Mechanical behavior of a novel non-fusion scoliosis correction device

Abstract

Introduction: We developed an innovative non-fusion correction system (XS LATOR) consisting of two individual implants that are extendable and extremely flexible. One implant, the XS LAT, generates a lateral, bending moment and one implant, the XS TOR, generates a torsion moment. Two 'inverse' implants were developed for generating torsion and lateral bending in a porcine model was tested for force delivery. An in vitro experiment was set up to describe the mechanical behavior of both implants.

Materials and methods: Narrow and wide ('inverse') versions of the XS TOR and XS LAT were mounted on an apparatus that was able to simulate different spinal geometries. The implants were anchored to three artificial vertebrae with integrated 6D force sensors, after which the vertebrae were rotated and translated towards the demanded position. The reaction forces and moments were recorded in all configurations. The maximal (lateral) bending moment, which occurred at the middle vertebra, was determined and, similarly, torque applied at the center of rotation of the middle vertebra was calculated.

Results: As expected, the wide and the small versions of the XS TOR generate a torque that increases during the growth of the system. Similarly, the XS LAT generates a bending moment that slightly increases during the growth of the system. The produced moments approximate the theoretically predicted ones. The contribution to the spinal stiffness ranges between 0.01Nm/° and 0.04Nm/° in bending and between 0.03Nm/° and 0.08Nm/° in torsion.

Conclusions: The XS TOR and the XS LAT are able to generate a torque and a bending moment that remain (fairly) constant during spinal growth when a shape change due to the generated moment/torque is achieved. The stiffness of the implants is extremely low, being only a fraction of the stiffness of conventional, spinal fusion constructs. Current fusion systems, such as non-segmental spinal constructs generally, have 11 times higher stiffness in torsion and 6 times higher stiffness in lateral bending. Implantation of the XS LATOR adds 9% stiffness in axial rotation and 17% stiffness in lateral bending (to the original spinal stiffness). By preserving the flexibility of the spine after implantation, fusion of the vertebrae in the instrumented region is likely to be prevented.

Keywords: Cobb-angle; Implant; Lateral bending; Moment; Non-fusion; Scoliosis; Torque; Torsion.