A Novel Device For Sternal Closure: Clinical Outcomes From A Prospective, Randomized, First-in-man, Pilot Study
Jacques Scherman, Tim Pennel, Natercia Da Silva, Paresh Keshaw, Allen Moodley, Peter Zilla.
Chris Barnard Division of Cardiothoracic Surgery, University of Cape town, Cape Town, South Africa.
Background: Where rigid fixation is standard in other disciplines, cardiac surgeons still use wire cerclage (WC) for sternal closure. WC provides good reduction of the sternal halves but does not provide optimal approximation or rigid fixation. Combining rigid fixation with cerclage may help improve sternal healing and recovery time. Here, we report a pilot, first-in-man, prospective, randomized, single-blinded study evaluating sternal healing, complications, and pain after sternal closure using either WC or a device combining a cerclage band for reduction with rigid plate fixation for stabilization (360).
Methods: Patients undergoing elective cardiac surgery were randomized to either 360 (n=26) or WC (n=24). Independent radiologists evaluated 3- and 6-month post-operative CT scans for sternal healing. Healing scores and rate of sternal union were evaluated along with pain, complications and proportion of pain-free patients up to 6 months. Logistic regression explored the relationship between healing and pain.
Results: At 3 months, sternal healing was greater in 360 compared to WC (69.2% vs. 25.0%; p=0.002) and remained higher at 6 months, though not significant (96.2% vs. 87.5%; p=0.340). Mean (±SD) CT scores at 3 months were 3.32 ± 0.85 for 360 and 2.23 ± 0.96 for WC (p<0.001, Fig. 1a); at 6 months, mean scores were 4.32 ± 0.47 for 360 and 3.88 ± 1.00 for WC (p=0.055). At 1 month, sternal pain after forced coughing was 59% lower in 360 compared to WC (0.81±1.02 vs. 2.17±1.95; p =0.004). Pain scores at both 3 and 6 months were not significantly different between the groups. Logistic regression demonstrated that improved healing leads to a higher probability of being pain-free after exertion (OR=2.5; 95% CI 1.2-5.1; p=0.005; Fig. 1b). Sternal complications resulting in reoperation occurred in 8.3% (2/24) and 3.8% (1/26) of WC and 360 patients, respectively (p=0.6).Conclusions: The results of this study show that sternal closure using rigid fixation with cerclage results in improved sternal healing at 3 months; a significant correlation between improved healing and the absence of post-operative pain; and no device related complications. Additional studies to further evaluate the utility of this method for sternal closure are warranted. 
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