M. Krämer
C. W. Müller
R. Pfeifer
S. Decker
K. Meier
V. Wesling
C. Hurschler

Non-invasive stiffness alteration during fracture healing by use of a novel shape memory osteosynthesis

Congress of the International Society of Biomechanics
12.-16. Juli
Glasgow
2015
Type: Konferenzbeitrag
Abstract
Introduction & Objectives: The fracture healing of bones is highly influenced by bio-logical parameters and biomechanical stimuli. These mechanical conditions are determined by the stiffness of fixation and loading. Fixation in an optimal stiffness range stimulates bone healing by callus formation. Latest studies have shown that the progress of healing can be influenced by modulating the fixation stiffness during fracture healing [1]. In the literature concepts for the dynamization as well as for the inverse dynamization of the fracture fixation are lively discussed [1], [2]. However, alterating the stiffness of the fixation non-invasivly is so far only possible by use of a Fixateur externe. In the present study a novel Nickel-Titanium shape memory plate osteosynthesis is introduced that allows contact-free stiffness modulation after fracture fixation. The study was designed to test the following hy-pothesis: A novel shape memory plate stabilizes tibia osteotomies in rabbits and allows for fracture healing. After non-invasive electromagnetic induction heating three weeks post op. the plate changes its configuration towards a state of higher stiffness. Methods: Prototype six-hole osteosynthesis plates were constructed and manufactured by laser based cutting and welding. The plates were manufactured from commercially available Nickel-Titanium alloy sheets. The design allows for change of shape and therewith bending stiffness. For the present study a plate which follows the concept of in-verse-dynamization was realized. The modulation is trig-gered by warming the implant up to 50°C for a short period of time by use of electro-magnetic induction heat-ing. 14 Rabbits were treated with prototypic plates after tibia osteotomies have been performed. Furthermore, four k-wires were implanted in each treated limb for in-vivo bending measurements. Three weeks after procedure, animals were divided in two randomized groups. Stiffness alteration of the plate was performed only in one group by electromagnetic induction warming. Repetitive in-vivo bending stiffness measurements were performed by use of an in-vivo bending stiffness test rig. All Animals were sacrificed after six weeks. Tibiae were analysed morphologically by x-ray, μCT, and histology. The implants were explanted and bending tests of the tibiae were carried out. Results: One rabbit died from anaesthesia during the induction warming procedure and one animal fractured its hind leg two days post op and was therefore sacrificed. The shape change of the implant in vivo could be observed radio-graphically during induction warming. There were no signs of implant loosening or displacement. Comparison between bending stiffness within minutes before and after induction warming confirmed a significant increase of mean bending stiffness of the tibiae. All osteotomies healed within six weeks. However, the ex-vivo bending tests showed not significant differences in stiffness be-tween the two groups. The μCT showed successful bone healing for both groups. The measured parameters such as bone volume, cortical wall thickness etc. showed no sig-nificant differences between both groups. Conclusion: To the best of our knowledge, the present work is the first study applying the idea of inverse dynamization to an inter-nal fracture fixation plate. We have demonstrated a success-ful application of a novel shape memory plate system for the stabilization of tibia osteotomies in rabbits. The contact-free triggering of the shape alteration of the plate could be ap-proved and resulted in an expected increase of stiffness. Successful fracture healing was observed in all cases. These results contribute to the development of novel concepts for bone fixation that might lead to better fracture healing and less need for surgical interventions. Furthermore, in future this concept might be used for counteractions in cases of non-union.