Secondary bone healing is impacted by the extent of interfragmentary motion at the fracture site. It provides mechanical stimulus that is required for the formation of fracture callus. In clinical settings, interfragmentary motion is induced by physiological loading of the broken bone – for example, by weight-bearing. However, there is no consensus about when mechanical stimuli should be applied to achieve fast and robust healing response. Therefore, this study aims to identify the effect of the immediate and delayed application of mechanical stimuli on secondary bone healing. A partial tibial osteotomy was created in twelve Swiss White Alpine sheep and stabilized using an active external fixator that induced well-controlled interfragmentary motion in form of a strain gradient. Animals were randomly assigned into two groups which mimicked early (immediate group) and late (delayed group) weight-bearing. The immediate group received daily stimulation (1000 cycles/day) from the first day post-op and the delayed group from the 22nd day post-op. Healing progression was evaluated by measurements of the stiffness of the repair tissue during mechanical stimulation and by quantifying callus area on weekly radiographs. At the end of the five weeks period, callus volume was measured on the post-mortem high-resolution computer tomography (HRCT) scan. Stiffness of the repair tissue (p<0.05) and callus progression (p<0.01) on weekly radiographs were significantly larger for the immediate group compared to the delayed group. The callus volume measured on the HRCT was nearly 3.2 times larger for the immediate group than for the delayed group (p<0.01). This study demonstrates that the absence of immediate mechanical stimuli delays callus formation, and that mechanical stimulation already applied in the early post-op phase promotes bone healing

In the course of uneventful secondary bone healing, a fracture gap is progressively overgrown by callus which subsequently calcifies and remodels into new bone. It is widely accepted that callus formation is promoted by mechanical stimulation of the tissue in the fracture gap. However, the optimal levels of the interfragmentary motion's amplitude, frequency and timing remain unknown. The aim of this study was to develop an active fixation system capable of installing a well-controlled mechanical environment in the fracture gap with continuous monitoring of the bone healing progression. The experimental model was adapted from Tufekci et al. 2018 and required creation of a critical size defect and an osteotomy in a sheep tibia. They were separated by a mobile bone fragment. The distal and proximal parts of the tibia were fixed with an external fixator, whereas the mobile fragment was connected to the proximal part with an active fixator equipped with a linear actuator to move it axially for mechanical stimulation of the tissue in the fracture gap. This configuration installed well-controlled mechanical conditions in the osteotomy, dependent only on the motion of the active fixator and shielded from the influence of the sheep's functional weightbearing. A load sensor was integrated to measure the force acting in the fracture gap during mechanical stimulation. The motion of the bone fragment was controlled by means of a custom-made controller allowing to program stimulation protocols of various profiles, amplitudes and frequencies of loading events. Following in vitro testing, the system was tested in two Swiss White Alpine Sheep. It was configured to simulate immediate weightbearing for one of the animals and delayed weightbearing for the other. The applied loading protocol consisted of 1000 loading events evenly distributed over 12 hours resulting in in a single loading event every 44 seconds. Bench testing confirmed the ability of the system to operate effectively with frequencies up to 1Hz over a range of stimulation amplitudes from 0.1 to 1.5 mm. Continuous measurements of in vivo callus stiffness revealed progressive fracture consolidation in the course of each experiment. A delayed onset of fracture healing was observed in the sheep with simulated delayed weightbearing. The conducted preclinical experiments demonstrated its robustness and reliability. The system can be applied for further preclinical research and comprehensive in-depth investigation of fracture healing

Osteosynthesis of high-energy metaphyseal proximal tibia fractures is still challenging, especially in patients with severe soft tissue injuries and/or short stature. Although the use of external fixators is the traditional treatment of choice for open comminuted fractures, patients' acceptance is low due to the high profile and therefore the physical burden of the devices. Recently, clinical case reports have shown that supercutaneous locked plating used as definite external fixation could be an efficient alternative. Therefore, the aim of this study was to evaluate the effect of implant configuration on stability and interfragmentary motions of unstable proximal tibia fractures fixed by means of externalized locked plating. Based on a right tibia CT scan of a 48 years-old male donor, a finite element model of an unstable proximal tibia fracture was developed to compare the stability of one internal and two different externalized plate fixations. A 2-cm osteotomy gap, located 5 cm distally to the articular surface and replicating an AO/OTA 41-C2.2 fracture, was virtually fixed with a medial stainless steel LISS-DF plate. Three implant configurations (IC) with different plate elevations were modelled and virtually tested biomechanically: IC-1 with 2-mm elevation (internal locked plate fixation), IC-2 with 22-mm elevation (externalized locked plate fixation with thin soft tissue simulation) and IC-3 with 32-mm elevation (externalized locked plate fixation with thick soft tissue simulation). Axial loads of 25 kg (partial weightbearing) and 80 kg (full weightbearing) were applied to the proximal tibia end and distributed at a ratio of 80%/20% on the medial/lateral condyles. A hinge joint was simulated at the distal end of the tibia. Parameters of interest were construct stiffness, as well as interfragmentary motion and longitudinal strain at the most lateral aspect of the fracture. Construct stiffness was 655 N/mm (IC-1), 197 N/mm (IC-2) and 128 N/mm (IC-3). Interfragmentary motions under partial weightbearing were 0.31 mm (IC-1), 1.09 mm (IC-2) and 1.74 mm (IC-3), whereas under full weightbearing they were 0.97 mm (IC-1), 3.50 mm (IC-2) and 5.56 mm (IC-3). The corresponding longitudinal strains at the fracture site under partial weightbearing were 1.55% (IC-1), 5.45% (IC-2) and 8.70% (IC-3). From virtual biomechanics point of view, externalized locked plating of unstable proximal tibia fractures with simulated thin and thick soft tissue environment seems to ensure favorable conditions for callus formation with longitudinal strains at the fracture site not exceeding 10%, thus providing appropriate relative stability for secondary bone healing under partial weightbearing during the early postoperative phase