fractured vertebra.
“This latest development is expected to shorten the enrollment phase of the study and we believe the 2:1 randomization will provide further positive impetus to all who are involved in this clinical program,” said Antony Koblish, president and CEO of Orthovita.