Kryptonite bone cement prevents pathologic sternal displacement.
BACKGROUND
Wire cerclage closure of sternotomy is the standard of care despite evidence of pathologic sternal displacement (> 2 mm) during physiologic distracting forces (coughing). Postoperative functional recovery, respiration, pain, sternal dehiscence, and infection are influenced by early bone stability. This translational research report provides proof-of-concept (part A) and first-in-man clinical data (part B) with use of a triglyceride-based porous adhesive to rapidly enhance the stability of conventional sternal closure.


METHODS
In part A, fresh human cadaver blocks were subjected to midline sternotomy and either conventional wire closure or modified adhesive closure. After 24 hours at 37 degrees C, using a biomechanical test apparatus, a step-wise increase in lateral distracting force simulated physiologic stress. Sternal displacement was measured by microdisplacement sensors. In part B, a selected clinical case series was performed and sternal perfusion assessed by serial single photon emission computed tomography imaging.


RESULTS
Wire closure resulted in measurable bony displacement with increasing load. Pathologic displacement (> or = 2 mm) was observed in all regional segments at loads 400 newton (N) or greater. In contrast, adhesive closure completely eliminated pathologic displacement at forces 600 N or less (p < 0.001). In patients, adhesive closure was not associated with adverse events such as adhesive migration, embolization, or infection. There was excellent qualitative correlation between cadaver and clinical computed tomographic images. Sternal perfusion was not compromised by adhesive closure.


CONCLUSIONS
This first-in-man series provides proof-of-concept indicating that a novel biologic bone adhesive is capable of rapid sternal fixation and complete elimination of pathologic sternal displacement under physiologic loading conditions. A randomized clinical trial is warranted to further define the potential risks and benefits of this innovative technique.
Fedak
Paul W M
PW
Department of Cardiac Sciences, Division of Cardiac Surgery, Libin Cardiovascular Institute of Alberta, Calgary, Alberta, Canada. paul.fedak@gmail.com
Kolb
Eric
E
Borsato
Garry
G
Frohlich
Dean E C
DE
Kasatkin
Aleksey
A
Narine
Kishan
K
Akkarapaka
Naresh
N
King
Kathryn M
KM
D001843:Bone Cements; D001864:Bone Wires; D002102:Cadaver; D002368:Castor Oil; D006801:Humans; D011108:Polymers; D011183:Postoperative Complications / Q000517:prevention & control; D013249:Sternum / Q000601:surgery*; D019616:Thoracic Surgical Procedures / Q000379:methods
D001843:Bone Cements; C552291:Kryptonite bone cement; D011108:Polymers; D002368:Castor Oil