The aim of this study was to elucidate the bone regeneration-inducing capability of Affinos®, a newly developed, high-porosity unidirectional porous β-TCP artificial bone. We compared the ability of Affinos® and OSferion®, a commercially available β-TCP product, to induce bone regeneration following implantation into bony defects left after fibula harvesting for spinal fusion surgery. Study subjects underwent surgery to harvest non-vascularized fibula grafts for spinal fusion surgery and were implanted with either Affinos® (19 patients) or OSferion® (15 patients, control group) at the defect site. The minimal and mean follow up periods were 6 and 11 months after surgery, respectively. X-rays of the lower leg taken 1-2 weeks after surgery and at the final follow-up visit were used to evaluate fibular-β-TCP continuity and fibula defect filling ratio. There was no significant difference in radiographic continuity in the fibula between the two groups. The fibula defect filling ratio for the Affinos® group decreased from 0.94 ± 0.17 at 1-2 weeks to 0.77 ± 0.14 at 10 months. For the OSferion® control group, the fibula defect filling ratio decreased from 0.94 ± 0.14 at 1-2 weeks to 0.52 ± 0.27 at final follow-up. The Affinos® group showed a significantly higher fibula defect filling ratio compared to that for the OSferion® group (p = 0.003). These results indicate that Affinos® has slow absorption rates and significant defect filling activity compared with OSferion®. Thus, Affinos® could be a suitable substitute to fill bony defects induced by fibula harvesting for spinal reconstruction surgery.
Keywords: Bone graft donor site; Bone remodeling; Regeneration of fibula; Spinal fusion surgery; β-tricalcium phosphate.
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