Cortoss™: An Alternative to PMMA for VCF

Cortoss Bone Augmentation Material is an FDA-cleared, bioactive polymer composite that mimics the mechanical properties of human cortical bone.  Cortoss is the first clinically substantiated alternative to Polymethylmethacrylate (PMMA) for the treatment of vertebral compression fractures.

In April 2009, Orthovita^®, Inc. submitted the 2-year follow-up clinical data for patients enrolled in the company’s prospective, randomized, multi-center study comparing the efficacy of PMMA to Cortoss. In this 256-patient pivotal trial conducted under an investigational device exemption, Cortoss achieved its primary end-point of non-inferiority to the PMMA control at 24-months using a composite endpoint. Patient success rates reflected an improvement in all of the following: Visual Analogue Pain Scale (VAS) score, maintenance or improvement in Oswestry Disability Index (ODI) function assessment, maintenance of vertebral height and alignment, and no subsequent device-related surgical intervention at the index treatment level.

In the pivotal study at 24 months:

• The composite endpoint success rate was 76.9% for patients treated with Cortoss and 73.4% for PMMA patients.
• With an ODI success rate of 96.7%, the Cortoss patient group experienced a statistically significant benefit in function success over the PMMA group, which had an ODI success rate of 88.4%.

Early patient outcomes were also assessed in the pivotal study at 3 months:

• The composite endpoint success rate was 82.8% for patients treated with Cortoss and 73.7% for PMMA patients.
• With a VAS success rate of 86.6%, the Cortoss patient group experienced a statistically significant benefit in pain success over the PMMA group, which had a VAS success rate of 75.0%.

In addition to these statistically significant benefits, the Cortoss population experienced the following clinically significant benefits over the PMMA cohort:

• A 43.4% reduction in subsequent, adjacent level fractures in Cortoss patients treated for a primary fracture at one level, as measured at the end of the 24-month follow-up period.
• The Cortoss patients required an average of 30% less material to achieve fracture fill.

With 83% follow-up at the 24-month time point, the study also represents a significant piece of clinical research in this field.  The pivotal study, in combination with various clinical trials previously completed in the U.S. and Europe, brings the total number of patients studied for Cortoss in vertebral compression fracture to 527.