A prospective randomized controlled study to assess the effectiveness of super FIXSORB WAVE® for sternal stabilization after sternotomy.

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. 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.

RESULTS

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.

CONCLUSIONS

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.

CLINICAL TRIAL REGISTRY NUMBER: This study was registered in the Japan Registry of Clinical Trials (February 21, 2019; jRCTs032180146).