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

Abstract

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.