Orthovita Completes Patient Enrollment in Cortoss® Study
By Elizabeth Hofheinz, MEd, MPH February 26, 2007
Patients routinely help companies march toward the FDA finish line. For spine and orthopedic biosurgery company Orthovita Inc., it is no different. The company is reporting the completion of patient enrollment for its pivotal, prospective, randomized study for Cortoss® Bone Augmentation Material in development for the treatment of vertebral compression fractures.
The study, involving 256 patients, is being conducted under an FDA investigational device exemption (IDE) and is designed to assess the safety and efficacy of Cortoss for the treatment of osteoporotic vertebral compression fractures compared to polymethylmethacrylate (PMMA) bone cement. Randomization is approximately 2:1 (162 patients treated using Cortoss® and 94 patients treated using a PMMA bone cement) at 22 sites.
Outcomes are being measured by the Visual Analog Scale (VAS), Oswestry Disability Index (ODI), SF-12 Health Survey, and maintenance of height and alignment at the level(s) treated. To be eligible for the study, patients must have had an osteoporotic compression fracture at one or two levels and a minimum VAS score of 50, a minimum ODI score of 30%, the presence of edema on MRI or bone scan, and other eligibility criteria. Exclusionary criteria include greater than 70% collapse of vertebrae, spinal canal compromise, neurologic deficit at the level(s) to be treated, or tumors.
In the news release, Dr. Erik Erbe, chief science officer of Orthovita, stated, "We appreciate the recruitment efforts of our dedicated clinical investigators and their diligent study coordinators for the Cortoss study. We anticipate that their work in the study will yield sufficient data for analysis and ultimate submission to the FDA.”
Added Antony Koblish, president and chief executive officer of Orthovita, "The completion of enrollment in this trial is a major milestone for Orthovita and an important event in the effort to understand and treat vertebral compression fractures of the spine. Pending regulatory clearance, Cortoss is positioned to be the first new proprietary biomaterial implant for the treatment of vertebral compression fractures and an alternative to PMMA bone cements available today."
Those in the EU can take advantage of Cortoss, as it has CE Certification for screw augmentation and for vertebral augmentation. Thus Cortoss can not only be sold in the European Union, but in other countries that have adopted the Union's regulatory standards. Cortoss® is not available for sale in the U.S. and is limited to investigational use.
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