Biomechanical Variability and Usability of a Novel Customizable Fracture Fixation Technique

Thomas Colding-Rasmussen*, Peter Schwarzenberg, Peter Frederik Horstmann, Casper Bent Smedegaard Ottesen, Jorge San Jacinto Garcia, Daniel John Hutchinson, Michael Malkoch, Michael Mørk Petersen, Peter Varga, Christian Nai En Tierp-Wong

*Corresponding author af dette arbejde
1 Citationer (Scopus)

Abstract

A novel in situ customizable osteosynthesis technique, Bonevolent™ AdhFix, demonstrates promising biomechanical properties under the expertise of a single trained operator. This study assesses inter- and intra-surgeon biomechanical variability and usability of the AdhFix osteosynthesis platform. Six surgeons conducted ten osteosyntheses on a synthetic bone fracture model after reviewing an instruction manual and completing one supervised osteosynthesis. Samples underwent 4-point bending tests at a quasi-static loading rate, and the maximum bending moment (BM), bending stiffness (BS), and AdhFix cross-sectional area (CSA: mm²) were evaluated. All constructs exhibited a consistent appearance and were suitable for biomechanical testing. The mean BM was 2.64 ± 0.57 Nm, and the mean BS was 4.35 ± 0.44 Nm/mm. Statistically significant differences were observed among the six surgeons in BM (p < 0.001) and BS (p = 0.004). Throughout ten trials, only one surgeon demonstrated a significant improvement in BM (p < 0.025), and another showed a significant improvement in BS (p < 0.01). A larger CSA corresponded to a statistically significantly higher value for BM (p < 0.001) but not for BS (p = 0.594). In conclusion, this study found consistent biomechanical stability both across and within the surgeons included, suggesting that the AdhFix osteosynthesis platform can be learned and applied with minimal training and, therefore, might be a clinically viable fracture fixation technique. The variability in BM and BS observed is not expected to have a clinical impact, but future clinical studies are warranted.

OriginalsprogEngelsk
Artikelnummer1146
TidsskriftBioengineering (Basel, Switzerland)
Vol/bind10
Udgave nummer10
ISSN2306-5354
DOI
StatusUdgivet - 29 sep. 2023

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