Randomized, multicenter trial comparing sternotomy closure with rigid plate fixation to wire cerclage

Objective: To evaluate sternal healing, complications, and costs after sternotomy closure with rigid plate fixation or wire cerclage. Methods: This prospective, single-blinded, multicenter trial randomized 236 patients at 12 US centers at the time of sternal closure to either rigid plate fixation (n = 116) or wire cerclage (n = 120). The primary endpoint, sternal healing at 6 months, was evaluated by a core laboratory using computed tomography and a 6-point scale (greater scores represent greater healing). Secondary endpoints included sternal complications and costs from the time of sternal closure through 6 months. Results: Rigid plate fixation resulted in better sternal healing scores at 3 (2.6 +/- 1.1 vs 1.8 +/- 1.0; P < .0001) and 6 months (3.8 +/- 1.0 vs 3.3 +/- 1.1; P < .0007) and greater sternal union rates at 3 (41% [42/103] vs 16% [16/102]; P < .0001) and 6 months (80% [81/101] vs 67% [67/100]; P < .03) compared with wire cerclage. There were fewer sternal complications through 6 months with rigid plate fixation (0% [0/116] vs 5% [6/120]; P < .03) and a trend towards fewer sternal wound infections (0% [0/116] vs 4.2% [5/120]; P < .06) compared with wire cerclage. Although rigid plate fixation was associated with a trend toward greater index hospitalization costs ($ 23,437 vs $ 20,574; P < .11), 6-month follow-up costs tended to be lower ($ 9002 vs $ 13,511; P < .14). As a result, total costs from randomization through 6 months were similar between groups ($ 32,439 vs $ 34,085; P < .61). Conclusions: Sternotomy closure with rigid plate fixation resulted in significantly better sternal healing, fewer sternal complications, and no additional cost compared with wire cerclage at 6 months after surgery.