Ex-vivo and in vitro validation of an innovative mandibular condyle implant concept

Purpose: The purpose of this study is to pre-validate an inovative implant concept, and to compare the behavior of the mandibular condyle against a commercial Biomet implant in an ex vivo model and present results of the first cadaveric studies. Materials and methods: Three experimental cadaveric condyles were tested under three conditions: one intact, another with the Biomet model, and one with the innovative concept. The condyle was tested with a reaction of 300 N in all situations and the principal strains were measured. Before the geometry of the cadaveric condyle was reconstructed from a microCT scan, and a finite element model was created. Finally, a procedure was carried out with the new implant by two expert surgeons on a two cadaveric head model. Results: In vitro the mandible condyle presents a linear behavior until maximum load. The strain measured with Biomet implant indicates a strain shielding effect in the proximal region, inducing bone loss in the long term. The lingual side of the Biomet implanted condyle presents an increase of +44% in strain. Conclusion: The new concept was evaluated and showed a similar behavior to the intact model, and better behavior than the Biomet. The innovative concept proves that it is possible to avoid screws for a TMJ fixation and improve the TMJ alloplastic behavior. (C) 2018 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.