Bone healing response to a synthetic calcium sulfate/β‐tricalcium phosphate graft material in a sheep vertebral body defect model

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.

Characterization of a new composite PMMA-HA/Brushite bone cement for spinal augmentation

“…16,22 The addition of CaP fillers into PMMA bone cement has been reported to be detrimental to cement handling, and mechanical performance. [16][17][18][19][20][21][22] In this study, we have shown that in a premixed two-solution system this can be done without these issues. This allows for the introduction of a bioactive phase to induce cement interdigitation with the surrounding cancellous bone.…”

Methodological Consideration of Various Intraosseous and Heterotopic Bone Grafts Implantation in Animal Models

“…After that, various parameters are further evaluated through small animal models [106][107][108]. In the next step, large animal models are used to test the practicability functionality of graft materials before clinical application [86,105,[109][110][111][112][113][114][115]. For each specific question, a suitable animal model is needed.…”

“…A possible explanation for the difference between large and small animal in subcutaneous implantation of granule bone graft may be the increased micromovement in small animals [73,82,[84][85][86]88,90,93,94,96,100]. Small animals show constant and comparatively large movements of their body after implantation of granulated bone grafts compared to large animals [104,105]. Subcutaneous tissue in large animal provides relatively lesser movement of the subcutaneous tissue environment for implanted bone granules, which may be favourable for ectopic new bone formation.…”

The effect of water on the mechanical properties of soluble and insoluble ceramic cements

“…Over the past decades, strengths of newly developed ceramic cements have been frequently reported (Charriere et al, 2001;Drosos et al, 2012;Huan and Chang, 2007;Lewis et al, 2006;Liu et al, 2013;Morgan et al, 1997;Van Lieshout et al, 2011;Yamadi and Kobayashi, 2009;Yang et al, 2012, Zhang et al, 2011. Stiffnesses of ceramic cements are reported sporadically (Charriere et al, 2001, Drosos et al, 2012Morgan et al, 1997;Van Lieshout et al, 2011;Welch et al, 2002, Zhang et al, 2011, while only limited reports are available on the toughness and durability of ceramic cements (Morgan et al, 1997;Zhang et al, 2011).…”

“…This is due to their ease of application and biological advantages (Heini and Berlemann, 2001;Huan and Chang, 2007;Liu et al, 2013;Nilsson et al, 2003;Yang et al, 2012). Calcium sulfate dihydrate (CSD, gypsum) and dicalcium phosphate dihydrate (DCPD, brushite) are self-setting, biocompatible, bioresorbable, osteoinductive and non-toxic injectable pastes.…”