A randomized trial comparing the effects of sternal band and plate fixation of the sternum with that of figure-of-8 wires on sternal edge motion and quality of recovery after cardiac surgery
Alistair G Royse, Doa El-Ansary, William Hoang, Elaine Lui, Mark McCusker, Lynda Tivendale, Yang Yang, David J Canty, Colin F Royse
Interactive Cardiovascular and Thoracic Surgery | OXFORD UNIV PRESS | Published : 2020
OBJECTIVES: We sought to compare the effects of conventional wire cerclage with that of the band and plate fixation of the sternum. METHODS: A parallel randomized open-label trial with 1:1 allocation ratio compared healing after adult cardiac surgery using 'figure-of-8' stainless steel wire cerclage or a band and plate system (plates). The primary end point was maximal sternal edge displacement during active coughing of ≥2 mm in ≥2 of 4 sites measured with ultrasound by 2 assessors blinded to the other at 6 weeks postoperatively. Secondary end points at 12 weeks included ultrasound assessment, computed tomography (CT) scan and multidimensional assessment of quality of recovery using the Post..View full abstract
The study was investigator-initiated with complete independence of study design, conduct, analysis and manuscript production. Partial funding support was provided by an unrestricted educational grant from the manufacturers of SternaLock360, Zimmer Biomet, Jacksonville, FL, USA. The funds were used to assist with CT scans and salary support for a research nurse. All clinical, ultrasound and CT analyses were undertaken by unfunded and independent research academics and named as authors on this manuscript.