Oishi Kiyotoshi, Arai Hirokuni, Kuroki Hidehito, Fujioka Tomoyuki, Tomita Makoto, Tasaki Dai, Oi Keiji, Nagaoka Eiki, Fujiwara Tatsuki, Takeshita Masashi, Yoshizaki Tomoya, Someya Takeshi, Mizuno Tomohiro
Department of Cardiovascular Surgery, Graduate School of Medical and Dental Science, Tokyo Medical and Dental University, 1-5-45, Yushima, Bunkyo-Ku, Tokyo, 113-8519, Japan.
Department of Thoracic Surgery, Ome Municipal General Hospital, Tokyo, Japan.
Gen Thorac Cardiovasc Surg. 2023 Nov;71(11):665-673. doi: 10.1007/s11748-023-01928-5. Epub 2023 Mar 25.
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.
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. Displacement of the sternal halves in the anteroposterior and lateral directions was measured using computed tomography horizontal section images at the third costal and fourth intercostal levels. The secondary endpoints were sternal pain and quality-of-life over 6 months.
Group W showed significantly reduced sternal anteroposterior displacement at both the third costal (0 [0-1.9] mm vs. 1.1 [0-2.1] mm; P = 0.014) and fourth intercostal (0 [0-1.0] mm) vs. 1.0 [0-1.8] mm; P = 0.015) levels than group C. In group W, lateral displacement was suppressed without a significant increase from 2 weeks to 6 months, while it increased in group C. There was no significant difference in postoperative sternal pain and quality-of-life between the two groups. No adverse events, such as infection, inflammation, or foreign body reaction, were observed with this device.
Using Super FIXSORB WAVE, sternal displacement was significantly suppressed in both the anteroposterior and lateral directions. The use of this device results in safe and easy sternal reinforcement without any adverse events, and sternal healing can be accelerated.
This study was registered in the Japan Registry of Clinical Trials (February 21, 2019; jRCTs032180146).
我们研发了一种新型胸骨固定装置——Super FIXSORB WAVE，这是一种由u-HA/PLLA制成的波纹板，旨在提高胸骨切开术后的胸骨稳定性。本研究旨在对该新型装置进行临床评估。
这项前瞻性、单盲、多中心试验将69例患者随机分为单纯钢丝环扎组（C组，n = 30）和钢丝环扎加Super FIXSORB WAVE组（W组，n = 39）。主要终点是6个月时的胸骨移位程度。使用计算机断层扫描水平断面图像在第三肋和第四肋间水平测量胸骨两半在前后方向和横向的移位。次要终点是6个月内的胸骨疼痛和生活质量。
W组在第三肋（0[0 - 1.9]mm对1.1[0 - 2.1]mm；P = 0.014）和第四肋间（0[0 - 1.0]mm对1.0[0 - 1.8]mm；P = 0.015）水平的胸骨前后移位均显著低于C组。在W组中，从2周龄到6个月龄横向移位受到抑制且无显著增加，而在C组中则增加。两组术后胸骨疼痛和生活质量无显著差异。使用该装置未观察到感染、炎症或异物反应等不良事件。
使用Super FIXSORB WAVE可显著抑制胸骨在前后方向和横向的移位。使用该装置可安全、简便地加强胸骨，且无任何不良事件，并可加速胸骨愈合。
本研究已在日本临床试验注册中心注册（2019年2月21日；jRCTs03218014）。
