Abstract

reactive tissue and osteoid. Proportion of the filling by these tissue types was variable between individuals and varied within portions of the PTN material. At 4 months, some areas of the inner pores were completely filled with bone suggesting new bone could form a complete bridge between the osteotomy sites with implant incorporated into this bony bridging. On average, 73.90% of the PTN pores were filled with bone þ fibrous tissue þ osteoid at 4-months, with two out of the four PTN devices having 100% of the pores being filled. At 4 and 6 month time points, perimeter surface area in direct contact with bone was greater for PTN compared to PEEK (23.90% vs 9.94% and 56.09% vs 27.31% at 6 months). In both 4 and 6 month time points, PTN had a single implant with bone apposition values of 72.58% and 77.48% respectively. CONCLUSIONS: Unlike PEEK, the novel PTN intervertebral fusion device tested in this study allowed for osseointegration of the implant surface adjacent to both endplates and osteoconduction within pores which has potential to improve overall spine fusion outcomes. FDA DEVICE/DRUG STATUS: Phusion Metal, PorOsteon, Inc. (Approved for this indication)

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