Orthovita studies of bioceramic Cortoss show promise for vertebral compression fractures

By E. Janene Geiss

Philadelphia, Dec. 2 - Orthovita, Inc. said that preliminary results of an ongoing study of the bioceramic Cortoss for treating vertebral compression fractures suggest that patients treated with Cortoss using the vertebroplasty technique show improvement as their Visual Analog Score for pain decreased from 73 pre-op to 36 at four days, 44 at one week, 24 at three months and 28 at 12 months.

These patients also seemed to show improvement in their Oswestry Disability Index as it decreased from 52% pre-op to 42% at one week, 30% at three months and 23% at 12 months, according to a company news release.

Similarly, the preliminary study results suggest that patients treated with Cortoss using the kyphoplasty technique show improvement as their Visual Analog Score for pain decreased from 78 pre-op to 43 at four days, 38 at one week, 22 at three months and 20 at six months.

These patients also seemed to show improvement in their Oswestry Disability Index as it decreased from 60% pre-op to 49% at one week, 33% at three months and 38% at six months.

In both studies, the improvements in VAS and ODI were statistically significant. No statistically significant differences in pain and function follow-up results were seen between the two techniques in this preliminary analysis, officials said.

The SF-12 scores improved or were maintained at each time point in both treatment groups. The Visual Analog Score, Oswestry Disability Index and the SF-12 are validated tests commonly used to assess the benefits of treatment for spinal fractures.

The study, entitled, "Characteristics and Clinical Experience Using A Novel Bioceramic For Treating Vertebral Compression Fractures in Vertebroplasty and Kyphoplasty; Report On The First 40 Patients," was presented Friday at the annual meeting of the Radiological Society of North America held in Chicago.

The study results to date with Cortoss seem to validate this biomaterial's safety and efficacy and could potentially offer many important benefits to patients in treating compression fractures using either technique," Philip Maurer, lead author of the study, said in the release.

The results also seemed to suggest that a relatively small volume of Cortoss, averaging 1.9 cubic centimeters per treated vertebra in vertebroplasty and 4.1 cubic centimeters in kyphoplasty, may be able to reinforce the vertebrae and achieve symptomatic relief, as compared to the larger volumes reported in the literature for polymethylmethacrylate bone cement, officials said.

This observation is believed to be due to the ability of Cortoss to interdigitate with the native bone within the treated vertebra. These overall results appear to be consistent with those obtained in the prospective vertebroplasty study conducted in Europe using Cortoss, officials said.

Orthovita is a Malvern, Pa., biomaterials company with proprietary technologies for the development and commercialization of synthetic, biologically active, tissue engineering products for orthopedic and neurosurgical applications.

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