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

H L Yang, X S Zhu, L Chen, C M Chen, D C Mangham, L A Coulton, S S Aiken, H L Yang, X S Zhu, L Chen, C M Chen, D C Mangham, L A Coulton, S S Aiken

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.

Copyright © 2012 Wiley Periodicals, Inc.

Figures

Figure 1
Figure 1
Rendered 3D models sliced to show the cavity at 0, 8, 16, and 36 weeks.
Figure 2
Figure 2
Percentage radiopaque tissue volume at 36 weeks, excluding higher density PMMA cement.
Figure 3
Figure 3
Sliced three dimensional rendered models of normal bone trabeculae and regions repaired with Test material and PMMA.
Figure 4
Figure 4
Percentage radiopaque tissue volume for Test material and Sham sites, compared to that observed in normal vertebral trabecular bone. ▪ High value at 0 week indicates test material filled sites and not radiopaque tissues. ● Low value refers to empty sham sites.
Figure 5
Figure 5
Sliced three dimensional rendered models of the sham group and regions repaired with Test material.
Figure 6
Figure 6
Mean trabecular thickness for Test material and Sham sites, compared to that observed in normal vertebral trabecular bone. ▪ High value at 0 week indicates test material filled sites and not bone trabeculae thickness. ● Low value refers to empty sham sites.
Figure 7
Figure 7
Mean trabecular separation for Test material and Sham sites, compared to that observed in normal vertebral trabecular bone. ▪ Low value at 0 week refers to test material filled sites and not trabecular separation. ● High value refers to empty sham sites.
Figure 8
Figure 8
Mean trabecular number for Test material and Sham sites, compared to that observed in normal vertebral trabecular bone. ▪ Value at 0 week relates to test material-filled sites and not bone trabeculae. ● Value refers to empty sham sites.
Figure 9
Figure 9
Paraffin histology, Mag x25, H&E Stain, Composite images. Sham procedure, (a1) Immediate, (a2) 8 weeks, (a3) 16 weeks, and (a4) 36 weeks post op. PMMA implanted vertebrae, (b1) Immediate, (b2) 8 weeks, (b3) 16 weeks, and (b4) 36 weeks post op. Test material implanted vertebrae, (c1) Immediate, (c2) 8 weeks, (c3) 16 weeks, and (c4) 36 weeks post op. [Color figure can be viewed in the online issue, which is available at wileyonlinelibrary.com.]
Figure 10
Figure 10
Paraffin histology, Mag ×200, H&E Stain. PMMA implanted vertebra. P, PMMA; M, fibrous membrane. [Color figure can be viewed in the online issue, which is available at wileyonlinelibrary.com.]
Figure 11
Figure 11
Paraffin histology, Mag ×200, H&E Stain. Test material implanted vertebra. T, test material; NB, new bone. [Color figure can be viewed in the online issue, which is available at wileyonlinelibrary.com.]
Figure 12
Figure 12
Compressive testing data. *22 comparison differences have statistical significance (Post hoc Tukey–Kramer test for multiple post hoc group comparisons, p < 0.05).
Figure 13
Figure 13
Stiffness testing data.

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Source: PubMed

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