Introduction: The biomechanical stability of a newly developed humerus nail (Sirustrade mark) for the treatment of fractures of the proximal humerus was analyzed in comparison to established systems. In total, three randomized groups were formed (n = 4 pairs) from 12 matched pairs of human cadaver humeri.
Materials and methods: All intact bones were mechanically characterized by five subsequent load cycles under bending and torsional loading. The bending moment at the osteotomy was 7.5 N m the torsional moment was 8.3 N m over the hole specimen length. Loading was consistently initiated at the distal epiphysis and the deformation at the distal epiphysis was continuously recorded. Prior to implant reinforcement, a defect of 5 mm was created to simulate an unstable subcapital humerus fracture. For paired comparison, one humerus of each pair was stabilized with the Sirus proximal humerus nail while the counterpart was stabilized by a reference implant. In detail, the following groups were created: Sirus versus Proximal humerus nail (PHN) with spiral blade (group I); Sirus versus PHILOS plate (group II); Sirus versus 4.5 mm AO T-plate (group III).
Results: The Sirus nail demonstrated significantly higher stiffness values compared to the reference implants for both bending and torsional loading. The following distal epiphyseal displacements were recorded for a bending moment of 7.5 N m at the osteotomy: Sirus I: 8.8 mm, II: 8.4 mm, III: 7.7 mm (range 6.9-10.9), PHN 21.1 mm (range 15.7-25.2) (P = 0.005), PHILOS plate 27.5 mm (range 21.6-35.8) (P < 0.001), 4.5 AO T-plate 26.3 mm (range 24.3-33.9) (P = 0.01). The rotations corresponding to 8.3 N m torsional moment were: Sirus I: 9.1 degrees , II: 9.3 degrees , III: 10.6 degrees (range 7.5-12.2), PHN 13.5 degrees (range 10.3-15.6) (P = 0.158), PHILOS plate 15.6 degrees (range 13.7-20.8) (P = 0.007), 4.5 AO T-Platte 14.1 degrees (range 11.5-19.7) (P = 0.158).
Conclusion: The intramedullary load carriers were biomechanically superior when compared to the plating systems in the fracture model presented here. Supplementary, the Sirus Nail showed higher stiffness values than the PHN. However, the latter are gaining in importance due to the possibility of minimal invasive implantation. Whether this will be associated with functional advantages requires further clinical investigation.