Abstract

Primary stability and secondary fixation of orthopedic implants to bony tissues are important for healing and long-term functionality. Load sharing and stress transfer are key requirements of an effective implant/tissue interface. This paper presents a novel, macro-scale osseointegration surface morphology which addresses the implant/tissue interface from both the biologic as well as biomechanical perspective. The surface morphology is a controlled, engineered, open topography manifested as discrete pillars projecting from the implant enabling continuous bone ingrowth.The pillared surface is distinct from other porous surfaces and can be differentiated by the localization of the implant material into discrete pillars enabling a continuous mass of bone to freely and easily interdigitate into the pillared structure. Traditional porous structures distribute the implant material throughout the surface forcing the bone to grow in a discontinuous manner. Creating an open and continuous space or “open porosity” in and around the pillar structure allows the bone to easily interdigitate with the implant surface without encumberment from a continuous porous structure.An in-vivo study, using an established ovine model, was undertaken examining the effects of pillar morphology on bone ingrowth and mechanical performance. Cortical and cancellous sites were evaluated utilizing histology, histomophometry, and mechanical pushout, at 4 and 12 weeks. Robust bone ingrowth occurred for all morphologies as was noted in review of the study results. An increase in volume and maturity of bone was noted between the intermediated and final time points. Histomophometry demonstrated over 40% and 80% new bone occupied the available “ingrowth” area at 12 weeks for cancellous and cortical sites (respectively). Histologic review showed little fibrous tissue ingrowth at the interface with no adverse cellular reactions. Testing of cortical samples demonstrated a significant increase in pushout load between the 4 and 12 week timepoints and a 4–8 fold increase in pushout load as compared to the grit blast control. These results demonstrated the effectiveness of the novel interface for orthopedic applications in an in-vivo ovine model.

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