Distraction osteogenesis device to estimate the axial stiffness of the callus in Vivo

• A new device to monitor stiffness of the callus in vivo during distraction osteogenesis was proposed.
• An in vitro calibration of the new device was carried out.
• Relative errors in calibration tests were 7.8% and 9.5% for distraction and consolidation phases respectively.
• The device was used successfully in vivo in a preliminary experiment.

Knowing the evolution of callus stiffness is very important in distraction osteogenesis and bone healing. It allows the characterization of the bone maturation process and the assessment of the moment to retire the fixator. A new distractor device that monitors the callus axial stiffness is presented in this study. It quantifies the callus stiffness during the bone transport process with some advantages over previous methods to assess stiffness during simple distraction and bone healing. This device avoids a misalignment between bone segments, uses real load conditions, monitors forces continuously, does not involve radiation for patients, and allows the study of the complete distraction process, i.e., the distraction and consolidation phases. The device was calibrated in vitro simulating different real bone load conditions depending on the stage of the process. The stiffness of the callus could be estimated for values between 4.2 N/mm and 9066.8 N/mm. The average relative error in measurements carried out in in vitro calibration tests was 7.8% during the distraction phase and 9.5% during the consolidation phase. These results improve the accuracy and increase the callus stiffness range of estimation with respect to other devices in the literature. In addition, the device was used successfully in vivo in a preliminary experiment.