This paper presents an in vivo test for assessment of regenerate axial stiffness after the distraction phase of lengthening therapy. The test result supplements radiography in evaluating bone healing and assists in determining when the regenerate stiffness is sufficient for removal of the external fixator. The test is non-invasive and does not require fixator removal. The theoretical basis for the method is that an externally applied load is shared between the fixator and the regenerating bone. The amount of load carried by the regenerate depends on its axial stiffness, which increases with advanced mineralization. By measuring the force in the fixator while applying a known external load to the limb, the load-share ratio between fixator and limb can be assessed. A load-share ratio of 100% indicates that the entire load is carried by the fixator. The ratio decreases as the regenerate structure gradually stiffens. In a clinical trial of 22 individuals with tibia1 lengthening, the fixator was removed when the load-share ratio dropped below 100/0. None of the patients experienced fracture after removal of the fixator.
A bilateral New Zealand white rabbit model of distraction osteogenesis (DO) was used to investigate the relationship between strain environment and bone regeneration during limb lengthening. In seven (n = 7) rabbits, a stiffener was applied to the fixator on one side to reduce strains within the gap tissue after lengthening was completed. Animals were euthanized six days later and their distraction zones were harvested and analyzed for changes in new bone volume and architecture. Nonlinear finite element analyses (FEA) were performed to predict changes in the gap strain environment. FEA results predicted a nearly uniform sevenfold decrease in average strain measures within the distraction zone. No change in total average new bone volume and significant decreases in both bone volume fraction (BV/TV) and trabecular thickness (Tb.Th) were observed in tibiae in which gap strains were reduced experimentally, compared to contralateral controls. These results suggest that fixator stiffening influenced the architecture but not the amount of newly formed bone. This animal model of distraction might be used to study the mechanisms by which strain fields affect events in bone repair and regeneration, such as cell proliferation, precursor tissue differentiation, and altered growth factor and nutrient delivery to tissues.
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