Abstract
Introduction and Aims
Sensor technology is seeing increased utility in joint arthroplasty, guiding surgeons in assessing the soft tissue envelope intra-operatively (OrthoSensor, FL, USA). Meanwhile, surgical navigation systems are also transforming, with the recent introduction of inertial measurement unit (IMU) based systems no longer requiring optical trackers and infrared camera systems in the operating room (i.e. OrthAlign, CA, USA). Both approaches have now been combined by embedding an IMU into an intercompartmental load sensor. As a result, the alignment of the tibial varus/valgus cut is now measured concurrently with the mediolateral tibiofemoral contact load magnitudes and locations. The wireless sensor is geometrically identical to the tibial insert trial and is placed on the tibial cutting plane after completing the proximal tibial cut. Subsequently, the knee is moved through a simple calibration maneuver, rotating the tibia around the heel. As a result, the sensor provides a direct assessment of the obtained tibial varus/valgus alignment. This study presents the validation of this measurement.
Method
In an in-vitro setting, sensor-based alignment measurements were repeated for several simulated conditions. First, the tibia was cut in near-neutral alignment as guided by a traditional, marker-based surgical navigation system (Stryker, MI, USA). Subsequently, the sensor was inserted and a minimum of five repeated sensor measurements were performed.
Following these measurements, a 3D printed shim was inserted between the sensor and the tibial cutting plane, introducing an additional 2 or 4 degrees of varus or valgus, with the measurements then being repeated. Again, for each condition, a minimum of five sensor measurements were performed. Following completion of the tests, a computed tomography (CT) scan of the tibia was obtained and reconstructed using open source software (3DSlicer).
Results
By identifying anatomic landmarks on the 3D reconstructed tibia and fibula, the actual tibial coronal alignment of 0.43° valgus was obtained (Figure 1a), in close agreement with the one degree valgus alignment reported by the optical navigation system. Both reference values match well with the 1.16° valgus (SD: 0.91°) calculated by the IMU- based sensor system. When introducing the shims, the sensor consistently predicts the relative angular changes, with a maximum relative difference between the expected and measured condition of 1.29°. For each condition, the standard deviation remained small, with values ranging from 0.27° to 0.60° based on at least five repeated measures (Figure 1b).
Conclusion
In conclusion, this paper demonstrates that sensor technology can be used to evaluate tibial coronal alignment, with an accuracy in line with available 3D measurement systems. The authors recognize however the need for further validation, currently being undertaken.
