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.

Percutaneous vertebroplasty and kyphoplasty for the stand‐alone augmentation of osteoporosis‐induced vertebral compression fractures: Present status and future directions

“…50 In the preponderance of cases, however, the first-mentioned type of cement is used. Further details regarding compositions and properties of all types of injectable bone cement have been given in a review article.…”

An Evaluation of Fracture Stabilization Comparing Kyphoplasty and Titanium Mesh Repair Techniques for Vertebral Compression Fractures

“…4,[17][18][19][20][21][22][23] In one study, Kettler et al examined the capability of a metallic implant in restoring and maintaining initial vertebral height and stability after fracture. 31 Using cyclic loading, they showed that their technique-which required pressing small titanium rolls, along with additional bone cement, into the vertebral bodies-was biomechanically superior to vertebroplasty in restoring vertebral body height and equivalent to vertebroplasty in stabilizing bisegmental specimens.…”

Sacroplasty in a cadaveric trial: comparison of CT and fluoroscopic guidance with and without balloon assistance

“…The injection of PMMA into the fracture cleft may contribute to temporary pain relief, but the cement also inhibits fracture healing and may cause incident fractures, especially in patients with osteoporotic insufficiency fractures [14,39]. It remains to be seen to what extent alternative materials (e.g., bisphenol-a-glycidyl dimethacrylate) with altered features may modify these influences [33].…”