Effects of hip implant modular neck material and assembly method on fatigue life and distraction force.

Hip implant neck fractures and adverse tissue reactions associated with fretting-corrosion damage at modular interfaces are a major source of concern. Therefore, there is an urgent clinical need to develop accurate in vitro test procedures to better understand, predict and prevent in vivo implant failures. This study aimed to simulate in vivo fatigue fracture and distraction of modular necks in an in vitro setting, and to assess the effects of neck material (Ti6Al4V vs. CoCrMo) and assembly method (hand vs. impact) on the fatigue life and distraction of the necks. Fatigue tests were performed on the cementless PROFEMUR® Total Hip Modular Neck System under two different loads and number of cycles: 2.3 kN for 5 million cycles, and 7.0 kN for 1.3 million cycles. The developed in vitro simulation setup successfully reproduced in vivo modular neck fracture mode and location. Neck failure occurred at the neck-stem taper and the fracture ran from the distal lateral neck surface to the proximal medial entry point of the neck into the stem. None of the necks failed under the 2.3 kN load. However, all hand-assembled Ti6Al4V necks failed under the 7.0 kN load. In contrast, none of the hand-assembled CoCrMo necks and impact-assembled necks (Ti6Al4V or CoCrMo) failed under this higher load. In conclusion, Ti6Al4V necks were more susceptible to fatigue failure than CoCrMo necks. In addition, impact assembly substantially improved the fatigue life of Ti6Al4V necks and also led to overall higher distraction forces for both neck materials. Overall, this study shows that the material and assembly method can affect the fatigue strength of modular necks. Finally, improper implant assembly during surgery may result in diminished modular neck survivability and increased failure rates.