The preliminary results of an ongoing study, "Clinical Experience Using A Novel Bio-Composite For Treating Vertebral Compression Fractures in Vertebroplasty and Kyphoplasty; Report On The First 40 Patients," conducted by Orthovita, and involving patients with vertebral compression fractures were presented in an abstract at the International Meeting on Advanced Spine Techniques (IMAST) in Banff, Canada.
The purpose of the two pilot IDE studies, conducted in 20 patients each, was to obtain preliminary information for assessing the feasibility and clinical outcome in using Cortoss, Orthovita's product to treat osteoporotic vertebral compression fractures. Patients in the study were treated minimally invasively with Corstoss using either the vertebroplasty technique, where Cortoss is injected directly into the fracture area, or the kyphoplasty technique, where a balloon is first inserted into the fracture area and inflated to create a void prior to injection of Cortoss into the fracture area.
The preliminary study results suggest that patients treated with Cortoss using the vertebroplasty technique show improvement as their Visual Analog Score for pain decreased from 73.3 pre-op to 24.1 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 30% at three months and 23% at 12 months. 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 78.1 pre-op to 22 at three months, and 19.6 at six months. These patients also seemed to show improvement in their Oswestry Disability Index as it decreased from 61% pre-op to 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. The Visual Analog Score and Oswestry Disability Index are validated tests commonly used to assess the benefits of treatment for spinal fractures.
The overall results appear to be consistent with those obtained in the prospective vertebroplasty study conducted in Europe using Cortoss. Leakages were analysed on post-op CT scans and appeared to be similar in both treatment groups. All leakages observed in each treatment group were asymptomatic. A larger, prospective randomised controlled multi-centre IDE study is underway in the US designed to demonstrate that Cortoss is safe and effective for the treatment of osteoporotic vertebral compression fractures.
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