Kiyotoshi Oishi, Hirokuni Arai, Hidehito Kuroki, Tomoyuki Fujioka, Makoto Tomita, Dai Tasaki, Keiji Oi, Eiki Nagaoka, Tatsuki Fujiwara, Masashi Takeshita, Tomoya Yoshizaki, Takeshi Someya, Tomohiro Mizuno
BACKGROUND: We developed a new sternal fixation device, Super FIXSORB WAVE® , a corrugated plate made of u-HA/PLLA, to improve sternal stability after sternotomy. This present study aimed to evaluate the new device clinically. METHODS: This prospective, single-blinded, multicenter trial randomized 69 patients to either wire cerclage only (group C, n = 30) or wire cerclage plus Super FIXSORB WAVE® (group W, n = 39). The primary endpoint was a degree of sternal displacement at six months...
March 25, 2023: General Thoracic and Cardiovascular Surgery