LAUSR

Background Rigid plate fixation (RPF) is the cornerstone in managing fractures and osteotomies except for sternotomy, where most cardiac surgeons continue to use wire cerclage (WC). Results of a multicenter randomized trial evaluating sternal healing, sternal complications, patient reported outcome measures (PROMs), and costs after sternotomy closure with RPF or WC are summarized here. Methods Twelve US centers randomized 236 patients to either RPF (n=116) or WC (n=120). The primary endpoint, sternal healing at 6 months, was evaluated by a core laboratory using computed tomography and a validated 6-point scale (greater scores represent greater healing). Secondary endpoints assessed through 6 months included sternal complications and PROMs. Costs from the time of sternal closure through 90 days and 6 months were analyzed by a health economic core laboratory. Results RPF compared to WC resulted in better sternal healing scores at 3 (2.6±1.1 vs. 1.8±1.0; P<0.0001) and 6 months (3.8±1.0 vs. 3.3±1.1; P=0.0007) and higher sternal union rates at 3 [41% (42/103) vs. 16% (16/102); P<0.0001] and 6 months [80% (81/101) vs. 67% (67/100); P=0.03]. There were fewer sternal complications with RPF through 6 months [0% (0/116) vs. 5% (6/120); P=0.03] and a trend towards fewer sternal wound infections [0% (0/116) vs. 4.2% (5/120); P=0.06]. All PROMs including sternal pain, upper extremity function (UEF), and quality-of-life scores were numerically better in RPF patients compared to WC patients at all follow-up time points. Although RPF was associated with a trend toward higher index hospitalization costs, a trend towards lower follow-up costs resulted in total costs that were $1,888 less at 90 days in RPF patients compared to WC patients (95% CI: -$8,889 to $4,273; P=0.52) and $1,646 less at 6 months (95% CI: -$9,127 to $4,706; P=0.61). Conclusions Sternotomy closure with RPF resulted in significantly better sternal healing, fewer sternal complications, improved PROMs and was cost neutral through 90 days and 6 months compared to WC.