Introduction: In this paper, the different steps of development and experimental validation of a new type of three-dimensional (3-D) trapezoidal osteosynthesis plate (Modus TCP 2.0, Medartis, Basel, Switzerland) is described. These plates have been designed to stabilize sub-condylar and condylar neck fractures of the mandible.
Material and methods: In order to apply the principles of functionally stable osteosynthesis to the mandibular condyle, i.e. to put the plate as close as possible to the tensile strain lines occurring during function, two new 4- and 9-hole 3-D trapezoidal plates were designed. Tests were conducted on fresh human mandibles before and after osteosynthesis of a standardised unilateral sub-condylar 'fracture', and a static biting exercise between the ipsilateral first molars was reproduced on a test bench. The resulting condylar fragment displacement in the sagittal plane was measured and the alterations of the condylar tensile strain lines induced by the osteosynthesis were investigated by using photoelastic strain tests.
Results: None of the plates broke. No macroscopic condylar displacement was noted when assessing the quality of the primary stabilization. Strain analysis showed the ability of these 3-D plates to transmit physiological strains across the fracture line and the absence of potentially damaging strains around the plate.
Discussion: These results were accredited to the 3-D and trapezoidal features of the plates.
Conclusion: The Modus TCP plates experimentally fulfil the principles of functionally stable osteosynthesis in the condylar region and are able to resist physiological strains.