Is load control necessary to produce physiological AP displacement and axial rotation in wear testing of TAR?

The International Standard Organization, ISO 22622, specifies two options for joint wear simulator evaluation of total ankle replacements (TARs): load-controlled and displacement-controlled. In the present study, the load-controlled testing parameters were applied to cadaveric specimens to quantify and compare the observed sagittal translations and axial rotations to those specified under the displacement-controlled option. Twelve cadaveric specimens were stripped of extraneous tissues, keeping surrounding ankle ligaments. A halo was used to produce plantarflexion and dorsiflexion of the talus through two screws, while a baseplate resisted axial loads. The axial force and torque were applied to the tibia and fibula under force and torque feedback control. An anterior-posterior force was applied to the tibia. Plantarflexion-dorsiflexion were applied using rotation control. To protect the cadaveric specimens, loads were applied at 50% of the specified load profile while plantarflexion-dorsiflexion rotation was applied as specified. There was variation among specimens in magnitudes of anterior-posterior displacement with peaks ranging from 3.3 mm posteriorly to 3.0 mm anteriorly. Likewise, there was variation among specimens in magnitude of axial rotation, with peaks ranging from 11° external rotation to 4.5° internal rotation. However, the mean magnitudes of AP displacement and axial rotation did not exceed those specified by ISO 22622.