Abstract
The introduction of a material able to promote osteogenesis and remodelling activity in a clinically relevant time frame in vertebroplasty and kyphoplasty procedures may have patient benefit. We report the in-vivo performance of a biphasic synthetic bone graft material (Genex Paste, Biocomposites, UK) [test material], composed of calcium sulfate and β-tricalcium phosphate, implanted into a sheep vertebral defect model. Cavities drilled into 4 adjacent vertebrae (L2 to L5) of 24 skeletally mature sheep were; (1) filled with the test material; (2) filled with commercially available polymethylmethacrylate [PMMA] cement; (3) remained empty [sham]. Analysis was performed immediately after implantation and at 8, 16, and 36 weeks post implantation. Sites were evaluated for bone growth with microCT analysis, histological examination, and mechanical testing under compression. The test material exhibited an improved tissue response over the PMMA, indicating a superior biological tolerance. MicroCT and histology indicated marked osteoregenerative capacity of the test material when compared with sham and the PMMA. The percentage of new bone formation was higher for the test material than sham at 16 and 36 weeks post implantation, with bone regeneration almost complete at 36 weeks in this group. Resorption of test material and the integration into new bone tissue were demonstrated. © 2012 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 2012.
Highlights
Vertebral body augmentation is widely used to treat fractures of the vertebral body due to trauma, osteoporosis, or other lytic conditions
Since the mid-1980s,1 the most commonly used treatment for vertebral body augmentation involves the introduction of polymethylmethacrylate (PMMA) bone cements into the vertebral body
Vertebrae from the 8-week time point showed some differences; for vertebrae from the test material group, the drill hole had become completely covered with new cortical bone and no test material was evident
Summary
Vertebral body augmentation is widely used to treat fractures of the vertebral body due to trauma, osteoporosis, or other lytic conditions. Since the mid-1980s,1 the most commonly used treatment for vertebral body augmentation involves the introduction of polymethylmethacrylate (PMMA) bone cements into the vertebral body. The study presented here evaluates the performance of the test material (Genex Paste, Biocomposites, UK) in a sheep vertebral body defect model. This test material consists of calcium sulfate and btricalcium phosphate (b-TCP), in a weight ratio of 1:1. The setting is due to the calcium sulfate hemihydrate component present in the supplied powder which reacts when combined with a supplied volume of water
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