title: 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.
authors: Department of Orthopaedic Surgery, The First Affiliated Hospital of Soochow University, Suzhou, China.
authors: H L
authors: HL
authors: Yang
authors: X S
authors: XS
authors: Zhu
authors: L
authors: L
authors: Chen
authors: C M
authors: CM
authors: Chen
authors: D C
authors: DC
authors: Mangham
authors: L A
authors: LA
authors: Coulton
authors: S S
authors: SS
authors: Aiken
mesh_terms: D020341:Absorbable Implants; D000818:Animals; D001843:Bone Cements / Q000494:pharmacology; D001861:Bone Regeneration / Q000187:drug effects*; D018786:Bone Substitutes / Q000737:chemistry / Q000494:pharmacology*; D002130:Calcium Phosphates / Q000737:chemistry / Q000494:pharmacology*; D002133:Calcium Sulfate / Q000737:chemistry / Q000494:pharmacology*; D004195:Disease Models, Animal; D008422:Materials Testing; D010012:Osteogenesis / Q000187:drug effects; D019904:Polymethyl Methacrylate / Q000494:pharmacology; D012756:Sheep; D013124:Spinal Injuries / Q000000981:diagnostic imaging / Q000628:therapy*; D013131:Spine; D013997:Time Factors; D055114:X-Ray Microtomography
chemical_list: D001843:Bone Cements; D018786:Bone Substitutes; D002130:Calcium Phosphates; C485817:beta-tricalcium phosphate; D019904:Polymethyl Methacrylate; D002133:Calcium Sulfate