Despite substantial attention given to the development of osteoregenerative biomaterials, severe deficiencies remain in current products. These limitations include an inability to adequately, rapidly, and reproducibly regenerate new bone; high costs and limited manufacturing capacity; and lack of surgical ease of handling. To address these shortcomings, we generated a new, synthetic osteoregenerative biomaterial, hyperelastic "bone" (HB). HB, which is composed of 90 weight % (wt %) hydroxyapatite and 10 wt % polycaprolactone or poly(lactic-co-glycolic acid), could be rapidly three-dimensionally (3D) printed (up to 275 cm(3)/hour) from room temperature extruded liquid inks. The resulting 3D-printed HB exhibited elastic mechanical properties (~32 to 67% strain to failure, ~4 to 11 MPa elastic modulus), was highly absorbent (50% material porosity), supported cell viability and proliferation, and induced osteogenic differentiation of bone marrow-derived human mesenchymal stem cells cultured in vitro over 4 weeks without any osteo-inducing factors in the medium. We evaluated HB in vivo in a mouse subcutaneous implant model for material biocompatibility (7 and 35 days), in a rat posterolateral spinal fusion model for new bone formation (8 weeks), and in a large, non-human primate calvarial defect case study (4 weeks). HB did not elicit a negative immune response, became vascularized, quickly integrated with surrounding tissues, and rapidly ossified and supported new bone growth without the need for added biological factors.
This animal study presents data suggesting that the use of intra-articular vancomycin powder for reducing the risk of periprosthetic joint infections should be investigated further in clinical studies.
Spine fusion is a tool used in the treatment of spine trauma, tumors, and degenerative disorders. Poor outcomes related to failure of fusion, however, have directed the interests of practitioners and scientists to spinal biologics that may impact fusion at the cellular level. These biologics are used to achieve successful arthrodesis in the treatment of symptomatic deformity or instability. Historically, autologous bone grafting, including iliac crest bong graft harvesting, had represented the gold standard in spinal arthrodesis. However, due to concerns over potential harvest site complications, supply limitations, and associated morbidity, surgeons have turned to other bone graft options known for their osteogenic, osteoinductive, and/or osteoconductive properties. Current bone graft selection includes autograft, allograft, demineralized bone matrix, ceramics, mesenchymal stem cells, and recombinant human bone morphogenetic protein. Each pose their respective advantages and disadvantages and are the focus of ongoing research investigating the safety and efficacy of their use in the setting of spinal fusion. Rh-BMP2 has been plagued by issues of widespread off-label use, controversial indications, and a wide range of adverse effects. The risks associated with high concentrations of exogenous growth factors have led to investigational efforts into nanotechnology and its application in spinal arthrodesis through the binding of endogenous growth factors. Bone graft selection remains critical to successful fusion and favorable patient outcomes, and orthopaedic surgeons must be educated on the utility and limitations of various biologics in the setting of spine arthrodesis.
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