Clinical study of emerging sternal rigid plate: a randomized controlled double-center trial

Objective To evaluate the security and effectiveness of emerging sternal rigid plate by comparing with wires closure. Methods 60 patients who undergoing median sternotomy from two centers were enrolled in this study, 30 received wire cerclage(control group) and the other 30 received rigid plate fixation(experimental group). Patients’ sternal were closed with wires or rigid plates, and the painness, sternal union and status of wires or rigid plates were followed up and assessed one week, three months and six months after procedures. Results All patients survived and were followed up. 117 rigid plates were implanted. There was no significant difference in pre-operative data, post-operative painness, sternal union and status of wires and plates between control and experimental group. No patient reached the standard of clinical sternal union one week post-operation, but all patients reached the standard of clinical sternal six months post-operation. One patient in control group suffered sternal nonunion, movement and wound infection after sternotomy. Conclusion Compared to wire closure, sternal closure with rigid plates is the same safe and effective. Key words: Sternal rigid plate; Wire; Sternal union