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

doi:10.1093/icvts/ivaa040

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

Interact Cardiovasc Thorac Surg. 2020 Jun 1;30(6):863-870. doi: 10.1093/icvts/ivaa040.

Authors

Alistair G Royse^{1

2

3}, Doa El-Ansary^{1

2

3}, William Hoang², Elaine Lui⁴, Mark McCusker⁴, Lynda Tivendale^{1

2}, Yang Yang^{1

5}, David J Canty^{1

6}, Colin F Royse^{1

2

3

7

8}

Affiliations

¹ Department of Surgery, The University of Melbourne, Parkville, VIC, Australia.
² Department of Surgery, The Royal Melbourne Hospital, Melbourne, VIC, Australia.
³ Department of Health Professions, Faculty of Art, Design and Health, Swinburne University of Technology, Melbourne, VIC, Australia.
⁴ Department of Radiology, The University of Melbourne, Parkville, VIC, Australia.
⁵ Department of Intensive Care, Western Hospital, Melbourne, VIC, Australia.
⁶ Department of Anaesthesia and Pain Management, Monash Medical Centre, Melbourne, VIC, Australia.
⁷ Department of Anaesthesia and Pain Management, Royal Melbourne Hospital, Melbourne, VIC, Australia.
⁸ Outcomes Research Consortium, The Cleveland Clinic, Cleveland, OH, USA.

PMID: 32236553
DOI: 10.1093/icvts/ivaa040

Abstract

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 Postoperative Quality of Recovery Scale.

Results: Of 50 patients, 26 received plates and 24 wires. Two patients died and 1 withdrew consent leaving 25 plates and 22 wires for primary end point analysis. Operations included 37 coronary, 5 valve and 8 combined coronary and valve procedures. At 6 weeks, less sternal movement was observed in patients with plates than those with wires, 4% (1/25) vs 32% (7/22), P = 0.018. Agreement between observers was high, kappa = 0.850. At 12 weeks, less ultrasound motion was seen in patients with plates, 0% (0/23) than those with wires, 25% (5/20), P = 0.014. Recovery from pain was higher for patients with plates 92% (22/24) than those with wires 67% (14/21), P = 0.004. CT bone edge separation was less for plates 38% (9/24) than wires 71% (15/21), P = 0.036. CT mild bone synthesis or greater was similar between patients with plates 21% (5/24) and wires 14% (3/21), P = 0.71.

Conclusions: Patients receiving the band and plate system had significantly less sternal edge motion than those receiving wires, 6 and 12 weeks after cardiac surgery and experienced less pain.

Clinical trial registration: clinicaltrials.gov NCT03282578.

Keywords: Cardiac surgery; Pain; Plate fixation; Sternum; Ultrasound; Wire cerclage.

Publication types

Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Video-Audio Media

MeSH terms

Bone Plates*
Bone Wires*
Cardiac Surgical Procedures / methods*
Female
Humans
Male
Middle Aged
Postoperative Period
Quality of Life*
Recovery of Function*
Sternotomy / methods*
Sternum / surgery*
Tomography, X-Ray Computed
Ultrasonography
Wound Closure Techniques
Wound Healing

Associated data

ClinicalTrials.gov/NCT03282578