Page 245 - Demo

Development of a patient-specific TMJ prosthesis2439Fig 1: Renders of a TMJ Parametro with pterygoid muscle reattachment. (a) Lateral view of a TMJ Parametro total joint. (b) Frontal view of a bilateral TMJ Parametro total joint. (c) Frontal view of the Ti6Al4V mandibular component with the HadSat® coating. (d) The fossa component consisting of highly cross-linked polyethylene and a grade 23 Ti6Al4V extra-low interstitial. (e) The boneimplant interface, which shows the 3D-printed lattice structure used to induce osseointegration as a secondary fixation method. (f) Lateral pterygoid muscle reattachment using bone chips and the corresponding enthesis.Table 1: Overview of Biocompatibility Tests Performed on the HadSat Coating by the North American Science Associates.Test ResultCytotoxicity – ISO Elution Nontoxic (Cytotoxicity grade was 0)ISO Maximization Sensitization No evidence of delayed dermal contact sensitizationIntracutaneous Reactivity Study No evidence of significant irritationAcute Systemic Toxicity No mortality or evidence of significant systemic toxicity Rabbit Pyrogen Test NonpyrogenicIn Vitro Hemolysis Nonhemolytic (Mean hemolytic index was 0%)Bacterial Reverse Mutation Study NonmutagenicMuscle Implantation Study (1 week) NonirritatingPolymeric component. The articulating part of the fossa component, which is in contact with the condyle, is made of γ-irradiated tocopherol-enriched highly cross-linked UHMWPE (HXLPE) (Fig. 1d). This HXLPE component is hot pressed onto the scaffold of a Ti6Al4V component, which in turn is fitted onto the glenoid fossa. Processing parameters as temperature, time, and pressure settings are confidential.Nikolas de Meurechy NW.indd 243 05-06-2024 10:14