In this open prospective trial, 53 patients with
acute pain from osteoporotic vertebral fracture related to
osteoporosis or
malignancy underwent vertebral augmentation with a new
bisphenol-a-glycidyl dimethacrylate (
bis-GMA) resin (
Cortoss, Orthovita, Malvern, Pa, USA). Treatment consisted of up to 8 ml of
Cortoss injected into a given vertebra. The procedure encompassed single and multiple
injections (including the contralateral hemivertebra, to a maximum of 3 vertebral levels). Follow-up was at 4 and 8 days and at 1, 3, and 6 months. The primary efficacy end point was patient-rated
pain using a 100-point visual analog scale (VAS, with 100 as severest
pain) on day 4 following treatment; secondary end points were
analgesic use and quality-of-life and disability scores from the Oswestry Disability Index (ODI) and a short-form 12-item questionnaire (SF-12). The present report contains interim results collected up to the 1-month post-treatment time point. At baseline, the group's mean VAS score was 69, indicating moderate to severe
pain; at day 4, 32 of 53 patients (60.4%) reported a 30% or greater reduction in baseline
pain accompanied by a VAS
pain score less than 50 (mean 38.1).
Pain reduction was maintained at 1 month (mean VAS 31.3). The average ODI score at baseline was 55, suggesting significant disability among participants prior to
Cortoss treatment. Following treatment, the ODI scores were significantly reduced from these baseline levels (day 8, 47.4; 1 month, 33.6). Further, SF-12 physical and mental component scores at 1 month
after treatment increased from baseline by 26% and 11%, respectively; while
analgesic use decreased concomitantly, primarily among patients with underlying
osteoporosis. A total of 20 adverse events were deemed to be device-related. The most frequent clinically significant adverse events attributed to
Cortoss were leakage of
Cortoss from within the vertebral body at placement (12%),
back pain (7%), and unspecified
pain (7%). These results indicate that vertebral augmentation with
Cortoss rapidly reduces
pain, decreases disability, and improves physical functioning in patients with painful vertebral
compression fractures.