Abstract
Obtaining accurate bone cuts based on mechanical axes and ligament balancing, are necessary for a successful total knee procedure. The Orthosensor Tibial Trial displays on a GUI the magnitude and location of the lateral and medial contact forces at surgery. The goal of this study was to develop the algorithms to inform the surgeon which bone cuts or soft tissue releases were necessary to achieve balancing, from an initial unbalanced state.
A rig was designed for lower body specimens mounted on a standard operating table. Surgical Tests were then defined: Sag Test, leg supported at the foot; Dynamic Heel Push test, flexing to 120 degrees with the foot sliding along a rail; Varus-Valgus test; AP Drawer test; Internal-External Rotation test. The bone cuts were made using a Navigation system, to match the Triathlon PCL retaining knee. To determine the initial thickness of the tibial trial, the Sag Test was performed to reach 0 deg flexion. The Heel Push Test was then performed to check the AP position of the lateral and medial contacts, from which the rotational position of the tibial tray was determined. Pins were used to reproduce this position during the experiments.
Surgical Variables were then defined, which would influence the balancing: LCL Stiffness, MCL Stiffness, Distal Femoral Cut Level, Tibial Sagittal Slope, Tibial Varus or Valgus, and AP Femoral Component Length. Balancing was defined as equal lateral and medial forces due to soft tissue tensions throughout the flexion range, equal varus and valgus stiffnesses, and no contacts closer than 10mm to component edges. All of the above tests were then performed sequentially, and the changes in the contact force readings were considered as a signature of that Surgical Variable.
In an actual surgical case, having obtained readings from the Surgical Tests, the data will be compared with the signatures of the Surgical Variables. This will then identify the Variable which needed correction. The Surgical Tests will be repeated and the readings should be closer to balanced. Further correction of another Variable is carried out if necessary. In early clinical cases, it was found that this method allowed for identification of how to reach a balanced state, and achieved soft tissue balancing in a quantitative way.
