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Clinical results of an open prospective study of a bis-GMA composite in percutaneous vertebral augmentation.

Abstract
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.
AuthorsJean Palussière, Jérôme Berge, Afshin Gangi, Anne Cotten, Anne Pasco, Rudolf Bertagnoli, Hans Jaksche, Paolo Carpeggiani, Hervé Deramond
JournalEuropean spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society (Eur Spine J) Vol. 14 Issue 10 Pg. 982-91 (Dec 2005) ISSN: 0940-6719 [Print] Germany
PMID15931511 (Publication Type: Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
Chemical References
  • Bisphenol A-Glycidyl Methacrylate
Topics
  • Adult
  • Aged
  • Aged, 80 and over
  • Bisphenol A-Glycidyl Methacrylate (administration & dosage, adverse effects, therapeutic use)
  • Disability Evaluation
  • Female
  • Fractures, Compression (surgery)
  • Humans
  • Male
  • Middle Aged
  • Osteoporosis (complications)
  • Pain Measurement
  • Prospective Studies
  • Spinal Fractures (surgery)
  • Treatment Outcome

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