Pre-Clinical Analysis of the Performance of a New Elastic Stable Intramedullary Nail Design

The advent of Elastic Stable Intramedullary Nailing has revolutionised the conservative treatment of long human bone fractures in children (Metaizeau, 1988; Metaizeau et al., 2004). Unfortunately, failures still occur due to excessive bending and fatigue (Linhart et al., 1999; Lascombes et al., 2006), bone refracture or nail failure (Bråten et al., 1993; Weinberg et al., 2003). Ideally, during surgery, nail insertion into the diaphyseal medullary canal should not interrupt or injure cartilage growth; nails should provide an improved rigidity and fracture stabilisation.

This study aims at comparing deflections and stiffnesses of nail-bone assemblies: standard cylindrically-shaped nails (MI) vs. new cylindrical nails (MII) with a flattened face across the entire length allowing more inertia and a curved tip allowing better penetration into the cancellous bone of the metaphysis (Figure 1). MII exhibits a section with two parameters: a diameter C providing nail stiffness and a height C' providing practical dimension when both nails are crossed at the isthmus of the diaphysis: C/C' is set to 1.25 for all MII nails.

A CT scan of a patient aged 22 years was used to segment a 3D model of a 471mm-long right femur model. The medullary canal diameters at the isthmus are 10.8mm and 11.4mm in the ML and AP direction, respectively. Titanium-made CAD models of MI (Ø=4mm) and MII (flat face: Ø=5mm) were pre-curved to maintain their flat face and carefully placed and positioned according to surgeon's instructions. Both nails were inserted via lateral holes in the distal femur with their extremities either bumping against the cortex or lying in the trabecular bone.

Transverse and comminuted fractures were simulated (Figure 1). For each assembly, a Finite Element (FE) tetrahedral mesh was generated (∼100181 nodes and 424398 elements). Grey-scale levels were used to assign heterogeneous material properties to the bone (E=6850 ρ1.49 (Morgan et al., 2003)). Two modes of loading were considered: 4-point bending (varus and recurvatum: Fmax=6000N) and internal torsion (Mmax=70kNmm). This led to the simulation of 15 FE models, including a reference intact femur.

Results show that in valgus, for the transverse (comminuted) fracture, the mean displacement of the assembly decreased by around 50%: from 15.24mm (27.49mm) to 8.15mm (13.85mm) for MI and MII, respectively, compared to 3.59mm for the intact bone. The assembly stiffness increased by 87% and 99% for transverse and comminuted fracture, respectively (Table 1). Similar trends were found in recurvatum with higher increases in assembly stiffness of 170% and 143% for transverse and comminuted fracture, respectively (Table 1). In torsion, for the transverse (comminuted) fracture, the measured angle of rotation decreased from: 0.43rad (0.66rad) to 0.22rad (0.43rad) for MI and MII, respectively, compared to 0.09rad for the intact bone. This corresponded to an increase of 95% and 55% in assembly stiffness for transverse and comminuted fracture, respectively.

In conclusion, using the 5mm-diameter new nails (MII) for the same intramedullar space, during either bending or torsion, assemblies were always stiffer than when using standard cylindrical nails.